Ligasure Hemorrhoidectomy Versus Open Hemorrhoidectomy. A Randomized Clinical Trial on the Long-term Effect on Hemorrhoidal Symptoms
Phase: NA
Conditions: Hemorrhoids
Sponsor: Holbaek Sygehus

 
 
Protocol 
 
 
LigaSureTM Hemorrhoidectomy (LH) versus Open Hemorrhoidectomy (OH) 
 
- A Randomized Clinical Trial on the long-term effects on hemorrhoidal 
symptoms.  
 
 
Version 4, September 1, 2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
André Heiner Campos, Medical afdelingslæge (Medical assistent) 
Per Olov Gunnar Olaison, dr. med, overlæge (Consultant) 
 
 
 
 
 
 
 

 
2 
TABLE OF CONTENTS 
 
 
 
PROTOCOL SUMMARY ................................................................................................................ 4 
INTRODUCTION .............................................................................................................................. 6 
Background ................................................................................................................................................... 6 
Rationale ........................................................................................................................................................ 8 
Postoperative complications and adverse effects ........................................................................... 8 
Search Methods ............................................................................................................................................ 8 
OBJECTIVES ..................................................................................................................................... 9 
Aim.................................................................................................................................................................... 9 
Main outcome variable .............................................................................................................................. 9 
Secondary outcome variable ................................................................................................................... 9 
SUBJECT CRITERIA ...................................................................................................................... 9 
Subject Inclusion Criteria ......................................................................................................................... 9 
Subject Exclusion Criteria ........................................................................................................................ 9 
DESIGN AND METHOD .............................................................................................................. 10 
Trial Design ................................................................................................................................................ 10 
Qualification of the surgeons ............................................................................................................... 10 
Operation date and type of anesthesia ............................................................................................. 10 
Patient Material and Recruitment ..................................................................................................... 10 
Inclusion procedure ................................................................................................................................ 10 
Randomization .......................................................................................................................................... 10 
Anesthesia and thromboembolic prophylaxis .............................................................................. 11 
STUDY INTERVENTION The operation methods ........................................................................... 11 
STUDY INTERVENTION Open Hemorrhoidectomy ....................................................................... 11 
STUDY INTERVENTION LigaSureTM Hemorrhoidectomy ........................................................... 11 
Postoperative Care .................................................................................................................................. 12 
Postoperative pain and return to daily activities ......................................................................... 12 
Immediate postoperative course ....................................................................................................... 12 
Evaluation of symptoms ........................................................................................................................ 12 
Evaluation quality of life ........................................................................................................................ 12 
Evaluation of anal continence.............................................................................................................. 12 
Evaluation of hemorrhoidal anatomy ............................................................................................... 13 
Security control......................................................................................................................................... 13 
STATISTICAL CONSIDERATIONS ........................................................................................ 14 
Study Hypothesis ...................................................................................................................................... 14 
Sample Size Considerations .................................................................................................................. 14 
ETHICS ............................................................................................................................................. 14 
DATA.................................................................................................................................................. 15 
Data handling and confidentiality ...................................................................................................... 15 
Data owners’ rights.................................................................................................................................. 15 
PUBLICATION ............................................................................................................................... 15 
FUNDING OF THIS STUDY ....................................................................................................... 15 
REFERENCES ................................................................................................................................. 16 
 
 

 
3 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
LIST OF ABBREVIATIONS 
ASA 
 
American Society of Anesthesiologists (ASA) score 
Consort 
Consolidated Standards of Reporting Trials 
EHR 
 
Electronic Health Record 
EQ-5D-5L 
Euro Quality of Life – 5 Dimensions – 5 Levels 
HAL 
 
Hemorrhoidal Artery Ligation 
HDSS  
Hemorrhoidal Disease Symptom Score 
LH 
 
LigaSureTM Hemorrhoidectomy 
N 
 
Number (typically refers to subjects) 
OH 
 
Open Hemorrhoidectomy 
p.n. 
 
pro necessitate 
QoL 
 
Quality of Life 
RFIS  
Revised Fecal Incontinence Scale  
SD 
 
Standard Deviation 
SH 
 
Stapled Hemorrhoidopexy 
SHS 
 
Short Health Scale 
THD  
Trans anal Hemorrhoidal Dearterialization 
WHO  
World Health Organization 
 

