A Comparative Study on Harmonic Scalpel Assisted Cystic Duct Ligation with Absorbable Suture Versus Clip Ligation of Cystic Duct in Conventional Laparoscopic Cholecystectomy.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 88
- Locations
- 1
Study Overview
Brief Summary
This study is a prospective, randomized, single-centre, comparative clinical trial comparing the safety and efficacy of harmonic scalpel-assisted cystic duct ligation using absorbable sutures versus conventional clip ligation of the cystic duct in patients undergoing elective laparoscopic cholecystectomy. The study will be conducted over a period of 2 years at a tertiary care teaching hospital in Central India and will include 88 adult patients with symptomatic gallstone disease, randomized equally into two groups. The primary outcome measures will be intraoperative safety and efficacy, assessed by operative time, intraoperative complications, and incidence of postoperative bile leakage. The secondary outcome measures will include cost analysis, postoperative pain scores, duration of hospital stay, and long-term complications such as clip migration or chronic inflammatory sequelae, assessed during a follow-up period of six months.
Study Design
- Study Type
- Interventional
- Allocation
- Other
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Adult patients aged 18–80 years Diagnosis of gallbladder stones confirmed by radiological investigations.
- •Symptomatic Cholelithiasis Resolved Acute Cholecystitis Post ERCP (for Choledocholithiasis) patients.
Exclusion Criteria
- Not provided
Investigators
UTKARSH SUNIL LANGADE
DATTA MEGHE MEDICAL COLLEGE
