Complete Rectal ProlapseNCT02601326
Laparoscopic Ventral Mesh Rectopexy Versus Delorme's Operation in Management of Complete Rectal Prolapse
A study testing Laparoscopic ventral mesh Rectopexy and Delorme's procedure in people with Complete Rectal Prolapse, run by Mansoura University at 1 site in Egypt.
Trial summary
A comparative randomized study between laparoscopic ventral mesh Rectopexy and Delorme's procedure in treatment of complete rectal prolapse to ass both efficacy and complications Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Complete Rectal Prolapse
- What is being tested?
- Laparoscopic ventral mesh Rectopexy and Delorme's procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2012to Dec 2015
- 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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with complete rectal prolapse
Who cannot join
- patients who underwent previous surgery for complete rectal prolapse
- patients unfit for surgery
- patients with associated colorectal diseases or pathology
Trial locations and contacts
1 site in 1 country.
About this study
A comparative randomized study between laparoscopic ventral mesh Rectopexy and Delorme's procedure in treatment of complete rectal prolapse to ass both efficacy and complications
Read the detailed description
A comparative randomized study between laparoscopic ventral mesh Rectopexy and Delorme's procedure in treatment of complete rectal prolapse to ass both efficacy and complications.
Follow up is scheduled for 18 months to evaluate recurrence, continence state and complications
- Conditions
- Complete Rectal Prolapse
- Being tested
- Laparoscopic ventral mesh Rectopexy, Delorme's procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic ventral mesh RectopexyProcedure or surgery
Laparoscopic fixation of rectum to sacral promontory using mesh
Delorme's procedureProcedure or surgery
Transanal excision of rectal mucosa and plication of muscle layer
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic ventral mesh Rectopexy | Active comparator | Fixation of the rectum to the sacrum using laparoscopy and mesh Receives: Procedure: Laparoscopic ventral mesh Rectopexy |
| delorme's procedure | Active comparator | excision of excess rectal mucosa under spinal anesthesia then plication of the rectal muscles with vicryl 2/0 sutures Receives: Procedure: Delorme's procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of the condition
Measured by counting the number of patients with recurrence of rectal prolapse
Measured: 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2015 (estimated)
- Study startJan 2012
- Primary completionJan 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complete Rectal ProlapseStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Emile, Mansoura University
- Investigators
- Sameh Emile, M.D, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02601326
- Sponsor's protocol ID
- Mansourau24
- Status last verified
- Nov 2015
- First submitted
- 28 Oct 2015
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Ventral Mesh Rectopexy Versus Delorme's Operation in Management of Complete Rectal Prolapse
- ClinicalTrials.gov ID
- NCT02601326
- Acronym / sponsor ID
- Mansourau24
- Conditions
- Complete Rectal Prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 Nov 2015 (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.
A comparative randomized study between laparoscopic ventral mesh Rectopexy and Delorme's procedure in treatment of complete rectal prolapse to ass both efficacy and complications
Detailed description
A comparative randomized study between laparoscopic ventral mesh Rectopexy and Delorme's procedure in treatment of complete rectal prolapse to ass both efficacy and complications.
Follow up is scheduled for 18 months to evaluate recurrence, continence state and complications
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic ventral mesh Rectopexy | Active comparator | Procedure: Laparoscopic ventral mesh RectopexyFixation of the rectum to the sacrum using laparoscopy and mesh |
| delorme's procedure | Active comparator | Procedure: Delorme's procedureexcision of excess rectal mucosa under spinal anesthesia then plication of the rectal muscles with vicryl 2/0 sutures |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with complete rectal prolapse
Key exclusion criteria (3 listed)
- patients who underwent previous surgery for complete rectal prolapse
- patients unfit for surgery
- patients with associated colorectal diseases or pathology
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 |
|---|---|---|
| Laparoscopic ventral mesh RectopexyLaparoscopic fixation of rectum to sacral promontory using mesh | Procedure or surgery | Laparoscopic ventral mesh Rectopexy |
| Delorme's procedureTransanal excision of rectal mucosa and plication of muscle layer | Procedure or surgery | delorme's procedure |
Primary outcome
Recurrence of the condition
Time frame: 18 month
Measured by counting the number of patients with recurrence of rectal prolapse
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 16 Mar 2016.
- Individual participant dataSharing planned: Undecided
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 Emile, M.D principal investigator
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic ventral mesh Rectopexy and Delorme's procedure in people with Complete Rectal Prolapse, run by Mansoura University at 1 site 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 3 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 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Recurrence of the condition (time frame: 18 month). 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 16 Mar 2016.