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Swedish Rectal Prolapse Trial

NCT04893642 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2021-05-19

No results posted yet for this study

Summary

Rectal prolapse is a medical condition where rectum is protruding through the anal opening. The treatment is by surgery that can be performed with an anterior approach through the abdomen or a posterior perineal approach. The condition is more common in elderly patients and much more common in women compared to men. All used surgical techniques have advantages and disadvantages. The primary aim of this study is to evaluate if an abdominal or perineal surgical approach is best to correct a rectal prolapse. The outcome measures will be validated questionnaires on quality of Life (SF-36) and bowel function (modified Wexner incontinence score) as well as recurrence of the rectal prolapse and surgical complications.

The study is a randomized multicenter trial with a 2x2 factorial design. Patients will be randomized between perineal and abdominal approach in a first randomization and the perineal group will then further be randomized into one of two specific operations (delorme or altemeier) and the abdominal group will be further randomized into suture rectopexy or resection rectopexy.

The patients will be followed for 3 months, 1 year and 3 years and a longterm follow up of up to 17 years for recurrence.

Conditions

  • Rectal Prolapse

Interventions

PROCEDURE

Suture rectopexy

PROCEDURE

resection rectopexy

PROCEDURE

Delorme's operation

PROCEDURE

Altemeier's operation

Sponsors & Collaborators

  • Uppsala University Hospital

    collaborator OTHER

  • Danderyd Hospital

    lead OTHER

Principal Investigators

  • Fredrik Hjern, Ass Prof, MD · Danderyd Hospital

  • Klas Pekkari, Md PhD · Danderyd Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-03-23
Primary Completion
2018-06-01
Completion
2018-06-01

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04893642 on ClinicalTrials.gov