ClinicalTrials.gg
CompletedNCT06330857Updated Nov 28, 2025

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

An interventional study of Laparoscopic vaginorectopexy in Rectal Prolapse, Fecal Incontinence and Defecation Disorder, sponsored by Sahlgrenska University Hospital. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-28.

Sponsored by Sahlgrenska University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 21 years 9 months after the study started (first participant enrolled May 2002, registered Mar 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

Read the detailed description

Patients and Methods

Patients From 2002 to 2008, referred patients with symptoms of obstructed defecation (=OD) and diagnosed with multiple posterior pelvic organ prolapse (=PPOP) (protocol below) were considered for inclusion in the study. More than one defect (internal-or external rectal prolapse, Enterocele (EC) or Rectocele (RC)) was denoted as multiple PPOP. Patients were evaluated with clinical examination, defecography and a questionnaire that evaluated bowel function and bowel-related quality of life (QoL). Patients who did not respond to conservative treatment (diet advice, oral bulking agents, rectal enemas and/or bio-feedback) were offered inclusion in the study.

Patients with anismus were excluded after evaluation with a combination of defecography (see below) and manometry.

Surgical procedure Pneumoperitoneum was established with Verres needle. Two 12 mm trocars are placed at the umbilicus and two cm above the symphysis. Two 5 mm trocars are placed in the right and left iliac fossa. The procedure starts with an incision exposing the promontory which continues down along the right peritoneal reflection (Fig 9). A limited dissection of the promontory and a shallow unilateral incision was employed to avoid damage to the superior hypogastric plexus and the hypogastric nerves. The rectovaginal space was opened down to the pelvic floor, exposing the pelvic floor muscles. A T-shaped Vypro-mesh was inserted into the rectovaginal space and sutured to the pelvic floor muscles lateral to the vagina and to the distal vagina with a non-absorbable suture (EthibondR,). Two additional sutures fixated the mesh to the sacrouterine ligaments, closing the rectovaginal space and elevating the pouch of Douglas. Staples were used to anchor the mesh to the promontory as well as the mesorectum to the mesh, preventing rectal intussusception. The peritoneal defect was closed with a running, absorbable suture.

Bowel Function Questionnaire The symptom load was evaluated with Linkoping Bowel function Questionnaire (LBQ). It is a quantitative bowel function questionnaire that evaluates four domains: fecal incontinence, constipation, OD and bowel-related quality of life. Symptom load is graded in four levels. Questions considered most relevant for each category of OD, incontinence and QoL were used for the longitudinal analyses.

Defecography

The defecography used plain X-ray and pictures/film were recorded at rest and during straining with the patient situated on a commode. Preparations included oral, rectal and vaginal contrast. Examination of the investigation was made by two senior radiologists and the following protocol was used for evaluation:

Rectal prolapse Oxford grading system 1-5 for intususception and external prolapse.

Enterocele Grade1 EC reaching below cervix, but not distal to half of the vaginal length. Grade 2 EC reaching below half of the vaginal length, but not below the sphincter plane.

Grade 3 EC protruding below the sphincter plane and out of the anal canal.

Rectocele A protrusion beyond the imaginary line between the sphincter and the rectum over or equal to 2 cm in depth.

Anismus The inability to open the anal canal during evacuation of rectal contrast without an anatomical reason. The puborectal function is evaluated separately regardless of signs of anismus with assessment of the anorectal angle.

The following protocol was used at follow-up visits:

3 months: Recording of per -and postoperative complications. Review of medical records and visit at the outpatient clinic.

12 months:

  1. Clinical examination by one surgeon and one gynaecologist
  2. Defecography
  3. Bowel function questionnaire (LBQ)

Since defecographic evaluation was not always available due to technical failure and/or patient related factors, the evaluation protocol was adjusted according to the reliability of the clinical examination. Clinical evaluation of EC and internal prolapse (IRP) is difficult and unreliable. However, clinical evaluation of RC (> 2cm), is considered reliable. Therefore, clinical evaluation was considered sufficient for evaluation of rectocele, but not for enterocele or internal prolapse.

The following protocol was used:

Rectal prolapse and RC: Clinical evaluation and defecography. If defecography was not evaluable, clinical evaluation was considered sufficient.

IRP and EC: Clinical evaluation and defecography. If defecography was not evaluable, clinical evaluation was considered insufficient.

Long term:

During 2020, LBQ was sent to all patients who were alive achieving a minimum of 10 years follow-up; patients who did not respond were contacted via telephone. Median follow-up was 16 years (10-18 years)

02

Conditions studied

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

Keywords

  • laparoscopy
  • obstructive defecation
03

In context

Rectal Prolapse

55 studies on the registry are indexed under Rectal Prolapse; 12 are open to participants now.

This study's enrollment of 25 is below the median of 55 across 34 interventional studies indexed under Rectal Prolapse.

Browse Rectal Prolapse studies →

Lead sponsor

Sahlgrenska University Hospital is the lead sponsor of 263 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Anismus
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Surgical intervention

    Operated with the intervention, ie vaginorectopexy

    Procedure: Laparoscopic vaginorectopexy

Interventions

  • ProcedureLaparoscopic vaginorectopexy

    Modified laparoscopic anterior rectopexy for multiple pelvic prolapses

06

What researchers measure

Primary outcomes

  1. Recurrence

    Clinical and radiological assesment of relapse of prolapse

    Time frame: One year

  2. Bowel function

    Questionnaire regarding fecal incontinence and obstructed defecation

    Time frame: Over ten years

  3. Bowel related quality of life

    Questionnaire regarding bowel related quality of life

    Time frame: Over ten years

Secondary outcomes

  1. Postoperative complications

    Complications within 30 days after surgery

    Time frame: 30 days

  2. Peroperative complications

    Complications during surgery

    Time frame: surgery

  3. Operative time

    Time from start of operative procedure to the end of surgery

    Time frame: minutes

  4. Conversions to open surgery

    Numbers of operations where conversion to open surgery were necessary

    Time frame: Numbers

  5. Hospital days

    Number of days in hospital after surgery

    Time frame: days

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 7956583 ↗
  • 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. PubMed 17031741 ↗
  • 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. PubMed 23741928 ↗
  • 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. PubMed 8055725 ↗
  • 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. PubMed 19486104 ↗
  • 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. PubMed 34633567 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2002 to primary completion in Apr 2024, 262 months.

Of 18 interventional studies with no phase under Rectal Prolapse, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 94. This study's 262 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 11, 2024
First posted
Mar 26, 2024
StartActual
May 28, 2002
Primary completionActual
Apr 1, 2024
CompletionActual
Oct 1, 2025
Last update
Nov 28, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06330857
Responsible party
Bjarne Melvas (Consultant, Sahlgrenska University Hospital) — Principal investigator
First posted
Mar 26, 2024
Start date
May 28, 2002
Primary completion
Apr 1, 2024
Completion
Oct 1, 2025
Last update
Nov 28, 2025

Study contacts

Lars Borjesson, Professor
principal investigator · Göteborg University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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