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Hemorrhoidal Artery Ligation and Rectoanal Repair Versus Stapled Hemorrhoidopexy

NCT01647763 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2023-08-08

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Cantonal Hospital of St. Gallen

    lead OTHER

Principal Investigators

  • Lukas Marti, MD · Cantonal Hospital St. Gallen, Department of Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2022-12-31
Completion
2024-12-31

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01647763 on ClinicalTrials.gov