Enhanced Recovery for Patients Undergoing Radical Cystectomy.

Post Procedural Discharge Clinical Trial

Official title:

Enhanced Recovery for Patients Undergoing Radical Cystectomy. A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05210673
• Other study ID #: ERAS in radical cystectomy
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: January 2022
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Post Procedural Discharge

Intervention

Other:
• ERAS
Preoperative: Preoperative explanation of ERAS. Preoperative medical optimization. Smoking cessation 4-8 weeks before surgery. Nutritional status assessment. Preoperative fasting: 2hours for Clear fluids and water, 6hours for Semi-solid foods and 8 hours for Solid food. Preoperative carbohydrate loading. Pre-anesthetic medication: Avoid long active sedatives. Thromboembolic prophylaxis and Compression stockings Intraoperative: Antimicrobial prophylaxis and skin preparation. Epidural analgesia. Prevention of intraoperative hypothermia. Intraoperative fluid management. Minimize incision. Drain strategy Postoperative: Nasogastric intubation. Early oral intake. Early mobilization. Prevention of postoperative ileus through. Prevention of postoperative nausea and vomiting. Multimodal opioid sparing analgesia. Discharge criteria: Patients have resumed adequate oral intake and normal bowel function, Effective oral pain management and No other clinical or biochemical concerns
• Non ERAS pathway
standard preoperative preparation intraoperative: combined general and epidural anesthesia postoperative standard care

Locations

Country	Name	City	State
Egypt	Ashraf Magdy Eskandr	Shibeen Elkoom

Sponsors (5)

Lead Sponsor	Collaborator
Menoufia University	asmaa ibrahim mohamed, asmaa mohamed hamza, Ezzeldin Saleh Ibrahim, mohamed marzouk abdallah

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	length of hospital stay	length of hospital stay in days	1-15 days
Secondary	Onset of bowel movement	Onset of bowel movement in days	1-5 days
Secondary	Onset of early mobilization	Onset of early mobilization in days	1-15 days
Secondary	Postoperative analegesic consumption	opioid and paracetamol	1-15 days