 
4 
PROTOCOL SUMMARY 
 
Title: 
LigaSureTM Hemorrhoidectomy versus Open 
Hemorrhoidectomy - A Randomized Clinical Trial on the 
long-term effect on hemorrhoidal symptoms 
 
Précis: 
A randomized clinical trial that will compare two operations 
used for grade II - IV hemorrhoids. Patients referred to the 
department of surgery in Holbæk Hospital for hemorrhoids 
and eligible for operation will be included consecutively. 
Evaluation will be done by assessing symptoms, quality of 
life, anal continence and hemorrhoidal anatomy pre- and 
postoperatively.  
Objectives: 
 
Primary:   
Symptoms related to hemorrhoids one year postoperatively, 
according to a hemorrhoidal disease symptom score (HDSS) 
 
 
 
Secondary:   
1) Patient satisfaction with the operation. 
2) Health related Quality of Life 
3) Anal continence as evaluated by two scores for symptoms 
of incontinence. 
All one year postoperatively  
 
 
Population: 
Male or female, ASA I-II, aged 18 to 85 at the time of 
randomization, referred to surgical assessment and 
presenting with grade II hemorrhoids refractory to banding or 
sclerosing and grade III og IV hemorrhoids at the surgical 
department, Holbæk Hospital.  
 
Site: 
Single center study. Holbæk Hospital, Surgical Department   
Description of 
Intervention: 
Hemorrhoidectomy with either Open Hemorrhoidectomy or 
LigaSureTM Hemorrhoidectomy 
Study Duration: 
48 months (from when the study opens to enrollment until 
completion of follow up.) 
Subject 
Participation 
Duration: 
One year 
Estimated Time to 
Complete 
Enrollment: 
36 months 
 

 
5 
Schematic of Study Design: 
 
 
Prior to  
Enrollment 
 
 
Visit 1 
Proctologic 
Outpatient Clinic  
 
 
 
 
 
 
 
 
 
Visit 2 
Month 1-2 
 
 
 
 
 
 
 
 
 
Visit 3 
Month 4-5  
 
 
 
 
Visit 4 
Month 13-14 
 
 
 
 
Randomize 
Patients referred to the surgical department, Holbæk Hospital for hemorrhoidal disease 
receives “Protokol for symptomer” and “Protokol for livskvalitet”  (to be completed by the 
patient) and time for assessment in the proctologic outpatient clinic 
Total 50: Screen potential subjects by inclusion and exclusion criteria; obtain history. 
“Protokol for anatomi”, “Protokol for anamnese”  and “Protokol for inklusion” (completed 
by surgeon). Informed consent by “Deltagerinformation og samtykkeerklæring” is 
obtained (signed by patient and surgeon) 
Endoscopic examination (if not done within 3 months before inclusion) and assessment 
by anesthesiologist 
Arm 1: 35 subjects 
Operation LH 
“Protokol for operation” 
(completed by surgeon)  
Arm 2:  35 subjects 
Operation OH 
“Protokol for operation” 
(completed by surgeon) 
“Sygehusprotokol” (completed by nurse on department 09.5). Patient is given 
“Patientdagbog” and a self-addressed envelope when discharged. 
Follow-up assessment in proctologic outpatient clinic of outcome measures and safety  
3 months postoperatively 
 “Protokol for symptomer” and “Protokol for livskvalitet” (to be completed by the patient) 
“Protokol for anatomi” (completed by surgeon) 
Follow-up assessment in proctologic outpatient clinic of outcome measures and safety  
12 months postoperatively 
“Protokol for symptomer” and “Protokol for livskvalitet”  (to be completed by the patient) 
“Protokol for anatomi” (completed by surgeon) 
Final Assessments 
List analyses 

 
6 
INTRODUCTION 
 
Background  
Hemorrhoids is one of the oldest known medical conditions. Description of hemorrhoids 
is found as early as 2250BC in the code of king Hammurabi in Babylon. Even though first 
recorded treatment is thought to be found in the “Edwin Smith Papyrus” from 1700BC 1 
as of today the treatment of this benign state is still debated.  A wide range of prevalence 
rates of hemorrhoids have been stated in part because of the varying definition ,but the 
general consensus is that hemorrhoidal disease is a common anorectal disease affecting 
the quality of life of millions of people worldwide2 3.  Operation for hemorrhoid is one of 
the most common operations for benign disease in Denmark. 
 
