NCT04881734

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
235

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2021

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 11, 2021

Completed
Last Updated

May 12, 2021

Status Verified

May 1, 2021

Enrollment Period

3 months

First QC Date

May 6, 2021

Last Update Submit

May 11, 2021

Conditions

Keywords

PancreaticoduodenectomyOvertime surgeryFatigueOutcomes

Outcome Measures

Primary Outcomes (2)

  • Operative time

    The time elapsed from the patient's opening to closing the abdomen

    Intraoperative

  • Postoperative complication rate

    Postoperative complications include pancreatic fistula, gastric emptying disorder, abdominal cavity infection, and non-surgical-related complications.

    1 year

Secondary Outcomes (1)

  • Blood loss

    Intraoperative

Study Arms (2)

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

the overtime group

Patients who started surgery from 17:00 to 22:00 were included in the overtime group.

Other: Overtime pancreaticoduodenectomy

Interventions

Compared with daytime surgery, the intervention in this study is to work overtime after 17:00 to perform pancreaticoduodenectomy.

the control group and the overtime groupthe overtime group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • Patients with missing clinical data were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, 100044, China

Location

Related Publications (8)

  • 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.

    PMID: 10329298BACKGROUND
  • Mu 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.

    PMID: 16171288BACKGROUND
  • Folkard 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.

    PMID: 16570251BACKGROUND
  • Bosca 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.

    PMID: 30611547BACKGROUND
  • Brunschot 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.

    PMID: 26369548BACKGROUND
  • McEvoy 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.

    PMID: 25026968BACKGROUND
  • Warshaw 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.

    PMID: 15358336BACKGROUND
  • Cameron 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.

    PMID: 16794383BACKGROUND

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dafang Zhang, PhD

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

May 6, 2021

First Posted

May 11, 2021

Study Start

January 1, 2021

Primary Completion

April 10, 2021

Study Completion

April 29, 2021

Last Updated

May 12, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

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.

Locations