NCT03801291

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2019

Completed
Last Updated

January 11, 2019

Status Verified

January 1, 2019

Enrollment Period

2.2 years

First QC Date

January 9, 2019

Last Update Submit

January 9, 2019

Conditions

Rectocele

Outcome Measures

Primary Outcomes (1)

  • Improvement in constipation

    decrease in Wexner constipation score by 25%

    6 and 12 months after surgery

Study Arms (2)

Transvaginal repair

ACTIVE COMPARATOR

Repair of anterior rectocele via the vagina

Procedure: Transvaginal repair

Transperineal repair

ACTIVE COMPARATOR

Repair of anterior rectocele via the perineum

Procedure: Transperineal repair

Interventions

Transvaginal repairPROCEDURE

Vaginal incision through which plication of the rectovaginal septum is done

Transvaginal repair
Transperineal repairPROCEDURE

Perineal incision through which plication of the rectovaginal septum is done

Transperineal repair

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale only
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult female patients with anterior rectocele

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, Egypt

Location

Related Publications (1)

  • Balata M, Elgendy H, Emile SH, Youssef M, Omar W, Khafagy W. Functional Outcome and Sexual-Related Quality of Life After Transperineal Versus Transvaginal Repair of Anterior Rectocele: A Randomized Clinical Trial. Dis Colon Rectum. 2020 Apr;63(4):527-537. doi: 10.1097/DCR.0000000000001595.

    PMID: 31996580DERIVED

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

    PRINCIPAL INVESTIGATOR

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
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of general surgery

Study Record Dates

First Submitted

January 9, 2019

First Posted

January 11, 2019

Study Start

April 1, 2016

Primary Completion

July 1, 2018

Study Completion

January 7, 2019

Last Updated

January 11, 2019

Record last verified: 2019-01

Locations

EG(1)