Gynecologic Cancer, Gynecologic Disease
Conditions
Keywords
preoperative / intraoperative/ postoperative management
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.
Interventions
PROCEDUREERAS protocol
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.
Sponsors
Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shorter Length Of Hospitalization (LOH) | Up to 4 weeks after surgery | Total amount of days spent in hospital |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence/Absence of nausea | At moment 0, 3, 6, 12 and 24 hours after surgery | Treatment for postoperative nausea |
| Presence/Absence of vomiting | At moment 0, 3, 6, 12 and 24 hours after surgery | Treatment for postoperative vomiting |
| Time to flatus | Up to 4 weeks after surgery | Hours elapsed to event |
| Time to bowel movement | Up to 4 weeks after surgery | Hours elapsed to event |
| Foley catheter removal | From 1 to 14days post surgery | Time to Foley catheter removal postoperative |
| 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 eating | 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 |
| Time to adjuvant treatment | 60 days | Time participant receives adjuvant treatment, if needed (chemotherapy or radiation) |
| Readmission rates | Up to 21 days post surgery | Readmissions to the hospital |
| Time to drink | Up to 4 weeks after surgery | Hours elapsed to event |
Countries
China
Outcome results
None listed