Outcomes Clinical Trial
Official title:
Prognostic Value of Preoperative 6-Minute Walk Test in Patients Undergoing Laparoscopic Gastrointestinal Surgery: a Prospective Cohort Study
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05563662 -
SURgical Registry of ENDocarditis EuRope
|
||
Completed |
NCT03444116 -
Long-Term Outcomes of Femoral Derotation Osteotomy for Individuals With Cerebral Palsy
|
||
Recruiting |
NCT04715581 -
Multicomponent Prehabilitation and Outcomes in Elderly Patients With Frailty
|
N/A | |
Recruiting |
NCT05595200 -
Prevalence, Phenotypes, Predictors and Prognostic Implication of Obstructive Sleep Apnea in Pulmonary Hypertension
|
||
Recruiting |
NCT05360212 -
Anatomy-based Fitting in Cochear Implant Users
|
N/A | |
Terminated |
NCT05379452 -
Outcomes of Neonates Born to Mothers With SARS-CoV-2 Infection in Shanghai
|
||
Completed |
NCT01176110 -
Thermal Management in Patients With Interventional Minimally Invasive Valve Replacement
|
N/A | |
Terminated |
NCT02167685 -
The Chimerix CMX001 Registry
|
||
Recruiting |
NCT05506293 -
European Multicentre Registry of Percutaneous Paravalvular Leak Closure
|
||
Recruiting |
NCT03123536 -
Use of Point-of-care Ultrasound in High Risk Surgical Patients
|
N/A | |
Recruiting |
NCT05551923 -
Predictive Value of Human Microbiome and Serological Markers for Clinical Outcome of Cerebral Hemorrhage
|
||
Recruiting |
NCT05494632 -
Interaural Mismatch in SSD CI Users
|
N/A | |
Completed |
NCT03736304 -
The Effect of Automated Electronic Alert for Acute Kidney Injury on the Outcomes of Hospitalized Patients
|
N/A | |
Completed |
NCT03354546 -
Development and Validation of a Preoperative Frailty Index Using Health Administrative Data
|
N/A | |
Completed |
NCT00013130 -
Ambulatory Care Quality Improvement (ACQUIP)
|
Phase 2 |