Menu
Recruiting NCT07263061

Time to Post-operative Recovery of Serum Albumin as a Predictor of Outcome in Major Hepato Pancreato Biliary Surgeries

Observational Hepatobiliary Disease Pancreas Disease Bile Duct Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NO TREATMENT.
Who it may be relevant to
Registry conditions: Hepatobiliary Disease, Pancreas Disease, Bile Duct Diseases. Basic parameters: 13 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
India
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Hepatobiliary and Pancreatic surgery is associated with substantial risk of postoperative complications. Albumin is a negative acute phase protein. Its rapid decline may be due to degree of inflammation due to surgical procedures. The decline may due to multifactorial causes. Currently, contemporary data regarding the time to recovery of albumin, as a marker for early recovery of patient from surgical stress is sparse. Delta albumin is influenced by perioperative fluid administration and albumin supplementation. Delta albumin may not reflect the true surgical stress. Early post op albumin is a reflection of intraoperative events and not postoperative recovery or events and is unpredictable. Shorter recovery time of albumin is associated with less post op complications and hospital stay. Earlier recovery of albumin predicts lower morbidity and shorter hospital stay.

Detailed description

Hepatobiliary and Pancreatic surgery is associated with substantial risk of postoperative complications. Albumin is a negative acute phase protein. Its rapid decline may be due to degree of inflammation due to surgical procedures. The decline may due to multifactorial causes. Currently, contemporary data regarding the time to recovery of albumin, as a marker for early recovery of patient from surgical stress is sparse. Delta albumin is influenced by perioperative fluid administration and albumin supplementation. Delta albumin may not reflect the true surgical stress.

Interventions

  • Other NO TREATMENT
    NO TREATMENT

Primary outcome measures

  • Time to recovery of serum albumin as a predictor of outcome in major hepatobiliary surgeries as measured by hospital stay. [Time frame: 30 days]
Secondary outcome measures (3)
  • To correlate the time to recovery of albumin with complications and morbidity (Clavien Dindo classification, Comprehensive Complication Index, Intensive Care Unit Stay) [Time frame: 30 days]
  • Time to reversal trend of albumin and Hospital stay [Time frame: 30 days]
  • correlation of time to recovery of albumin and re admission rates [Time frame: 90 days]

Eligibility criteria

Inclusion criteria

  • All patients undergoing major Hepato pancreatico Biliary surgeries.
  • Patients who are more than 12 years of age
  • Retrospective arm - Data from 2010

Exclusion criteria

  • Patients who refuse or are unable to give consent.
  • Patients with Nephrotic syndrome, Protein losing enteropathies, Inflammatory bowel
  • Disease, Chronic Liver Disease.
  • Emergency Surgeries

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

India · 1 center
  • ILBS — New Delhi

Identifiers

NCT: NCT07263061 · IEC/2024/110/MA04

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