Hemorrhoids arise from the normal vascular structures in the anal canal also referred to 
as anal cushions or sinusoids as they do not contain muscular cells like arteries or veins. 
These cushions are typically arranged in three main columns or piles in the anal canal 
forming an important part of the intricate mechanism of the anal canal preventing 
incontinence4.  
 
Hemorrhoids is a pathologic term describing the symptomatic abnormal downward 
displacement and enlargement of the anal cushions5. The term hemorrhoidal disease is 
used when the hemorrhoids cause symptoms.  
 
Treatment of hemorrhoidal disease consists of conservative management with lifestyle 
and diet changes or local treatment, minor surgery and surgical treatment depending on 
the severity of disease and symptoms. The staging of internal hemorrhoids in four 
categories by the Goligher classification6 is the classification that generally forms the 
basis of the treatment in Denmark.  
 
Local treatment consists of corticosteroids and anesthetic ointments. Minor surgery 
includes rubber band ligation and sclerotherapy. Operation is reserved for subjects with 
prolapse7, Goligher grade II and IV. Grade II hemorrhoids may be treated by operation if 
still symptomatic after banding or sclerosing.   
 
The gold standard in the operative treatment of hemorrhoidal is the Milligan-Morgan 
Hemorrhoidectomy8 also referred to as hemorrhoidal excision or Open 
Hemorrhoidectomy (OH). The operation can also be performed as a Closed 
Hemorrhoidectomy when the wound is closed with sutures (Ferguson’s 
Hemorrhoidectomy). 
 
The conventional excisional operation has been associated with postprocedural pain 
and delayed healing of wounds.  In recent years there have been suggestions for and a 
development toward a less traumatic Open Hemorrhoidectomy.  Injuries to the internal 
anal sphincter during dissection is thought to be one cause for pain. The less traumatic 
operations include dissection of the hemorrhoid preserving the fascia over the internal 
anal sphincter and also smaller excision of skin and mucosa9 - the technique used in this 
study is described in more detail under Methods. 
 
Several new procedures have been proposed in the last decades. Common for all is the 
implementation of a new technical device, meaning increased operative costs. 

 
7 
 
Stapled Hemorrhoidopexy (SH) was first described by Longo in 1993 and uses a circular 
stapler to resect part of the rectal mucosa a couple of centimeters from the dentate line, 
thus reducing the prolapsed hemorrhoids into the anal canal10. The reasoning behind 
this procedure is that the prolapse of hemorrhoids is the main pathologic factor causing 
symptoms, and by reducing the prolapse the patient’s symptoms may be treated without 
leaving wounds in the anal canal. In this operation a circular stapler is used to resect the 
rectal mucosa a few centimeters above the dentate line, thereby lifting the prolapsed 
hemorrhoids into the anal canal. SH has showed to cause less postoperative pain and 
faster recovery, but has a higher recurrence rate compared to traditional 
hemorrhoidectomy11-12-13. 
 
Hemorrhoidal Artery Ligation (HAL) and Trans anal Hemorrhoidal Dearterialization 
(THD) were introduced in 1995 and 2001 respectively. These methods are aimed at 
reducing the arterial blood supply to the anal venous plexus. The arteria supplying the 
anal venous plexus are located with a ultrasound doppler flowmeter and ligated14 15.  
During the procedure the anal prolapse is also reduced into the anal canal by a 
mucopexy, suturing of the mucosa. A few studies could demonstrate promising results 
for these operations. One non-randomized study found less postoperative pain at 1-6 
months, but similar results at 1 year as regards hemorrhoidal symptoms and quality of 
life when compared to LigaSureTM hemorrhoidectomy16. A small randomized study, 
comparing THD to open hemorrhoidectomy, found less pain the first five days. 
Hemorrhoidal symptoms as pain, bleeding and the need for manual reduction of 
hemorrhoids were reduced one year after operation in both groups, whereas reduction 
of soiling was seen only in the open hemorrhoidectomy group. 
 
