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

U

Universitätsklinikum Hamburg-Eppendorf

Status and phase

Completed
Phase 3

Conditions

Internal Hemorrhoids

Treatments

Procedure: Milligan Morgan
Procedure: Stapled hemorrhoidopexy

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

130 patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

130 participants in 2 patient groups

Stapled hemorrhoidopexy
Active Comparator group
Description:
surgical procedure to treat hemorrhoids
Treatment:
Procedure: Stapled hemorrhoidopexy
Milligan Morgan
Active Comparator group
Description:
surgical procedure to treat hemorrhoids
Treatment:
Procedure: Milligan Morgan

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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