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
Patients aging less than 45 years with rectal prolapse will undergo full pathologic and functional assessment to determine the underlying etiology.
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.
55 studies on the registry are indexed under Rectal Prolapse; 12 are open to participants now.
This study's planned enrollment of 10 is below the median of 200 across 21 observational studies indexed under Rectal Prolapse.
Browse Rectal Prolapse studies →Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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
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Exclusion Criteria:
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
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
Plan to share: No — No plan to share IPD
No publications or documents are linked to this record.
The record gives a start of Jan 2017, a primary completion of Jan 2018 and a completion of Mar 2018. It does not say whether these dates are actual or estimated.
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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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