Comparison Between the Ligation and Hemorrhoidopexy Technique and the Conventional Ligation of Hemorrhoidal Arteries Using Ultrasound: a Prospective, Randomized Controlled Study
Phase: NA
Conditions: Hemorrhoids
Sponsor: Larissa University Hospital

COVER  PAGE 
Research Protocol
OFFICIAL TITLE: Comparison between the ligation and hemorrhoidopexy 
technique and the conventional ligation of hemorrhoidal arteries using 
ultrasound: a prospective, randomized controlled study
BRIEF TITLE: Ligation and Hemorrhoidopexy Technique Versus Ligation of Hemorrhoidal Arteries Using 
Ultrasound for Hemorrhoids 
UNIQUE PROTOCOL ID: Hemorrhoids RCT 
DOCUMENT DATE: September 26, 2017
 
NCT03298997 
Principal Investigator:
Perivoliotis Konstantinos, MD, MSc
Telephone: 00306944113329
Email: kperi19@gmail.com  
Study Director
Tepetes Konstantinos, Professor of General Surgery
Telephone: 00302413502804
Email: tepetesk@gmail.com
Department of Surgery
University Hospital of Larissa
Mezourlo 41110 Larissa
Greece
1

Comparison between the ligation and hemorrhoidopexy technique and the 
conventional ligation of hemorrhoidal arteries using ultrasound: a prospective, 
randomized controlled study
1.  Research Subject
1.1 Description of the proposed project 
The  purpose  of  this  study  is  to  compare  two  techniques  for  treating  hemorrhoids,  the  ligation  and 
hemorrhoidopexy technique and the conventional ligation of hemorrhoidal arteries using ultrasound, in patients with 
non-complicated hemorrhoids.
2. INTRODUCTION
2.1 Literature
Surgical operations for the treatment of perianal diseases are a major part of all elective surgical cases. The 
reduction in the hospitalization time of patients undergoing surgical procedures for benign perianal diseases is to the 
benefit of  both the patient and healthcare provider1. The importance of  ‘one day’ surgical operations lies in the fact 
that the patient returns directly to his social and working environment, while the number of occupied hospital beds 
and the total hospitalization costs are reduced. A typical example is the goal set by NHS, where the 75% of the 
scheduled operations should consist of ‘one day’ operations1. In order to achieve this goal, several obstacles should 
be dealt with, including the implementation of more efficient and safe surgical techniques. Therefore, this would be 
associated with a decrease in the operation time, early recovery and faster hospital discharge.
Hemorrhoids is one of the most common benign perianal diseases. According to a recent prospective study2 
of 976 patients, 38.93% of them suffered from hemorrhoids, with 8.16% and 0.53% being Grade III and IV, 
according to Goligher classification, respectively. The percentage of the symptomatic patients was, also, significant 
(44.74%). Symptomatic hemorrhoids, includes bleeding, pruritus, pain, poor hygiene and the presence of palpable 
hemorrhoid nodules.
As far as the blood supply of the rectum and the broader anatomic region is concerned, it is provided by the 
superior, middle and inferior hemorrhoidal arteries. The superior hemorrhoidal artery is a branch of the inferior 
mesenteric artery and is carried behind the rectum, where it provides branches up to the internal sphincter muscle. 
The right and left middle hemorrhoidal artery originate from the respective internal iliac artery and their branches 
are cross-linked with the respective branches deriving from the superior hemorrhoidal artery. Finally, inferior 
hemorrhoidal arteries derive from the respective internal pudendal arteries. Correspondingly, hemorrhoidal venous 
plexus consists of the middle and inferior hemorrhoidal veins, which through the internal iliac veins drain into the 
inferior cava vein. Hemorrhoidal tissue constitutes a continence mechanism of the upper rectum and consists of 
vascular tissue, connective tissue and smooth muscle fibers, within the rectal canal. Through the approximation of 
the hemorrhoidal tissue, closure of the anal canal and protection of the sphincter mechanism is achieved. Since 
modern pathogenesis theories of hemorrhoids attribute to the increased arterial flow in the hemorrhoidal plexus the 
generating cause of this disease, recent anatomical studies mapped the vascular network, indicating that the arteries 
are not confined to the anatomical regions described in the literature3. 
According to recent guidelines 4, the modification of dietary intake, through the increase of fluid and fiber 
intake, consists the first line treatment of symptomatic hemorrhoids. However, in Grade III-IV hemorrhoidal disease 
or in Grade II, where conservative therapy failed, surgical intervention is required. Surgeon has plenty of techniques 
