Cholecystectomy Blunt Dissection
Day-care Laparoscopic Cholecystectomy With Diathermy Hook Versus 5mm Suction Irrigation Blunt Dissection: a Randomized Study
1 other identifier
interventional
20
1 country
1
Brief Summary
Day case laparoscopic cholecystectomy can be made with conventional diathermy hook starting at triangle of Calot´s. 5mm suction irrigation blunt dissection starting from the gallbladder fundus is another option. The aim is to test the hypothesis that with 5mm suction irrigation blunt dissection technique a better same day discharge and a shorter operative time can be achieved.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2022
CompletedFirst Posted
Study publicly available on registry
May 9, 2022
CompletedStudy Start
First participant enrolled
July 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2023
CompletedDecember 28, 2022
December 1, 2022
6 months
April 17, 2022
December 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
number of days for discharge after surgery
30 days
operative time
30 days
intraoperative bleeding amount
bleeding which require suction or draining
30 days
Secondary Outcomes (4)
type of analgesic and dose
30 days
number of events of postoperative nausea and vomiting which require anti emetic drug
30 day
number of days after surgery when readmission is required
30 days
presence of a morbidity
30days
Study Arms (2)
conventional diathermy hook
ACTIVE COMPARATORLaparoscopic cholecystectomy made with diathermy hook starting from Calot´s triangle Intervention: Procedure: dissection of gallbladder in laparoscopic cholecystectomy
5 mm suction irrigation blunt dissection
ACTIVE COMPARATORLaparoscopic cholecystectomy made with 5mm suction irrigation blunt dissection starting from gallbladder fundus Intervention: Procedure: dissection of gallbladder in laparoscopic cholecystectomy
Interventions
Laparoscopic cholecystectomy with diathermy hook starting from triangle of Calot
Eligibility Criteria
You may qualify if:
- ASA I-II
- BMI under 35
- normal liver enzymes
- no bile duct dilatation in ultrasound
- cholecystolithiasis
You may not qualify if:
- NSAID allergy
- previous upper gi-surgery
- common bile duct stones in preoperative imaging
- history of severe acute pancreatitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Central fourth Health Cluster
Hail, Saudi Arabia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Single (Participant)
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associate professor
Study Record Dates
First Submitted
April 17, 2022
First Posted
May 9, 2022
Study Start
July 15, 2022
Primary Completion
December 30, 2022
Study Completion
February 1, 2023
Last Updated
December 28, 2022
Record last verified: 2022-12