Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
Trial record 2 of 22 for:    rectal prolapse | Open Studies

Pathologic Assessment of Rectal Prolapse in the Young

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by Mansoura University
Sponsor:
Information provided by (Responsible Party):
Sameh Emile, Mansoura University
ClinicalTrials.gov Identifier:
NCT03012464
First received: January 3, 2017
Last updated: January 4, 2017
Last verified: January 2017
  Purpose
Patients aging less than 45 years with rectal prolapse will undergo full pathologic and functional assessment to determine the underlying etiology.

Condition Intervention
Rectal Prolapse
Other: Pathologic and functional assessment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pathologic and Functional Assessment of Rectal Prolapse in Young Patients

Resource links provided by NLM:


Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • Collagen I:III ratio [ Time Frame: immediate after surgery ]
    Pathologic assessment of the taken biopsies to examine the ratio between collagen type I and type III


Estimated Enrollment: 10
Study Start Date: January 2017
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   5 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03012464

Contacts
Contact: Sameh H Emile, M.D 1006267150 sameh200@hotmail.com

Locations
Egypt
Mansoura University hospitals Recruiting
Mansoura, Dakahlia, Egypt, 35516
Contact: Sameh H Emile, M.D.    +201006267150    sameh200@hotmail.com   
Mansoura university hospital Recruiting
Mansoura, Dakahlia, Egypt
Contact: Sameh Emile, M.D       sameh200@hotmail.com   
Sponsors and Collaborators
Mansoura University
Investigators
Principal Investigator: Sameh H Emile, M.D. Mansoura University
  More Information

Responsible Party: Sameh Emile, Lecturer of general surgery, Mansoura University
ClinicalTrials.gov Identifier: NCT03012464     History of Changes
Other Study ID Numbers: mansourau2017
Study First Received: January 3, 2017
Last Updated: January 4, 2017
Individual Participant Data  
Plan to Share IPD: No
Plan Description: No plan to share IPD

Additional relevant MeSH terms:
Prolapse
Rectal Prolapse
Pathological Conditions, Anatomical
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pelvic Organ Prolapse

ClinicalTrials.gov processed this record on May 22, 2017