West China Hospital of Sichuan University
Chengdu, Sichuan, 610000, China
Completed
NCT Number: NCT05600335
Short-term Outcomes of ERAS Protocol in RAME 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.
Completed
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Notify MeKey information
Conditions
Age range
20 year–80 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- first detected and endoscopically confirmed esophageal cancer;
- preoperative evaluation showed no distant metastases and suitable for RAME;
- preoperative clinical stage of I to III;
Exclusion criteria
- 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
Treatment and study plan
ERAS protocol
ProcedurePatients with esophageal cancer have undergone RAME using ERAS protocol and conventional management strategy
Primary outcomes
-
time to first flatus
Time frame: 2019-2022
time to first flatus characterized by postoperative outcome
-
time to out-of-bed activity
Time frame: 2019-2022
time to out-of-bed activity characterized by postoperative outcome
-
time to liquid diet
Time frame: 2019-2022
time to liquid diet characterized by postoperative outcome
-
postoperative pain score
Time frame: 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.
-
duration of analgesic pump
Time frame: 2019-2022
duration of analgesic pump characterized by postoperative outcome
-
postoperative hospital stay
Time frame: 2019-2022
postoperative hospital stay characterized by postoperative outcome
-
ICU length of stay
Time frame: 2019-2022
ICU length of stay characterized by postoperative outcome
-
in-hospital mortality
Time frame: 2019-2022
in-hospital mortality characterized by postoperative outcome
-
incidence of various postoperative complications
Time frame: 2019-2022
incidence of various postoperative complications characterized by postoperative outcome
Secondary outcomes
-
postoperative chest drainage volume
Time frame: 2019-2022
postoperative chest drainage volume characterized by postoperative outcome
-
preoperative anesthesia time
Time frame: 2019-2022
preoperative anesthesia time characterized by intraoperative outcome
-
operation time
Time frame: 2019-2022
operation time characterized by intraoperative outcome
-
blood loss
Time frame: 2019-2022
blood loss characterized by intraoperative outcome
-
conversion rate
Time frame: 2019-2022
conversion rate characterized by intraoperative outcome
-
radicality of surgery
Time frame: 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
Sponsors and collaborators
Lead sponsor
West China Hospital
Other
Registry information
Official study title
Short-term Outcomes of Enhanced Recovery After Surgery Protocol in Robotic-assisted McKeown Esophagectomy for Esophageal Cancer
Important dates
- Study start
- 2019
- Primary completion
- 2021
- Study completion
- 2022
- First posted
- Oct 31, 2022
- Registry last updated
- Nov 3, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.