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Clinical Trials/NCT04502953
NCT04502953CompletedNot Applicable

Outcome of Vertical Versus Horizontal Plicataion in Transperienal Repair of Rectocele; a Randomized Controlled Trial

Mansoura University1 site in 1 country40 target enrollmentStarted: June 1, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
Complete cure of symptoms

Study Overview

Brief Summary

We assumed that the technique of plication of the rectovaginal septum and rectal wall may factor in providing better and more sustained repair that confers more satisfactory improvement in symptoms. The present randomized study aimed to evaluate the outcome of TPR with vertical plication of the rectovaginal septum as compared to the horizontal plication with regards to improvement in ODS, recurrence of rectocele, postoperative complications and dyspareunia.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Vertical plication of the rectovaginal septum was done

Exclusion Criteria

  • •patients with ODS caused by conditions other than rectocele such as anismus and internal rectal prolapse
  • •patients with slow transit constipation.
  • •patients with recurrent rectocele after previous surgery.
  • •patients with pre-existing FI
  • •patients with associated anorectal pathology.

Arms & Interventions

Vertical plication

Active Comparator

Vertical plication of the rectovaginal septum was done

Intervention: Vertical plication (Procedure)

Horizontal plication

Active Comparator

Horizontal plication of the rectovaginal septum was done

Intervention: Horizontal plication (Procedure)

Outcomes

Primary Outcomes

Complete cure of symptoms

Time Frame: 12 months after repair

Absence of symptoms of constipation with Wexner score \<2

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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