at  his  disposal,  in  order  to  treat  hemorrhoids.  Examples  of  these  techniques  are operations,  such  as 
hemorrhoidectomy (open 5,  closed 5,  Milligan-Morgan 6, Parks  6, using staplers  7, using energy sources, e.g. 
Harmonic 8,  Ligasure 9,  Laser 10, bipolar forceps11 ), elastic rings ligation12, sclerotherapy  13 and hemorrhoidal 
arteries ligation (ΗΑL) or Transanal Hemorrhoidal Dearterialization (THD) 14. 
Ligation of hemorrhoidal arteries using a Doppler apparatus, is a minimally invasive technique that was first 
applied by Morinaga et al.15 in 1995 and has as principle the elective ligation of the arteries that supply the 
hemorrhoidal plexus. In a recent meta-analysis the superiority of HAL in areas such as, postoperative bleeding, 
emergency reoperation, operative duration, length of hospital stay and postoperative pain, was shown. A major 
drawback of this technique, however, remains the high rate of recurrence, which ranges from 11.1% to 59.3%, for 
Grade IV hemorrhoids17. 
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Despite the comparative advantages of this minimally invasive technique, the high cost of the necessary 
equipment and the respective consumables, is a barrier to its broad application. Gupta et al.18 in a prospective 
randomized study, compared Doppler-Guided HAL (DG-HAL) to hemorrhoid artery ligation and hemorrhoidopexy. 
Ligation was performed on the hemorrhoid nodule at the 3rd, 7th and 11th hours, followed by continuous 
hemorrhoidal nodule ligation and hemorrhoidopexy19. The DG-HAL group had a significantly longer operative time 
(31 min vs 9 min) and post-operative pain (4.4 vs 2.2), without any differences in complication or recurrence rates. 
Similarly, Huang et al.20, reported a respective ligation technique, where, through the use of the index finger, the 
artery was palpated, followed by repeating compression and ligation cycles, in order to fix the affected hemorrhoids 
above the dental line. In this group, operative time was longer when compared to the DG-HAL group (35.57 vs. 
12.73). There was no difference in terms of postoperative improvement of symptoms and hospitalization duration. 
In the experimental group, however, the cost of hospitalization and the relapse rate was significantly lower. Finally, 
Aigner  et  al.21,  in  a  recent  randomized  study,  investigated  the  efficacy  of  hemorrhoidopexy  for  Grade  III 
hemorrhoids. They concluded that the techniques of hemorrhoidopexy are effective and the addition of DG-HAL 
does not affect the results.
Given these facts, the present trial was designed, in order to compare the two techniques for hemorrhoids 
treatment, the ligation and hemorrhoidopexy technique and the conventional ligation of hemorrhoid arteries using 
ultrasound.
2.2 Research Group Experience
In a prospective 4-year study with a total of 90 patients  22, the  immediate post-operative and long-term 
course of patients undergoing DG-HAL hemorrhoid artery ligation was investigated. Totally, 64.4% of the included 
patients was discharged from the hospital, within 24 hours of the operation, 4.4% of patients needed additional 
analgesic treatment in the next 24 hours, while only 6.6% developed disease recurrence, one year after the 
operation. Additionally, a prospective randomized study of our clinic, compared pudendal nerve block and local 
anesthesia in 120 patients who underwent ultrasound scissors hemorrhoidectomy. A statistically significant lower 
rate of additional postoperative analgesic treatment was observed in the pudendal nerve block, while the level of 
postoperative pain, calculated on the Visual Analogue Scale (VAS scale),  on the operative day was higher in the 
group of local anesthesia (5.1 vs. 2.2 p<0.001) 23.
3. RESEARCH PROTOCOL
3.1 Sample
The sample will consist of male and female patients aged 18 to 80 years, with an  American Society of 
Anesthesiologists (ASA) score of I and II.
3.2 Diseases
Patients with GradeIII hemorrhoids, according to Goligher's classification, will be included.
3.3 Exclusion Criteria
 The exclusion criteria include:
o
Acute perianal diseases, such as perianal abscesses, complicated hemorrhoids (e.g., thrombosis) and 
acute anal fissure
o
Malignant perianal disorders
o
Patient age  80 years 
o
ASA score  ΙΙΙ
o
Presence of inflammatory bowel disease
o
History of a previous rectoanal operation 
o
Presence of a clinically significant cardiovascular, respiratory, renal, hepatic or metabolic disorder. 
Furthermore, diseases, such as obesity, psychiatric disorders or gastrointestinal disorders constitute 
exclusion criteria.
3

