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A Study Comparing Restrictive and Liberal Fluid Therapy During Pancreatecoduodenectomy Surgery

Restrictive Versus Liberal Fluid Therapy in Patients Undergoing Pancreaticoduodenectomy: A Prospective Randomized Controlled Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07072897
Enrollment
44
Registered
2025-07-18
Start date
2020-05-01
Completion date
2021-08-31
Last updated
2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer, Resected, Whipple Procedure

Brief summary

ancreaticoduodenectomy (also known as PD or the Whipple procedure) is a major surgery often done for conditions like pancreatic cancer. Over the past few decades, doctors around the world have greatly improved surgical techniques, reducing the risk of death after PD from about 24% in the 1980s to less than 2% today in good volume hospitals. However, even though fewer patients are dying from the surgery, many still face complications after surgery, such as infections, delayed healing, or other problems called as morbidities. These problems can affect 17% to 50% of patients. One important factor that may affect recovery is fluid management - the amount of fluids patients receive around the time of surgery. Traditionally, surgeons gave large amounts of fluid during and after surgery, thinking it helped keep blood pressure and urine output stable. This approach is called liberal fluid therapy. But giving too much fluid can cause swelling, weight gain, and slower recovery. A newer method, called restrictive fluid therapy, gives smaller, more controlled amounts of fluid to avoid these problems. This approach is new and has shown good results in some studies however the exact role is yet unclear. At our hospital, we usually use liberal fluid therapy and give fluids based on the treating physician, using these fluids or restricting them as per the treating physician's choice. So, the study compares these two fluid strategies in patients having PD. Our goal is to find out whether using less fluid (restrictive therapy) could help reduce complications and improve patient outcomes when compared to using more liberal fluids.

Interventions

fluid boluses 250 ml were given when required

OTHERFrusemide was given when required

fluid is given in a fixed regimen

Sponsors

Tribhuvan University Teaching Hospital, Institute Of Medicine.
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* All patients who underwent PD at TUTH during the research duration. * All patients above 18 years.

Exclusion criteria

* Those not willing to participate in the study. * All patients with age ≥ 75 years. * Patients with Chronic renal failure. * Patients with major Cardiac illness. * Patients who died within 24 hours of surgery. * Failure to comply with the regimen due to any reason. * Those who underwent palliative procedure instead of planned PD.

Design outcomes

Primary

MeasureTime frameDescription
postoperative complications CD≥ IIIb1 monthCD IIIb and more were chosen as major complications as major morbidity occurs when the patient is taken to operating room or ICU to manage these complications.

Secondary

MeasureTime frameDescription
other complications1 monthOther complications were procedure specific complications like POPF,DGE and other complications that can occur after pancreaticoduodenectomy like Pneumonia, SSI

Countries

Nepal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026