Clinical trial NCT03629626: Enhanced Recovery After Surgery (ERAS) in Gynecological Surgery (ERASGS-01)
Official title: A Prospective, Randomized Trial Comparing ERAS and Conventional Protocol for Perioperative Care of Patients After Gynecological Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Disease
Gynecologic Cancer
Keywords: preoperative / intraoperative/ postoperative management
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 540
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Shorter Length Of Hospitalization (LOH)
timeFrame: Up to 4 weeks after surgery
Secondary outcomes:
measure: Assessment of postoperative pain
timeFrame: At moment 24 hours after surgery
measure: Presence/Absence of nausea
timeFrame: At moment 0, 3, 6, 12 and 24 hours after surgery
measure: Presence/Absence of vomiting
timeFrame: At moment 0, 3, 6, 12 and 24 hours after surgery
measure: Time to flatus
timeFrame: Up to 4 weeks after surgery
measure: Time to bowel movement
timeFrame: Up to 4 weeks after surgery
measure: Foley catheter removal
timeFrame: From 1 to 14days post surgery
measure: Time to drink
timeFrame: Up to 4 weeks after surgery
measure: Time to eating
timeFrame: Up to 4 weeks after surgery
measure: Time to walking
timeFrame: Up to 4 weeks after surgery
measure: Postoperative complications
timeFrame: Up to 2 weeks after surgery
measure: Time to adjuvant treatment
timeFrame: 60 days
measure: Readmission rates
timeFrame: Up to 21 days post surgery
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Beihua Kong, MD.PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Peng J, Dong R, Jiao J, Liu M, Zhang X, Bu H, Dong P, Zhao S, Xing N, Feng S, Yang X, Kong B. Enhanced Recovery After Surgery Impact on the Systemic Inflammatory Response of Patients Following Gynecological Oncology Surgery: A Prospective Randomized Study. Cancer Manag Res. 2021 Jun 1;13:4383-4392. doi: 10.2147/CMAR.S294718. eCollection 2021.