NCT05894226

Brief Summary

The ideal surgical strategy for treating complex rectocele remains a topic for debate, with the transanal, transperineal, and transvaginal approach and the abdominal approach being at conflict with one another. While the transvaginal repair is more popular among gynecologists, the trans abdominal approach has become increasingly common among colorectal surgeons, in part due to the rising demand for minimally invasive surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

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

March 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 8, 2023

Completed
Last Updated

June 8, 2023

Status Verified

June 1, 2023

Enrollment Period

11 months

First QC Date

May 26, 2023

Last Update Submit

June 6, 2023

Conditions

RectoceleObstructive Defecation Syndrome

Keywords

Anterior rectocelelaparoscopic ventral mesh rectopexy

Outcome Measures

Primary Outcomes (1)

  • changes in the Wexner constipation score

    improvement in constipation, if the score is decreasing this means improving

    6 months

Secondary Outcomes (1)

  • sexual function changes

    6 months

Study Arms (1)

laparoscopic ventral mesh rectopexy arm

EXPERIMENTAL

those who were underwent laparoscopic ventral mesh rectopexy for rectocele.

Procedure: laparoscopic ventral mesh rectopexy

Interventions

laparoscopic ventral mesh rectopexyPROCEDURE

patients are treated by laparoscopic ventral mesh rectopexy for anterior rectocele

laparoscopic ventral mesh rectopexy arm

Eligibility Criteria

Age30 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsonly female patients with anterior rectocele
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • multiparous female patients.
  • aged between 30 and 60 years
  • who were diagnosed with complex anterior rectocele- more than 3cm after failed medical treatment- with history of either vaginal delivery or caesarian section.
  • complex rectocele was one having any of the following features: size \> 3 cm in diameter, associated enterocoele or internal rectal prolapse

You may not qualify if:

  • paradoxical contraction of puborectalis muscle (anismus),
  • complete external rectal prolapse
  • fecal incontinence
  • other benign anal conditions
  • those who are unfit for surgery due to associated severe co-morbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmad

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Rectocele

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
consultant and lecturer of general surgery

Study Record Dates

First Submitted

May 26, 2023

First Posted

June 8, 2023

Study Start

March 1, 2021

Primary Completion

February 1, 2022

Study Completion

August 30, 2022

Last Updated

June 8, 2023

Record last verified: 2023-06

Locations

EG(1)