Study About Patient Comfort and Long-term Outcome After Stapled Hemorrhoidopexy

Internal Hemorrhoids Clinical Trial

Official title: Patient Comfort After Stapled Hemorrhoidopexy Long Term Results of a Randomized Controlled Trial

Status Completed

Clinical Trial Summary

The purpose of this study was to determine the influence on Patient comfort after Stapled Hemorrhoidopexy versus Milligan Morgan (two surgical procedures)in third degree circular hemorrhoids.

Clinical Trial Description

There are well known advantages in the short-outcome, however, there are still some uncertainties about the long-term results and recurrence rates, and only a few data of randomized trials are available.

In most studies the patient population was heterogeneous with a varied degree of treated hemorrhoids, and different surgical procedures were performed. Therefore we initiated this prospective randomized controlled study of a homogeneous patient population with only circular third-degree hemorrhoids and clearly defined operative procedures. All patients with symptomatic, reducible circular third-degree hemorrhoidal disease were randomly assigned to undergo either the Milligan-Morgan technique or the stapling procedure. Patients were excluded from the study if they had single third-degree hemorrhoids, acute incarcerated hemorrhoids, intercurrent acute anal fissure and/or acute anal fistula, or prior hemorrhoidectomy. The main end point parameter of this study was to compare both groups with respect to patient comfort and postoperative pain. Secondary end points included the long-term recurrence rate of hemorrhoidal disease after a minimum of 4 years. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhoids
• Internal Hemorrhoids

• NCT number: NCT01533363
• Study type: Interventional
• Source: Universitätsklinikum Hamburg-Eppendorf
• Status: Completed
• Phase: Phase 3
• Start date: July 2000
• Completion date: September 2007