Rectal ProlapseNCT02901210
A Modified Technique to Facilitate Pealing of the Rectal Mucosa in Delorme Operation
A study testing Modified delorme procedure in people with Rectal Prolapse, run by Yasser Mohamed Abdel-samii.
Trial summary
The aim of this study is to evaluate the investigator new modification for delorme procedure in patients with rectal prolapse , assessing intra-operative morbidity and recurrence rate . Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Rectal Prolapse
- What is being tested?
- Modified delorme procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Aug 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Mild to moderate rectal prolapse
- Singed informed consent.
Who cannot join
- Huge rectal prolapse .
- Recurrent rectal prolapse
About this study
The aim of this study is to evaluate the investigator new modification for delorme procedure in patients with rectal prolapse , assessing intra-operative morbidity and recurrence rate .
Read the detailed description
In classic delorme operation stripping of the mucosa done and this is associated with extensive bleeding in addition to the time consumed in this step.the new modification done by the investigator replace this step with another associated with less intraoperative bleeding and not time consuming.
- Conditions
- Rectal Prolapse
- Being tested
- Modified delorme procedure
- Keywords
- Recta prolapse, Intraoperative bleeding, mucosal cauterization
- Medical subject headings
- Rectal Prolapse, Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified delorme procedureProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Modified Delorme | Experimental | Modified technique for delorme procedure done in mild to moderate rectal prolapse as the investigator destroy use the electrocautery to peal the mucosa with less intraoperative bleeding ,avoiding stripping of the mucosa done in classic delorme that induce major bleeding intraoperative . Receives: Procedure: Modified delorme procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate assessed in this modified technique
Measured: One year follow up post operative
intraoperative bleeding measured in this modified technique
Measured: one year follow up post operative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study startJan 2015
- Primary completionJan 2016
- Study completionAug 2016
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yasser Mohamed Abdel-samii
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yasser Mohamed Abdel-samii, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02901210
- Sponsor's protocol ID
- IRB00006379
- Status last verified
- Sep 2016
- First submitted
- 14 Jul 2016
- Last updated
- 15 Sep 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 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Modified Technique to Facilitate Pealing of the Rectal Mucosa in Delorme Operation
- ClinicalTrials.gov ID
- NCT02901210
- Acronym / sponsor ID
- IRB00006379
- Conditions
- Rectal Prolapse
- Keywords
- Recta prolapse, Intraoperative bleeding, mucosal cauterization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Yasser Mohamed Abdel-samiiUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 15 Sep 2016 (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.
The aim of this study is to evaluate the investigator new modification for delorme procedure in patients with rectal prolapse , assessing intra-operative morbidity and recurrence rate .
Detailed description
In classic delorme operation stripping of the mucosa done and this is associated with extensive bleeding in addition to the time consumed in this step.the new modification done by the investigator replace this step with another associated with less intraoperative bleeding and not time consuming.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Modified Delorme | Experimental | Procedure: Modified delorme procedureModified technique for delorme procedure done in mild to moderate rectal prolapse as the investigator destroy use the electrocautery to peal the mucosa with less intraoperative bleeding ,avoiding stripping of the mucosa done in classic delorme that induce major bleeding intraoperative . |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Mild to moderate rectal prolapse
- Singed informed consent.
Key exclusion criteria (2 listed)
- Huge rectal prolapse .
- Recurrent rectal prolapse
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 |
|---|---|---|
| Modified delorme procedure | Procedure or surgery | Modified Delorme |
Primary outcome
Recurrence rate assessed in this modified technique
Time frame: One year follow up post operative
intraoperative bleeding measured in this modified technique
Time frame: one year follow up post operative.
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 15 Sep 2016.
- Individual participant dataSharing planned: Undecided
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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 Modified delorme procedure in people with Rectal Prolapse, run by Yasser Mohamed Abdel-samii.
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 2 inclusion and 2 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 15 Sep 2016. 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?
Recurrence rate assessed in this modified technique (time frame: One year follow up post operative). The study lists 2 primary outcomes in all. 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 15 Sep 2016.