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Comparing Two Methods for Safer Laparoscopic Gallbladder Stone Surgery A Study on Between Two Techniques

Comparative efficacy of body first versus conventional techniques in achieving critical view of safety in laparoscopic cholecystectomy a single blinded block randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/075571
Enrollment
80
Registered
2024-10-21
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

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: Body First Approach of Laparoscopic Cholecystectomy: Patients in this group will undergo Laparoscopic cholecystectomy by Body First Approach under general anesthesia and sterile conditi

Sponsors

Dr Jagani Harsha Sai
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients scheduled for elective Laparoscopic cholecystectomy 2. Patients diagnosed with symptomatic gallbladder stone diseases based on clinical evaluation and imaging studies 3.Patients who provide informed consent to participate in the study

Exclusion criteria

Exclusion criteria: 1. Patients requiring urgent or emergency surgery due to acute cholecystitis will be excluded from the study as they may have different surgical considerations and outcomes 2.Patients with a history of previous upper abdominal surgery that may significantly alter the surgical anatomy such as gastric bypass or liver resection 3. Patients with known or suspected biliary tract anomalies (e.g Mirizzi syndrome, anomalous biliary anatomy) or ductal pathology (e.g choledocholithiasis, strictures) identified preoperatively 4. Patients with contraindications to laparoscopic surgery such as severe cardiopulmonary disease, uncontrolled coagulopathy, or intra-abdominal adhesions precluding safe laparoscopic access 5. Pregnant females will be excluded due to potential risks to maternal and fetal health and limitations in imaging modalities 6. Patients underwent administration of immunosuppressive agents in the past month 7. Patients with cognitive impairment or inability to provide informed consent.

Design outcomes

Primary

MeasureTime frame
1.Rate and quality of achievement of the Critical View of Safety which will be defined according to Strasberg criteria of doublet photography 2.Duration of surgeryTimepoint: Primary outcome will be assessed intraoperatively and post operatively after completion of surgery

Secondary

MeasureTime frame
1.Comparison of intraoperative and postoperative complications 2.Recovery of gastrointestinal function (passing of first flatus) 3.Post-operative pain, nausea and vomiting 4.Length of hospital stay 5.Pre and post operative change in inflammatory marker 6.Patient satisfaction using SF 36 criteriaTimepoint: All Patients will be followed in post operative period , at the time of discharge , 1 month and 3 months interval.

Countries

India

Contacts

Public ContactDr Ravi Gupta

All India Institute of Medical Sciences Gorakhpur

ravikgmc2004@gmail.com9453302264

Outcome results

None listed

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