Laparoscopic CholecystectomyNCT05366920
Cholecystectomy Blunt Dissection
A study testing dissection of gallbladder in laparoscopic cholecystectomy in people with Laparoscopic Cholecystectomy, run by Imam Mohammad ibn Saud Islamic University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- dissection of gallbladder in laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Jul 2022to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-II
- BMI under 35
- normal liver enzymes
- no bile duct dilatation in ultrasound
- cholecystolithiasis
Who cannot join
- NSAID allergy
- previous upper gi-surgery
- common bile duct stones in preoperative imaging
- history of severe acute pancreatitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Day-care Laparoscopic Cholecystectomy With Diathermy Hook Versus 5mm Suction Irrigation Blunt Dissection: a Randomized Study
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.
Read the detailed description
After initiation of general anaesthesia patients are randomized either to conventional(cautery) or 5mm suction irrigation blunt dissection group. The patients and recovery room personnel are blinded to the operative technique used.
- Conditions
- Laparoscopic Cholecystectomy
- Being tested
- dissection of gallbladder in laparoscopic cholecystectomy
- Keywords
- Cholecystolithiasis, Cholelithiasis, Gallstones, Biliary Tract Diseases, Digestive System Diseases, Gallbladder Diseases, Calculi, Pathological Conditions, Anatomical
- Medical subject headings
- Cholecystolithiasis, Cholelithiasis, Gallstones, Biliary Tract Diseases, Digestive System Diseases, Gallbladder Diseases, Calculi, Pathological Conditions, Anatomical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dissection of gallbladder in laparoscopic cholecystectomyProcedure or surgery
Laparoscopic cholecystectomy with diathermy hook starting from triangle of Calot
dissection of gallbladder in laparoscopic cholecystectomyProcedure or surgery
laparoscopic cholecystectomy with 5mm suction irrigation blunt dissection starting from fundus
| Study group | Role | What they receive |
|---|---|---|
| conventional diathermy hook | Active comparator | Laparoscopic cholecystectomy made with diathermy hook starting from Calot´s triangle Intervention: Procedure: dissection of gallbladder in laparoscopic cholecystectomy Receives: Procedure: dissection of gallbladder in laparoscopic cholecystectomy |
| 5 mm suction irrigation blunt dissection | Active comparator | Laparoscopic cholecystectomy made with 5mm suction irrigation blunt dissection starting from gallbladder fundus Intervention: Procedure: dissection of gallbladder in laparoscopic cholecystectomy Receives: Procedure: dissection of gallbladder in laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of days for discharge after surgery
Measured: 30 days
operative time
Measured: 30 days
intraoperative bleeding amount
bleeding which require suction or draining
Measured: 30 days
Secondary outcomes (4)
type of analgesic and dose
Measured: 30 days
number of events of postoperative nausea and vomiting which require anti emetic drug
Measured: 30 day
number of days after surgery when readmission is required
Measured: 30 days
presence of a morbidity
number of days needed for discharge from service
Measured: 30days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start15 Jul 2022
- Primary completion30 Dec 2022 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imam Mohammad ibn Saud Islamic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohammad bukhetan alharbi, Imam Mohammad ibn Saud Islamic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05366920
- Sponsor's protocol ID
- CHOLECYSTECTOMY BLUNT
- Status last verified
- Dec 2022
- First submitted
- 17 Apr 2022
- Last updated
- 28 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Day-care Laparoscopic Cholecystectomy With Diathermy Hook Versus 5mm Suction Irrigation Blunt Dissection: a Randomized Study
- ClinicalTrials.gov ID
- NCT05366920
- Acronym / sponsor ID
- CHOLECYSTECTOMY BLUNT
- Conditions
- Laparoscopic Cholecystectomy
- Keywords
- Cholecystolithiasis, Cholelithiasis, Gallstones, Biliary Tract Diseases, Digestive System Diseases, Gallbladder Diseases, Calculi, Pathological Conditions, Anatomical
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Imam Mohammad ibn Saud Islamic UniversityUniversity, hospital or other
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 9 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
After initiation of general anaesthesia patients are randomized either to conventional(cautery) or 5mm suction irrigation blunt dissection group. The patients and recovery room personnel are blinded to the operative technique used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional diathermy hook | Active comparator | Procedure: dissection of gallbladder in laparoscopic cholecystectomyLaparoscopic 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 comparator | Procedure: dissection of gallbladder in laparoscopic cholecystectomyLaparoscopic cholecystectomy made with 5mm suction irrigation blunt dissection starting from gallbladder fundus Intervention: Procedure: dissection of gallbladder in laparoscopic cholecystectomy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ASA I-II
- BMI under 35
- normal liver enzymes
- no bile duct dilatation in ultrasound
- cholecystolithiasis
Key exclusion criteria (4 listed)
- NSAID allergy
- previous upper gi-surgery
- common bile duct stones in preoperative imaging
- history of severe acute pancreatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dissection of gallbladder in laparoscopic cholecystectomyLaparoscopic cholecystectomy with diathermy hook starting from triangle of Calot | Procedure or surgery | 5 mm suction irrigation blunt dissection, conventional diathermy hook |
| dissection of gallbladder in laparoscopic cholecystectomylaparoscopic cholecystectomy with 5mm suction irrigation blunt dissection starting from fundus | Procedure or surgery | 5 mm suction irrigation blunt dissection, conventional diathermy hook |
Primary outcome
number of days for discharge after surgery
Time frame: 30 days
operative time
Time frame: 30 days
intraoperative bleeding amount
Time frame: 30 days
bleeding which require suction or draining
4 secondary outcomes
type of analgesic and dose
Time frame: 30 days
number of events of postoperative nausea and vomiting which require anti emetic drug
Time frame: 30 day
number of days after surgery when readmission is required
Time frame: 30 days
presence of a morbidity
Time frame: 30days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dissection of gallbladder in laparoscopic cholecystectomy in people with Laparoscopic Cholecystectomy, run by Imam Mohammad ibn Saud Islamic University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of days for discharge after surgery (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2022.