Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05210673
Other study ID # ERAS in radical cystectomy
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT01983436 - Impact of Manual Lymphatic Drainage on Postoperative Edema of the Face and the Neck After Orthognathic Surgery N/A
Recruiting NCT02230436 - Early Versus Late Drain Removal After Pancreatectomy: A Randomized Prospective Trial N/A
Completed NCT04696991 - Effect of the Pecha-Kucha Method on the Discharge Readiness and Anxiety Levels N/A
Completed NCT05790317 - Comparison of the Effect of Traditional Method and Eras Protocol in Obesity Surgery N/A
Completed NCT04656756 - Determining the Severity of Physical Symptoms Displayed and Their Level of Perceived Readiness for Discharge After Birth N/A
Completed NCT04705675 - The Impact of Breastfeeding Education on Breastfeeding Behavior and the Use of Traditional Practices N/A