Pathologic Assessment of Rectal Prolapse in the Young | NCT03012464

Studies
Pathologic Assessment of Rectal Prolapse in the Young

NCT03012464

Sponsor

Mansoura University

Status

Unknown status

Last Update Posted

Jan 6, 2017Estimated

Enrollment

10Estimated

Phase

Not provided

Conditions

Rectal Prolapse

Interventions

Pathologic and functional assessment

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

Jan 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2017

Primary Completion Date

Jan 2018Estimated

Completion Date

Mar 2018Estimated

First Submitted Date

Jan 3, 2017

First Submission Date that Met QC Criteria

Jan 4, 2017

First Posted Date

Jan 6, 2017Estimated

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

Jan 4, 2017

Last Update Posted Date

Jan 6, 2017Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sameh Emile, Lecturer of general surgery, Mansoura UniversityPrincipal Investigator

Lead Sponsor

Mansoura UniversityOTHER

Collaborators

Not provided

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

Patients aging less than 45 years with rectal prolapse will undergo full pathologic and functional assessment to determine the underlying etiology.

Detailed Description

Full clinical assessment of the patients will be conducted by history taking querying the type and duration of symptoms, associated medical conditions, history of previous surgery for rectal prolapse, and presence of fecal incontinence which will be graded by Wexner continence score. In addition, patients will undergo thorough general and local examination to determine the type of rectal prolapse (internal or external) and the condition of the anal sphincters and pelvic floor muscles.

Functional assessment of the anorectal region will be done by anal manometry to measure the resting and squeeze anal pressures, rectal sensation and compliance; endorectal ultrasonography to assess the integrity of the anal sphincters; and pudendal nerve terminal motor latency (PNTML) to exclude pudendal neuropathy.

Random biopsies (2-4 in number) will be taken from the pelvic floor muscles, external anal sphincter, and the lateral supportive ligaments of the rectum during surgical treatment of rectal prolapse whether via the abdominal or perineal approach. Tissue samples will be preserved in formalin solution and will be sent for histopathological examination. Tissue samples will be subjected to immunohistochemistry to calculate the ratio between collagen type I and type III, and to reveal any myopathic or degenerative changes. Additionally, schistosomal affection of the pelvic floor muscles will be detected by immunohistochemistry examination for the ova of schistosomal mansoni.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pathologic and functional assessment		Patients of both genders, aging below 45 years with internal or external rectal prolapse	Other: Pathologic and functional assessment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pathologic and functional assessment	Other	Random biopsies will be taken from the pelvic floor muscles, external anal sphincter, and the lateral supportive ligaments of the rectum during surgical treatment of rectal prolapse whether via the abdominal or perineal approach. Tissue samples will be subjected to immunohistochemistry to calculate the ratio between collagen type I and type III, and to reveal any myopathic or degenerative changes

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Collagen I:III ratio	Pathologic assessment of the taken biopsies to examine the ratio between collagen type I and type III	immediate after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients of both genders aging below 45 years with primary or recurrent rectal prolapse, whether internal or external prolapse

Exclusion Criteria:

Patients above 45 years, patients with associated anorectal pathology as anal fissure, hemorrhoids or neoplasm, and patients with documented psychiatric or mental disorders.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

45 Years

Standard Ages

ChildAdult

Study Population

Patients of both genders aging below 45 years with primary or recurrent rectal prolapse, whether internal or external prolapse, will be included. Patients above 45 years, patients with associated anorectal pathology as anal fissure, hemorrhoids or neoplasm, and patients with documented psychiatric or mental disorders will be excluded

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sameh H Emile, M.D	Contact	1006267150		sameh200@hotmail.com

Overall Officials

Name	Affiliation	Role
Sameh H Emile, M.D.	Mansoura University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mansoura University hospitals	Recruiting	Al Mansurah	Dakahlia Governorate	35516	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

No plan to share IPD

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012005	Rectal Prolapse

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