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

Gynecologic Cancer Clinical Trial

— ERAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03629626
• Other study ID #: ERASGS-01
• Status: Completed
• Phase: N/A
• Start date: August 15, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2023
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 540
• Est. completion date: December 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Gynecologic Cancer
• Gynecologic Disease

Intervention

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.

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shorter Length Of Hospitalization (LOH)	Total amount of days spent in hospital	Up to 4 weeks after surgery
Secondary	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.	At moment 24 hours after surgery
Secondary	Presence/Absence of nausea	Treatment for postoperative nausea	At moment 0, 3, 6, 12 and 24 hours after surgery
Secondary	Presence/Absence of vomiting	Treatment for postoperative vomiting	At moment 0, 3, 6, 12 and 24 hours after surgery
Secondary	Time to flatus	Hours elapsed to event	Up to 4 weeks after surgery
Secondary	Time to bowel movement	Hours elapsed to event	Up to 4 weeks after surgery
Secondary	Foley catheter removal	Time to Foley catheter removal postoperative	From 1 to 14days post surgery
Secondary	Time to drink	Hours elapsed to event	Up to 4 weeks after surgery
Secondary	Time to eating	Hours elapsed to event	Up to 4 weeks after surgery
Secondary	Time to walking	Hours elapsed to event	Up to 4 weeks after surgery
Secondary	Postoperative complications	Rate measurement	Up to 2 weeks after surgery
Secondary	Time to adjuvant treatment	Time participant receives adjuvant treatment, if needed (chemotherapy or radiation)	60 days
Secondary	Readmission rates	Readmissions to the hospital	Up to 21 days post surgery