LVMR Versus PSR for External FTRPin Elderly Patients

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.

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.

Study Overview

• Status: Completed
• Conditions: Rectal Prolapse
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 330

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

elderly patients with complete FTRP

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
recurrent rate of rectal prolapse	% of recurrence after surgery	4 years

Collaborators and Investigators

• Sponsor: Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2012
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): April 1, 2023

Study Registration Dates

• First Submitted: June 7, 2023
• First Submitted That Met QC Criteria: June 14, 2023
• First Posted (Actual): June 23, 2023

Study Record Updates

• Last Update Posted (Actual): June 23, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Pelvic Organ Prolapse; Prolapse; Rectal Prolapse
• Other Study ID Numbers: rectal prolapse

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No