ClinicalTrials.gg
CompletedNCT05894226Updated Jun 8, 2023

Functional and Sexual Outcomes After Laparoscopic Ventral Mesh Rectopexy for Complex Rectocele

An interventional study of laparoscopic ventral mesh rectopexy in Rectocele and Obstructive Defecation Syndrome, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to female participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-06-08.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 2 months after the study started (first participant enrolled Mar 2021, registered May 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
30 Years to 60 Years
Sex
Female
01

Study summary

The ideal surgical strategy for treating complex rectocele remains a topic for debate, with the transanal, transperineal, and transvaginal approach and the abdominal approach being at conflict with one another. While the transvaginal repair is more popular among gynecologists, the trans abdominal approach has become increasingly common among colorectal surgeons, in part due to the rising demand for minimally invasive surgery.

Read the detailed description

For the treatment of rectoceles and ODS in general, the laparoscopic method has recently come to light as a promising alternative.

Laparoscopic ventral mesh rectopexy (LVMR) was originally described for the management of rectal prolapse. However, It was also recommended with encouraging results for the treatment of large symptomatic rectocele.

The present study aims to evaluate the safety and efficacy of LVMR for complex rectocele.

02

Conditions studied

  • Rectocele
  • Obstructive Defecation Syndrome

Browse trials for

Keywords

  • Anterior rectocele
  • laparoscopic ventral mesh rectopexy
03

In context

Rectocele

50 studies on the registry are indexed under Rectocele; 9 are open to participants now.

This study's enrollment of 15 is below the median of 62 across 37 interventional studies indexed under Rectocele.

Browse Rectocele studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

04

Who can participate

Ages eligible
30 Years to 60 Years
Sexes eligible
Female
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

  • multiparous female patients.
  • aged between 30 and 60 years
  • who were diagnosed with complex anterior rectocele- more than 3cm after failed medical treatment- with history of either vaginal delivery or caesarian section.
  • complex rectocele was one having any of the following features: size > 3 cm in diameter, associated enterocoele or internal rectal prolapse

Exclusion criteria

Exclusion Criteria:

  • paradoxical contraction of puborectalis muscle (anismus),
  • complete external rectal prolapse
  • fecal incontinence
  • other benign anal conditions
  • those who are unfit for surgery due to associated severe co-morbidities
05

Study design

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

Study arms

  • Experimental
    laparoscopic ventral mesh rectopexy arm

    those who were underwent laparoscopic ventral mesh rectopexy for rectocele.

    Procedure: laparoscopic ventral mesh rectopexy

Interventions

  • Procedurelaparoscopic ventral mesh rectopexy

    patients are treated by laparoscopic ventral mesh rectopexy for anterior rectocele

06

What researchers measure

Primary outcomes

  1. changes in the Wexner constipation score

    improvement in constipation, if the score is decreasing this means improving

    Time frame: 6 months

Secondary outcomes

  1. sexual function changes

    changes in the sexual function score post operative (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire score(PISQ-12). The lower the score the better the function.

    Time frame: 6 months

07

Study locations

1 site
  • Ahmad
    Mansoura, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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 Mar 2021 to primary completion in Feb 2022, 11 months.

Of 16 interventional studies with no phase under Rectocele, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 38. This study's 11 months is below that.

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

Registered
May 26, 2023
First posted
Jun 8, 2023
StartActual
Mar 1, 2021
Primary completionActual
Feb 1, 2022
CompletionActual
Aug 30, 2022
Last update
Jun 8, 2023
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 Jun 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05894226
Responsible party
Ahmad Sakr (consultant and lecturer of general surgery, Mansoura University) — Principal investigator
First posted
Jun 8, 2023
Start date
Mar 1, 2021
Primary completion
Feb 1, 2022
Completion
Aug 30, 2022
Last update
Jun 8, 2023

Oversight

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

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion