Study About Patient Comfort and Long-term Outcome After Stapled Hemorrhoidopexy
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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 |
- Postoperative Pain [ Time Frame: within the first 30 days after surgery ] [ Designated as safety issue: No ]
- 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 |
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
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 May 21, 2013