PancreaticoduodenectomyEOPSPPNCT04881734
The Effect of Overtime Pancreaticoduodenectomy on the Short-term Prognosis of Patients(EOPSPP)
An observational study of Pancreaticoduodenectomy and Fatigue, run by Peking University People's Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreaticoduodenectomy, Fatigue
- What is being tested?
- Overtime pancreaticoduodenectomy
- How many people
- 235 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 29 Apr 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients who underwent pancreaticoduodenectomy at the Department of Hepatobiliary Surgery, Peking University People's Hospital from January 2017 to December 2019
Who may be able to join
- patients who underwent pancreaticoduodenectomy at the Department of Hepatobiliary Surgery, Peking University People's Hospital from January 2017 to December 2019
Who cannot join
- Patients with missing clinical data were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
- 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.
- 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.
- 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.
- 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).
- Conditions
- Pancreaticoduodenectomy, Fatigue
- Being tested
- Overtime pancreaticoduodenectomy
- Keywords
- Pancreaticoduodenectomy, Overtime surgery, Fatigue, Outcomes
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Overtime pancreaticoduodenectomyOther
Compared with daytime surgery, the intervention in this study is to work overtime after 17:00 to perform pancreaticoduodenectomy.
| Study group | Role | What they receive |
|---|---|---|
| the control group and the overtime group | Patients who started surgery between 8:00 and 16:59 were included in the control group. Receives: Other: Overtime pancreaticoduodenectomy | |
| the overtime group | Patients who started surgery from 17:00 to 22:00 were included in the overtime group. Receives: Other: Overtime pancreaticoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
The time elapsed from the patient's opening to closing the abdomen
Measured: Intraoperative
Postoperative complication rate
Postoperative complications include pancreatic fistula, gastric emptying disorder, abdominal cavity infection, and non-surgical-related complications.
Measured: 1 year
Secondary outcomes (1)
Blood loss
The amount of bleeding of the patient during the operation
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start1 Jan 2021
- Primary completion10 Apr 2021
- Study completion29 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for PancreaticoduodenectomyStudies of the same condition, open and under way.
- More trials run by Peking University People's 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
- Retrospective
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Dafang, Peking University People's Hospital
- Investigators
- Dafang Zhang, PhD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04881734
- Sponsor's protocol ID
- 2021PHB050-001
- Acronym
- EOPSPP
- Status last verified
- May 2021
- First submitted
- 6 May 2021
- Last updated
- 12 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Harrison Y, Horne JA. One night of sleep loss impairs innovative thinking and flexible decision making. Organ Behav Hum Decis Process. 1999 May;78(2):128-45. doi: 10.1006/obhd.1999.2827.
PubMed 10329298Mu Q, Mishory A, Johnson KA, Nahas Z, Kozel FA, Yamanaka K, Bohning DE, George MS. Decreased brain activation during a working memory task at rested baseline is associated with vulnerability to sleep deprivation. Sleep. 2005 Apr;28(4):433-46. doi: 10.1093/sleep/28.4.433.
PubMed 16171288Folkard S, Lombardi DA. Modeling the impact of the components of long work hours on injuries and "accidents". Am J Ind Med. 2006 Nov;49(11):953-63. doi: 10.1002/ajim.20307.
PubMed 16570251Bosca A, Montalva EM, Maupoey J, Arguelles B, Navio A, Calatayud D, Camacho A, Garcia-Eliz M, Lopez-Andujar R. Does Surgeon Fatigue Influence the Results of Liver Transplantation? Transplant Proc. 2019 Jan-Feb;51(1):67-70. doi: 10.1016/j.transproceed.2018.03.139. Epub 2019 Jan 2.
PubMed 30611547Brunschot DM, Hoitsma AJ, van der Jagt MF, d'Ancona FC, Donders RA, van Laarhoven CJ, Hilbrands LB, Warle MC. Nighttime kidney transplantation is associated with less pure technical graft failure. World J Urol. 2016 Jul;34(7):955-61. doi: 10.1007/s00345-015-1679-0. Epub 2015 Sep 14.
PubMed 26369548McEvoy SH, Lavelle LP, Hoare SM, O'Neill AC, Awan FN, Malone DE, Ryan ER, McCann JW, Heffernan EJ. Pancreaticoduodenectomy: expected post-operative anatomy and complications. Br J Radiol. 2014 Sep;87(1041):20140050. doi: 10.1259/bjr.20140050. Epub 2014 Jul 16.
PubMed 25026968Warshaw AL, Thayer SP. Pancreaticoduodenectomy. J Gastrointest Surg. 2004 Sep-Oct;8(6):733-41. doi: 10.1016/j.gassur.2004.03.005. No abstract available.
PubMed 15358336Cameron JL, Riall TS, Coleman J, Belcher KA. One thousand consecutive pancreaticoduodenectomies. Ann Surg. 2006 Jul;244(1):10-5. doi: 10.1097/01.sla.0000217673.04165.ea.
