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

NCT ID: NCT01533363

Last Updated: 2012-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-07-31
• Study Completion Date: 2007-09-30

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.

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.

Conditions

Internal Hemorrhoids

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stapled hemorrhoidopexy

surgical procedure to treat hemorrhoids

Group Type: ACTIVE_COMPARATOR

Stapled hemorrhoidopexy

Intervention Type: PROCEDURE

Milligan Morgan

surgical procedure to treat hemorrhoids

Group Type: ACTIVE_COMPARATOR

Milligan Morgan

Intervention Type: PROCEDURE

Interventions

Stapled hemorrhoidopexy

Intervention Type: PROCEDURE

Milligan Morgan

Intervention Type: PROCEDURE

Other Intervention Names

Ethicon PPH 01

Eligibility 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Dr. med. Asad Kutup

Senior Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jakob R Izbicki, MD

Role: STUDY_CHAIR

Dept. of Surgery, Martinistreet 52, University Hospital Hamburg Eppendorf, 20246 Hamburg

References

Gravie JF, Lehur PA, Huten N, Papillon M, Fantoli M, Descottes B, Pessaux P, Arnaud JP. Stapled hemorrhoidopexy versus milligan-morgan hemorrhoidectomy: a prospective, randomized, multicenter trial with 2-year postoperative follow up. Ann Surg. 2005 Jul;242(1):29-35. doi: 10.1097/01.sla.0000169570.64579.31.

Reference Type: BACKGROUND

PMID: 15973098 (View on PubMed)

Other Identifiers

1612

Identifier Type: -

Identifier Source: org_study_id