Recurrence and Bowel Function After Laparoscopic Vaginorectopexy, a Modified Anterior Rectopexy

NCT06330857 | Completed

• 1 other identifier: Dnr2021-06921-02
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

Several pelvic prolapses can render defecation difficulties and they are often treated with different surgical techniques. This study will evaluate a novel variation of a laparoscopic technique used to treat rectal prolapse that is modified to treat multiple pelvic prolapses. 25 women with symptoms of obstructed defecation and multiple pelvic prolapses are assessed before and after surgery with clinical examination, defecography and a questionnaire for bowel function and quality of life. Follow up was scheduled after three and twelve months and at long term (minimum ten years).

Conditions

Rectal Prolapse; Fecal Incontinence; Defecation Disorder; Enterocele; Rectocele

Keywords

laparoscopy; obstructive defecation

Outcome Measures

Primary Outcomes (3)

• Recurrence

  Clinical and radiological assesment of relapse of prolapse

  One year

• Bowel function

  Questionnaire regarding fecal incontinence and obstructed defecation

  Over ten years

• Bowel related quality of life

  Questionnaire regarding bowel related quality of life

  Over ten years

Secondary Outcomes (5)

• Postoperative complications

  30 days

• Peroperative complications

  surgery

• Operative time

  minutes

• Conversions to open surgery

  Numbers

• Hospital days

  days

Study Arms (1)

Surgical intervention

EXPERIMENTAL

Operated with the intervention, ie vaginorectopexy

Procedure: Laparoscopic vaginorectopexy

Interventions

Laparoscopic vaginorectopexy PROCEDURE

Modified laparoscopic anterior rectopexy for multiple pelvic prolapses

Surgical intervention

Eligibility Criteria

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

You may qualify if:

• Symptoms of obstructed defecation, more than one posterior pelvic organ prolapse, undergone conservative treatment

You may not qualify if:

• Anismus

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Related Publications (6)

• Mellgren A, Bremmer S, Johansson C, Dolk A, Uden R, Ahlback SO, Holmstrom B. Defecography. Results of investigations in 2,816 patients. Dis Colon Rectum. 1994 Nov;37(11):1133-41. doi: 10.1007/BF02049817.

  PMID: 7956583 BACKGROUND

• D'Hoore A, Penninckx F. Laparoscopic ventral recto(colpo)pexy for rectal prolapse: surgical technique and outcome for 109 patients. Surg Endosc. 2006 Dec;20(12):1919-23. doi: 10.1007/s00464-005-0485-y.

  PMID: 17031741 BACKGROUND

• van Geluwe B, Wolthuis A, Penninckx F, D'Hoore A. Lessons learned after more than 400 laparoscopic ventral rectopexies. Acta Chir Belg. 2013 Mar-Apr;113(2):103-6.

  PMID: 23741928 BACKGROUND

• Mellgren A, Dolk A, Johansson C, Bremmer S, Anzen B, Holmstrom B. Enterocele is correctable using the Ripstein rectopexy. Dis Colon Rectum. 1994 Aug;37(8):800-4. doi: 10.1007/BF02050145.

  PMID: 8055725 BACKGROUND

• Boons P, Collinson R, Cunningham C, Lindsey I. Laparoscopic ventral rectopexy for external rectal prolapse improves constipation and avoids de novo constipation. Colorectal Dis. 2010 Jun;12(6):526-32. doi: 10.1111/j.1463-1318.2009.01859.x. Epub 2009 Apr 10.

  PMID: 19486104 BACKGROUND

• Tsunoda A, Takahashi T, Matsuda S, Kusanagi H. Long-term annual functional outcome after laparoscopic ventral rectopexy for rectoanal intussusception and/or rectocele: evaluation of sustained improvement. Tech Coloproctol. 2021 Dec;25(12):1281-1289. doi: 10.1007/s10151-021-02499-4. Epub 2021 Oct 11.

  PMID: 34633567 BACKGROUND

MeSH Terms

Conditions

Rectal Prolapse; Fecal Incontinence; Hernia; Rectocele

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

• Lars Borjesson, Professor

  Göteborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Model Details: Evaluation of recurrence with clinical examination and defecography. Evaluation of bowel function with a questionnaire.

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 26, 2024
• Study Start: May 28, 2002
• Primary Completion: April 1, 2024
• Study Completion: October 1, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share