CompletedNCT03801291Updated Jan 11, 2019

Transvaginal Versus Transperineal Repair of Rectocele

An interventional study of Transvaginal repair and Transperineal repair in Rectocele, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-01-11.

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

From the registry’s dates

Registered 2 years 9 months after the study started (first participant enrolled Apr 2016, registered Jan 2019).

Phase: Not applicable
Study type: Interventional
Enrollment: 64
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: Female

Study summary

Patients with anterior rectocele were randomized to undergo either transvaginal or transperineal repair. The primary outcome of the study was improvement in constipation at 6 and 12 months

Conditions studied

Rectocele

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Rectocele 50

In context

Rectocele

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

This study's enrollment of 64 is close to 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.

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

Who can participate

Ages eligible: 18 Years to 70 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

Adult female patients with anterior rectocele

Exclusion criteria

Exclusion Criteria:

Male patients.
Combined rectocele with internal rectal prolapse.
Anismus.
Associated anorectal condition such as hemorrhoids and anal fissure.
Pregnancy.
Unwilling to participate in the trial

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 64 participants (actual)

Study arms

Active comparator
Transvaginal repair
Repair of anterior rectocele via the vagina
Procedure: Transvaginal repair
Active comparator
Transperineal repair
Repair of anterior rectocele via the perineum
Procedure: Transperineal repair

Interventions

ProcedureTransvaginal repair
Vaginal incision through which plication of the rectovaginal septum is done
ProcedureTransperineal repair
Perineal incision through which plication of the rectovaginal septum is done

What researchers measure

Primary outcomes

Improvement in constipation
decrease in Wexner constipation score by 25%
Time frame: 6 and 12 months after surgery

Study locations

1 site

Mansoura university hospital
Mansourah, Dakahlia, Egypt

References and documents

Publications

Balata M, Elgendy H, Emile SH, Youssef M, Omar W, Khafagy W. Functional Outcome and Sexual-Related Quality of Life After Transperineal Versus Transvaginal Repair of Anterior Rectocele: A Randomized Clinical Trial. Dis Colon Rectum. 2020 Apr;63(4):527-537. doi: 10.1097/DCR.0000000000001595. PubMed 31996580 ↗

Individual participant data

Plan to share: Undecided

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 Apr 2016 to primary completion in Jul 2018, 27 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 27 months is above that.

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

Registered: Jan 9, 2019
First posted: Jan 11, 2019
StartActual: Apr 1, 2016
Primary completionActual: Jul 1, 2018
CompletionActual: Jan 7, 2019
Last update: Jan 11, 2019

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 Jan 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03801291
Lead sponsor: Mansoura University
Responsible party: Sameh Emile (Lecturer of general surgery, Mansoura University) — Principal investigator
First posted: Jan 11, 2019
Start date: Apr 1, 2016
Primary completion: Jul 1, 2018
Completion: Jan 7, 2019
Last update: Jan 11, 2019

Study contacts

Sameh H Emile

principal investigator · 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 Jan 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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