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OpenTrials
Completed

NCT Number: NCT05210673

Enhanced Recovery for Patients Undergoing Radical Cystectomy.

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.

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Key information

Conditions

Post Procedural Discharge

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ashraf Magdy Eskandr

Shibeen Elkoom, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Non ERAS pathway

Other

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

Primary outcomes

  1. length of hospital stay

    Time frame: 1-15 days

    length of hospital stay in days

Secondary outcomes

  1. Onset of bowel movement

    Time frame: 1-5 days

    Onset of bowel movement in days

  2. Onset of early mobilization

    Time frame: 1-15 days

    Onset of early mobilization in days

  3. Postoperative analegesic consumption

    Time frame: 1-15 days

    opioid and paracetamol

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Collaborators

  • Ezzeldin Saleh Ibrahim
  • asmaa ibrahim mohamed
  • asmaa mohamed hamza
  • mohamed marzouk abdallah

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 27, 2022
Registry last updated
Feb 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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