Rectal ProlapseNCT05915936
LVMR Versus PSR for External FTRPin Elderly Patients
An observational study of Rectal Prolapse, run by Zagazig University.
Trial summary
In frail patients with external full-thickness rectal prolapse (FTRP), the exact postoperative recurrence and functional result outcomes difference between Laparoscopic ventral mesh rectopexy (LVMR) and perineal stapler resection (PSR) have not been investigated, leading to ineffective treatment. Read more about this study
- Who is it for?
- Ages 61 years and older
- Conditions the study is for
- Rectal Prolapse
- What is being tested?
- LVMR and PSR
- Type of treatment
- Surgery or procedure
- How many people
- 330 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2012to 1 Apr 2023
- 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 61 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: elderly patients with complete FTRP
Who may be able to join
- complete external FTRP (grade 5 according to Oxford prolapse) only or with ODS or FI secondary to FTRP,
- ≥ 60 years,
- both sex,
- ASA-Score I-III, and
- completed at least four-years follow-up
Who cannot join
- < 60 years,
- incomplete medical records,
- concurrent colorectal procedures,
- multi-compartmental prolapse requiring combined operations,
- open abdominal rectopexy
About this study
Official title: Comparative Study of Laparoscopic Ventral Mesh Rectopexy Versus Perineal Stapler Resection for External Full-Thickness Rectal Prolapse in Elderly Patients: Enhanced Outcomes and Reduced Recurrence Rates - A Retrospective Cohort Study
In frail patients with external full-thickness rectal prolapse (FTRP), the exact postoperative recurrence and functional result outcomes difference between Laparoscopic ventral mesh rectopexy (LVMR) and perineal stapler resection (PSR) have not been investigated, leading to ineffective treatment.
Objectives: Evaluating the efficacy of PSR versus LVMR for treating external FTRP in the elderly.
Read more
Design: This was a retrospective study that involved multiple centers. Settings: This study was conducted in the colorectal surgical units of our Universities' Hospitals Patients: 330 elderly patients divided into LVMR group (250), and PSR (80) between April 2012 and April 2019. Before and after surgery, patients were evaluated using the Wexner Incontinence Scale, the Altomare Constipation Scale, and the patient's satisfaction.
Main outcomes measurement: The primary outcome was the recurrence rate and risk factors of FTRP. Secondary outcomes were postoperative incontinence and constipation and patients' satisfaction.
Read the detailed description
From March 2012 to March 2019, 330 frail Patients were evaluated retrospectively using a prospectively collected database in the colorectal surgical divisions of our universities' hospitals. Eligible patients were complete external FTRP (grade 5 according to Oxford prolapse) only or with ODS or FI secondary to FTRP, ≥ 60 years, both sex, ASA-Score I-III, and completed at least four-years follow-up. Exclusion criteria were < 60 years, incomplete medical records, concurrent colorectal procedures, multi-compartmental prolapse requiring combined operations, open abdominal rectopexy, megacolon, pregnancy, inflammatory bowel disease, unfit for general anesthesia, recurrent rectal prolapse, prior anal surgery, patients under systemic steroid therapy, connective tissue disease, abnormal thyroid function, prior pelvic surgery, diverticulosis/stricture of the colon, previous colorectal resectional surgery, neurological disease, connective tissue disorders, psychiatric disorders, Chronic opioid use.
Outcome Definitions and Measurements:
The primary outcome focused on RP incidence and risk factors. Secondary outcomes included postoperative FI, ODS, and patient satisfaction. Recurrence entailed the presence of recurrent FTRP during follow-up, determined by physical examination and additional imaging. Continence status relied on the Jorge-Wexner grading scale , encompassing five items with a total score ranging from 0(complete continence) to 20 (complete incontinence). To assess ODS, the Altomare score uses 8 Likert scales for a maximum of 31 points for severe constipation []. Postoperative morbidity was assessed by Clavien and Dindo classification []. The measurement of external FTRP was obtained by assessing the distance between the distal margin of the rectum and the anal margin during straining. Anal stenosis was defined as the narrowing of the orifice, characterized by the inability of a 12-mm colonoscopy or the passage of one finger through the constricted opening. [].
- Conditions
- Rectal Prolapse
- Being tested
- LVMR, PSR
- Medical subject headings
- Rectal Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LVMRProcedure or surgery
laoparoscopic ventral mesh rectopexy
PSRProcedure or surgery
perineal stapler resection
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic ventral mesh rectopexy | correction of rectal prolapse through laparoscopic ventral mesh rectopexy Receives: Procedure: LVMR | |
| perineal stapler resection | correction of rectal prolapse through perineal stapler resection Receives: Procedure: PSR |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrent rate of rectal prolapse
% of recurrence after surgery
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start1 Apr 2012
- Primary completion1 Apr 2019
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tamer.A.A.M.Habeeb, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05915936
- Sponsor's protocol ID
- rectal prolapse
- Status last verified
- Jun 2023
- First submitted
- 7 Jun 2023
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Habeeb TAAM, Podda M, Chiaretti M, Kechagias A, Lledo JB, Kalmoush AE, Mustafa FM, Nassar MS, Labib MF, Teama SRA, Elshafey MH, Elbelkasi H, Alsaad MIA, Sallam AM, Ashour H, Mansour MI, Mostafa A, Elshahidy TM, Yehia AM, Rushdy T, Ramadan A, Hamed AEM, Yassin MA, Metwalli AM. Comparative study of laparoscopic ventral mesh rectopexy versus perineal stapler resection for external full-thickness rectal prolapse in elderly patients: enhanced outcomes and reduced recurrence rates-a retrospective cohort study. Tech Coloproctol. 2024 Apr 15;28(1):48. doi: 10.1007/s10151-024-02919-1.
