Swedish Rectal Prolapse Trial

Sponsor
Danderyd Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT04893642
Collaborator
Uppsala University Hospital (Other)
134
12
4
218.3
11.2
0.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Suture rectopexy
  • Procedure: resection rectopexy
  • Procedure: Delorme's operation
  • Procedure: Altemeier's operation
N/A

Detailed Description

Background Full thickness rectal prolapse, or procidentia, is a benign but distressing condition. It is defined as the circumferential protrusion of all layers of the rectal wall through the anal sphincters. The annual incidence is 2,5 per 100 000, predominantly in the elderly, and male-to-female ratio is about 1:6.

More than 100 different procedures have been described for surgical treatment of rectal prolapse and consensus has not yet been reached. Traditionally, perineal procedures have been reserved for older patients who are not fit for an abdominal operation. The two most common perineal procedures are Delorme's operation, i.e. mucosectomy and rectal plication, and perineal rectosigmoidectomy, also known as Altemeier's operation, which is a full-thickness excision of the rectum.

The choices between abdominal vs. perineal approach and resection or not were all addressed in the Swedish rectal prolapse trial with possible differences in bowel function, quality of life, recurrence rate and complications as end points.

Study design and randomization This was a multicenter randomized trial with a 2 x 2 factorial design conducted in 13 sites in Sweden. At inclusion, patients signed an informed consent form and the attending surgeon contacted the central trial office at the Danderyd Hospital, Stockholm, Sweden. Randomization was performed with randomly assigned envelopes, stratified for each participating center. Patients were randomized between perineal and abdominal approach (A). The perineal group was further randomized to Delorme's or Altemeier's procedure (B) and the abdominal group to suture rectopexy or resection rectopexy (C). Patients who were considered unsuitable for random allocation to a perineal or an abdominal procedure were included only in (B) or (C).

Preoperative evaluation and procedures All patients were clinically examined and diagnosed with full thickness rectal prolapse. Further examinations with endoscopy, colon transit studies, anorectal manometry, defecography, endoanal ultrasound and pudendal nerve motor latency were optional and were performed as indicated at each surgeon's discretion. Operative procedures were described in the study protocol, see appendix. Abdominal procedures were performed laparoscopically or as open procedure.

In order to validate data all questionnaires were gathered at the central trial hospital and inspected by a second researcher.

The surgical procedures were identified and standardized to a large extent. Both minimal invasive and open surgery were allowed. For example the abdominal procedures were described that mobilization of rectum should be done in the posterior aspect, the lateral ligaments should not be divided, Suture rectopexy should be done with non-absorbable 0.0 sutures, the cul de sac should not be closed.

The sample size was calculated to 220 patients in the first randomization between abdominal and perineal approach. With 220 patients a difference in recurrence of 13% could be identified with 90% power in a significance level of 5%. The plan was to analyze the categorical variables with either Fisher´s exact test or multivariate analysis.

A main study office was situated at Danderyd Hospital and randomization was done from this office at the time when the patient was scheduled for surgery. All hospitals performing surgery for rectal prolapses in Sweden were invited to the study.

Study Design

Study Type:
Interventional
Actual Enrollment :
134 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Intervention Model Description:
This was a multicenter randomized trial with a 2 x 2 factorial design conducted in 13 sites in Sweden. Randomization was performed with randomly assigned envelopes, stratified for each participating center. Patients were randomized between perineal and abdominal approach (A). The perineal group was further randomized to Delorme's or Altemeier's procedure (B) and the abdominal group to suture rectopexy or resection rectopexy (C). Patients who were considered unsuitable for random allocation to a perineal or an abdominal procedure were included only in (B) or (C).This was a multicenter randomized trial with a 2 x 2 factorial design conducted in 13 sites in Sweden. Randomization was performed with randomly assigned envelopes, stratified for each participating center. Patients were randomized between perineal and abdominal approach (A). The perineal group was further randomized to Delorme's or Altemeier's procedure (B) and the abdominal group to suture rectopexy or resection rectopexy (C). Patients who were considered unsuitable for random allocation to a perineal or an abdominal procedure were included only in (B) or (C).
Masking:
Single (Outcomes Assessor)
Masking Description:
Masking was done for outcome assessor concerning the answers for questionnaires that were the primary endpoint. Masking of arms were not done concerning recurrence of rectal prolapse.
Primary Purpose:
Treatment
Official Title:
To Resect or Not Resect - The Randomized Swedish Rectal Prolapse Trial
Actual Study Start Date :
Mar 23, 2000
Actual Primary Completion Date :
Jun 1, 2018
Actual Study Completion Date :
Jun 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Abdominal suture rectopexy

