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UnknownNCT01647763

Hemorrhoidal Artery Ligation and Rectoanal Repair Versus Stapled Hemorrhoidopexy

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
84 (estimated)
Sponsor
Cantonal Hospital of St. Gallen · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

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

TypeNameDescription
PROCEDUREHemorrhoidal artery ligation with rectoanal repairHemorrhoidal 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.
PROCEDUREStapled hemorrhoidopexyA 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.

Timeline

Start date
2011-07-01
Primary completion
2022-12-01
Completion
2024-12-01
First posted
2012-07-24
Last updated
2023-08-08

Locations

2 sites across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT01647763. Inclusion in this directory is not an endorsement.

Hemorrhoidal Artery Ligation and Rectoanal Repair Versus Stapled Hemorrhoidopexy (NCT01647763) · Clinical Trials Directory