CClinicalTrials.gg
Status unknownNCT03012464Updated Jan 6, 2017

Pathologic Assessment of Rectal Prolapse in the Young

An observational study in Rectal Prolapse, sponsored by Mansoura University. Status unknown at 2 sites in Egypt. Open to participants aged 5 Years to 45 Years. Per ClinicalTrials.gov, last updated 2017-01-06.

Sponsored by Mansoura University · Observational

The sponsor has not verified this record recently (last verified Jan 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10
Ages
5 Years to 45 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Rectal Prolapse
03

Who can participate

Ages eligible
5 Years to 45 Years
Sexes eligible
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

Inclusion criteria

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

Exclusion criteria

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10 participants (estimated)
Patient registry
No

Groups and cohorts

  • Pathologic and functional assessment

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

    Other: Pathologic and functional assessment

Interventions

  • OtherPathologic 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

05

What researchers measure

Primary outcomes

  1. Collagen I:III ratio

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

    Time frame: immediate after surgery

06

Study locations

2 of 2 sites recruiting
  • Mansoura University hospitals
    Mansoura, Dakahlia 35516, Egypt
    Recruiting
  • Mansoura university hospital
    Mansoura, Dakahlia, Egypt
    Recruiting
07

References and documents

Individual participant data

Plan to share: No — No plan to share IPD

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03012464
Lead sponsor
Mansoura University
Responsible party
Sameh Emile (Lecturer of general surgery, Mansoura University) — Principal investigator
First posted
Jan 6, 2017
Start date
Jan 2017
Primary completion
Jan 2018 (estimated)
Completion
Mar 2018 (estimated)
Last update
Jan 6, 2017

Study contacts

Sameh H Emile, M.D
Contact
sameh200@hotmail.com
1006267150
Sameh H Emile, M.D.
principal investigator · Mansoura University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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