Effect of Enhanced Recovery After Surgery in Reducing the Incidence of Postoperative Urinary Retention After Surgery for Benign Anorectal Conditions: a Randomized Controlled Trial
| Registry | NCT06803550 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: triple, prevention |
| Enrollment | 100 (Estimated) |
| Sponsor | Mansoura University (Other) |
| Conditions | Anal Fistula, Anal Fissure Chronic, Haemorrhoid, Enhanced Recovery After Surgery (ERAS) Protocol |
| Interventions | Enhanced recovery after surgery protocol, Routine pathway (Other) |
| Dates | start 2024-12-17, primary completion 2025-04-30 (estimated), completion 2025-06-30 (estimated), first posted 2025-01-31, last updated 2025-02-03 |
| Locations | 1 site in Egypt |
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This study aims to assess the role of Enhanced recovery after surgery(ERAS) protocol in reducing postoperative urine retention (POUR) after surgery for benign anorectal conditions.
This study aims to assess the role of Enhanced recovery after surgery(ERAS) protocol in reducing postoperative urine retention (POUR) after surgery for benign anorectal conditions.
Patients of both sexes aged between 18 and 90 years old presented; with benign anorectal conditions including chronic anal fissure, hemorrhoids, and fistula-in-ano will be eligible for the study.
Eligible patients will be randomized in equal proportions to RRAS or ROUTINE pathways. The ERAS pathway was developed based on the available guidelines and protocols it includes 14 items.
Patients allocated to ERAS pathway must fulfill all the 14 items. The ROUTINE pathway will represent the routine practice which may include certain ERAS items or those who will not fulfill the 14 items.
For the end points of the study, all patients will be followed-up by a phone call 72 hours postoperatively then in the outpatients' department for a period of a total of 30 days postoperatively. However, patients will be advised to visit the outpatients' department at any other time during the trial if they developed any unfavorable event.
The primary outcome will be the 72-hours postoperative urinary retention after anorectal surgery.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Enhanced recovery after surgery protocol | Active comparator | Other: Enhanced recovery after surgery protocol | ERAS pathway was developed based on the available guidelines and protocols it includes 14 items |
| Routine practice | Other | Other: Routine pathway | This is the routine preoperative preparation |
Sex: All, ages: 18 Years to 65 Years
Inclusion Criteria: * both sexes * aged between 18 and 65 years old * presented with benign anorectal conditions including chronic anal fissure, hemorrhoids, and fistula-in-ano will be eligible for the study Exclusion Criteria: * younger than 18 * older than 65 years old * pregnant female * history of relevant urological diagnosis (benign prostatic hyperplasia/prostate cancer/urethral stricture/bladder neck stenosis/detrusor underactivity/detrusor overactivity) * history of relevant urological procedure (radical prostatectomy/ transurethral prostatectomy/bladder neck or urethral surgery/pelvic radiotherapy) * use of permanent urinary catheter * intraoperative urological procedures * with any form of urinary diversion * severe cognitive impairment * who undergo other anorectal procedures
| Facility | City | Country | Status |
|---|---|---|---|
| Mansoura University Hospital | Al Mansurah | Egypt | Recruiting |