Clinical trial NCT04893642: Swedish Rectal Prolapse Trial
Official title: To Resect or Not Resect - The Randomized Swedish Rectal Prolapse Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Rectal Prolapse
Keywords: Randomized controlled study
Multicenter
Prospective
Lead sponsor: Danderyd Hospital
Sponsor class: OTHER
Collaborators: name: Uppsala University Hospital
First posted: 2021-05-19
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Bowel function
timeFrame: 3 months
measure: Bowel function
timeFrame: 1 year
measure: Bowel function
timeFrame: 3 years
measure: Quality of Life
timeFrame: 3 months
measure: Quality of Life
timeFrame: 1 year
measure: Quality of Life
timeFrame: 3 years
Secondary outcomes:
measure: Recurrence of rectal prolapse
timeFrame: 3 months
measure: Recurrence of rectal prolapse
timeFrame: 1 year
measure: Recurrence of rectal prolapse
timeFrame: 3 years
measure: Recurrence of rectal prolapse
timeFrame: through study completion, an average of 12 years
Other outcomes:
measure: Length of staý
timeFrame: up to 30 days after surgical intervention
measure: Blood loss at operation
timeFrame: during the surgical procedure
measure: perioperative complications
timeFrame: up to 30 days after surgical intervention
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Karlstad
country: Sweden
facility: Karlstad Central Hospital
city: Linköping
country: Sweden
facility: Linköping University Hospital
city: Luleå
country: Sweden
facility: Sunderbyn Hopsital
city: Malmö
country: Sweden
facility: Skåne University Hospital
city: Norrköping
country: Sweden
facility: Vrinnevi Hospital
city: Stockholm
country: Sweden
facility: Danderyd Hospital
city: Stockholm
country: Sweden
facility: karolinska Univeristy Hospital Solna
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Huddiinge
city: Stockholm
country: Sweden
facility: Sankt göran hospital
city: Uddevalla
country: Sweden
facility: Uddevalla Hospital
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: Danderyd Hospital
name: Fredrik Hjern, Ass Prof, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Danderyd Hospital
name: Klas Pekkari, Md PhD
role: STUDY_DIRECTOR
References:
citation: Tou S, Brown SR, Nelson RL. Surgery for complete (full-thickness) rectal prolapse in adults. Cochrane Database Syst Rev. 2015 Nov 24;2015(11):CD001758. doi: 10.1002/14651858.CD001758.pub3.
citation: Kairaluoma MV, Kellokumpu IH. Epidemiologic aspects of complete rectal prolapse. Scand J Surg. 2005;94(3):207-10. doi: 10.1177/145749690509400306.
citation: Madiba TE, Baig MK, Wexner SD. Surgical management of rectal prolapse. Arch Surg. 2005 Jan;140(1):63-73. doi: 10.1001/archsurg.140.1.63.
citation: Lundby L, Iversen LH, Buntzen S, Wara P, Hoyer 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.
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.
citation: Orwelius L, Nilsson M, Nilsson E, Wenemark M, Walfridsson U, Lundstrom 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.
citation: Smedberg J, Graf W, Pekkari K, Hjern F. Comparison of four surgical approaches for rectal prolapse: multicentre randomized clinical trial. BJS Open. 2022 Jan 6;6(1):zrab140. doi: 10.1093/bjsopen/zrab140.