NCT04502953

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 6, 2020

Completed
Last Updated

August 6, 2020

Status Verified

August 1, 2020

Enrollment Period

11 months

First QC Date

August 4, 2020

Last Update Submit

August 4, 2020

Conditions

Rectocele

Outcome Measures

Primary Outcomes (1)

  • Complete cure of symptoms

    Absence of symptoms of constipation with Wexner score \<2

    12 months after repair

Study Arms (2)

Vertical plication

ACTIVE COMPARATOR

Vertical plication of the rectovaginal septum was done

Procedure: Vertical plication

Horizontal plication

ACTIVE COMPARATOR

Horizontal plication of the rectovaginal septum was done

Procedure: Horizontal plication

Interventions

Vertical plicationPROCEDURE

Vertical plication of the rectovaginal septum was done

Vertical plication
Horizontal plicationPROCEDURE

Horizontal plication of the rectovaginal septum was done

Horizontal plication

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Vertical plication of the rectovaginal septum was done

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, Egypt

Location

MeSH Terms

Conditions

Rectocele

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Sameh H Emile

    Mansoura University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2020

First Posted

August 6, 2020

Study Start

June 1, 2018

Primary Completion

April 30, 2019

Study Completion

May 30, 2020

Last Updated

August 6, 2020

Record last verified: 2020-08

Locations

EG(1)