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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01533363
Recruitment Status : Completed
First Posted : February 15, 2012
Last Update Posted : February 15, 2012
Information provided by (Responsible Party):
Dr. med. Asad Kutup, 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.

Condition or disease Intervention/treatment Phase
Internal Hemorrhoids Procedure: Stapled hemorrhoidopexy Procedure: Milligan Morgan Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Patient Comfort After Stapled Hemorrhoidopexy Long Term Results of a Randomized Controlled Trial
Study Start Date : July 2000
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Postoperative Pain [ Time Frame: within the first 30 days after surgery ]

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01533363

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

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Responsible Party: Dr. med. Asad Kutup, Senior Surgeon, Universitätsklinikum Hamburg-Eppendorf Identifier: NCT01533363    
Other Study ID Numbers: 1612
First Posted: February 15, 2012    Key Record Dates
Last Update Posted: February 15, 2012
Last Verified: February 2012
Keywords provided by Dr. med. Asad Kutup, Universitätsklinikum Hamburg-Eppendorf:
Milligan Morgan
Additional relevant MeSH terms:
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Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases