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

February 11, 2012 updated by: Dr. med. Asad Kutup, Universitätsklinikum Hamburg-Eppendorf

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

130

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Stapled hemorrhoidopexy
surgical procedure to treat hemorrhoids
Procedure: Stapled hemorrhoidopexy
Other Names:
  • Ethicon PPH 01
Active Comparator: Milligan Morgan
surgical procedure to treat hemorrhoids
Procedure: Milligan Morgan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative Pain
Time Frame: within the first 30 days after surgery
within the first 30 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
long-term recurrence rate
Time Frame: 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
up to 5 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Investigators

  • Study Chair: Jakob R Izbicki, MD, Dept. of Surgery, Martinistreet 52, University Hospital Hamburg Eppendorf, 20246 Hamburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2000

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

February 5, 2012

First Submitted That Met QC Criteria

February 11, 2012

First Posted (Estimate)

February 15, 2012

Study Record Updates

Last Update Posted (Estimate)

February 15, 2012

Last Update Submitted That Met QC Criteria

February 11, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1612

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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