Clinical trial NCT04139876: Ligasure Hemorrhoidectomy Versus Open Hemorrhoidectomy
Official title: Ligasure Hemorrhoidectomy Versus Open Hemorrhoidectomy. A Randomized Clinical Trial on the Long-term Effect on Hemorrhoidal Symptoms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemorrhoids
Keywords: Hemorrhoidectomy
Minimal Open hemorrhoidectomy
LigaSure hemorrhoidectomy
Lead sponsor: Holbaek Sygehus
Sponsor class: OTHER
First posted: 2019-10-25
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective Randomized Study
Primary purpose: TREATMENT

Brief summary: This is a single center randomized clinical trial comparing Ligasure Hemorrhoidectomy and Open Hemorrhoidectomy for the treatment of prolapsing haemorrhoids. The primary aim of the study is to evaluate symptoms related to hemorrhoids one year postoperatively, according to a hemorrhoidal disease symptom score (HDSS).

Secondary endpoints are patient satisfaction with the operation, Health related Quality of Life and effect on anal continence.

Detailed description: Background

Hemorrhoids is one of the oldest known medical conditions. Description of hemorrhoids is found as early as 2250 Before Christ (BC) in the code of king Hammurabi in Babylon. Even though first recorded treatment is thought to be found in the "Edwin Smith Papyrus" from 1700 BC 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 worldwide. 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 incontinence.

Hemorrhoids is a pathologic term describing the symptomatic abnormal downward displacement and enlargement of the anal cushions. 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 classification is the classification that generally forms the basis of the treatment in Denmark.

Local treatment consists of corticosteroids and anaesthetic ointments. Minor surgery includes rubber band ligation and sclerotherapy. Operation is reserved for subjects with prolapse, 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 Hemorrhoidectomy 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 mucosa - 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.

LigaSure Trademark (TM) hemorrhoidectomy (LH) is a hemorrhoidectomy performed with the use of the LigaSure TM instrument in stead of the traditional diathermy. The LigaSure TM technology patented in 1998 as "Energy Delivery System for Vessel Sealing" creates vessel fusion by a combination of pressure and energy17. The LigaSure 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.

Rationale

Hemorrhoidal Disease is a benign disease and should be evaluated by it's 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 haemorrhoidal disease.

Eligibility criteria: Inclusion Criteria:

* The patient has Grade III-IV haemorrhoids or Grade II haemorrhoids with bleeding resistant to rubber band ligation or sclerotherapy
* The patient has a Haemorrhoidal Symptom Score of 4 or more
* The patient has an American Society of Anaesthesiologists (ASA) score I-II
* The patient's age is 18-85 years at inclusion
* The patient has had a colonoscopy, sigmoidoscopy or rigid rectoscopy within 3 months before inclusion

Exclusion Criteria:

* The patient has had previous operation for haemorrhoids within the last 2 years
* The patient has had previous operation for anal incontinence
* The patient has an active anal fistula
* The patient has an active anal fissure
* The patient has anal incontinence for solid stools
* Active immunosuppressive therapy (increased risk of anorectal sepsis)
* Cirrhosis / portal hypertension
* Mb Crohn.

Primary outcomes:
measure: Hemorrhoidal symptoms assessed by the Hemorrhoidal Disease Symptom Score (HDSS).
timeFrame: 1 year postoperatively
Secondary outcomes:
measure: Patient satisfaction assessed by a seven grade Likert Scale.
timeFrame: Preoperatively (baseline) and 1 year postoperatively
measure: Hemorrhoidal affection of the patient's daily life assessed by Short Health Scale adapted to hemorrhoidal disease (SHSHD).
timeFrame: Preoperatively (baseline) and 1 year postoperatively
measure: Anal continence (gas and solids) assessed by the Wexner incontinence scale.
timeFrame: Preoperatively (baseline) and 1 year postoperatively
measure: Fecal continence assessed by the Revised Fecal Incontinence Scale (RFIS).
timeFrame: Preoperatively (baseline) and 1 year postoperatively
Other outcomes:
Locations:
city: Holbaek
country: Denmark
facility: Departement of Surgery, Holbaek County Hospital.
Study officials:
affiliation: Department of Surgery, Holbaek County Hospital
name: Per Olov Gunnar Olaison, MD, pHD
role: STUDY_DIRECTOR
References:
citation: Rorvik HD, Styr K, Ilum L, McKinstry GL, Dragesund T, Campos AH, Brandstrup B, Olaison G. Hemorrhoidal Disease Symptom Score and Short Health ScaleHD: New Tools to Evaluate Symptoms and Health-Related Quality of Life in Hemorrhoidal Disease. Dis Colon Rectum. 2019 Mar;62(3):333-342. doi: 10.1097/DCR.0000000000001234.