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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

ZIJIA LIU, M.D. contact

+86-18501155710

liu-zj02@126.com

YUGUANG HUANG, M.D. contact

+86-13601121351

garypumch@163.com

China1 site, 1 recruiting
  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

    ZIJIA LIU, M.D.

    Recruiting

Other trials in China

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.

  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.

    Measured: 30 days

Secondary outcomes (4)
  1. Mortality rate

    Postoperative death due to any reason

    Measured: 30 days

  2. Second operation without plan

    During the same hospital stay, unplanned reoperations were performed for a variety of reasons.

    Measured: 30 days after surgery

  3. Rehospitalized

    Rehospitalized without plan due to any reason

    Measured: 30 days

  4. 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.

  1. First posted18 Oct 2018
  2. Study start1 Jan 2019
  3. Primary completion31 Dec 2019 (estimated)
  4. Study completion31 Mar 2020 (estimated)

Resources

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)
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

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.

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