LigaSureTM hemorrhoidectomy (LH) is a closed hemorrhoidectomy performed with the 
use of the LigaSureTM instrument instead of the traditional diathermy. The LigaSureTM 
technology patentented in 1998 as “Energy Delivery System for Vessel Sealing” creates 
vessel fusion by a combination of pressure and energy17. The LigaSureTM device excises 
the hemorrhoids and seals the wound in the same procedure delivering the energy in a 
controlled way between the diathermy forceps theoretically limiting thermal spray and 
tissue charring.  
 
Anal continence. OH and LH are both excisional operations. Anal continence has been a 
concern after these operations. Anal incontinence is defined as involuntary loss of air, 
liquid or solid stool that is a social or hygienic problem18. The anal cushions contribute 
to the closure of the anal canal and provide 15- 20% of maximal resting pressure of the 
anal canal19. A Cochrane review found that anal incontinence was reported in 1.6% of 
the patients after conventional hemorrhoidectomy20. Another Cochrane review reported 
3,6 % anal continence or hygiene problems at 1-2 years follow-up after conventional 
hemorrhoidectomy12. When patients are actually asked for symptoms of incontinence a 
retrospective multicenter study found that 33% of the patients reported anal 
incontinence after hemorrhoidectomy and 10% meant this was caused by the 
operation21. Another study found some deterioration of anal incontinence after 
hemorrhoidectomy in patients with preoperative impaired continence22.  Anal 
continence after LigaSureTM hemorrhoidectomy is scarcely investigated.  
 
 

 
8 
Previous studies comparing Open Hemorrhoidectomy and LigaSureTM 
Hemorrhoidectomy 
 
Open Hemorrhoidectomy and LigaSureTM are both techniques where the hemorrhoids 
are excised, (ablative techniques).  A few studies indicates that ablative techniques have 
better long term results in terms of reduction of symptoms11,23.  
 
There are so far 18 controlled studies comparing OH to LH24–41, all designed for and 
using postoperative pain as major outcome variable.  There are three metanalysis the 
largest including 11 studies42,43,44. In conclusion there seems to be less post procedural 
pain, somewhat faster recovery, slightly less bleeding and shorter operating time after 
LH. 
 
Patient’ satisfaction was evaluated in  a few studies with no difference between the two 
operations29,40,41. One small study on 30 patients investigated anal continence with no 
difference between the two operations30.  
 
No study has investigated hemorrhoidal symptoms with a validated instrument one year 
or more after the operation  
 
Rationale 
 
Hemorrhoidal Disease is a benign disease and should be evaluated by its effect on 
hemorrhoidal symptoms together with its effect on quality of life.  
Hemorrhoidal symptoms should be the main outcome variable when evaluating surgery 
for hemorrhoidal disease. This information is largely lacking. 
The use of a validated symptom score with long term follow-up could yield important 
information for the choice of treatment of hemorrhoidal disease. 
 
Postoperative complications and adverse effects 
Serious complications to hemorrhoidal operations occur rarely.  The most commonly 
early complications are urinary retention, bleeding or fever/infection. Late 
complications are anal fissure, anal stenosis and anal incontinence. A Cochrane review 
reported after open hemorrhoidectomy; postoperative bleeding 2.9%, urinary retention 
5.1%, anal fissure 3.1%, anal stenosis 0,9% and anal incontinence 1.6% 20.  
Search Methods 
A PubMed database search was conducted with following PICO query:  
((("haemorrhoids"[All Fields] OR "hemorrhoids"[MeSH Terms] OR "hemorrhoids"[All 
Fields]) AND (((Open[All Fields] AND ("hemorrhoidectomy"[MeSH Terms] OR 
"hemorrhoidectomy"[All Fields] OR "haemorrhoidectomy"[All Fields])) OR Milligan-
Morgan[All Fields]) OR ("diathermy"[MeSH Terms] OR "diathermy"[All Fields]))) AND 
(Ligasure[All Fields] OR (Ligasure[All Fields] AND ("hemorrhoidectomy"[MeSH Terms] 
OR "hemorrhoidectomy"[All Fields] OR "haemorrhoidectomy"[All Fields])))) AND 
("complications"[Subheading] OR "complications"[All Fields]) 
 
A Cochrane was done searching for h(a)emorroidectomy and h(a)emorrhoid. 
 

