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

Comparative Study Between Trans-perineal Repair With or Without Limited Internal Sphincterotomy in Treatment of Type I Anterior Rectocele: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02659176
Enrollment
60
Registered
2016-01-20
Start date
2011-01-31
Completion date
2016-02-29
Last updated
2016-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectocele

Brief summary

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

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.

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

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Patients with anterior rectocele

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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of recurrence18 monthsNumber of patients presenting with recurrent or persistent symptoms during follow up

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026