OutcomesNCT03711526
Prognostic Value of Preoperative 6-Minute Walk Test for Laparoscopic Gastrointestinal Surgery
An observational study of Outcomes, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Outcomes
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
ZIJIA LIU, M.D.
About this study
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.
Read the 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.
- Conditions
- Outcomes
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (4)
Mortality rate
Postoperative death due to any reason
Measured: 30 days
Second operation without plan
During the same hospital stay, unplanned reoperations were performed for a variety of reasons.
Measured: 30 days after surgery
Rehospitalized
Rehospitalized without plan due to any reason
Measured: 30 days
Patient satisfaction
telephone visits by a blinded doctor with same standardized questions were conducted.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start1 Jan 2019
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OutcomesStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- YUGUANG HUANG, MD., Principal investigator, Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03711526
- Sponsor's protocol ID
- LZJ001
- Status last verified
- May 2019
- First submitted
- 10 Oct 2018
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37948791
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Preoperative 6-Minute Walk Test in Patients Undergoing Laparoscopic Gastrointestinal Surgery: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03711526
- Acronym / sponsor ID
- LZJ001
- Conditions
- Outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 18 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Mortality rate
Time frame: 30 days
Second operation without plan
Time frame: 30 days after surgery
Rehospitalized
Time frame: 30 days
Patient satisfaction
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Derived from this study: PubMed 37948791Liu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YUGUANG HUANG, MD. principal investigator
Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Outcomes, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ZIJIA LIU, M.D. (+86-18501155710, liu-zj02@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03711526, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2019.