 
9 
Relevant articles were chosen and by title and abstract and by reading the reference lists 
further texts were identified. In addition Danish and Swedish guidelines from national 
medical journals were included. 
OBJECTIVES 
Aim 
To analyze and compare the long-term effects of LigaSureTM hemorrhoidectomy (LH) 
and Open Hemorrhoidectomy (OH) on hemorrhoidal symptoms. 
Main outcome variable 
Symptoms related to hemorrhoids one year postoperatively, according to a validated 
hemorrhoidal symptom score (HDSS)(appendix 3).  
Secondary outcome variable 
1) Patient satisfaction with the operation one year postoperatively, evaluated on a seven 
grade Lichert scale. 
2 ) Quality of Life as evaluated by Short health Scale (SHS), Short Form 36 (SF36) and 
EuroQualityofLife -5 Dimensions (EQ-5D-5L) (appendix 6).  
3) Anal continence as evaluated by the Wexner score45, the Revised Fecal Incontinence 
Scale (RFIS) 46.  
 
We will also analyze: anal function with anal manometry, anatomical result as evaluated 
by the surgeon, operation time, theatre time (time consumed in the operating room), 
postoperative complications, postoperative pain and need of analgesics, length of 
postoperative hospital stay and days before return to work or possibility of return to 
work. 
SUBJECT CRITERIA 
Subject Inclusion Criteria 
In order to be eligible to participate in this study, an individual must meet all of the 
following criteria: 
- 
Male or female aged 18 to 85 at the time of randomization 
- 
Grade III-IV hemorrhoids and grade II hemorrhoids refractory to previous 
treatment with rubber band ligation or sclerotherapy. 
- 
Hemorrhoidal symptom score of four or more 
- 
Colonoscopy, sigmoidoscopy or rigid rectoscopy within 3 months before 
inclusion. 
- 
American Society of Anesthesiologists (ASA) score of I or II. (day-care surgery) 
- 
Provide signed and informed consent form 
Subject Exclusion Criteria 
An individual who meets any of the following criteria will be excluded from 
participation in this study: 
- 
Previous operation of grade III and IV hemorrhoids within the last 2 years. 
- 
Previous operation for anal incontinence. 
- 
Active anal fistula or anal fissure 
- 
Incontinence for solid stool 

 
10 
- 
Active immunosuppressive therapy (increased risk of anorectal sepsis) 
- 
Cirrhosis / portal hypertension 
- 
Mb Crohn47 
DESIGN AND METHOD 
Trial Design 
This is a single center randomized clinical trial comparing two operative techniques in 
the treatment of hemorrhoids. 
Qualification of the surgeons 
The surgeon should have experience from at least ten open hemorrhoidectomies and ten 
LigaSureTM hemorrhoidectomies before operating independently 
Operation date and type of anesthesia 
Operation time, theater time, operative bleeding, grading of complexity of the operation 
and type of anesthesia is recorded by the surgeon after the operation in “Protokol for 
operation” (appendix 8) 
Study Interventions – Open Hemorrhoidectomy (OH) 
Patient Material and Recruitment 
According to the power calculation at least 62 subjects are needed for the analysis. 
Compensating for an estimated loss to follow-up of approximately 10%, 70 subjects will 
be included in the study. See statistical considerations in a later chapter. 
Subjects for this study will be recruited consecutively from patients attending the 
proctologic outpatient clinic at the department of surgery at Holbæk Hospital eligible for 
operation. 
Inclusion procedure 
Subjects recruited will receive written information about the study (appendix 1). 
Subjects will be offered a new appointment with one of the surgeons participating in the 
study offering further information if needed. It will be possible to bring an assessor. 
Subjects will be offered 14 days to consider their participation. Before inclusion in the 
study a declaration of acceptance will be signed by the subject (Appendix 2). A checklist, 
“Protokol for inklusion” (appendix 5), will be used at the first visit in the surgical 
outpatient clinic to ensure correct inclusion and patient history will be obtained in 
“Protokol for anamnese” (appendix 4). 
Randomization 
Subjects fulfilling the inclusion criteria and accepting to participate in this study will be 
randomized to LH or OH. Randomization is stratified by gender. List for randomization 
will be obtained from www.random.org. Notes assigning the subject to either operation 
according to the randomization lists will be placed in sealed envelopes. Each envelope is 
assigned gender and number in the study (Male 1,2,3.. or Female 1,2,3..). 
The envelope will be opened in the operating theatre after the patient has been 
anesthetized. Randomization lists and the sealed envelopes will be stored in a locked 
safe. 

