Rectal ProlapseNCT03012464
Pathologic Assessment of Rectal Prolapse in the Young
An observational study of Rectal Prolapse, run by Mansoura University at 2 sites in Egypt.
Trial summary
Patients aging less than 45 years with rectal prolapse will undergo full pathologic and functional assessment to determine the underlying etiology. Read more about this study
- Who is it for?
- Ages 5 to 45 years
- Conditions the study is for
- Rectal Prolapse
- What is being tested?
- Pathologic and functional assessment
- How many people
- 10 participants
- Where
- 2 sitesEgypt
- Study dates
- Jan 2017to Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- Patients of both genders aging below 45 years with primary or recurrent rectal prolapse, whether internal or external prolapse
Who cannot join
- Patients above 45 years, patients with associated anorectal pathology as anal fissure, hemorrhoids or neoplasm, and patients with documented psychiatric or mental disorders.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Mansoura University hospitals
Al Mansurah, Dakahlia Governorate, 35516
Sameh H Emile, M.D., +201006267150, sameh200@hotmail.com
- Recruiting
Mansoura university hospital
Al Mansurah, Dakahlia Governorate
Sameh Emile, M.D, sameh200@hotmail.com
About this study
Official title: Pathologic and Functional Assessment of Rectal Prolapse in Young Patients
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.
- Conditions
- Rectal Prolapse
- Being tested
- Pathologic and functional assessment
- Medical subject headings
- Rectal Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pathologic and functional assessmentOther
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
| Study group | Role | What they receive |
|---|---|---|
| Pathologic and functional assessment | Patients of both genders, aging below 45 years with internal or external rectal prolapse Receives: Other: Pathologic and functional assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collagen I:III ratio
Pathologic assessment of the taken biopsies to examine the ratio between collagen type I and type III
Measured: immediate after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJan 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Emile, Mansoura University
- Investigators
- Sameh H Emile, M.D., Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03012464
- Sponsor's protocol ID
- mansourau2017
- Status last verified
- Jan 2017
- First submitted
- 3 Jan 2017
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: No plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathologic and Functional Assessment of Rectal Prolapse in Young Patients
- ClinicalTrials.gov ID
- NCT03012464
- Acronym / sponsor ID
- mansourau2017
- Conditions
- Rectal Prolapse
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 6 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pathologic and functional assessment | – | Other: Pathologic and functional assessmentPatients of both genders, aging below 45 years with internal or external rectal prolapse |
Who may qualify
- Ages
- 5 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (1 listed)
- Patients of both genders aging below 45 years with primary or recurrent rectal prolapse, whether internal or external prolapse
Key exclusion criteria (1 listed)
- Patients above 45 years, patients with associated anorectal pathology as anal fissure, hemorrhoids or neoplasm, and patients with documented psychiatric or mental disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pathologic and functional assessmentRandom 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 | Other | Pathologic and functional assessment |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
- Individual participant dataSharing planned: No. No plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sameh H Emile, M.D. principal investigator
Mansoura University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Prolapse, run by Mansoura University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sameh H Emile, M.D (1006267150, sameh200@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collagen I:III ratio (time frame: immediate after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2017.