Liberal versus restrictive IV fluids after laparoscopic gallbladder removal
Effect of Liberal Versus Restrictive Intravenous Fluid Administration on Postoperative Homeostasis in Patients Undergoing Laparoscopic Cholecystectomy
This will see if giving less IV fluid compared with more IV fluid after laparoscopic gallbladder removal helps adults aged 18–60 stay stable and recover similarly.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 380 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | King Edward Medical University Academic / other |
| Locations | 1 site (Lahore, Punjab Province) |
| Trial ID | NCT07488078 on ClinicalTrials.gov |
What this trial studies
This randomized Phase 1 trial will assign adults (18–60 years, ASA I–II) undergoing elective laparoscopic cholecystectomy to receive either a more liberal or a more restrictive postoperative IV fluid regimen using lactated Ringer's solution. Researchers will track immediate postoperative physiologic stability (blood pressure, heart rate, urine output) and record recovery metrics and complications. Key exclusions include prior laparotomy, perforated gallbladder, surgeries lasting over three hours, or intraoperative blood loss greater than 100 ml. The goal is to compare safety and early recovery between the two fixed-volume fluid approaches.
Who should consider this trial
Good fit: Adults aged 18–60 years with ASA class I–II who are scheduled for elective laparoscopic cholecystectomy and meet the trial exclusion criteria are ideal candidates.
Not a fit: Patients outside the age or ASA ranges, those with perforated or complicated gallbladder disease, prior major abdominal surgery, long expected operative time, or significant intraoperative blood loss may not benefit or be eligible.
Why it matters
Potential benefit: If successful, patients could receive less IV fluid after gallbladder removal without increasing complications, potentially reducing fluid-related side effects and speeding recovery.
How similar studies have performed: Previous studies of restrictive or goal-directed fluid strategies in various abdominal surgeries have shown reduced complications and faster recovery in some settings, but direct evidence specifically for routine laparoscopic cholecystectomy is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients undergoing elective cholecystectomy * Age : 18-60 years * All genders * ASA class 1 and 2 Exclusion Criteria: * History of previous laparotomy * Perforated gall bladder * Duration of surgery more than 3 hours * More than 100ml intra operative blood loss
Where this trial is running
Lahore, Punjab Province
- King Edward Medical University Lahore / Mayo Hospital Lahore — Lahore, Punjab Province, Pakistan (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.