Patients were randomized first into either an abdominal or a perineal approach. The abdominal group was then further randomized to suture rectopexy or resection rectopexy.

Procedure: Suture rectopexy

Active Comparator: Abdominal resection rectopexy

Patients were randomized first into either an abdominal or a perineal approach. The abdominal group was then further randomized to suture rectopexy or resection rectopexy.

Procedure: resection rectopexy

Active Comparator: Perineal Delorme

Patients were randomized first into either an abdominal or a perineal approach. The perineal group was then further randomized to Delorme's operation or Altemeier's operation.

Procedure: Delorme's operation

Active Comparator: Perineal Altemeier

Patients were randomized first into either an abdominal or a perineal approach. The perineal group was then further randomized to Delorme's operation or Altemeier's operation.

Procedure: Altemeier's operation

Outcome Measures

Primary Outcome Measures

  1. Bowel function [3 months]

    Wexner incontinence score, points, 0-20, higher worse result

  2. Bowel function [1 year]

    Wexner incontinence score, points, 0-20, higher worse result

  3. Bowel function [3 years]

    Wexner incontinence score, points, 0-20, higher worse result

  4. Quality of Life [3 months]

    SF-36, points, 0-100 points, higher better result

  5. Quality of Life [1 year]

    SF-36, points, 0-100 points, higher better result

  6. Quality of Life [3 years]

    SF-36, points, 0-100 points, higher better result

Secondary Outcome Measures

  1. Recurrence of rectal prolapse [3 months]

    recurrence at outpatient visits

  2. Recurrence of rectal prolapse [1 year]

    recurrence at outpatient visits

  3. Recurrence of rectal prolapse [3 years]

    recurrence at outpatient visits

  4. Recurrence of rectal prolapse [through study completion, an average of 12 years]

    Recurrence in Medical records

Other Outcome Measures

  1. Length of staý [up to 30 days after surgical intervention]

    days

  2. Blood loss at operation [during the surgical procedure]

    milliliter

  3. perioperative complications [up to 30 days after surgical intervention]

    number classified by Clavien-Dindo

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Complete rectal prolapse

  2. Informed consent

  3. Surgical correction is considered appropriate

  4. Capable to participate in follow-up visits and answering questionnaires

Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sahlgrenska University Hospital Gothenburg Sweden
2 Karlstad Central Hospital Karlstad Sweden
3 Linköping University Hospital Linköping Sweden
4 Sunderbyn Hopsital Luleå Sweden
5 Skåne University Hospital Malmö Sweden
6 Vrinnevi Hospital Norrköping Sweden
7 Danderyd Hospital Stockholm Sweden 18150
8 karolinska Univeristy Hospital Solna Stockholm Sweden
9 Karolinska University Hospital Huddiinge Stockholm Sweden
10 Sankt göran hospital Stockholm Sweden
11 Uddevalla Hospital Uddevalla Sweden
12 Uppsala University Hospital Uppsala Sweden

Sponsors and Collaborators

  • Danderyd Hospital
  • Uppsala University Hospital

Investigators

  • Principal Investigator: Fredrik Hjern, Ass Prof, MD, Danderyd Hospital
  • Study Director: Klas Pekkari, Md PhD, Danderyd Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Klas Pekkari, Head of Colorectal unit, Senior consultant, Md, PhD, Danderyd Hospital
ClinicalTrials.gov Identifier:
NCT04893642
Other Study ID Numbers:
  • swedishrectalprolapse
First Posted:
May 19, 2021
Last Update Posted:
May 19, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Klas Pekkari, Head of Colorectal unit, Senior consultant, Md, PhD, Danderyd Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 19, 2021