 
11 
Anesthesia and thromboembolic prophylaxis 
After consulting with surgeon and patient the anesthesiologist will decide type of 
anesthesia to use (general, spinal or epidural). Respecting any contraindications, 
patients will receive a preoperative perianal block with a total of 40ml of Ropivacaine 
4,75mg/ml according to the technique described by Nyström et al48. 
All patients will receive thromboembolic prophylaxis with low molecular heparin unless 
contraindicated. 
STUDY INTERVENTION The operation methods 
Operations will be done in the outpatient day surgery setting in the surgical department 
of Holbæk Hospital. Irrational details will be recorded in “Protocol for operation” 
(Appendix 8). In the following description of the two operative techniques differences in 
operation is marked in italics. 
STUDY INTERVENTION Open Hemorrhoidectomy  
The procedure is according to the principles of Minimal open hemorrhoidectomy 
performed with the patient in lithotomy position. Initial overview is obtained using an 
anal speculum. The excision is done without speculum in the anus. “The external 
components are grasped by clamps using gentle traction. Diathermy is used for dissection 
and hemostasis. The skin is incised midway to one-third of the distance from the top of the 
pedicle, thus, minimizing the skin excision. The subdermal fascia continuing into a 
submucosal fascia covering the internal anal sphincter is identified as are fibers passing 
between the hemorrhoid and this fascia. The hemorrhoid is dissected free from the 
underlying internal sphincter in this plane, leaving the sphincter unharmed. The anal 
mucosa is incised at the transition from anal mucosa to hemorrhoidal mucosa and only 
anal mucosa overlying the hemorrhoid is excised. Only the caudal part of the hemorrhoid is 
excised. With the hemorrhoid held with gentle traction it is divided at the anal orifice. 
There will thus be a residual part of the hemorrhoid intra-anally with its caudal end 1–2 
cm proximal to the anal orifice. The number of excisions is individualized. The procedure is 
repeated for each hemorrhoid leaving adequate skin and mucosal bridges”49. 
STUDY INTERVENTION LigaSureTM Hemorrhoidectomy 
The procedure is performed with the patient in lithotomy position. Initial overview is 
obtained using an anal speculum, but the excision is done without speculum in the anus. 
“The main hemorrhoidal masses are identified and delineated, usually in the ‘classical’ 
location corresponding to the sites of inferior hemorrhoidal vessels - left and right -
posterolateral and right anterior quadrants. The hemorrhoids are prolapsed out from the 
anal canal with Allis clamps or similar pick up forceps. Tension should be applied to 
visualize the junction between the nodule and the mucosal wall (internal) or the perianal 
tissue (external). A small V-shaped anodermal seal is performed by applying the 
LigaSureTM forceps close to the edge of each pile. The seal is then transacted with scissors 
along the line of coagulum. Care should be taken to limit the amount of tissue removed to 
minimize the stricture risk. Repeated applications of the device are performed, and the 
excision is continued into the anal canal, lifting the pile from the internal anal sphincter to 
the level of the vascular pedicle that is finally sealed by LigaSureTM and divided ”50.  
The procedure is repeated for each hemorrhoid taking care of leaving adequate “skin 
bridges” between each excision.    

 
12 
Postoperative Care 
All patients will be discharged on the day of the operation unless there are any 
immediate postoperative complications or if the patient is living alone without 
attendance at home the first 24 postoperative hours. 
 
