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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
540
preoperative management Optimization of relevant medical uncontrolled situations, avoid fasting, avoid bowel preparation, avoid premedications, nutritional assessment, stop smoking, stop alcohol and appropriate counselling intraoperative management Multimodal prevention of prophylaxis against nausea and vomiting (PONV) (according to preoperative assessment of Apfel Score) with a combination of multiple antiemetic drugs. postoperative management Postoperative pain control is obtained with opioid sparing strategies, in order to avoid Post Operative Ileus (POI) and PONV. It is proposed to chew gum three times daily , fluid therapy, early mobilization, early feeding within 2 hours postoperative for at least 15 minutes and eventually to promote a faster bowel function.
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shorter Length Of Hospitalization (LOH)
Total amount of days spent in hospital
Time frame: Up to 4 weeks after surgery
Assessment of postoperative pain
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 frame: At moment 24 hours after surgery
Presence/Absence of nausea
Treatment for postoperative nausea
Time frame: At moment 0, 3, 6, 12 and 24 hours after surgery
Presence/Absence of vomiting
Treatment for postoperative vomiting
Time frame: At moment 0, 3, 6, 12 and 24 hours after surgery
Time to flatus
Hours elapsed to event
Time frame: Up to 4 weeks after surgery
Time to bowel movement
Hours elapsed to event
Time frame: Up to 4 weeks after surgery
Foley catheter removal
Time to Foley catheter removal postoperative
Time frame: From 1 to 14days post surgery
Time to drink
Hours elapsed to event
Time frame: Up to 4 weeks after surgery
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Time to eating
Hours elapsed to event
Time frame: Up to 4 weeks after surgery
Time to walking
Hours elapsed to event
Time frame: Up to 4 weeks after surgery
Postoperative complications
Rate measurement
Time frame: Up to 2 weeks after surgery
Time to adjuvant treatment
Time participant receives adjuvant treatment, if needed (chemotherapy or radiation)
Time frame: 60 days
Readmission rates
Readmissions to the hospital
Time frame: Up to 21 days post surgery