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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. med. Asad Kutup, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01533363
First received: February 5, 2012
Last updated: February 11, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Internal Hemorrhoids
Procedure: Stapled hemorrhoidopexy
Procedure: Milligan Morgan
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Patient Comfort After Stapled Hemorrhoidopexy Long Term Results of a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • Postoperative Pain [ Time Frame: within the first 30 days after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • long-term recurrence rate [ Time Frame: up to 5 years after surgery ] [ Designated as safety issue: No ]
    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


Enrollment: 130
Study Start Date: July 2000
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Stapled hemorrhoidopexy
surgical procedure to treat hemorrhoids
Procedure: Stapled hemorrhoidopexy
Other Name: Ethicon PPH 01
Active Comparator: Milligan Morgan
surgical procedure to treat hemorrhoids
Procedure: Milligan Morgan

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01533363

Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
Study Chair: Jakob R Izbicki, MD Dept. of Surgery, Martinistreet 52, University Hospital Hamburg Eppendorf, 20246 Hamburg
  More Information

Publications:
Responsible Party: Dr. med. Asad Kutup, Senior Surgeon, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01533363     History of Changes
Other Study ID Numbers: 1612
Study First Received: February 5, 2012
Last Updated: February 11, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Hemorrhoids
Surgery
Hemorrhoidopexy
Milligan Morgan

Additional relevant MeSH terms:
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014