Hemorrhoidal Artery Ligation and Rectoanal Repair Versus Stapled Hemorrhoidopexy

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hemorrhoids
• Intervention / Treatment: Procedure: Hemorrhoidal artery ligation with rectoanal repair; Procedure: Stapled hemorrhoidopexy

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lukas Marti, MD; Phone Number: +41 71 494 1339; Email: lukas.marti@kssg.ch
• Study Contact Backup: Name: Stephan Bischofberger, MD; Phone Number: +41 71 494 1111

Study Locations

• Switzerland
  • St. Gallen, Switzerland, 9007
    • Kantonsspital St. Gallen
  • _Rorschach, Switzerland, 9400
    • Kantonsspital Rorschach

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HAL/RAR; hemorrhoidal artery ligation with rectoanal repair	Procedure: Hemorrhoidal artery ligation with rectoanal repair; Hemorrhoidal arteries will be detected using an ultrasound Doppler probe. The arteries will be sutured with at least 4 Z-sutures. In the area with the 3 largest knots a purse string suture will be placed.; Other Names: HAL (hemorrhoidal artery ligation); RAR (rectoanal repair)
Active Comparator: Stapled hemorrhoidopexy; procedure for prolapse and hemorrhoids (PPH) Resection using a circular stapler	Procedure: Stapled hemorrhoidopexy; A purse string suture will be placed just below the hemorrhoidal cushion. Fixing the suture around the shaft of a circular PPH 03 stapler (Ethicon Endo-Surgery). Hemorrhoids will be removed by firing the stapler. Sufficiency of the stapler line will be examined through a proctoscope. Eventual sources of bleeding will be sutured.; Other Names: Longo procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain POD1	Visual analogue scale (VAS). Additionally recording of the pain medication used.	between 6:00 am and 8:00 am the day after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cantonal Hospital of St. Gallen
• Investigators: Principal Investigator: Lukas Marti, MD, Cantonal Hospital St. Gallen, Department of Surgery

Publications and helpful links

Helpful Links

• Website of the Department of Surgery (in German only)

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2011
• Primary Completion (Actual): December 1, 2022
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 18, 2012
• First Submitted That Met QC Criteria: July 19, 2012
• First Posted (Estimated): July 24, 2012

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 7, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Hemorrhoids
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Hemorrhoids
• Other Study ID Numbers: EKSG11/042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO