Prognostic Value of Preoperative 6-Minute Walk Test for Laparoscopic Gastrointestinal Surgery
1 other identifier
observational
200
1 country
1
Brief Summary
6-minute walk test (6MWT) is widely used in cardiopulmonary surgery as a prognostic marker. This prospective cohort study aims to find whether 6MWT will be a good prognostic factor for patients who will undergo laparoscopic gastrointestinal surgery.The investigators will enroll patients awaiting elective laparoscopic gastrointestinal surgery in this study. After informed consent was obtained, the participants will be evaluated through 6MWT. Preoperative assessment and conditions during operation will be recorded. The investigators will analyze the correlation between preoperative 6MWT's result and outcomes after laparoscopic gastrointestinal surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2018
CompletedFirst Posted
Study publicly available on registry
October 18, 2018
CompletedStudy Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2020
CompletedJuly 16, 2019
May 1, 2019
12 months
October 10, 2018
July 13, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative complications
Postoperative complications includes postoperative wound infections, delayed union or nonunion, intraperitoneal abscesses, intestinal obstruction, anastomotic fistula, postoperative hemorrhage which need blood transfusion, pulmonary complications, cardiovascular complications, cerebrovascular complications, thrombotic events, acute liver failure or deterioration of liver function, acute renal failure or deterioration of renal function, urinary infection, gastrointestinal hemorrhage, postoperative delirium, et al.
30 days
Secondary Outcomes (4)
Mortality rate
30 days
Second operation without plan
30 days after surgery
Rehospitalized
30 days
Patient satisfaction
30 days
Eligibility Criteria
Inpatient from 18 y/o to 75 y/o going to have elective laparoscopic gastrointestinal surgery in Peking Union Medical College Hospital from January 2019 to December 2019.
You may qualify if:
- Inpatient in Peking Union Medical College Hospital from January 2019 to December 2019
- From 18 y/o to 75 y/o
- Consent got from patients
- Decide to take the elective laparoscopic gastrointestinal surgery in Peking Union Medical College Hospital
You may not qualify if:
- Refuse to take part in the study (due to any reason)
- ASA grade ≥ IV
- Unable to cooperate with the study (mental disorder, disturbance of consciousness, dysnoesia)
- Have developed unstable angina or myocardial infarction in the recent 6 months
- HR\>120 beats/min or SBP\>180mm/Hg or DBP\>100mmHg at resting state
- During acute episode of asthma
- Diseases cause severe limitation of walking, including severe lumbar spondylosis, knee osteoarthritis, lower extremity varicose veins, et al.
- Other conditions make patients can't cooperate with 6MWT
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Related Publications (1)
Liu Y, Liu Z, Zhang L, Zhang Y, Zhang N, Han Y, Shen L. Preoperative 6-minute walk distance is associated with postoperative complications in patients undergoing laparoscopic gastrointestinal cancer surgery. Eur J Surg Oncol. 2024 Jan;50(1):107139. doi: 10.1016/j.ejso.2023.107139. Epub 2023 Nov 4.
PMID: 37948791DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
YUGUANG HUANG, MD.
Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2018
First Posted
October 18, 2018
Study Start
January 1, 2019
Primary Completion
December 31, 2019
Study Completion
March 31, 2020
Last Updated
July 16, 2019
Record last verified: 2019-05