Comparision of cholecystectomy using laparoscopy vs mini-laparoscopy as a day care procedure

COMPARISON BETWEEN MINI-LAPAROSCOPIC AND CONVENTIONAL LAPAROSCOPIC CHOLECYSTECTOMY AS A DAY CARE PROCEDURE – A RANDOMIZED CONTROLLED STUDY - NIL

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/09/057858

Enrollment

Registered

2023-09-20

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Mini-Laparoscopic Cholecystectomy: Mini-laparoscopic cholecystectomy – Peumoperitoneum will be achieved by open technique. A 10 mm 30°telescope will be used at the umbilicus for vision.

Eligibility

Inclusion criteria

Inclusion criteria: Patients eligible for day care surgery. (as per ASA guidelines for Ambulatory Anesthesia and Surgery

Exclusion criteria

Exclusion criteria: 1. History of cholecystitis (Biliary colic lasting for >24hours or requiring hospitalization) within 2months 2. History of previous upper abdominal surgeries 3. Coagulopathies 4. Morbid Obesity 5. Choledocholithiasis 6. Pregnancy

Design outcomes

Primary

Measure	Time frame
1. Operative time 2. Conversion of MLC/CLC to CLC/ Open cholecystectomyTimepoint: At the time of completion of Procedure (skin closure)	—

Secondary

Measure	Time frame
1. Intraoperative events [for e.g., bleeding, bile duct injury, gall bladder perforation, bowel injury etc.]Timepoint: During Procedure;2. Post operative complications [for e.g., fever, bile leak, surgical site infection]Timepoint: Post operative day 1,3,7 and at 1 month;3. Post operative pain using Visual Analogue Scale (VAS) scoreTimepoint: At 2,4,6,8,24,72 hour from surgery and at post operative day 7;4. Cosmetic outcome [measured as, average of Stony Brook Scar Evaluation Scale score (SBSES) of all the port sites by the investigator, and with a self-assessment scale for cosmetic results of 1 (not satisfied at all) to 5 (extremely satisfied) by the patient themselvesTimepoint: At 1 month after operation	—

Measure

Time frame

1. Intraoperative events [for e.g., bleeding, bile duct injury, gall bladder perforation, bowel injury etc.]Timepoint: During Procedure;2. Post operative complications [for e.g., fever, bile leak, surgical site infection]Timepoint: Post operative day 1,3,7 and at 1 month;3. Post operative pain using Visual Analogue Scale (VAS) scoreTimepoint: At 2,4,6,8,24,72 hour from surgery and at post operative day 7;4. Cosmetic outcome [measured as, average of Stony Brook Scar Evaluation Scale score (SBSES) of all the port sites by the investigator, and with a self-assessment scale for cosmetic results of 1 (not satisfied at all) to 5 (extremely satisfied) by the patient themselvesTimepoint: At 1 month after operation

—

Countries

India

Contacts

Public ContactHarsha

Maulana Azad Medical College And Associated Lok Nayak Hospital

profplal@gmail.com9968604380

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026