Vertical Versus Horizontal Plicataion in Transperienal Re... | NCT04502953

Studies
Vertical Versus Horizontal Plicataion in Transperienal Repair of Rectocele

NCT04502953

Sponsor

Mansoura University

Status

Completed

Last Update Posted

Aug 6, 2020Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Rectocele

Interventions

Vertical plication
Horizontal plication

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2018Actual

Primary Completion Date

Apr 30, 2019Actual

Completion Date

May 30, 2020Actual

First Submitted Date

Aug 4, 2020

First Submission Date that Met QC Criteria

Aug 4, 2020

First Posted Date

Aug 6, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 4, 2020

Last Update Posted Date

Aug 6, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Vertical plication	Procedure	Vertical plication of the rectovaginal septum was done	Vertical plication

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complete cure of symptoms	Absence of symptoms of constipation with Wexner score <2	12 months after repair

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sameh H Emile	Mansoura University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mansoura university hospital		Al Mansurah	Dakahlia Governorate		Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020047	Rectocele

Ancestor Terms

ID	Term
D012002	Rectal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided