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

Phase 3

Completed

• Conditions: Internal Hemorrhoids
• Interventions: Procedure: Stapled hemorrhoidopexy; Procedure: Milligan Morgan

• Registration Number: NCT01533363
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief 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.

Detailed 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 Timeline

• Study Start: 2000-07
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2012-02
• Study First Submitted: 2012-02-05
• Study First Submitted QC: 2012-02-11
• Last Update Submitted: 2012-02-11
• Study First Posted: 2012-02-15
• Last Update Posted: 2012-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• third degree circular hemorrhoids
• symptomatic
• reducible

Exclusion Criteria

• single third-degree hemorrhoids
• acute incarcerated hemorrhoids
• intercurrent acute anal fissure
• acute anal fistula
• prior hemorrhoidectomy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stapled hemorrhoidopexy	Stapled hemorrhoidopexy	surgical procedure to treat hemorrhoids
Milligan Morgan	Milligan Morgan	surgical procedure to treat hemorrhoids

Primary Outcome Measures

Name	Time	Method
Postoperative Pain	within the first 30 days after surgery

Secondary Outcome Measures

Name	Time	Method
long-term recurrence rate	up to 5 years after surgery	Secondary end points included the long-term recurrence rate of hemorrhoidal disease after a minimum of 4 years. Postoperative morbidity such as bleeding, wound infection, urinary retention, and itching and burning, and transient incontinence symptoms, and parameters such as length of hospital stay and operating time were evaluated