Trans-perineal Repair With or Without Limited Internal Sp... | NCT02659176

Studies
Trans-perineal Repair With or Without Limited Internal Sphincterotomy for Treatment of Type I Anterior Rectocele

NCT02659176

Sponsor

Mansoura University

Status

Completed

Last Update Posted

Mar 16, 2016Estimated

Enrollment

60Actual

Phase

Not Applicable

Conditions

Rectocele

Interventions

Transperineal repair with PIS
Transperineal repair without PIS

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

Mar 2016

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

Jan 2011

Primary Completion Date

Jan 2016Actual

Completion Date

Feb 2016Actual

First Submitted Date

Jan 15, 2016

First Submission Date that Met QC Criteria

Jan 19, 2016

First Posted Date

Jan 20, 2016Estimated

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

Mar 14, 2016

Last Update Posted Date

Mar 16, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Comparison between transperineal repair of rectocele with or without posterior internal sphincterotomy.

Detailed Description

Transperineal repair of anterior rectocele is performed in two groups of patients, the first will undergo limited posterior internal sphincterotomy, the second group will not have internal sphincteroromy. The two groups are compared regarding recurrence of rectocele and improvement of symptoms.

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

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Transperineal repair with PIS	Active Comparator	transperineal repair of anterior rectocele with limited internal sphincterotomy	Procedure: Transperineal repair with PIS
Transperineal repair without PIS	Active Comparator	transperineal repair of anterior rectocele only	Procedure: Transperineal repair without PIS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transperineal repair with PIS	Procedure	Repair of anterior rectocele via transperineal approach followed by limited internal sphincterotomy at 6 o'clock.	Transperineal repair with PIS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of recurrence	Number of patients presenting with recurrent or persistent symptoms during follow up	18 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with anterior rectocele

Exclusion Criteria:

Pregnant females
Rectocele with pelvic organ prolapse
Any patient with previous anorectal surgery
Pudendal nerve neuropathy
Anal fistula and sepsis
Patients with sphincter defect proved by endo-anal sonography
Patients proved to have colonic inertia either by colon transit time and/or history
Patients with defecography anomalies causing obstructed defecation other than rectocele (e.g. Anismus).
Also patients with vascular diseases, scleroderma, malnutrition, and coagulopathy were excluded.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 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
Mohamed Youssef, M.D	Mansoura Univesity	Principal Investigator

Locations

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

IPD Sharing Statement Module

Plan to Share IPD

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

Intervention Browse Module

MeSH Terms

ID	Term
D051607	CDP-Diacylglycerol-Inositol 3-Phosphatidyltransferase

Ancestor Terms

ID	Term
D017855	Transferases (Other Substituted Phosphate Groups)
D010770	Phosphotransferases
D014166	Transferases
D004798	Enzymes

Browse Leaves

Not provided

Browse Branches

Not provided