An observational study in Rectal Prolapse, sponsored by Zagazig University. Completed. Open to participants aged 61 Years and older. Per ClinicalTrials.gov, last updated 2023-06-23.
Sponsored by Zagazig University · Observational
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.
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. [].
55 studies on the registry are indexed under Rectal Prolapse; 12 are open to participants now.
This study's enrollment of 330 is above the median of 200 across 21 observational studies indexed under Rectal Prolapse.
Browse Rectal Prolapse studies →Zagazig University is the lead sponsor of 459 studies on the registry; 77 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
elderly patients with complete FTRP
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Exclusion Criteria:
correction of rectal prolapse through laparoscopic ventral mesh rectopexy
Procedure: LVMR
correction of rectal prolapse through perineal stapler resection
Procedure: PSR
laoparoscopic ventral mesh rectopexy
perineal stapler resection
recurrent rate of rectal prolapse
% of recurrence after surgery
Time frame: 4 years
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2012 to primary completion in Apr 2019, 84 months.
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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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