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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Internal Hemorrhoids

Intervention / Treatment
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* Procedure: Stapled hemorrhoidopexy
* Procedure: Milligan Morgan


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stapled hemorrhoidopexy<br>surgical procedure to treat hemorrhoids | Procedure: Stapled hemorrhoidopexy<br> <br> * Other names: Ethicon PPH 01;|
| Active Comparator: Milligan Morgan<br>surgical procedure to treat hemorrhoids | Procedure: Milligan Morgan<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Pain |  | within the first 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| long-term recurrence rate | 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 | up to 5 years after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemorrhoids, Surgery, Hemorrhoidopexy, Milligan Morgan