Swedish Rectal Prolapse Trial

NCT04893642 | Terminated

• 1 other identifier: swedishrectalprolapse
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 12

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.

Conditions

Rectal Prolapse

Keywords

Randomized controlled study; Multicenter; Prospective

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• Recurrence of rectal prolapse

  3 months

• Recurrence of rectal prolapse

  1 year

• Recurrence of rectal prolapse

  3 years

• Recurrence of rectal prolapse

  through study completion, an average of 12 years

Other Outcomes (3)

• Length of staý

  up to 30 days after surgical intervention

• Blood loss at operation

  during the surgical procedure

• perioperative complications

  up to 30 days after surgical intervention

Study Arms (4)

Abdominal suture rectopexy

ACTIVE COMPARATOR

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

Abdominal resection rectopexy

ACTIVE COMPARATOR

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

Perineal Delorme

ACTIVE COMPARATOR

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

Perineal Altemeier

ACTIVE COMPARATOR

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

Interventions

Suture rectopexy PROCEDURE

Abdominal suture rectopexy

resection rectopexy PROCEDURE

Abdominal resection rectopexy

Delorme's operation PROCEDURE

Perineal Delorme

Altemeier's operation PROCEDURE

Perineal Altemeier

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Complete rectal prolapse
• Informed consent
• Surgical correction is considered appropriate
• Capable to participate in follow-up visits and answering questionnaires

Sponsors & Collaborators

• Danderyd Hospital: lead
• Uppsala University Hospital: collaborator

Study Sites (12)

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Karlstad Central Hospital

Karlstad, Sweden

Location

Linköping University Hospital

Linköping, Sweden

Location

Sunderbyn Hopsital

Luleå, Sweden

Location

Skåne University Hospital

Malmo, Sweden

Location

Vrinnevi Hospital

Norrköping, Sweden

Location

Danderyd Hospital

Stockholm, 18150, Sweden

Location

karolinska Univeristy Hospital Solna

Stockholm, Sweden

Location

Karolinska University Hospital Huddiinge

Stockholm, Sweden

Location

Sankt göran hospital

Stockholm, Sweden

Location

Uddevalla Hospital

Uddevalla, Sweden

Location

Uppsala University Hospital

Uppsala, Sweden

Location

Related Publications (7)

• 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.

  PMID: 26599079 BACKGROUND

• Kairaluoma MV, Kellokumpu IH. Epidemiologic aspects of complete rectal prolapse. Scand J Surg. 2005;94(3):207-10. doi: 10.1177/145749690509400306.

  PMID: 16259169 BACKGROUND

• 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.

  PMID: 15655208 BACKGROUND

• 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.

  PMID: 28404199 BACKGROUND

• 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.

  PMID: 23461778 BACKGROUND

• 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.

  PMID: 29757320 BACKGROUND

• 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.

  PMID: 35045155 DERIVED

MeSH Terms

Conditions

Rectal Prolapse

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Fredrik Hjern, Ass Prof, MD

  Danderyd Hospital

  PRINCIPAL INVESTIGATOR

• Klas Pekkari, Md PhD

  Danderyd Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Colorectal unit, Senior consultant, Md, PhD

Model Details: 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).

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 19, 2021
• Study Start: March 23, 2000
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: May 19, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (12)