Enhanced Recovery for Patients Undergoing Radical Cystectomy.

NCT05210673 | Completed DMC

• 1 other identifier: ERAS in radical cystectomy
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Procedural Discharge

Outcome Measures

Primary Outcomes (1)

• length of hospital stay

  length of hospital stay in days

  1-15 days

Secondary Outcomes (3)

• Onset of bowel movement

  1-5 days

• Onset of early mobilization

  1-15 days

• Postoperative analegesic consumption

  1-15 days

Study Arms (2)

group A

EXPERIMENTAL

non ERAS pathway

Other: Non ERAS pathway

group B

ACTIVE COMPARATOR

ERAS pathway

Other: ERAS

Interventions

ERAS OTHER

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

group B

Non ERAS pathway OTHER

standard preoperative preparation intraoperative: combined general and epidural anesthesia postoperative standard care

group A

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• ASA IV

Sponsors & Collaborators

• Menoufia University: lead
• Ezzeldin Saleh Ibrahim: collaborator
• asmaa mohamed hamza: collaborator
• asmaa ibrahim mohamed: collaborator
• mohamed marzouk abdallah: collaborator

Study Sites (1)

Ashraf Magdy Eskandr

Shibeen Elkoom, Egypt

Location

Study Officials

• ashraf M eskandr

  menoufia faculty of medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of anesthesia

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: January 27, 2022
• Study Start: September 1, 2019
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: February 11, 2022

Record last verified: 2022-01

Locations

EG (1)