Health Condition 1: K851- Biliary acute pancreatitis Health Condition 2: K800- Calculus of gallbladder with acutecholecystitis
Conditions
Interventions
Intervention1: Endobag-assisted gallbladder extraction: Gallbladder extraction is performed using a sterile endobag through a standardized port epigastric or umbilical as per protocol after comple
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: Adult patients aged 18 to 80 years undergoing elective laparoscopic cholecystectomy for symptomatic gallstone disease who are willing to provide written informed consent.
Exclusion criteria
Exclusion criteria: Patients with suspected or proven gallbladder malignancy on preoperative evaluation, emergency cholecystectomy, conversion to open cholecystectomy before gallbladder extraction, pregnancy, or refusal to provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of intraoperative bile spillage occurring specifically during the gallbladder extraction phase of laparoscopic cholecystectomy and incidence of port site surgical site infection.Timepoint: Incidence of intraoperative bile spillage occurring specifically during the gallbladder extraction phase of laparoscopic cholecystectomy, assessed intraoperatively during the index surgery from initiation of gallbladder extraction to complete specimen removal; and incidence of port-site surgical site infection, assessed postoperatively on day 7, day 15, and day 30, with final assessment at postoperative day 30. | — |
Secondary
| Measure | Time frame |
|---|---|
| 3. Requirement for fascial extension of the extraction port.Timepoint: During surgery.;4. Incidence of early port site hernia.Timepoint: Six to twelve months after surgery. ;Incidence of port site surgical site infection as per CDC criteria Timepoint: Time Point: Within 30 days after surgery;1 Positivity of gallbladder bile culture (infected bile) Timepoint: Intra operative;2. Incidence of intra abdominal collection or abscess related to bile leak.Timepoint: Within 30 days after surgery. | — |
Countries
India
Contacts
Public ContactDr Vipan Kumar
Indira Gandhi Medical College Shimla, HP - 171001
Outcome results
None listed