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Completed

NCT Number: NCT02659176

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

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

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Key information

Conditions

Rectocele Digestive System Diseases Gastrointestinal Diseases Hernia Intestinal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rectal Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Transperineal repair with PIS

Procedure

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

Transperineal repair without PIS

Procedure

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

Primary outcomes

  1. Incidence of recurrence

    Time frame: 18 months

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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Jan 20, 2016
Registry last updated
Mar 16, 2016

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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