LVMR Versus PSR for External FTRPin Elderly Patients

NCT05915936 | Completed

• 1 other identifier: rectal prolapse
• Study Type: observational
• Target: 330
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rectal Prolapse

Outcome Measures

Primary Outcomes (1)

• recurrent rate of rectal prolapse

  % of recurrence after surgery

  4 years

Study Arms (2)

laparoscopic ventral mesh rectopexy

correction of rectal prolapse through laparoscopic ventral mesh rectopexy

Procedure: LVMR

perineal stapler resection

correction of rectal prolapse through perineal stapler resection

Procedure: PSR

Interventions

LVMR PROCEDURE

laoparoscopic ventral mesh rectopexy

laparoscopic ventral mesh rectopexy

PSR PROCEDURE

perineal stapler resection

perineal stapler resection

Eligibility Criteria

• Age: 61 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

elderly patients with complete FTRP

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Zagazig University: lead

Related Publications (1)

• 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.

  PMID: 38619626 DERIVED

MeSH Terms

Conditions

Rectal Prolapse

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professour of general and laparoscopic surgery

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: June 23, 2023
• Study Start: April 1, 2012
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2023
• Last Updated: June 23, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share