Clinical trial NCT03012464: Pathologic Assessment of Rectal Prolapse in the Young
Official title: Pathologic and Functional Assessment of Rectal Prolapse in Young Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rectal Prolapse
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2017-01-06
Enrollment: 10
Sex: ALL
Minimum age (years): 5
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

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 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.

Primary outcomes:
measure: Collagen I:III ratio
timeFrame: immediate after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University hospitals
state: Dakahlia
city: Mansoura
country: Egypt
facility: Mansoura university hospital
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Sameh H Emile, M.D.
role: PRINCIPAL_INVESTIGATOR
References: