Short-term Outcomes of ERAS Protocol in RAME for Esophageal Cancer

Short-term Outcomes of Enhanced Recovery After Surgery Protocol in Robotic-assisted McKeown Esophagectomy for Esophageal Cancer

This single-center, retrospective cohort study aimed to evaluate the short-term outcomes of enhanced recovery after surgery (ERAS) protocol in perioperative robotic-assisted McKeown esophagectomy (RAME) among esophageal cancer patients.

Study Overview

• Status: Completed
• Conditions: Esophageal Cancer Patients
• Intervention / Treatment: Procedure: ERAS protocol

• Study Type: Observational
• Enrollment (Actual): 211

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610000
      • West China Hospital of Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with esophageal cancer undertaking resection by RAME were included. According to different perioperative management strategies, all eligible patients were divided into the ERAS group and conventional group.

Description

Inclusion Criteria:

1. first detected and endoscopically confirmed esophageal cancer;
2. preoperative evaluation showed no distant metastases and suitable for RAME;
3. preoperative clinical stage of I to III;

Exclusion Criteria:

1. patients had a history of thoracic or abdominal surgery;
2. patients were IV to VI in the American Society of Anesthesiologists (ASA) physical status classification system;
3. patients had other malignancies;
4. patients had missing clinical data

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ERAS group	Procedure: ERAS protocol; Patients with esophageal cancer have undergone RAME using ERAS protocol and conventional management strategy
Conventional group	Procedure: ERAS protocol; Patients with esophageal cancer have undergone RAME using ERAS protocol and conventional management strategy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to first flatus	time to first flatus characterized by postoperative outcome	2019-2022
time to out-of-bed activity	time to out-of-bed activity characterized by postoperative outcome	2019-2022
time to liquid diet	time to liquid diet characterized by postoperative outcome	2019-2022
postoperative pain score	postoperative pain score characterized by postoperative outcome and was scored according to the numeric pain rating scale (NPRS) to assess the patient's pain on the first day after surgery.	2019-2022
duration of analgesic pump	duration of analgesic pump characterized by postoperative outcome	2019-2022
postoperative hospital stay	postoperative hospital stay characterized by postoperative outcome	2019-2022
ICU length of stay	ICU length of stay characterized by postoperative outcome	2019-2022
in-hospital mortality	in-hospital mortality characterized by postoperative outcome	2019-2022
incidence of various postoperative complications	incidence of various postoperative complications characterized by postoperative outcome	2019-2022

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative chest drainage volume	postoperative chest drainage volume characterized by postoperative outcome	2019-2022
preoperative anesthesia time	preoperative anesthesia time characterized by intraoperative outcome	2019-2022
operation time	operation time characterized by intraoperative outcome	2019-2022
blood loss	blood loss characterized by intraoperative outcome	2019-2022
conversion rate	conversion rate characterized by intraoperative outcome	2019-2022
radicality of surgery	R0 resection was defined as > 1mm from all resection margins, R1 resection was defined as microscopic residual tumor, and R2 resection was defined as macroscopic residual tumor	2019-2022

Collaborators and Investigators

• Sponsor: West China Hospital
• Investigators: Study Director: Yidan Lin, MD, West China Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): August 16, 2021
• Study Completion (Actual): March 9, 2022

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: October 26, 2022
• First Posted (Actual): October 31, 2022

Study Record Updates

• Last Update Posted (Actual): November 3, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: HXDB-1908

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No