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OpenTrials
Completed

NCT Number: NCT03801291

Transvaginal Versus Transperineal Repair of Rectocele

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

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult female patients with anterior rectocele

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

Treatment and study plan

Transvaginal repair

Procedure

Vaginal incision through which plication of the rectovaginal septum is done

Transperineal repair

Procedure

Perineal incision through which plication of the rectovaginal septum is done

Primary outcomes

  1. Improvement in constipation

    Time frame: 6 and 12 months after surgery

    decrease in Wexner constipation score by 25%

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Transvaginal Versus Transperineal Repair of Anterior Rectocele: a Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Jan 11, 2019
Registry last updated
Jan 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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