Patient Comfort After Stapled Hemorrhoidopexy Long Term Results of a Randomized Controlled Trial
| Registry | NCT01533363 |
|---|---|
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 130 (Actual) |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf (Other) |
| Conditions | Internal Hemorrhoids |
| Interventions | Stapled hemorrhoidopexy, Milligan Morgan (Procedure) |
| Dates | start 2000-07-01, primary completion 2007-09-01, completion 2007-09-01, first posted 2012-02-15, last updated 2012-02-15 |
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All trials for Internal Hemorrhoids All trials of Stapled hemorrhoidopexy All trials of Milligan Morgan
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Stapled hemorrhoidopexy | Active comparator | Procedure: Stapled hemorrhoidopexy | surgical procedure to treat hemorrhoids |
| Milligan Morgan | Active comparator | Procedure: Milligan Morgan | surgical procedure to treat hemorrhoids |
Sex: All
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.