ERAS (Enhanced Recovery After Surgery) Protocol Implementation in Piedmont Region for Hysterectomy.

Uterine Neoplasms Clinical Trial

— ERAS-Gyneco  

Official title:

ERAS (Enhanced Recovery After Surgery) Protocol Implementation in Piedmont Region for Hysterectomy of Benign or Malignant Tumors of the Uterus. A Stepped-wedge Cluster Randomized Clinical Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04063072
• Other study ID #: ERAS-Gyneco-Piemonte
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: October 31, 2021

Study information

• Verified date: June 2021
• Source: Ospedale Regina Montis Regalis
• Contact: Andrea Puppo, MD
• Phone: 0039 0174677
• Email: andrea.puppo[@]aslcn1.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study assesses the impact on quality of care of implementing the ERAS (Enhanced Recovery After Surgery) protocol for hysterectomy of benign or malignant tumors of the uterus in the network of public hospitals in the Regione Piemonte (North-West Italy). Every hospital is a cluster entering the study treating patients according to its current clinical practice. On the basis of a randomized order, each hospital switches from current clinical practice to the adoption of the ERAS protocol.

Description:

ERAS (Enhanced Recovery After Surgery) protocol is a multimodal perioperative care pathways designed to achieve early recovery after surgical procedures by maintaining preoperative organ function and reducing the profound stress response following surgery. Even if efficacy and safety of ERAS protocol in gynaecological surgery is well-established in the literature, its implementation is limited to few selected centres in Piemonte. The aim of the study is to extend the implementation of the ERAS protocol to whole regional network of hospitals. Specific objectives are to estimate its impact on different dimensions of quality of care, including length of stay, complications and patient satisfaction, and to identify possible barriers or facilitating factors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1800
• Est. completion date: October 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All the hospital wards within the Piemonte Region performing hysterectomy.
• All the patients receiving an elective hysterectomy for benign or malignant tumors of the uterus.

Exclusion Criteria:

• Hospital wards performing less than 20 expected cases per year
• Emergency hysterectomy
• Hysterectomy for pelvic floor disorders
• High severity cases not allowing ERAS protocol implementation (i.e. American Society of Anesthesiologists score: ASA V).

Related Conditions & MeSH terms

• Neoplasms
• Uterine Neoplasms

Intervention

Procedure:
• ERAS protocol
In gynecological surgery, the ERAS protocol involves an accurate interview with the patient in the preoperative phase aimed at smoking and alcohol cessation, the reduction of preoperative fasting, the omission of intestinal preparation, the prophylaxis of thromboembolism, a correct antibiotic prophylaxis, the prevention of intraoperative hypothermia, prevention of volume overload, prevention of postoperative nausea and vomiting, very limited use of the nasogastric tube, early removal of the urinary catheter, multimodal analgesia to minimize opiate consumption, early postoperative mobilization and early post-operative feeding, to promote rapid recovery of gastro-intestinal functions.

Locations

Country	Name	City	State
Italy	Ospedale Regina Montis Regalis	Mondovì

Sponsors (5)

Lead Sponsor	Collaborator
Ospedale Regina Montis Regalis	Azienda Ospedaliera Città della Salute e della Scienza di Torino, Martini Hospital, Turin, Italy, Ministry of Health, Italy, Regione Piemonte

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Nelson G, Bakkum-Gamez J, Kalogera E, Glaser G, Altman A, Meyer LA, Taylor JS, Iniesta M, Lasala J, Mena G, Scott M, Gillis C, Elias K, Wijk L, Huang J, Nygren J, Ljungqvist O, Ramirez PT, Dowdy SC. Guidelines for perioperative care in gynecologic/oncology: Enhanced Recovery After Surgery (ERAS) Society recommendations-2019 update. Int J Gynecol Cancer. 2019 May;29(4):651-668. doi: 10.1136/ijgc-2019-000356. Epub 2019 Mar 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of stay	Mean length of stay calculated as difference between date of discharge and date of admission of the hospitalization for surgery, excluding length of stay >12 days (98th percentile of the expected distribution).	12 days after admission
Secondary	Length of stay >12 days	Rate of patients with a length of stay >12 days	30 days after admission
Secondary	Recovery after surgery	Score of quality of recovery at 24 hours after surgery, assessed with the questionnaire Quality of Recovery (QoR-15), a 15-items instrument, with responses recorded on a 11-point Likert-type scale form 0 (worst scenario) to 10 (best scenario) and an overall score ranging from 0 (poor recovery) to 150 (excellent recovery).; A visual analogue scale (VAS), ranging from 0 (worst imaginable health state) to 10 (worst imaginable health state) is also supplied as summary evaluation.	24 hours after surgery
Secondary	Complications	Rate of surgical and medical complication after surgery For surgical complications: Comprehensive Complication Index	30 days after discharge
Secondary	Transfer to intensive care unit	Rate of transfers to intensive care unit after surgery	30 days after surgery
Secondary	Emergency visits after discharge	Rate of emergency visit in the first month after discharge	30 days after discharge
Secondary	Hospital admissions after discharge	Rate of new admissions in the first month after discharge	30 days after discharge
Secondary	Reintervention	Rate of reintervention in the first month after surgery, excluding planned interventions	30 days after surgery
Secondary	Patients' satisfaction	Score of patients' satisfaction measured 2 weeks after discharge, assessed with the questionnaire Surgical Satisfaction Questionnaire (SSQ8) supplied by telephone. SSQ8 is a 8-items instrument, with responses recorded on a 5-point Likert-type scale from 0 (worst scenario) to 4 (best scenario) and an overall score ranging from 0 (very unsatisfied) to 32 (very satisfied).	15 days after discharge
Secondary	Healthcare costs	Mean healthcare costs from pre admission visit to 30 days after discharge	30 days after discharge