Hemorrhoidal Artery Ligation and Rectoanal Repair Versus Stapled Hemorrhoidopexy

Not Applicable

Active, not recruiting

• Conditions: Hemorrhoids
• Interventions: Procedure: Stapled hemorrhoidopexy; Procedure: Hemorrhoidal artery ligation with rectoanal repair

• Registration Number: NCT01647763
• Lead Sponsor: Cantonal Hospital of St. Gallen

Brief Summary

Background:

Hemorrhoids of grade 3 and 4 can be treated either by conventional, rather invasive procedures, like Milligan-Morgan or Ferguson or by modern, less invasive procedures with less postoperative pain. Doppler guided hemorrhoidal artery ligation and stapled hemorrhoidopexy are examples for such modern procedures. Hemorrhoidal artery ligation causes less post operative pain than stapled hemorrhoidopexy, however the former has a higher recurrence rate. Combining hemorrhoidal artery ligation with rectoanal repair should reduce the recurrence rate without increasing the post operative pain.

Hypothesis and aim:

The study tries to prove the assumption that combined hemorrhoidal artery ligation and rectoanal repair cause less pain and have less post operative complications than stapled hemorrhoidopexy.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2012-07-18
• Study First Submitted QC: 2012-07-19
• Study First Posted: 2012-07-24
• Primary Completion: 2022-12
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-07
• Last Update Posted: 2023-08-08
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• hemorrhoids grade 3
• no active anti-coagulation treatment
• no hemorrhoidal recurrence
• no previous surgery on rectum or anus
• no previous local radiotherapy
• no mental incapacities, good study compliance can be expected
• no severe incontinence (Wexner score > 12)
• no severe comorbidities
• no inflammatory anal diseases (abscesses, fistulas)
• informed consent

Exclusion Criteria

• patient wish
• inoperability with the assigned intervention, switching to other treatment method

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stapled hemorrhoidopexy	Stapled hemorrhoidopexy	procedure for prolapse and hemorrhoids (PPH) Resection using a circular stapler
HAL/RAR	Hemorrhoidal artery ligation with rectoanal repair	hemorrhoidal artery ligation with rectoanal repair

Primary Outcome Measures

Name	Time	Method
Pain POD1	between 6:00 am and 8:00 am the day after surgery	Visual analogue scale (VAS).; Additionally recording of the pain medication used.

Secondary Outcome Measures

Name	Time	Method
Pain 30d	30 days after surgery	visual analogue scale
Pain 1y	1 year after surgery	visual analogue scale
post operative surgical complications	within 30 post operative days	Number and severity according to the Dindo classification (Ann Surg 240:205)
Continence 30d	30 days after surgery	Physician obtains data to calculate the Wexner Score (Dis Colon Rectum 36:77).; Score will be compared with pre-operative score.
Continence 1y	1 year after surgery	Wexner score
Pain after 8h	8 hours after surgery	Measuring post operative pain using the visual analogue scale (0 - 10).; Additionally recording of the pain medication used.
Continence 2y	2 years after surgery	Wexner score; Additionally anorectal manometry (results will be compared with pre-operative data).
duration of medical leave	up to 3 months after surgery	data will be obtained from primary care physician
Pain 2y	2 years after surgery	visual analogue scale

Trial Locations

Locations (2)

Kantonsspital St. Gallen; 🇨🇭 St. Gallen, Switzerland

Kantonsspital Rorschach; 🇨🇭 _Rorschach, Switzerland