PubMed 38619626
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Laparoscopic Ventral Mesh Rectopexy Versus Perineal Stapler Resection for External Full-Thickness Rectal Prolapse in Elderly Patients: Enhanced Outcomes and Reduced Recurrence Rates - A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05915936
- Acronym / sponsor ID
- rectal prolapse
- Conditions
- Rectal Prolapse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Apr 2012 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 23 Jun 2023 (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.
In frail patients with external full-thickness rectal prolapse (FTRP), the exact postoperative recurrence and functional result outcomes difference between Laparoscopic ventral mesh rectopexy (LVMR) and perineal stapler resection (PSR) have not been investigated, leading to ineffective treatment.
Objectives: Evaluating the efficacy of PSR versus LVMR for treating external FTRP in the elderly.
Design: This was a retrospective study that involved multiple centers. Settings: This study was conducted in the colorectal surgical units of our Universities' Hospitals Patients: 330 elderly patients divided into LVMR group (250), and PSR (80) between April 2012 and April 2019. Before and after surgery, patients were evaluated using the Wexner Incontinence Scale, the Altomare Constipation Scale, and the patient's satisfaction.
Main outcomes measurement: The primary outcome was the recurrence rate and risk factors of FTRP. Secondary outcomes were postoperative incontinence and constipation and patients' satisfaction.
Detailed description
From March 2012 to March 2019, 330 frail Patients were evaluated retrospectively using a prospectively collected database in the colorectal surgical divisions of our universities' hospitals. Eligible patients were complete external FTRP (grade 5 according to Oxford prolapse) only or with ODS or FI secondary to FTRP, ≥ 60 years, both sex, ASA-Score I-III, and completed at least four-years follow-up. Exclusion criteria were < 60 years, incomplete medical records, concurrent colorectal procedures, multi-compartmental prolapse requiring combined operations, open abdominal rectopexy, megacolon, pregnancy, inflammatory bowel disease, unfit for general anesthesia, recurrent rectal prolapse, prior anal surgery, patients under systemic steroid therapy, connective tissue disease, abnormal thyroid function, prior pelvic surgery, diverticulosis/stricture of the colon, previous colorectal resectional surgery, neurological disease, connective tissue disorders, psychiatric disorders, Chronic opioid use.
Outcome Definitions and Measurements:
The primary outcome focused on RP incidence and risk factors. Secondary outcomes included postoperative FI, ODS, and patient satisfaction. Recurrence entailed the presence of recurrent FTRP during follow-up, determined by physical examination and additional imaging. Continence status relied on the Jorge-Wexner grading scale , encompassing five items with a total score ranging from 0(complete continence) to 20 (complete incontinence). To assess ODS, the Altomare score uses 8 Likert scales for a maximum of 31 points for severe constipation []. Postoperative morbidity was assessed by Clavien and Dindo classification []. The measurement of external FTRP was obtained by assessing the distance between the distal margin of the rectum and the anal margin during straining. Anal stenosis was defined as the narrowing of the orifice, characterized by the inability of a 12-mm colonoscopy or the passage of one finger through the constricted opening. [].
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic ventral mesh rectopexy | – | Procedure: LVMRcorrection of rectal prolapse through laparoscopic ventral mesh rectopexy |
| perineal stapler resection | – | Procedure: PSRcorrection of rectal prolapse through perineal stapler resection |
Who may qualify
- Ages
- 61 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- elderly patients with complete FTRP
Key inclusion criteria (5 listed)
- complete external FTRP (grade 5 according to Oxford prolapse) only or with ODS or FI secondary to FTRP,
- ≥ 60 years,
- both sex,
- ASA-Score I-III, and
- completed at least four-years follow-up
Key exclusion criteria (5 listed)
- < 60 years,
- incomplete medical records,
- concurrent colorectal procedures,
- multi-compartmental prolapse requiring combined operations,
- open abdominal rectopexy
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 |
|---|---|---|
| LVMRlaoparoscopic ventral mesh rectopexy | Procedure or surgery | laparoscopic ventral mesh rectopexy |
| PSRperineal stapler resection | Procedure or surgery | perineal stapler resection |
Primary outcome
recurrent rate of rectal prolapse
Time frame: 4 years
% of recurrence after surgery
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 23 Jun 2023.
- Derived from this study: PubMed 38619626Habeeb TAAM, Podda M, Chiaretti M, Kechagias A, Lledo JB, Kalmoush AE, Mustafa FM, Nassar MS, Labib MF, Teama SRA, Elshafey MH, Elbelkasi H, Alsaad MIA, Sallam AM, Ashour H, Mansour MI, Mostafa A, Elshahidy TM, Yehia AM, Rushdy T, Ramadan A, Hamed AEM, Yassin MA, Metwalli AM. Comparative study of laparoscopic ventral mesh rectopexy versus perineal stapler resection for external full-thickness rectal prolapse in elderly patients: enhanced outcomes and reduced recurrence rates-a retrospective cohort study. Tech Coloproctol. 2024 Apr 15;28(1):48. doi: 10.1007/s10151-024-02919-1.
- Individual participant dataSharing planned: No
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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?
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 5 inclusion and 5 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 23 Jun 2023. 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?
recurrent rate of rectal prolapse (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05915936, which also lists 1 linked publication.
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 23 Jun 2023.