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Clinical Trials/CTRI/2025/08/092774
CTRI/2025/08/092774
Not yet recruiting
Phase 4

Comparison of Postoperative Pain Between Standard 4-Port Laparoscopic and Robotic Cholecystectomy: An Open-Label Randomised Controlled Trial

All India Institute of Medical Sciences1 site in 1 country126 target enrollmentStarted: August 21, 2025Last updated:
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Overview

Phase
Phase 4
Status
Not yet recruiting
Enrollment
126
Locations
1
Primary Endpoint
To compare postoperative pain between standard 4 port laparoscopic cholecystectomy
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

An open label randomised controlled trial comparing the post operative pain between the patients of symptomatic gall stone disease following standard 4 port laparoscopic cholecystectomy and robotic cholecystectomy.

Study Design

Study Type
Interventional
Allocation
Other
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 75.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •ASA Grade 1,2 and 3
  • •BMI below 35 kg/m2
  • •Symptomatic Cholelithiasis planned for routine OT.

Exclusion Criteria

  • •Acute cholycestitis and associated complications like Pyocelele, emphysematous or gangrenous cholecystitis
  • •Emergency cholecystectomy
  • •History of choledocholithiasis
  • •Presence of umbilical hernia
  • •History of upper abdominal surgery
  • •Pregnant women
  • •History of chronic analgesic medication intake
  • •Known case of chronic kidney disease
  • •Unfit for general anesthesia
  • •Refusal of consent for participation in study.

Outcomes

Primary Outcomes

To compare postoperative pain between standard 4 port laparoscopic cholecystectomy

Time Frame: On admission (baseline), 6 hours after | surgery, 24 hours after surgery, 7 days after surgery.

and robotic cholecystectomy.

Time Frame: On admission (baseline), 6 hours after | surgery, 24 hours after surgery, 7 days after surgery.

Secondary Outcomes

  • To compare the operative time between standard 4 port laparoscopic cholecystectomy(and robotic cholecystectomy.)
  • To compare the conversion rate from laparoscopic to open procedure in standard 4 port(laparoscopic cholecystectomy & robotic to laparoscopic/open procedure in robotic)
  • To compare the overall complication rate in terms of bile duct injury, surgical site(infections(SSI), port site pain,port site hernia, port site sinus & re-admission rates)

Investigators

Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Ankadala Anirudh Babu

All India Institute of Medical Sciences

Study Sites (1)

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