Enhanced Recovery for Patients Undergoing Radical Cystectomy.

NCT ID: NCT05210673

Last Updated: 2022-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2021-09-30

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.

Conditions

Post Procedural Discharge

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

group A

non ERAS pathway

Group Type: EXPERIMENTAL

Non ERAS pathway

Intervention Type: OTHER

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

group B

ERAS pathway

Group Type: ACTIVE_COMPARATOR

ERAS

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

Non ERAS pathway

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ezzeldin Saleh Ibrahim

UNKNOWN

Sponsor Role: collaborator

asmaa mohamed hamza

UNKNOWN

Sponsor Role: collaborator

asmaa ibrahim mohamed

UNKNOWN

Sponsor Role: collaborator

mohamed marzouk abdallah

UNKNOWN

Sponsor Role: collaborator

Menoufia University

OTHER

Sponsor Role: lead

Responsible Party

ashraf magdy eskandr

assistant professor of anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ashraf M eskandr

Role: STUDY_DIRECTOR

menoufia faculty of medicine

Locations

Ashraf Magdy Eskandr

Shibeen Elkoom, , Egypt

Countries

Egypt

Other Identifiers

ERAS in radical cystectomy

Identifier Type: -

Identifier Source: org_study_id