The Effect of Overtime Pancreaticoduodenectomy on the Short-term Prognosis of Patients(EOPSPP) (EOPSPP)

May 11, 2021 updated by: Zhang Dafang, Peking University People's Hospital

The Effect of Overtime Pancreaticoduodenectomy on the Short-term Prognosis of Patients: a Retrospective Cohort Study of 235 Patients

Surgeons sometimes need to work overtime or even stay up late to perform pancreaticoduodenectomy. Fatigue and sleep deprivation can result in an increased error rate at work. The effect of overtime work for pancreaticoduodenectomy on the prognosis of patients is unclear. The study explores the impact of overtime work for pancreaticoduodenectomy on the prognosis of patients.

This was a single-center, retrospective study. The patients who underwent pancreaticoduodenectomy in Peking University People's Hospital between 2017 and 2019 were included. Patients were stratified by operative start time into the control group (surgery that started between 8:00 and 16:49) and the overtime group (surgery that started between 17:00 and 22:00) and compared intraoperative and postoperative parameters to clarify the impact of overtime surgery on the short-term prognosis of patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. Research Background Due to the large number of operations, surgeons sometimes need to work overtime to perform elective surgery. At this time, surgeons need to perform the operation under fatigue or even sleep deprivation. Fatigue and sleep deprivation will affect the cognitive function, leading an increased error rate at work. There have been numerous studies about the effect of overtime surgery on the prognosis of patients. However, the impact of surgery on patients under fatigue and sleep deprivation is still controversial. Halvachizadeh et al. observed higher complication and mortality rates for orthopedic trauma surgery performed after-hours. Boscà et al. believe that there is no poor prognosis in patient undergoing liver transplantation by a fatigued surgeons. Brunschot et al. reported that nighttime kidney transplantation is associated with less pure technical graft failure.

    Pancreaticoduodenectomy is widely used to treat pancreatic cancer, bile duct carcinoma, duodenal carcinoma, and ampullary carcinoma. The operation is complicated, and usually lasts more than 5 hours. Postoperative complications such as pancreatic fistula, gastroparesis, abdominal infection, and abdominal hemorrhage are prone to occur. Extensive literature have clarified the risk factors related to complications after pancreaticoduodenectomy. At present, there is no report on the effect of pancreaticoduodenectomy under overtime on the prognosis of patients. Therefore, the study explores the impact of overtime work for pancreaticoduodenectomy on the prognosis of patients.

  2. Research method and design This study is a retrospective cohort study. The clinical data of patients who underwent pancreaticoduodenectomy at the Department of Hepatobiliary Surgery, Peking University People's Hospital from January 2017 to December 2019 were retrospectively analyzed. The clinical data of patients are collected through the medical record management system of Peking University People's Hospital; the collected data includes the time of admission, age, gender, BMI, ASA classification, preoperative total bilirubin level, and past concomitant diseases (hypertension, diabetes, coronary heart disease, brain Vascular disease), tumor location, surgeon, operation time, intraoperative blood loss, surgical reconstruction method, anastomosis method, postoperative hospital stay, intra-abdominal infection, gastric emptying disorder, pancreatic fistula, intraoperative death, hemorrhage, and death during hospitalization , Take the number of lymph nodes; The research data is completed by two researchers independently and simultaneously. After completion, the data completed by the two are compared to ensure the accuracy of the data; All patients were scheduled to undergo elective surgery. Patients were stratified by operative start time into the control group (surgery that started between 8:00 and 16:49) and the overtime group (surgery that started between 17:00 and 22:00). The following parameters as possible confounders were compared: patient age, gender, body mass index (BMI), American Society of Anesthesiologists (ASA) grade, medical co-morbidities, preoperative total bilirubin, site of lesion, surgeon, technique of reconstruction, techinique of pancreaticojejunostomy. The following parameters between overtime group and control group were compared, including operative time, blood loss, number of lymph nodes removed, duration of treatment in ICU, and complication rate.
  3. Sample size calculation According to the research on the incidence of pancreatic fistula in pancreaticoduodenectomy, it is estimated that the incidence of pancreatic fistula in the normal group is 10%, and the incidence of pancreatic fistula in the fatigue group is 25%. Assuming that the test type I error α is 0.05, the type II error β is 0.20, and the sample size ratio of the normal group and the fatigue group is 3:1. According to the sample size calculation formula, 228 cases in the normal group and 76 cases in the fatigue group were obtained.
  4. Statistical analysis Continuous variable was tested by Shapiro-Wilk test to determine whether it is a normal distribution. Continuous variables that were proved to be a normal distribution were reported by mean and standard deviations. Otherwise, continuous variables were reported by median. Categorical variables were reported by frequency or percentage. Continuous, normally distributed variables were compared with the t-test and non-normally distributed variables were compared with the Mann-Whitney test. Chi-square test is used to compare categorical variables. Reverse stepwise multivariable logistic regression was performed to assess the effects of the potential covariates on outcome. Potential confounders were selected based on a p-value less than 0.2 in univariable analysis. P-values less than 0.05 were considered significant. Data was analyzed in Statistical Package for the Social Sciences version 21.0 (SPSS 21.0).

Study Type

Observational

Enrollment (Actual)

235

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100044
        • Peking University People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients who underwent pancreaticoduodenectomy at the Department of Hepatobiliary Surgery, Peking University People's Hospital from January 2017 to December 2019

Description

Inclusion Criteria:

  • patients who underwent pancreaticoduodenectomy at the Department of Hepatobiliary Surgery, Peking University People's Hospital from January 2017 to December 2019

Exclusion Criteria:

  • Patients with missing clinical data were excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
the control group and the overtime group
Patients who started surgery between 8:00 and 16:59 were included in the control group.
Other: Overtime pancreaticoduodenectomy
Compared with daytime surgery, the intervention in this study is to work overtime after 17:00 to perform pancreaticoduodenectomy.
the overtime group
Patients who started surgery from 17:00 to 22:00 were included in the overtime group.
Other: Overtime pancreaticoduodenectomy
Compared with daytime surgery, the intervention in this study is to work overtime after 17:00 to perform pancreaticoduodenectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: Intraoperative
The time elapsed from the patient's opening to closing the abdomen
Intraoperative
Postoperative complication rate
Time Frame: 1 year
Postoperative complications include pancreatic fistula, gastric emptying disorder, abdominal cavity infection, and non-surgical-related complications.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood loss
Time Frame: Intraoperative
The amount of bleeding of the patient during the operation
Intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Investigators

  • Principal Investigator: Dafang Zhang, PhD, Peking University People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

April 10, 2021

Study Completion (Actual)

April 29, 2021

Study Registration Dates

First Submitted

May 6, 2021

First Submitted That Met QC Criteria

May 10, 2021

First Posted (Actual)

May 11, 2021

Study Record Updates

Last Update Posted (Actual)

May 12, 2021

Last Update Submitted That Met QC Criteria

May 11, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021PHB050-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data cannot be publicly available due to regulations of the Ethics Committee of Peking University People's Hospital. But the data can be available from the researcher on reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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