Standard postoperative pain treatment is initiated for all patients regardless of 
operation type and consists of: 
Paracetamol tablet 1-gram x4/day for 7 days, hereafter p.n. 
Ibuprofen tablet 400mg x3/day for the first 7 days, hereafter p.n. (patients  65 years 
old will receive supplementary Pantoprazole tablet 40mgx1/day when using ibuprofen) 
Morphine tablet 10mg p.n. Max 6 tablets/day for 3 days 
Magnesia tablet 1gx2/day for 7 days, hereafter p.n. 
Xylocaine gel p.n. 
At discharge from the hospital and in the preoperative material (appendix 1) patients 
are informed that there are no limitations concerning physical activity and they are 
encouraged to return to daily activity as soon they feel fit enough and the postoperative 
pain permits it. Patients are told not to drive, operate heavy machinery or performing 
other potentially dangerous tasks while on morphine.  
Postoperative pain and return to daily activities 
During the first 14 postoperative days the patient will report postoperative pain, use of 
analgesics and return to daily activities or work in “Patientdagbog” (appendix 10). Since 
weekends and holidays can influence when a patient returns to work, patients will 
answer a question when they feel fit enough to return to work. It will also be noted if the 
patient is self-employed. 
Immediate postoperative course 
Immediate postoperative complications, postoperative pain, use of analgesics and length 
of hospital stay will be noted in “Sygehusprotokol” (appendix 9). 
 
Evaluation of symptoms 
The questionnaire “Protokol for symptomer” (appendix 3) is used for evaluating 
hemorrhoidal symptoms recorded by the subject. Five questions on pain, itching, 
bleeding, soiling and prolapse graded from 0-4. Resulting in a score of 0-20. 
The hemorrhoidal symptoms will be evaluated preoperatively at randomization, after 3 
months, one-, three- and five years. 
 
Patient’s satisfaction with the operation will be evaluated on a 7-grade Lichert scale. 
 
Evaluation quality of life 
Quality of life will be evaluated by SHS, SF-36 and EQ-5D-5L, recorded by the patient 
preoperatively at the randomization and one, three and five years postoperatively (appendix 
7). 
Evaluation of anal continence 
Anal continence will be evaluated using both the Wexner score and the RFIS, registered 
by the patient in “protokol for symptomer” (appendix 3). Five questions with a score 
from 0-4 resulting in a total score of 0-20 for both operations. Evaluation will be done 
preoperatively at randomization, after 3 months, one-, three- and five years. 

 
13 
 
Anal function will also be analyzed with anal manometry preoperatively at 
randomization, after 3 months, one-, three- and five years. In addition we will 
investigate the amount of smooth muscle in the resected specimen from the two groups 
indicating the amount of injury to the internal anal sphincter. 
 
Evaluation of hemorrhoidal anatomy 
Hemorrhoidal anatomy is evaluated by the surgeon using “Protokol for 
anatomi”(appendix 7). Late postoperative complications are also reported in “Protokol 
for anatomi” at follow-up. 
 
Hemorrhoids are graded according to the Goligher classification6: 
 
Grade Grade of prolapse 
I 
No prolapse, just prominent blood vessels 
II 
Prolapse upon bearing down or by physical exercise with spontaneous 
reduction  
III 
Prolapse upon bearing down and requires manual reduction 
IV 
Prolapse which cannot be manually reduced 
         Table 1: Goligher’s classification of internal hemorrhoids 
 
The classification of hemorrhoids is based on physical examination by the surgeon and 
patient history. If prolapse is not present at physical examination the patient can be 
classified as having grade II or III based on the patient history. External skin flaps will 
also be recorded in “Protokol for anatomi” (Appendix 7). 
 
Hemorrhoidal anatomy will be evaluated preoperatively at randomization, operatively 
and after 3 months, one-, three- and five years. 
 
Security control 
In order to detect adverse events and non-satisfactory results a security control of the 
study will be performed after operation of 10 patients in each arm. An open control of 
the immediate postoperative course, postoperative complications and postoperative 
hemorrhoidal symptoms three months after the operation will be performed.  
 
 

 
14 
STATISTICAL CONSIDERATIONS 
 
Study Hypothesis  
There is no difference in hemorrhoidal symptoms one year after an operation for 
hemorrhoids performed as LigaSureTM Hemorrhoidectomy or Open Hemorrhoidectomy. 
Sample Size Considerations 
The primary outcome variable is symptom score based on the patient questionnaire. 
The five questions graded from 0 to 4 results in a score from 0 to 20. Preliminary data 
from an ongoing study in our center comparing OH with THD and using the same 
questionnaire shows a symptom score after 3 months of 5 with a standard deviation 
(SD) of 4,2. The power calculator on www.stat.ubc.ca comparing the means for two 
independent samples with a two sided test has been used. We postulate that a difference 
of 3 points in symptom score would be clinically relevant with the standard deviation of 
4,2. To demonstrate a difference in mean score of 3 points with a SD of 3.5 in both 
groups, an alpha error of 5% and a beta error of 20%, 31 patients in each group Is 
needed.  
 
