Pathologic Assessment of Rectal Prolapse in the Young
Pathologic and Functional Assessment of Rectal Prolapse in Young Patients
1 other identifier
observational
10
1 country
2
Brief Summary
Patients aging less than 45 years with rectal prolapse will undergo full pathologic and functional assessment to determine the underlying etiology.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2017
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 3, 2017
CompletedFirst Posted
Study publicly available on registry
January 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedJanuary 6, 2017
January 1, 2017
1 year
January 3, 2017
January 4, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Collagen I:III ratio
Pathologic assessment of the taken biopsies to examine the ratio between collagen type I and type III
immediate after surgery
Study Arms (1)
Pathologic and functional assessment
Patients of both genders, aging below 45 years with internal or external rectal prolapse
Interventions
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
Eligibility Criteria
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
You may qualify if:
- Patients of both genders aging below 45 years with primary or recurrent rectal prolapse, whether internal or external prolapse
You may not qualify if:
- Patients above 45 years, patients with associated anorectal pathology as anal fissure, hemorrhoids or neoplasm, and patients with documented psychiatric or mental disorders.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Mansoura University hospitals
Al Mansurah, Dakahlia Governorate, 35516, Egypt
Mansoura university hospital
Al Mansurah, Dakahlia Governorate, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sameh H Emile, M.D.
Mansoura University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of general surgery
Study Record Dates
First Submitted
January 3, 2017
First Posted
January 6, 2017
Study Start
January 1, 2017
Primary Completion
January 1, 2018
Study Completion
March 1, 2018
Last Updated
January 6, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share
No plan to share IPD