Enhanced Recovery for Patients Undergoing Radical Cystectomy.

Not Applicable

Completed

• Conditions: Post Procedural Discharge
• Interventions: Other: Non ERAS pathway; Other: ERAS

• Registration Number: NCT05210673
• Lead Sponsor: Menoufia University

Brief Summary

Investigators hypothesize that with the use of enhanced recovery of surgery (ERAS), the postoperative hospital stay after radical cystectomy is reduced, and also postoperative complications are decreased.

Detailed Description

Radical cystectomy (RC) is believed to be associated with high morbidity and prolonged length of hospital stay even with advances in perioperative medical care. Enhanced Recovery After Surgery (ERAS) pathways are multidisciplinary, multimodal evidence-based approaches to perioperative protocol by which patients are treated. The most important aims of this multimodal approach are modifying as many of the factors contributing to the morbidity of RC as possible, the improvement of patients' preoperative status, and the perioperative maintenance of homeostasis by minimizing stress response and inflammation to improve patient outcomes and decrease the length of inpatient hospital stay. The investigators hypothesize that with the use of enhanced recovery of surgery (ERAS), the postoperative hospital stay after radical cystectomy is reduced, and also postoperative complications are decreased.

Study Timeline

• Study Start: 2019-09-01
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Status Verified: 2022-01
• Study First Submitted: 2022-01-14
• Study First Submitted QC: 2022-01-14
• Study First Posted: 2022-01-27
• Last Update Submitted: 2022-01-28
• Last Update Posted: 2022-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age: 40-85 years.
• Adequate cognitive state (able to understand and collaborate)
• American society of anesthesia (ASA) I, II and III.

Exclusion Criteria

• ASA IV

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group A	Non ERAS pathway	non ERAS pathway
group B	ERAS	ERAS pathway

Primary Outcome Measures

Name	Time	Method
length of hospital stay	1-15 days	length of hospital stay in days

Secondary Outcome Measures

Name	Time	Method
Postoperative analegesic consumption	1-15 days	opioid and paracetamol
Onset of bowel movement	1-5 days	Onset of bowel movement in days
Onset of early mobilization	1-15 days	Onset of early mobilization in days

Trial Locations

Locations (1)

Ashraf Magdy Eskandr; 🇪🇬 Shibeen Elkoom, Egypt