As for the secondary objectives analyzing anal incontinence by the Wexner score and the 
Revised Fecal Incontinence Scale, both consists of five questions graded from 0 to 4 
results in a score from 0 to 20. Preliminary data from the study mentioned above shows 
a mean of 4 and SD of 3,9 for the Wexner score and a mean of 2,3 with an SD of 3,9 for 
the RFIS. To demonstrate a difference in mean score of 3 points with a SD of 3.9 in both 
groups, an alpha error of 5% and a beta error of 20%, 27 patients in each group Is 
needed.   
 
Patient satisfaction is analyzed after year on a scale from 1 to 7. Preliminary data from 
the above-mentioned study shows a mean of 5,8 and a SD of 1,6. Assuming that a 
difference in 1,5 points would be clinically relevant 19 patients are needed in each group 
with an alpha error of 5% and a beta error of 20%. 
 
Thus a sample size of 31 patients in each group should provide sufficient power in 
addressing analysis of primary and secondary endpoints. We estimate that there 
will be a loss of 9 patients for follow up. We will include 70 patients in the study. 
ETHICS 
The investigators will ensure that this study is conducted in full conformity with the 
principles set forth in the Declaration of Helsinki seventh edition51. 
 
The patients included in this study will have hemorrhoidal disease and satisfy the 
indications for surgical treatment in accordance with guidelines for treatment of 
hemorrhoids by The Danish Society of Surgeons. Surgery will only be performed after 
informed consent have been obtained following the routine in our daily clinical practice. 
Both operation methods are recommended in the national guidelines and are regarded 
safe and with low risk of serious complications7. Presently there are no evidence that 
one method is better than the other, so the operative method chosen varies between 
hospitals and surgeons. The participants in this study will consequently not be exposed 
to additional unnecessary risks.  Further, a security control of the study will be 

 
15 
performed after inclusion of 10 patients in each group, to detect unexpected adverse 
effects. 
This study will hopefully provide important information about the efficacy and 
economical aspects of hemorrhoidectomy performed with diathermy and LigaSureTM 
helping future decision-making in the treatment of hemorrhoids.  
 
This trial has been approved by the Regional Committee on Health Research Ethics.  
(Protocol number: SJ-584) 
DATA 
Data handling and confidentiality 
Subject confidentiality is strictly held in trust by the investigators in accordance with the  
Danish law of handling personal information. Data storage and analysis will be done 
without name and personal ID-number (CPR-number) by making a personal data 
transformation key, which will be stored in a locked safety box only accessible only by 
the study secretary. 
 
Access to information in the patient’s electronic health records (EHR) will be used for 
self-monitoring and to reassure the quality control required in the study. Above all, 
information in the EHR will be used to verify that important information regarding 
possible complications are not missed. This will only be done after a signed informed 
consent. Only the participating surgeons and the study group will have access to the 
patients EHR (appendix 1). 
 
This trial will be performed after approval from the Danish Data protection Agency. 
Data owners’ rights 
The data will be owned by the participating surgeons and the study group. The 
participating surgeons must not publish or present the data without permission from 
the study manager. 
PUBLICATION 
Before this clinical trial is initiated its details are to be registered in a publicly available, 
free to access, searchable clinical trial registry complying with WHO’s international 
agreed standards1. 
The main findings, both positive and negative, of this clinical trial is to be submitted in a 
peer reviewed journal within 12 months of study completion2 
FUNDING OF THIS STUDY 
This study is to be done without funding from the medical industry. The surgical 
department at Holbæk Hospital provides the necessary facilities and funding. An 
 
1 www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html 
2 See www.consort-statement.org for broadly accepted standards on presentation of results in peer reviewed 
manuscripts reporting clinical trials 
 

 
16 
application will be sent to Zealand region Research Fund for financial support if the 
study is accepted by the Regional Committee on Health Research Ethics. Neither the 
study manager nor the study assistant or the participating surgeons have any conflicts 
of interest relevant for the study.  
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