PubMed 16794383
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Overtime Pancreaticoduodenectomy on the Short-term Prognosis of Patients: a Retrospective Cohort Study of 235 Patients
- ClinicalTrials.gov ID
- NCT04881734
- Acronym / sponsor ID
- EOPSPP / 2021PHB050-001
- Conditions
- Pancreaticoduodenectomy, Fatigue
- Keywords
- Pancreaticoduodenectomy, Overtime surgery, Fatigue, Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 10 Apr 2021 (actual)
- Study completion
- 29 Apr 2021 (actual)
- First posted
- 11 May 2021 (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.
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.
Detailed description
- 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.
- 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.
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the control group and the overtime group | – | Other: Overtime pancreaticoduodenectomyPatients who started surgery between 8:00 and 16:59 were included in the control group. |
| the overtime group | – | Other: Overtime pancreaticoduodenectomyPatients who started surgery from 17:00 to 22:00 were included in the overtime group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients who underwent pancreaticoduodenectomy at the Department of Hepatobiliary Surgery, Peking University People's Hospital from January 2017 to December 2019
Key inclusion criteria (1 listed)
- patients who underwent pancreaticoduodenectomy at the Department of Hepatobiliary Surgery, Peking University People's Hospital from January 2017 to December 2019
Key exclusion criteria (1 listed)
- Patients with missing clinical data were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Overtime pancreaticoduodenectomyCompared with daytime surgery, the intervention in this study is to work overtime after 17:00 to perform pancreaticoduodenectomy. | Other | the control group and the overtime group, the overtime group |
Primary outcome
Operative time
Time frame: Intraoperative
The time elapsed from the patient's opening to closing the abdomen
Postoperative complication rate
Time frame: 1 year
Postoperative complications include pancreatic fistula, gastric emptying disorder, abdominal cavity infection, and non-surgical-related complications.
1 secondary outcome
Blood loss
Time frame: Intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2021.
- Background: PubMed 10329298Harrison Y, Horne JA. One night of sleep loss impairs innovative thinking and flexible decision making. Organ Behav Hum Decis Process. 1999 May;78(2):128-45. doi: 10.1006/obhd.1999.2827.
- Background: PubMed 16171288Mu Q, Mishory A, Johnson KA, Nahas Z, Kozel FA, Yamanaka K, Bohning DE, George MS. Decreased brain activation during a working memory task at rested baseline is associated with vulnerability to sleep deprivation. Sleep. 2005 Apr;28(4):433-46. doi: 10.1093/sleep/28.4.433.
- Background: PubMed 16570251Folkard S, Lombardi DA. Modeling the impact of the components of long work hours on injuries and "accidents". Am J Ind Med. 2006 Nov;49(11):953-63. doi: 10.1002/ajim.20307.
- Background: PubMed 30611547Bosca A, Montalva EM, Maupoey J, Arguelles B, Navio A, Calatayud D, Camacho A, Garcia-Eliz M, Lopez-Andujar R. Does Surgeon Fatigue Influence the Results of Liver Transplantation? Transplant Proc. 2019 Jan-Feb;51(1):67-70. doi: 10.1016/j.transproceed.2018.03.139. Epub 2019 Jan 2.
- Background: PubMed 26369548Brunschot DM, Hoitsma AJ, van der Jagt MF, d'Ancona FC, Donders RA, van Laarhoven CJ, Hilbrands LB, Warle MC. Nighttime kidney transplantation is associated with less pure technical graft failure. World J Urol. 2016 Jul;34(7):955-61. doi: 10.1007/s00345-015-1679-0. Epub 2015 Sep 14.
- Background: PubMed 25026968McEvoy SH, Lavelle LP, Hoare SM, O'Neill AC, Awan FN, Malone DE, Ryan ER, McCann JW, Heffernan EJ. Pancreaticoduodenectomy: expected post-operative anatomy and complications. Br J Radiol. 2014 Sep;87(1041):20140050. doi: 10.1259/bjr.20140050. Epub 2014 Jul 16.
- Background: PubMed 15358336Warshaw AL, Thayer SP. Pancreaticoduodenectomy. J Gastrointest Surg. 2004 Sep-Oct;8(6):733-41. doi: 10.1016/j.gassur.2004.03.005. No abstract available.
- Background: PubMed 16794383Cameron JL, Riall TS, Coleman J, Belcher KA. One thousand consecutive pancreaticoduodenectomies. Ann Surg. 2006 Jul;244(1):10-5. doi: 10.1097/01.sla.0000217673.04165.ea.
- Individual participant dataSharing planned: No. 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.
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Patients Who Undergo Pancreaticoduodenectomy
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.
Dafang Zhang, PhD principal investigator
Peking University People's Hospital
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 Pancreaticoduodenectomy and Fatigue, run by Peking University People's 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 12 May 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: Intraoperative). The study lists 2 primary outcomes in all. 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 NCT04881734, which also lists 8 linked publications.
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 12 May 2021; AzTrials last refreshed its copy on 8 Nov 2026.