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CompletedNCT02659176Updated Mar 16, 2016

Trans-perineal Repair With or Without Limited Internal Sphincterotomy for Treatment of Type I Anterior Rectocele

An interventional study of Transperineal repair with PIS and Transperineal repair without PIS in Rectocele, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-03-16.

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

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
Female
01

Study summary

Comparison between transperineal repair of rectocele with or without posterior internal sphincterotomy.

Read the detailed description

Transperineal repair of anterior rectocele is performed in two groups of patients, the first will undergo limited posterior internal sphincterotomy, the second group will not have internal sphincteroromy. The two groups are compared regarding recurrence of rectocele and improvement of symptoms.

02

Conditions studied

  • Rectocele

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03

In context

Rectocele

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

This study's enrollment of 60 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.

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

04

Who can participate

Ages eligible
18 Years to 80 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

  • Patients with anterior rectocele

Exclusion criteria

Exclusion Criteria:

  • Pregnant females
  • Rectocele with pelvic organ prolapse
  • Any patient with previous anorectal surgery
  • Pudendal nerve neuropathy
  • Anal fistula and sepsis
  • Patients with sphincter defect proved by endo-anal sonography
  • Patients proved to have colonic inertia either by colon transit time and/or history
  • Patients with defecography anomalies causing obstructed defecation other than rectocele (e.g. Anismus).
  • Also patients with vascular diseases, scleroderma, malnutrition, and coagulopathy were excluded.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Transperineal repair with PIS

    transperineal repair of anterior rectocele with limited internal sphincterotomy

    Procedure: Transperineal repair with PIS

  • Active comparator
    Transperineal repair without PIS

    transperineal repair of anterior rectocele only

    Procedure: Transperineal repair without PIS

Interventions

  • ProcedureTransperineal repair with PIS

    Repair of anterior rectocele via transperineal approach followed by limited internal sphincterotomy at 6 o'clock.

  • ProcedureTransperineal repair without PIS

    Repair of anterior rectocele via transperineal approach without performing limited internal sphincterotomy

06

What researchers measure

Primary outcomes

  1. Incidence of recurrence

    Number of patients presenting with recurrent or persistent symptoms during follow up

    Time frame: 18 months

07

Study locations

1 site
  • Mansoura university hospital
    Mansoura, Dakahlia, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2011, a primary completion of Jan 2016 and a completion of Feb 2016. It does not say whether these dates are actual or estimated.

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

Registered
Jan 15, 2016
First posted
Jan 20, 2016
Start
Jan 2011
Primary completionActual
Jan 2016
CompletionActual
Feb 2016
Last update
Mar 16, 2016
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 Mar 16, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02659176
Responsible party
Sameh Emile (Lecturer of surgery, Mansoura University) — Principal investigator
First posted
Jan 20, 2016
Start date
Jan 2011
Primary completion
Jan 2016
Completion
Feb 2016
Last update
Mar 16, 2016

Study contacts

Mohamed Youssef, M.D
principal investigator · Mansoura Univesity

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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