NCT03629626

Enhanced Recovery After Surgery (ERAS) in Gynecological Surgery (ERASGS-01)

A Prospective, Randomized Trial Comparing ERAS and Conventional Protocol for Perioperative Care of Patients After Gynecological Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 540 (actual)
• Sponsor: Shandong University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gynecologic Disease
• Gynecologic Cancer

Interventions

Type	Name	Description
PROCEDURE	ERAS 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.

Timeline

• Start date: 2018-08-15
• Primary completion: 2021-06-30
• Completion: 2021-12-31
• First posted: 2018-08-14
• Last updated: 2023-04-25

Locations

1 site across 1 country: China