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

NCT05600335 | Completed

• 1 other identifier: HXDB-1908
• Study Type: observational
• Target: 211
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer Patients

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (6)

• postoperative chest drainage volume

  2019-2022

• preoperative anesthesia time

  2019-2022

• operation time

  2019-2022

• blood loss

  2019-2022

• conversion rate

  2019-2022

Study Arms (2)

ERAS group

Procedure: ERAS protocol

Conventional group

Procedure: ERAS protocol

Interventions

ERAS protocol PROCEDURE

Patients with esophageal cancer have undergone RAME using ERAS protocol and conventional management strategy

Conventional group; ERAS group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610000, China

Location

Study Officials

• Yidan Lin, MD

  West China Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: October 31, 2022
• Study Start: January 1, 2019
• Primary Completion: August 16, 2021
• Study Completion: March 9, 2022
• Last Updated: November 3, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)