Enhanced Recovery After Surgery (ERAS) in Gynecological Surgery (ERASGS-01)
- Conditions
- Gynecologic DiseaseGynecologic Cancer
- Interventions
- Procedure: ERAS protocol
- Registration Number
- NCT03629626
- Lead Sponsor
- Shandong University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 540
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ERAS protocol ERAS protocol preoperative / intraoperative/ postoperative management
- Primary Outcome Measures
Name Time Method Shorter Length Of Hospitalization (LOH) Up to 4 weeks after surgery Total amount of days spent in hospital
- Secondary Outcome Measures
Name Time Method Presence/Absence of nausea At moment 0, 3, 6, 12 and 24 hours after surgery Treatment for postoperative nausea
Readmission rates Up to 21 days post surgery Readmissions to the hospital
Time to flatus Up to 4 weeks after surgery Hours elapsed to event
Presence/Absence of vomiting At moment 0, 3, 6, 12 and 24 hours after surgery Treatment for postoperative vomiting
Foley catheter removal From 1 to 14days post surgery Time to Foley catheter removal postoperative
Time to drink Up to 4 weeks after surgery Hours elapsed to event
Time to eating Up to 4 weeks after surgery Hours elapsed to event
Time to bowel movement Up to 4 weeks after surgery Hours elapsed to event
Time to walking Up to 4 weeks after surgery Hours elapsed to event
Postoperative complications Up to 2 weeks after surgery Rate measurement
Assessment of postoperative pain At moment 24 hours after surgery Measurement of pain score post-operation will be obtained using clinical data gathered by the care team providing routine clinical care, and asking routine pain score questions. The scale used is the standard 1-10 pain scale, with 1 being no pain or very mild discomfort, and 10 being very severe pain.
Time to adjuvant treatment 60 days Time participant receives adjuvant treatment, if needed (chemotherapy or radiation)
Trial Locations
- Locations (1)
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China