Pathologic Assessment of Rectal Prolapse in the Young

Sponsor
Mansoura University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03012464
Collaborator
(none)
10
2
13.9
5
0.4

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Pathologic and functional assessment

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
10 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Pathologic and Functional Assessment of Rectal Prolapse in Young Patients
Study Start Date :
Jan 1, 2017
Anticipated Primary Completion Date :
Jan 1, 2018
Anticipated Study Completion Date :
Mar 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Pathologic and functional assessment

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

Other: Pathologic and functional assessment
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

Outcome Measures

Primary Outcome Measures

  1. Collagen I:III ratio [immediate after surgery]

    Pathologic assessment of the taken biopsies to examine the ratio between collagen type I and type III

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mansoura University hospitals Mansoura Dakahlia Egypt 35516
2 Mansoura university hospital Mansoura Dakahlia Egypt

Sponsors and Collaborators

  • Mansoura University

Investigators

  • Principal Investigator: Sameh H Emile, M.D., Mansoura University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sameh Emile, Lecturer of general surgery, Mansoura University
ClinicalTrials.gov Identifier:
NCT03012464
Other Study ID Numbers:
  • mansourau2017
First Posted:
Jan 6, 2017
Last Update Posted:
Jan 6, 2017
Last Verified:
Jan 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 6, 2017