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Rectal ProlapseNCT06330857

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

A study testing Laparoscopic vaginorectopexy in people with Rectal Prolapse and Fecal Incontinence, run by Sahlgrenska University Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Laparoscopic vaginorectopexy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
No sites listed yet
Study dates
28 May 2002to 1 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Anismus

About this study

Official title: Evaluation of Anatomy and Symptoms After Surgery With a Novel Anterior Rectopexy in a Cohort With Combined Pelvic Defects.

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)

Being tested
Laparoscopic vaginorectopexy
Keywords
laparoscopy, obstructive defecation
Medical subject headings
Rectal Prolapse, Fecal Incontinence, Hernia, Rectocele

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laparoscopic vaginorectopexyProcedure or surgery

    Modified laparoscopic anterior rectopexy for multiple pelvic prolapses

Study groups in NCT06330857
Study groupRoleWhat they receive
Surgical interventionExperimentalOperated with the intervention, ie vaginorectopexy
Receives: Procedure: Laparoscopic vaginorectopexy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrence

    Clinical and radiological assesment of relapse of prolapse

    Measured: One year

  2. Bowel function

    Questionnaire regarding fecal incontinence and obstructed defecation

    Measured: Over ten years

  3. Bowel related quality of life

    Questionnaire regarding bowel related quality of life

    Measured: Over ten years

Secondary outcomes (5)
  1. Postoperative complications

    Complications within 30 days after surgery

    Measured: 30 days

  2. Peroperative complications

    Complications during surgery

    Measured: surgery

  3. Operative time

    Time from start of operative procedure to the end of surgery

    Measured: minutes

  4. Conversions to open surgery

    Numbers of operations where conversion to open surgery were necessary

    Measured: Numbers

  5. Hospital days

    Number of days in hospital after surgery

    Measured: days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2024
  2. Study start28 May 2002
  3. Primary completion1 Apr 2024
  4. Study completion1 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Evaluation of recurrence with clinical examination and defecography. Evaluation of bowel function with a questionnaire.
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06330857
Sponsor's protocol ID
Dnr2021-06921-02
Status last verified
Nov 2025
First submitted
11 Mar 2024
Last updated
28 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Laparoscopic vaginorectopexy in people with Rectal Prolapse and Fecal Incontinence, run by Sahlgrenska University Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence (time frame: One year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06330857, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.

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