Effects of Surgical Timing on Perioperative Clinical Outcomes in Pancreaticoduodenectomy

Sichuan University

Status: Completed

Conditions: Perioperative Complication; Surgery Timing; Pancreaticoduodenal; Fistula

Study type: Observational

Funder types: Other

Identifiers

NCT06874660

2025-001

Details and patient eligibility

About

With the advancement of surgical techniques and the increase in pancreatic oncologic diseases, the volume of pancreaticoduodenal surgeries has been increasing year by year in our center, and multiple pancreaticoduodenal surgeries are often performed on the day of surgery. This study will compare the effect of pancreaticoduodenal surgery performed at different times on patient prognosis. This study plans to divide the patients into morning group, afternoon group, and night group through the start time of surgery, and this study plans to analyze subgroups such as laparoscopic pancreaticoduodenal surgery. The outcome indicators include perioperative complications such as pancreatic fistula, bleeding, abdominal infection, hospitalization cost, and length of hospital stay. The conclusions drawn from this study will suggest to surgeons whether pancreaticoduodenal surgery performed at different times of the day will have different outcomes for patients and will guide surgeons on the timing of pancreaticoduodenal surgery.

Enrollment: 350 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients must be required to sign an informed consent form;
2. Age 18-80 years, male and female;
3. ECOG Physical Status Score (PS Score) 0 or 1.
4. Pancreaticoduodenectomy at our center without contraindications related to the surgery.

Exclusion criteria

1. Pre-existing or concurrent other malignant tumors
2. Severe cardiopulmonary and renal dysfunction.
3. Autoimmune disease or history of immunodeficiency
4. Active infections and infectious diseases requiring systemic therapy.
5. History of psychotropic substance abuse, alcoholism or drug addiction.
6. Failure to meet the inclusion criteria as determined by the investigator.

Trial design

350 participants in 2 patient groups

1

Description:

surgery before 12.00 pm

2

Description:

surgery before 12.00 pm