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

Completed

• Conditions: Esophageal Cancer Patients
• Interventions: Procedure: ERAS protocol

• Registration Number: NCT05600335
• Lead Sponsor: West China Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2021-08-16
• Study Completion: 2022-03-09
• Status Verified: 2022-10
• Study First Submitted: 2022-10-26
• Study First Submitted QC: 2022-10-26
• Study First Posted: 2022-10-31
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 211

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Conventional group	ERAS protocol	-
ERAS group	ERAS protocol	-

Primary Outcome Measures

Name	Time	Method
postoperative hospital stay	2019-2022	postoperative hospital stay characterized by postoperative outcome
time to out-of-bed activity	2019-2022	time to out-of-bed activity characterized by postoperative outcome
duration of analgesic pump	2019-2022	duration of analgesic pump characterized by postoperative outcome
incidence of various postoperative complications	2019-2022	incidence of various postoperative complications characterized by postoperative outcome
time to first flatus	2019-2022	time to first flatus characterized by postoperative outcome
time to liquid diet	2019-2022	time to liquid diet characterized by postoperative outcome
postoperative pain score	2019-2022	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.
ICU length of stay	2019-2022	ICU length of stay characterized by postoperative outcome
in-hospital mortality	2019-2022	in-hospital mortality characterized by postoperative outcome

Secondary Outcome Measures

Name	Time	Method
blood loss	2019-2022	blood loss characterized by intraoperative outcome
conversion rate	2019-2022	conversion rate characterized by intraoperative outcome
postoperative chest drainage volume	2019-2022	postoperative chest drainage volume characterized by postoperative outcome
preoperative anesthesia time	2019-2022	preoperative anesthesia time characterized by intraoperative outcome
operation time	2019-2022	operation time characterized by intraoperative outcome
radicality of surgery	2019-2022	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

Trial Locations

Locations (1)

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China