- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03711526
Prognostic Value of Preoperative 6-Minute Walk Test for Laparoscopic Gastrointestinal Surgery
Prognostic Value of Preoperative 6-Minute Walk Test in Patients Undergoing Laparoscopic Gastrointestinal Surgery: a Prospective Cohort Study
Study Overview
Status
Conditions
Detailed Description
This is a prospective observational cohort study, which focus on the prognostic value of 6-minute walk test (6MWT) in patients who will undergo laparoscopic gastrointestinal surgery.
Enhanced recovery after surgery (ERAS) is an optimized program which help patients accelerate recovery and improve outcomes by integrating evidence-based protocols and guidelines. With the rapid development of ERAS, the preoperative clinical data of patients are paid more and more attention to evaluate the risk of perioperative complications and choose an appropriate time for surgery. A better perioperative evaluation method will lead to lower morbidity and mortality rates of postoperative complications and shorter time of hospital stay. So, it is important to find an appropriate evaluation method to predict the outcomes of patients undergoing surgery.
6MWT is a low-cost, easy to operate and well-tolerated test to evaluate exercise tolerance to predict cardiopulmonary function. It has widely used in cardiopulmonary surgery as a prognostic marker. Even though massive studies showed that decreased perioperative 6-minute walk distance (6MWD) related to postoperative complication in patients underwent cardiac or pulmonary surgery, there are only small numbers of studies with small number sizes presenting correlation of decreased 6MWD and postoperative complication in abdominal surgery. Even some studies of upper abdomen got the opposite result. Furthermore, the critical value for 6MWD is still controversial. Based on these conditions, this study was designed to investigate if 6MWT cloud be used as an accurate assessment with the prognostic value in patients who will undergo laparoscopic gastrointestinal surgery to improve the ERAS program.
The investigators decide to enroll 200 patients awaiting elective laparoscopic gastrointestinal surgery in this study at Peking Union Medical College Hospital. After informed consent was obtained, the patients will be comprehensively evaluated from demographic characteristics, complications of systems and organs, laboratory tests results, 6MWT, metabolic equivalents (METs), psychological states assessed by hospital anxiety and depression scale. Outcomes will be assessed according to the Clavien-Dindo Classification of Surgical Complications. Operative name, operation date, operative method, blood loss, situation of blood transfusion, operation time, duration of anesthesia, whether return to ICU or not (treatment time and tubulization time), drainage flow of within 24 hours after surgery will be recorded. Other outcome measures include the mortality rate within 30 days after surgery, second operation without plan, rehospitalized rate without plan, postoperative hospitalization time, patient satisfaction.
Descriptive analysis, univariate analysis, multivariate analysis and establishment of complication prediction model will be used to analyze the correlation between preoperative 6MWD and outcomes.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: ZIJIA LIU, M.D.
- Phone Number: +86-18501155710
- Email: liu-zj02@126.com
Study Contact Backup
- Name: YUGUANG HUANG, M.D.
- Phone Number: +86-13601121351
- Email: garypumch@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100730
- Recruiting
- Peking Union Medical College Hospital
-
Contact:
- ZIJIA LIU, M.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative complications
Time Frame: 30 days
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality rate
Time Frame: 30 days
|
Postoperative death due to any reason
|
30 days
|
Second operation without plan
Time Frame: 30 days after surgery
|
During the same hospital stay, unplanned reoperations were performed for a variety of reasons.
|
30 days after surgery
|
Rehospitalized
Time Frame: 30 days
|
Rehospitalized without plan due to any reason
|
30 days
|
Patient satisfaction
Time Frame: 30 days
|
telephone visits by a blinded doctor with same standardized questions were conducted.
|
30 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: YUGUANG HUANG, MD., Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- LZJ001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Outcomes
-
Zimmer BiometActive, not recruitingClinical Outcomes | Survivorship | Safety | Functional Outcomes | Radiological OutcomesUnited States
-
Third Military Medical UniversityCompletedPerioperative Outcomes | Oncological OutcomesChina
-
ModernaTX, Inc.CompletedPregnancy | Maternal Outcomes | Infant OutcomesUnited States
-
University of LiegeCompletedIntraoperative Outcomes | Postoperative Outcomes
-
Teachers College, Columbia UniversityColumbia UniversityNot yet recruitingAdverse Childhood Experiences | Mental Health Outcomes | Perceived School Safety | Educational Outcomes
-
Stony Brook UniversityRecruiting
-
Sophiahemmet UniversityKarolinska Institutet; Göteborg UniversityCompleted
-
Cedars-Sinai Medical CenterCompleted
-
University of ChicagoCompletedNonhealth Outcomes
-
Alcon ResearchWithdrawnVisual OutcomesUnited States