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Completed

NCT Number: NCT01533363

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

stapled hemorrhoidopexy

Procedure

Other names: Ethicon PPH 01

Milligan Morgan

Procedure

Primary outcomes

  1. Postoperative Pain

    Time frame: within the first 30 days after surgery

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2007
Study completion
2007
First posted
Feb 15, 2012
Registry last updated
Feb 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.