Hemorrhoidal Pedicle Ligation vs Laser Hemorrhoidectomy vs Open Hemorrhoidectomy: Randomized, Double Blind, Multicenter Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Vilnius University
- Enrollment
- 121
- Locations
- 1
- Primary Endpoint
- Recurrence rate of rectal prolapse
Study Overview
Brief Summary
The aim of this study is to compare three different modalities for treatment of symptomatic 2 ° to 3 ° haemorrhoids: open haemorrhoidectomy, intrahaemorrhoidal laser procedure and haemorrhoidal pedicle ligation.
To assess early outcomes (after one week and one month) of the procedures: pain, bleeding, wound healing, return to work and quality of life; To assess late outcomes (after one year) of the procedures: late functional results (continence) and recurrence of symptoms and haemorrhoids.
Study design This is a multi-center, double-blind, prospective RCT comparing three different modalities for treatment of symptomatic 2 ° to 3 ° haemorrhoids: open haemorrhoidectomy, intrahaemorrhoidal laser coagulation and haemorrhoidal artery ligation.
Detailed Description
Hemorrhoidal pedicle ligation vs laser hemorrhoidectomy vs open hemorrhoidectomy: randomized, double blind, multicenter trial
AIMS AND OBJECTIVES The aim of this study is to compare three different modalities for treatment of symptomatic 2 to 3 ° haemorrhoids: open haemorrhoidectomy, intrahaemorrhoidal laser procedure and haemorrhoidal pedicle ligation.
Objectives of the study are:
To assess early outcomes (after one week and one month) of the procedures: pain, bleeding, wound healing, return to work and quality of life; To assess late outcomes (after one year) of the procedures: late functional results (continence) and recurrence of symptoms and haemorrhoids.
MATERIALS AND METHODS Study design This is a randomized, parallel group (1:1:1) double-blinded single centre prospective study. No changes in methods of the study were allowed after commen cement. This RCT compares three different modalities for treatment of symptomatic 2 to 3 ° haemorrhoids: open haemorrhoidectomy, intrahaemorrhoidal laser coagulation and haemorrhoidal artery ligation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •All consented >18 year old male and female patients with 2 to 3 degree
Exclusion Criteria
- •Patients with 1st and 4th degree haemorrhoids.
- •Patients with associated anorectal pathology (anorectal fistula, abscess, fissure, tumor or inflammatory bowel disease).
- •Patients who had undergone previous anorectal surgery.
Arms & Interventions
open haemorrhoidectomy
Open haemorrhoidectomy is performed using an anal retractor, exposed haemorrhoids at 3 - 7- 11 hours are excised using cautery. The arteries are ligated or cauterized. Open or closed technique is used (the choice of the surgeon). The Spongostan plug is then introduced
Intervention: Haemorrhoidectomy operations (Procedure)
Haemorrhodal pedicle ligation
Haemorrhodal pedicle ligation is performed using operating proctoscope. The pedicle of symptomatic haemorrhoid is suture ligated with absorbable Vycril 2/0. Mucopexy is performed simultaneously if the prolapse is noticed. No tissue removal is performed
Intervention: Haemorrhoidectomy operations (Procedure)
Intrahaemoroidal laser coagulation
Intrahaemoroidal laser coagulation is performed using disposable THD kit [Biolitec Co]. The haemorrhoidal pedicle is sutured. 1mm opening is created at the external haemorrhoid (skin level). Laser is then introduced up to pedicle and coagulation performed. This is repeated to all the piles. The procedure is finished with placing Spongostan plug into anal canal
Intervention: Haemorrhoidectomy operations (Procedure)
Outcomes
Primary Outcomes
Recurrence rate of rectal prolapse
Time Frame: one years
Visual rectal prolapse during postoperative anoscopy requiring any kind of medical attention or treatment (visit to the doctor or pharmacy, medical, invasive or surgical treatment).
Recurrence rate of rectal bleeding
Time Frame: one years
Intensity and frequency of postoperative bleeding requiring any kind of medical attention or treatment (visit to the doctor or pharmacy, medical, invasive or surgical treatment).
Secondary Outcomes
- Fecal incontinence quality of life (FIQOL) score(One years)
- Evaluation of the operation by the patient(One years)
- Continence(after one year)
- Recurrence of any perianal symptoms(One years)
- Time to return to work(One years)
- Intensity and duration of postoperative perianal pain(7 postoperative days)
- Quality of life(One years)
Investigators
Tomas Poskus
Professor
Vilnius University