NCT06803550

Effect of Enhanced Recovery After Surgery for Benign Anorectal Conditions

Effect of Enhanced Recovery After Surgery in Reducing the Incidence of Postoperative Urinary Retention After Surgery for Benign Anorectal Conditions: a Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Anal Fistula
• Anal Fissure Chronic
• Haemorrhoid
• Enhanced Recovery After Surgery (ERAS) Protocol

Interventions

Type	Name	Description
OTHER	Enhanced recovery after surgery protocol	ERAS pathway was developed based on the available guidelines and protocols it includes 14 items: 1. Preoperative patient education using an information sheet which includes instructions on postoperative wound care, pain management, and preventing and managing constipation. 2. Single preoperative enema 2 hours prior to surgery. 3. Solid or semisolid food stopped 6 hours before surgery. 4. Clear liquids may be continued up to 2 hours before surgery. 5. Preoperative carbohydrate loading in non-diabetic patients for up to 2 hours prior to surgery in the form of a single 330 ml high-carbohydrate clear drink (apple juice). 6. Saddle anesthesia. 7. Single dose of intravenous 500 mg metronidazole at the time of the anaesthesi induction. 8. Restriction of intraoperative intravenous fluids to less than 500 ml. 9. Balanced chloride-restricted crystalloid solutions should be used for maintenance infusions and fluid boluses. 10. A bundle measures to reduce surgical site infection which includes
OTHER	Routine pathway	This is the routine preoperative preparation at our institute

Timeline

• Start date: 2024-12-17
• Primary completion: 2025-04-30
• Completion: 2025-06-30
• First posted: 2025-01-31
• Last updated: 2025-02-03

Locations

1 site across 1 country: Egypt