3.4 1st Arm
The patient will be placed in the Lloyd-Davies position and having provided a sterile field, using a 10% 
povidone iodine solution, rectal dilatation will be performed with a 10% xylocaine gel, thus allowing the entrance of 
the proctoscope (THD America). The proctoscope will be combined with a Doppler sensor in order to detect the 
hemorrhoidal arteries and, also, a light source. Furthermore, a casing at the distal end of the apparatus that allows 
the proper placement and rotation of the needle-holder and a special window above the sensor and, thus, enables the 
placement of the ligations at the correct height and depth, through the capturing of the mucosa and the submucosa 
and the prevention of  the perforation of the rectal wall. After the hemorrhoidal artery location, through the use of 
the ultrasound, Z ligations will be placed, using an absorbable polyglycolic acid suture (2-0, 5/8 inch needle). The 
proper artery ligation will be confirmed by the absence of the Doppler signal. In the presence of residual 
hemorrhoidal tissue, the upper part of the proctoscope will be removed and hemorrhoidopexy will be performed, by 
applying a continuous suture from the hemorrhoidal stem and peripherally. During hemorrhoidopexy, only the 
mucosa and the submucosa of the hemorrhoidal nodules, above the dental line, will be captured. At the end of the 
procedure, a hemostatic gauze will be placed in the surgical field. Prior to operation, the patients will be submitted 
to spinal anesthesia. Using an atraumatic 25 Gauge (G) needle, a levobupivacaine 5mg/ml and fentanyl 25mg 
solution, will be administered at the height of lumbar (L)2-L3 or L3-L424.
     
3.5 2nd Arm
In the experimental arm, the patient will be placed in the Lloyd-Davies position and having provided a 
sterile field, using a 10% povidone iodine solution, rectal dilatation will be performed with a 10% xylocaine gel, 
thus allowing the entrance of a conventional proctoscope, with an attached light source. After the identification of 
the hemorrhoidal nodules (3rd, 7th, 11th hour), their ligation, using an absorbable polyglycolic acid suture (2-0, 5/8 
inch needle), will be performed. The location of the hemorrhoidal artery will be confirmed, through palpation, with 
the use of the index finger. Initially, a fixative suture will be placed in the hemorrhoidal nodule and then, using a 
continuous suture from the hemorrhoidal stem and peripherally, hemorrhoidopexy, will be performed. During 
hemorrhoidopexy, only the mucosa and the submucosa of the hemorrhoidal nodules, above the dental line, will be 
captured. At the end of the procedure, a hemostatic gauze will be placed in the surgical field. Prior to operation, the 
patients will be submitted to pudendal nerve block. Using an atraumatic 25 Gauge (G) needle, a 20ml lidocaine 
solution (diluted with saline in a 1:1 rate) will be administered bilaterally, medially to the ischial tuberosity25. Ten 
minutes before the operation, the patient will receive 1-2.5mg midazolam and 0.1-0.2 mg fentanyl.
3.6 Primary endpoint
The primary endpoint of the present study, is the identification of difference in the symptoms remission rate, 
within one month postoperatively, between the ligation and hemorrhoidopexy technique and the conventional 
ligation of hemorrhoidal arteries using ultrasound, in patients with non-complicated hemorrhoids. If the symptoms 
are treated then it will be defined as=1 'YES' If the symptoms are not treated then it will be defined as=0 'NO'. The 
time frame will be 1 month postoperatively.
3.7 Secondary endpoints
The secondary endpoints of the present study are:
o
Operative time. Measurement unit: minutes. Time Frame: Intraoperative period
o
 Postoperative mobilization time. Measurement unit: hours. Time Frame: Postoperative period up to 
hospital discharge. Maximum time frame 24 hours 
o
Postoperative pain level at 12 hours after surgery, quantified with the use of the VAS scale. Time 
Frame: 12 hours postoperatively
o
Onset of oral feeding. Measurement unit: hours. Time Frame: Postoperative period up to hospital 
discharge.Maximum time frame 24 hours
o
Difference in the rates of adverse effects during hospitalization:

