A Prospective, Randomized Trial Comparing ERAS and Conventional Protocol for Perioperative Care of Patients After Gynecological Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gynecologic Disease
- Sponsor
- Shandong University
- Enrollment
- 540
- Locations
- 1
- Primary Endpoint
- Shorter Length Of Hospitalization (LOH)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
Enhanced recovery programs are composed of preoperative, intraoperative and postoperative strategies combined to form a multi-modal pathway. ERAS requires a multidisciplinary team of anesthetists, surgeons and nurses for successful implementation and realization of its advantages.The aim of this study is to compare outcomes of conventional perioperative care with those of an enhanced recovery after surgery (ERAS) perioperative care plan in women undergoing surgery for gynecologic cancer or suspected gynecologic disease.
Detailed Description
The study design is a two-arm, randomized, controlled trial. The control arm will consist of standard conventional perioperative care. The intervention arm will consist of a protocol-driven ERAS program. The investigators believe that this information will be very useful because although there is a national interest in creating ERAS protocols for gynecology, there currently is very little published on the subject. Investigators hypothesize that those patients randomized to the ERAS protocol will have shorter lengths of hospital stay and complications, without increasing readmission rates. The investigators would like to publish the investigators' results and protocol as a resource for other institutions to adopt.
Investigators
Beihua Kong
Clinical Professor
Shandong University
Eligibility Criteria
Inclusion Criteria
- •Age \>18 and \<70 years old
- •Patients candidated for elective gynecological surgery for benign pathology
- •Patients with diagnosis of gynecological neoplasm and candidated for elective gynecological surgery
- •Signed consent form
Exclusion Criteria
- •Contraindication to loco-regional anaesthesia
- •Patients with ileus or subocclusive condition prior surgery
- •Coagulation disorders
- •Organ failure or severe disfunction (heart, renal, pulmonary, hepatic)
- •Uncontrolled hypertension (\>180/95)
- •Alcohol or drug abuser (current or previous)
- •Psychiatric condition or language barriers
- •Planned Intensive Care Recovery
Outcomes
Primary Outcomes
Shorter Length Of Hospitalization (LOH)
Time Frame: Up to 4 weeks after surgery
Total amount of days spent in hospital
Secondary Outcomes
- Presence/Absence of nausea(At moment 0, 3, 6, 12 and 24 hours after surgery)
- Readmission rates(Up to 21 days post surgery)
- Time to flatus(Up to 4 weeks after surgery)
- Presence/Absence of vomiting(At moment 0, 3, 6, 12 and 24 hours after surgery)
- Foley catheter removal(From 1 to 14days post surgery)
- Time to drink(Up to 4 weeks after surgery)
- Time to eating(Up to 4 weeks after surgery)
- Time to bowel movement(Up to 4 weeks after surgery)
- Time to walking(Up to 4 weeks after surgery)
- Postoperative complications(Up to 2 weeks after surgery)
- Assessment of postoperative pain(At moment 24 hours after surgery)
- Time to adjuvant treatment(60 days)