LVMR Versus PSR for External FTRPin Elderly Patients

Sponsor

Zagazig University (Other)

Overall Status

Completed

CT.gov ID

NCT05915936

Collaborator

(none)

330

Enrollment

132

Actual Duration (Months)

Study Details

Study Description

Brief 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.

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.

Condition or Disease	Intervention/Treatment	Phase
Rectal Prolapse	Procedure: LVMR Procedure: PSR

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

Study Type:

Observational

Actual Enrollment :

330 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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

Actual Study Start Date :

Apr 1, 2012

Actual Primary Completion Date :

Apr 1, 2019

Actual Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
laparoscopic ventral mesh rectopexy correction of rectal prolapse through laparoscopic ventral mesh rectopexy	Procedure: LVMR laoparoscopic ventral mesh rectopexy
perineal stapler resection correction of rectal prolapse through perineal stapler resection	Procedure: PSR perineal stapler resection

Arm

Intervention/Treatment

laparoscopic ventral mesh rectopexy

correction of rectal prolapse through laparoscopic ventral mesh rectopexy

Procedure: LVMR

laoparoscopic ventral mesh rectopexy

perineal stapler resection

correction of rectal prolapse through perineal stapler resection

Procedure: PSR

perineal stapler resection

Outcome Measures

Primary Outcome Measures

recurrent rate of rectal prolapse [4 years]
% of recurrence after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

61 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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:

< 60 years,
incomplete medical records,
concurrent colorectal procedures,
multi-compartmental prolapse requiring combined operations,
open abdominal rectopexy

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Zagazig University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tamer.A.A.M.Habeeb, professour of general and laparoscopic surgery, Zagazig University

ClinicalTrials.gov Identifier:

NCT05915936

Other Study ID Numbers:

rectal prolapse

First Posted:

Jun 23, 2023

Last Update Posted:

Jun 23, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Rectal Prolapse

Prolapse

Study Results

No Results Posted as of Jun 23, 2023