Swedish Rectal Prolapse Trial

Study Overview
=================
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.

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.

Official Title
-----------------
To Resect or Not Resect - The Randomized Swedish Rectal Prolapse Trial

Conditions
-----------------
Rectal Prolapse

Intervention / Treatment
-----------------
* Procedure: Suture rectopexy
* Procedure: resection rectopexy
* Procedure: Delorme's operation
* Procedure: Altemeier's operation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Complete rectal prolapse Informed consent Surgical correction is considered appropriate Capable to participate in follow-up visits and answering questionnaires Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional 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).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Abdominal suture rectopexy<br>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<br> <br> |
| Active Comparator: Abdominal resection rectopexy<br>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<br> <br> |
| Active Comparator: Perineal Delorme<br>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<br> <br> |
| Active Comparator: Perineal Altemeier<br>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<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel function | Wexner incontinence score, points, 0-20, higher worse result | 3 months | 
| Bowel function | Wexner incontinence score, points, 0-20, higher worse result | 1 year | 
| Bowel function | Wexner incontinence score, points, 0-20, higher worse result | 3 years | 
| Quality of Life | SF-36, points, 0-100 points, higher better result | 3 months | 
| Quality of Life | SF-36, points, 0-100 points, higher better result | 1 year | 
| Quality of Life | SF-36, points, 0-100 points, higher better result | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of rectal prolapse | recurrence at outpatient visits | 3 months | 
| Recurrence of rectal prolapse | recurrence at outpatient visits | 1 year | 
| Recurrence of rectal prolapse | recurrence at outpatient visits | 3 years | 
| Recurrence of rectal prolapse | Recurrence in Medical records | through study completion, an average of 12 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Randomized controlled study, Multicenter, Prospective