LVMR Versus PSR for External FTRPin Elderly Patients

NCT ID: NCT05915936

Last Updated: 2023-06-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 330 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-04-01
• Study Completion Date: 2023-04-01

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

laparoscopic ventral mesh rectopexy

correction of rectal prolapse through laparoscopic ventral mesh rectopexy

LVMR

Intervention Type: PROCEDURE

laoparoscopic ventral mesh rectopexy

perineal stapler resection

correction of rectal prolapse through perineal stapler resection

PSR

Intervention Type: PROCEDURE

perineal stapler resection

Interventions

LVMR

laoparoscopic ventral mesh rectopexy

Intervention Type: PROCEDURE

PSR

perineal stapler resection

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 61 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Tamer.A.A.M.Habeeb

professour of general and laparoscopic surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 38619626 (View on PubMed)

Other Identifiers

rectal prolapse

Identifier Type: -

Identifier Source: org_study_id