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Port site problems in laparoscopic cholecystectomy

Port-site morbidities following extraction of gallbladder from umbilical port in comparison to epigastric port in laparoscopic cholecystectomy â?? a double blinded randomized controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/10/037123
Enrollment
104
Registered
2021-10-06
Start date
Unknown
Completion date
Unknown
Last updated
2023-03-06

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: K801- Calculus of gallbladder with othercholecystitis Health Condition 3: K801- Calculus of gallbladder with othercholecystitis Health Condition 4: K801- Calculus of gallbladder with othercholecystitis Health Condition 5: K801- Calculus of gallbladder with othercholecystitis

Interventions

Intervention1: Extraction of gallbladder via umbilical port: Gallbladder will be extracted via umbilical port after laparoscopic cholecystectomy. Duration of therapy - time taken in minutes from gallb

Sponsors

All India Institute of Medical Sciences Patna
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with symptomatic gallstone disease undergoing an elective standard 4-port laparoscopic cholecystectomy with: - i) Age between 18-80 years ii) American Society of Anesthesiologists (ASA) grade 1 and 2 iii) Consenting to participate iv) Not a part of any other trial or research project

Exclusion criteria

Exclusion criteria: i) Patients in whom laparoscopic cholecystectomy will be converted into an open procedure ii) Suspicion of gallbladder malignancy in pre-operative imaging modality iii) BMI > 30kg/m2 iv) Immunocompromised and diabetic patients v) Perforation of gallbladder â?? intra-abdominal or during its extraction vi) Bile spillage vii) Any stone > 2cm in size in pre-operative imaging viii) Empyema of the gallbladder â?? pre-op imaging or intra-op ix) Patients undergoing some other abdominal surgery in the follow-up period

Design outcomes

Primary

MeasureTime frame
To determine the post-operative pain score by VAS (Visual analogue scale) after gallbladder extraction via umbilical or epigastric ports in patients undergoing an elective standard 4-port laparoscopic cholecystectomy for symptomatic gallstone disease.Timepoint: To determine the post-operative pain score by VAS (Visual analogue scale) at 3 hours, 6 hours, 9 hours, 12 hours, 24 hours, 7 days and 30 days after gallbladder extraction via umbilical or epigastric ports in patients undergoing an elective standard 4-port laparoscopic cholecystectomy for symptomatic gallstone disease.

Secondary

MeasureTime frame
To determine the incidence of Surgical site infection (SSI), incidence of port site herniation and time for gallbladder extraction via umbilical or epigastric ports in patients undergoing an elective standard 4-port laparoscopic cholecystectomy for symptomatic gallstone disease.Timepoint: SSI- 7days, 30 days Port site herniation- 1 month, 3 months Time for gallbladder extraction- in minutes from gallbladder dissected off the gallbladder fossa till its actual extraction out of the abdominal cavity

Countries

India

Contacts

Public ContactDr Ashesh Kumar Jha

AIIMS-Patna

drasheshjha@aiimspatna.org9582199341

Outcome results

None listed

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