ClinicalTrials.gg
Sign In
CompletedNCT04502953Updated Aug 6, 2020

Vertical Versus Horizontal Plicataion in Transperienal Repair of Rectocele

An interventional study of Vertical plication and Horizontal plication in Rectocele, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-08-06.

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 Jun 2018, registered Aug 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

We assumed that the technique of plication of the rectovaginal septum and rectal wall may factor in providing better and more sustained repair that confers more satisfactory improvement in symptoms. The present randomized study aimed to evaluate the outcome of TPR with vertical plication of the rectovaginal septum as compared to the horizontal plication with regards to improvement in ODS, recurrence of rectocele, postoperative complications and dyspareunia.

02

Conditions studied

  • Rectocele

Browse trials for

03

In context

Rectocele

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

This study's enrollment of 40 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.

Browse Mansoura University studies →

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

04

Who can participate

Ages eligible
18 Years to 75 Years
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

  • Vertical plication of the rectovaginal septum was done

Exclusion criteria

Exclusion Criteria:

  • patients with ODS caused by conditions other than rectocele such as anismus and internal rectal prolapse
  • patients with slow transit constipation.
  • patients with recurrent rectocele after previous surgery.
  • patients with pre-existing FI
  • patients with associated anorectal pathology.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    Vertical plication

    Vertical plication of the rectovaginal septum was done

    Procedure: Vertical plication

  • Active comparator
    Horizontal plication

    Horizontal plication of the rectovaginal septum was done

    Procedure: Horizontal plication

Interventions

  • ProcedureVertical plication

    Vertical plication of the rectovaginal septum was done

  • ProcedureHorizontal plication

    Horizontal plication of the rectovaginal septum was done

06

What researchers measure

Primary outcomes

  1. Complete cure of symptoms

    Absence of symptoms of constipation with Wexner score \<2

    Time frame: 12 months after repair

07

Study locations

1 site
  • Mansoura university hospital
    Mansourah, Dakahlia, 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 Jun 2018 to primary completion in Apr 2019, 10 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 10 months is below that.

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

Registered
Aug 4, 2020
First posted
Aug 6, 2020
StartActual
Jun 1, 2018
Primary completionActual
Apr 30, 2019
CompletionActual
May 30, 2020
Last update
Aug 6, 2020
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 Aug 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04502953
Lead sponsor
Mansoura University
Responsible party
Sponsor
First posted
Aug 6, 2020
Start date
Jun 1, 2018
Primary completion
Apr 30, 2019
Completion
May 30, 2020
Last update
Aug 6, 2020

Study contacts

Sameh H Emile
study chair · Mansoura University

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 Aug 2020. 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.

Other studies in this condition

Rectocele →

Other studies from this sponsor

Mansoura University →

Start the discussion