Swedish Rectal Prolapse Trial

Rectal Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04893642
• Other study ID #: swedishrectalprolapse
• Status: Terminated
• Phase: N/A
• Start date: March 23, 2000
• Est. completion date: June 1, 2018

Study information

• Verified date: May 2021
• Source: Danderyd Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 134
• Est. completion date: June 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Prolapse
• Rectal Prolapse

Intervention

Procedure:
• Suture rectopexy

• resection rectopexy

• Delorme's operation

• Altemeier's operation

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg
Sweden	Karlstad Central Hospital	Karlstad
Sweden	Linköping University Hospital	Linköping
Sweden	Sunderbyn Hopsital	Luleå
Sweden	Skåne University Hospital	Malmö
Sweden	Vrinnevi Hospital	Norrköping
Sweden	Danderyd Hospital	Stockholm
Sweden	karolinska Univeristy Hospital Solna	Stockholm
Sweden	Karolinska University Hospital Huddiinge	Stockholm
Sweden	Sankt göran hospital	Stockholm
Sweden	Uddevalla Hospital	Uddevalla
Sweden	Uppsala University Hospital	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Danderyd Hospital	Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (6)

Kairaluoma MV, Kellokumpu IH. Epidemiologic aspects of complete rectal prolapse. Scand J Surg. 2005;94(3):207-10. — View Citation

Lundby L, Iversen LH, Buntzen S, Wara P, Høyer K, Laurberg S. Bowel function after laparoscopic posterior sutured rectopexy versus ventral mesh rectopexy for rectal prolapse: a double-blind, randomised single-centre study. Lancet Gastroenterol Hepatol. 2016 Dec;1(4):291-297. doi: 10.1016/S2468-1253(16)30085-1. Epub 2016 Oct 4. — View Citation

Madiba TE, Baig MK, Wexner SD. Surgical management of rectal prolapse. Arch Surg. 2005 Jan;140(1):63-73. Review. — View Citation

Orwelius L, Nilsson M, Nilsson E, Wenemark M, Walfridsson U, Lundström M, Taft C, Palaszewski B, Kristenson M. The Swedish RAND-36 Health Survey - reliability and responsiveness assessed in patient populations using Svensson's method for paired ordinal data. J Patient Rep Outcomes. 2017;2(1):4. doi: 10.1186/s41687-018-0030-0. Epub 2018 Feb 7. — View Citation

Senapati A, Gray RG, Middleton LJ, Harding J, Hills RK, Armitage NC, Buckley L, Northover JM; PROSPER Collaborative Group. PROSPER: a randomised comparison of surgical treatments for rectal prolapse. Colorectal Dis. 2013 Jul;15(7):858-68. doi: 10.1111/codi.12177. — View Citation

Tou S, Brown SR, Nelson RL. Surgery for complete (full-thickness) rectal prolapse in adults. Cochrane Database Syst Rev. 2015 Nov 24;(11):CD001758. doi: 10.1002/14651858.CD001758.pub3. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of staý	days	up to 30 days after surgical intervention
Other	Blood loss at operation	milliliter	during the surgical procedure
Other	perioperative complications	number classified by Clavien-Dindo	up to 30 days after surgical intervention
Primary	Bowel function	Wexner incontinence score, points, 0-20, higher worse result	3 months
Primary	Bowel function	Wexner incontinence score, points, 0-20, higher worse result	1 year
Primary	Bowel function	Wexner incontinence score, points, 0-20, higher worse result	3 years
Primary	Quality of Life	SF-36, points, 0-100 points, higher better result	3 months
Primary	Quality of Life	SF-36, points, 0-100 points, higher better result	1 year
Primary	Quality of Life	SF-36, points, 0-100 points, higher better result	3 years
Secondary	Recurrence of rectal prolapse	recurrence at outpatient visits	3 months
Secondary	Recurrence of rectal prolapse	recurrence at outpatient visits	1 year
Secondary	Recurrence of rectal prolapse	recurrence at outpatient visits	3 years
Secondary	Recurrence of rectal prolapse	Recurrence in Medical records	through study completion, an average of 12 years