Rectal ProlapseNCT04117633
Laparoscopic Suture Versus Mesh Rectopexy for the Treatment of Persistent Complete Rectal Prolapse in Children
A study testing Laparoscopy in people with Rectal Prolapse, run by Al-Azhar University.
Trial summary
Purpose: to compare Laparoscopic mesh rectopexy with laparoscopic suture rectopexy The operative time, recurrence rate, post-operative constipation, and effect on fecal incontinence, were reported and evaluated for each group Results: Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Rectal Prolapse
- What is being tested?
- Laparoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2010to 18 Dec 2018
- Phase
- Interventional
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with persistant complete Rectal Prolapse.
- Failure of conservative treatment.
- more than 2 attacks of prolapse requiring manual reduction.
Who cannot join
- Sever constipation
- Previous abdominal or pelvic surgery with extensive adhesions.
- Cases older than 12ys,
- Patients with rectal polyp
About this study
Official title: Laparoscopic Suture Versus Mesh Rectopexy for the Treatment of Persistent Complete Rectal Prolapse in Children : A Comparative Randomized Study
Purpose: to compare Laparoscopic mesh rectopexy with laparoscopic suture rectopexy The operative time, recurrence rate, post-operative constipation, and effect on fecal incontinence, were reported and evaluated for each group Results:
Read the detailed description
Purpose: to compare Laparoscopic mesh rectopexy with laparoscopic suture rectopexy Patient and Methods: The prospective study was conducted at Pediatric Surgery Department, Al-Azhar university hospitals, Cairo, Egypt . The operative time, recurrence rate, post-operative constipation, and effect on fecal incontinence, were reported and evaluated for each group
- Conditions
- Rectal Prolapse
- Being tested
- Laparoscopy
- Keywords
- Rectal Prolapse, Laparoscopy, Mesh, Rectopexy, pediatrics
- Medical subject headings
- Rectal Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaparoscopyDevice
Laparoscopic Procedures for Rectopexy
| Study group | Role | What they receive |
|---|---|---|
| Mesh Rectopexy | Active comparator | Using Laparoscopy Receives: Device: Laparoscopy |
| Suture Rectopexy | Active comparator | Using Laparoscopy Receives: Device: Laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signs of improvement
No recurrence of Rectal Prolapse
Measured: 12 weeks
Secondary outcomes (1)
Signs of improvement
Improvement of Fecal Incontinence score(Rintala score)
Measured: 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start1 Feb 2010
- Primary completion15 Jan 2015
- Study completion18 Dec 2018
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.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study included two equal groups. one group underwent laparoscopic mesh rectopexy and the other underwent suture rectopexy.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, abdelaziz yehya, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117633
- Sponsor's protocol ID
- Azh-Ped-Surg-70712018
- Status last verified
- Oct 2019
- First submitted
- 28 Sep 2019
- Last updated
- 8 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Suture Versus Mesh Rectopexy for the Treatment of Persistent Complete Rectal Prolapse in Children : A Comparative Randomized Study
- ClinicalTrials.gov ID
- NCT04117633
- Acronym / sponsor ID
- Azh-Ped-Surg-70712018
- Conditions
- Rectal Prolapse
- Keywords
- Rectal Prolapse, Laparoscopy, Mesh, Rectopexy, pediatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Feb 2010 (actual)
- Primary completion
- 15 Jan 2015 (actual)
- Study completion
- 18 Dec 2018 (actual)
- First posted
- 7 Oct 2019 (actual)
- 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.
Purpose: to compare Laparoscopic mesh rectopexy with laparoscopic suture rectopexy The operative time, recurrence rate, post-operative constipation, and effect on fecal incontinence, were reported and evaluated for each group Results:
Detailed description
Purpose: to compare Laparoscopic mesh rectopexy with laparoscopic suture rectopexy Patient and Methods: The prospective study was conducted at Pediatric Surgery Department, Al-Azhar university hospitals, Cairo, Egypt . The operative time, recurrence rate, post-operative constipation, and effect on fecal incontinence, were reported and evaluated for each group
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- The study included two equal groups. one group underwent laparoscopic mesh rectopexy and the other underwent suture rectopexy.
| Arm | Type | Receives |
|---|---|---|
| Mesh Rectopexy | Active comparator | Device: LaparoscopyUsing Laparoscopy |
| Suture Rectopexy | Active comparator | Device: LaparoscopyUsing Laparoscopy |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children with persistant complete Rectal Prolapse.
- Failure of conservative treatment.
- more than 2 attacks of prolapse requiring manual reduction.
Key exclusion criteria (4 listed)
- Sever constipation
- Previous abdominal or pelvic surgery with extensive adhesions.
- Cases older than 12ys,
- Patients with rectal polyp
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 |
|---|---|---|
| LaparoscopyLaparoscopic Procedures for Rectopexy | Device | Mesh Rectopexy, Suture Rectopexy |
Primary outcome
Signs of improvement
Time frame: 12 weeks
No recurrence of Rectal Prolapse
1 secondary outcome
Signs of improvement
Time frame: 30 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopy in people with Rectal Prolapse, run by Al-Azhar University.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Signs of improvement (time frame: 12 weeks). 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 8 Oct 2019.