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Comparison of hand fatigue of surgeon during Laparoscopic entry in low and standard abdominal pressure in patients undergoing laparoscopic cholecystectomy

Impact of Low versus Standard Intra-peritoneal Pressure on Surgeon's Hand Fatigue During Closed Laparoscopic Entry: An Open Label Randomized Controlled Study- LISIHaFa Trial - LISIHaFa Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/102026
Enrollment
128
Registered
2026-01-27
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Health Condition 1: K801- Calculus of gallbladder with othercholecystitis Health Condition 2: K811- Chronic cholecystitis Health Condition 3: K802- Calculus of gallbladder without cholecystitis

Interventions

Intervention1: Low Intra-peritoneal Pressure: Pneumoperitoneum of 8 mmHg (LIP) will be achieved after inserting a Veress needle at Palmer s point. The insufflation tube will remain connected to the Ve

Sponsors

Department of General Surgery, AIIMS Deoghar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18-65 years. 2. ASA I-II, undergoing elective laparoscopic cholecystectomy. 3. Informed consent obtained

Exclusion criteria

Exclusion criteria: 1. Emergency procedures. 2. Previous upper abdominal laparotomy or significant adhesions. 3. BMI more than 35 kg per m (obscuring entry). 4. Coagulopathy or contraindications to pneumoperitoneum. 5. Surgeon inexperience (less than 50 laparoscopic LC cases).

Design outcomes

Primary

MeasureTime frame
To compare surgeon s non-dominant hand fatigue during umbilical port placement during closed laparoscopic entry.Timepoint: Mean of 3 readings using hand grip dynamometer at 15 seconds interval prior to umbilical port placement. Mean of 3 readings using hand grip dynamometer at 15 seconds interval just after umbilical port placement.—

Secondary

MeasureTime frame
To compare the difference in the difficulty in umbilical port placement during closed laparoscopic entry.Timepoint: 1. Time to port placement (in seconds) 2. Number of attempts 3. Assistance required ;To compare intraoperative complications.Timepoint: Bowel Injury - Monitored till 1 week Vascular injury- Monitored till 1 week ;To compare the postoperative pain.Timepoint: VAS score (0-10) at 2-, 6-, and 24- hours post-op.—

Countries

India

Contacts

Public ContactDr Amardeep Kumar

AIIMS Deoghar

rajamar82@gmail.com8920891044

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026