Hemorrhoidal Artery Ligation and Rectoanal Repair Versus Stapled Hemorrhoidopexy

Hemorrhoids Clinical Trial

Official title:

Hemorrhoidal Artery Ligation and Rectoanal Repair Versus Stapled Hemorrhoidopexy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01647763
• Other study ID #: EKSG11/042
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2011
• Est. completion date: December 2024

Study information

• Verified date: August 2023
• Source: Cantonal Hospital of St. Gallen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 84
• Est. completion date: December 2024
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhoids

Intervention

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.
• 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.

Locations

Country	Name	City	State
Switzerland	Kantonsspital Rorschach	_Rorschach
Switzerland	Kantonsspital St. Gallen	St. Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Cantonal Hospital of St. Gallen

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Pain 30d	visual analogue scale	30 days after surgery
Secondary	Pain 1y	visual analogue scale	1 year after surgery
Secondary	Pain 2y	visual analogue scale	2 years after surgery
Secondary	post operative surgical complications	Number and severity according to the Dindo classification (Ann Surg 240:205)	within 30 post operative days
Secondary	duration of medical leave	data will be obtained from primary care physician	up to 3 months after surgery
Secondary	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
Secondary	Continence 1y	Wexner score	1 year after surgery
Secondary	Continence 2y	Wexner score; Additionally anorectal manometry (results will be compared with pre-operative data).	2 years after surgery

External Links

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