Hypotension. Occurrence of postoperative hypotension. If such an episode occurs, then it will 
be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'. 
Time Frame: Postoperative period up to hospital discharge. Maximum time frame 24 hours
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
Nausea. Occurrence of postoperative nausea. If such an episode occurs, then it will be defined 
as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'. Time Frame: 
Postoperative period up to hospital discharge. Maximum time frame 24 hours

Vomiting. Occurrence of postoperative vomiting. If such an episode occurs, then it will be 
defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'. Time 
Frame: Postoperative period up to hospital discharge. Maximum time frame 24 hours

Headache. Occurrence of postoperative headache. If such an episode occurs, then it will be 
defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'. Time 
Frame: Postoperative period up to hospital discharge. Maximum time frame 24 hours

Urinary retention. Occurrence of postoperative urinary retention. If such an episode occurs, 
then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined 
as=0 'NO'. Time Frame: Postoperative period up to hospital discharge. Maximum time frame 
24 hours

Bleeding at the operative site. Occurrence of postoperative bleeding at the operative site. If 
such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, 
then it will be defined as=0 'NO'. Time Frame: Postoperative period up to hospital discharge. 
Maximum time frame 24 hours
o
Postoperative time that the patient can be safely discharged. Measurement unit: hours. Time Frame: 
Postoperative period up to hospital discharge. Maximum time frame 48 hours
o
Complications occuring at 7 days postoperatively:

Pain on the basis of the VAS scale. Postoperative pain level at 7 days after surgery, quantified 
with the use of the VAS scale. Time Frame: 7 days postoperatively

Oedema at the operative site. Occurrence of postoperative oedema at the operative site. If 
such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, 
then it will be defined as=0 'NO'. Time Frame: 7 days postoperatively

Hematoma at the operative site. Occurrence of postoperative hematoma at the operative site. 
If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not 
occur, then it will be defined as=0 'NO'. Time Frame: 7 days postoperatively

Infection at the operative site. Occurrence of postoperative infection at the operative site. If 
such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, 
then it will be defined as=0 'NO'. Time Frame: 7 days postoperatively

Stenosis at the operative site. Occurrence of postoperative stenosis at the operative site. If 
such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, 
then it will be defined as=0 'NO'. Time Frame: 7 days postoperatively
o
Postoperative return to work time. Measurement unit: days. Time Frame: Postoperative period up to 
1 month
o
Complications occurring at 1 year postoperatively:

Pruritus. Occurrence of postoperative pruritus at the operative site. If such an episode occurs, 
then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined 
as=0 'NO'. Time Frame: 1 year postoperatively

Mucosal proptosis. Occurrence of postoperative mucosal proptosis at the operative site. If 
such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, 
then it will be defined as=0 'NO'. Time Frame: 1 year postoperatively

Perianal nodules. Occurrence of postoperative perianal nodules. If such an episode occurs, 
then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined 
as=0 'NO'. Time Frame: 1 year postoperatively

Constipation. Occurrence of postoperative constipation. If such an episode occurs, then it will 
be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'. 
Time Frame: 1 year postoperatively

Tenesmus. Occurrence of tenesmus. If such an episode occurs, then it will be defined as=1 
'YES' If such an episode does not occur, then it will be defined as=0 'NO'. Time Frame: 1 
year postoperatively.
5


Reoperation. Occurrence of reoperation. If the patient is reoperated, then it will be defined 
as=1 'YES' If the patient is not reoperated, then it will be defined as=0 'NO'. Time Frame: 1 
year postoperatively
o
Disease recurrence rate  at 1 year postoperatively. Disease recurrence rate If such an episode occurs, 
then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 
'NO'. Time Frame: 1 year postoperatively
o
Satisfaction level at 1 year postoperatively. Satisfaction level measured at a 0-10 scale. Time Frame: 
1 year postoperatively
o
Difference in the quality of life of the patient, at 1 month and 1 year postoperatively, compared to the 
respective preoperative measurements, based on the SF-36 questionnaire, weighted for the Greek26. 
Time Frame: Preoperatively, 1 month postoperatively and 1 year postoperatively.
3.8 Sample Size calculation
The calculation of the sample size is based on the primary endpoint. According to the literature, the rate of 
the remission rate of symptoms, of patients who were submitted to hemorrhoidal artery ligation using ultrasound is 
72.5%, while the respective rate of the  ligation and hemorrhoidopexy technique  is 90%20. Therefore for a non-
inferiority trial, with alpha= 2,5%, beta= 80%  and a non inferiority limit of 10% , the calculated sample for each 
group is 30 patients27. Totally, the required number of patients is 60.
3.9 Randomization
The randomization of the patients, between the two groups, will be performed using a software and a 1: 1 
allocation ratio will be performed. Furthermore, an opaque envelope, which will contain the allocation group for the 
specific patient, will be opened preoperatively upon the entry of the patient into the surgical room, thus determining 
which technique will be applied. 
3.10 Blinding
Blinding will exist at the level of the patient and the investigator who will record the data postoperatively, 
regarding  the  surgical  technique  applied.  There  will  be  no  blinding  at  the  level  of  the  surgeon  and  the 
anesthesiologist.
3.11 Data
The following data will be recorded:
o
Demographics (Gender, Age, Weight, Height, ASA)
o
Hemorrhoid Grade
o
Operation type
o
Anesthesia type
o
Operative time
o
Mobilization time after the anesthesia administration
o
Occurrence of adverse effects 
o
Level of pain based on the VAS scale (0-10) at 12 hours postoperatively. 
o
Time of onset of oral feeding
o
Postoperative use of additional analgesia . 
o
Postoperative time that the patient can be safely discharged 
o
Complications occurring at 7 days postoperatively 
o
Postoperative return to work time 
o
Remission of symptoms, at 1 month postoperatively
o
Complications occurring at 1 year postoperatively 
o
Disease recurrence at 1 year postoperatively
o
Satisfaction level at 1 year postoperatively
o
SF-36 questionnaire, preoperatively, at 1 month and 1 year postoperatively
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3.12 Discharge Criteria
The patient will be discharged, when it is ensured that is medically safe to be released. In particular, as the 
exit time of the patient, will be regarded the time that the patient will fulfill the Clinical Discharge Criteria. More 
specifically, the patient should meet the following : steady vital signs, be oriented, without nausea or vomiting, 
mobilized with a steady gait, without a significant bleeding28. 
3.13 Follow up
One week after the operation, the patient will be summoned to reply for any postoperative complications, the 
return to work time, and the current pain level. One month postoperatively, the patient will be asked about the 
remission of the symptoms. One year after the operation, the patient will be examined for disease recurrence and 
will be asked about the overall satisfaction regarding the operation.    
3.14 Medication
Preoperatively, the patient will not receive any kind of analgesic treatment. Additionally, 8 and 1 hour 
preoperatively, the patient will receive a fleet enema. Intraoperatively, besides the applied anesthetic technique, 
additional analgesia (paracetamol 1000mg I.V.) will be administered if  deemed necessary. Perioperative antibiotic 
chemoprophylaxis will include the administration of  a single dose of  cefoxitin I.V. 2gr, and in case of  allergy to 
cefoxitin, ciprofloxacin I.V. 400mg. With regard to the postoperative analgesic treatment, the patient will receive 
paracetamol 1000mg I.V every 6 hours, and if needed lornoxicam 8mg. In case of nausea or vomiting, granisetron 
3mg/3ml I.V. will be administered. The patient will receive his systematic medication. Oral feeding will start upon 
absence of nausea and vomiting.
3.15 Research Group
Both the surgeon and the anesthesiologist who participate in the research group have years of experience in 
their field and have, therefore, completed the learning curve for the required operative and anesthesia techniques, 
respectively. The data collection and recording will be carried out by an independent, third party, researcher.
3.16 Trial
The study will be conducted in the Department of Surgery of the University Hospital of Larissa. Patient data 
will be recorded both in the patient charts and in an electronic database. The required laboratory examinations will 
be defrayed by the patient insurance funds. There will be no form of financial support for the present study.
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