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

M

Mansoura University

Status

Completed

Conditions

Rectocele

Treatments

Procedure: Transperineal repair without PIS
Procedure: Transperineal repair with PIS

Study type

Interventional

Funder types

Other

Identifiers

NCT02659176
mansoura31

Details and patient eligibility

About

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

Full 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.

Enrollment

60 patients

Sex

Female

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups

Transperineal repair with PIS
Active Comparator group
Description:
transperineal repair of anterior rectocele with limited internal sphincterotomy
Treatment:
Procedure: Transperineal repair with PIS
Transperineal repair without PIS
Active Comparator group
Description:
transperineal repair of anterior rectocele only
Treatment:
Procedure: Transperineal repair without PIS

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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