Rectal ProlapseNCT07230275
Frailty Increase Rectal Prolapse Recurrence
An observational study of Rectal Prolapse, run by Zagazig University.
Trial summary
evaluate recurrent RP in relation to frailty Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Rectal Prolapse
- What is being tested?
- LVMR for RP and PSR for RP
- Type of treatment
- Surgery or procedure
- How many people
- 342 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2014to 1 Oct 2025
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: elderly patients with RP
Who may be able to join
- EPs aged ≥60 years EFTRP (Oxford prolapse grade 5)
Who cannot join
- • aged < 60 years
- incomplete medical records,
- concurrent colorectal procedures,
- multi-compartmental prolapse requiring combined operations,
About this study
Official title: Rectal Prolapse and Recurrent RP
evaluate recurrent RP in relation to frailty
- Conditions
- Rectal Prolapse
- Being tested
- LVMR for RP, PSR for RP
- Keywords
- frailty
- Medical subject headings
- Rectal Prolapse, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LVMR for RPProcedure or surgery
LVMR for management of RP
PSR for RPProcedure or surgery
PSR for management of RP
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic ventral rectopexy | LVMR for management of rectal prolapse Receives: Procedure: LVMR for RP | |
| perineal stapler resection | PSR for management of RP Receives: Procedure: PSR for RP |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence in relation to frailty
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start1 Oct 2014
- Primary completion1 Oct 2020
- Study completion1 Oct 2025
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
- Retrospective
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tamer.A.A.M.Habeeb, Zagazig University
- Investigators
- Tamer.A.A.M. Habeeb, Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07230275
- Sponsor's protocol ID
- frailty and rectal prolapse
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rectal Prolapse and Recurrent RP
- ClinicalTrials.gov ID
- NCT07230275
- Acronym / sponsor ID
- frailty and rectal prolapse
- Conditions
- Rectal Prolapse
- Keywords
- frailty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 17 Nov 2025 (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.
evaluate recurrent RP in relation to frailty
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic ventral rectopexy | – | Procedure: LVMR for RPLVMR for management of rectal prolapse |
| perineal stapler resection | – | Procedure: PSR for RPPSR for management of RP |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- elderly patients with RP
Key inclusion criteria (1 listed)
- EPs aged ≥60 years EFTRP (Oxford prolapse grade 5)
Key exclusion criteria (4 listed)
- • aged < 60 years
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 |
|---|---|---|
| LVMR for RPLVMR for management of RP | Procedure or surgery | laparoscopic ventral rectopexy |
| PSR for RPPSR for management of RP | Procedure or surgery | perineal stapler resection |
Primary outcome
recurrence in relation to frailty
Time frame: 5 years
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 17 Nov 2025.
- Individual participant dataSharing planned: Yes
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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.
Tamer.A.A.M. Habeeb principal investigator
Zagazig University
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Prolapse, run by Zagazig 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 1 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 17 Nov 2025. 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 in relation to frailty (time frame: 5 years). 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 17 Nov 2025.