Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05915936 |
| Other study ID # |
rectal prolapse |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2012 |
| Est. completion date |
April 1, 2023 |
Study information
| Verified date |
June 2023 |
| Source |
Zagazig University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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.
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. [].
