CholecystolithiasisNCT01553331
Day Case Laparoscopic Cholecystectomy: Fundus First With Ultrasonic Dissection or Conventional Diathermy Hook
A study testing dissection of gallbladder in laparoscopic cholecystectomy in people with Cholecystolithiasis, run by Central Finland Hospital District at 1 site in Finland.
Trial summary
Day case laparoscopic cholecystectomy can be made with conventional diathermy hook starting at triangle of Calot´s. Ultrasonic 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
- Cholecystolithiasis
- 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
- 169 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2012to Oct 2014
- 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 Case Laparoscopic Cholecystectomy: Comparison of Fundus First With Ultrasonic Dissection or Conventional Diathermy Hook, Randomized Trial
Day case laparoscopic cholecystectomy can be made with conventional diathermy hook starting at triangle of Calot´s. Ultrasonic dissection starting from the gallbladder fundus is another option. The aim is to test the hypothesis that with ultrasonic dissection technique a better same day discharge and a shorter operative time can be achieved.
Read the detailed description
After initiation of general anesthesia patients are randomized either to conventional or ultrasonic dissection group. The patients and recovery room personnel are blinded to the operative technique used.
- Conditions
- Cholecystolithiasis
- Being tested
- dissection of gallbladder in laparoscopic cholecystectomy
- Keywords
- laparoscopic cholecystectomy
- Medical subject headings
- Cholecystolithiasis
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 ultrasonic scissors 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 Receives: Procedure: dissection of gallbladder in laparoscopic cholecystectomy |
| ultrasonic dissection | Active comparator | Laparoscopic cholecystectomy made with ultrasonic dissection starting from gallbladder fundus 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.
same day discharge
Measured: 30 days
operative time
Measured: 30 days
intraoperative complications
Measured: 30 days
Secondary outcomes (4)
analgetic use
Measured: 30 days
postoperative nausea and vomiting
Measured: 30 days
readmission
Measured: 30 days
morbidity
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CholecystolithiasisStudies 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
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Finland Hospital District
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Mattila, Central Finland Hospital District
- Investigators
- Ilmo Kellokumpu, Docent, Study director, Jyvaskyla Central HospitalAnne K Mattila, MD, Principal investigator, Jyvaskyla Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01553331
- Sponsor's protocol ID
- KSSHPB10208
- Status last verified
- Dec 2014
- First submitted
- 10 Mar 2012
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cengiz Y, Janes A, Grehn A, Israelsson LA. Randomized trial of traditional dissection with electrocautery versus ultrasonic fundus-first dissection in patients undergoing laparoscopic cholecystectomy. Br J Surg. 2005 Jul;92(7):810-3. doi: 10.1002/bjs.4982.
PubMed 15880649Cengiz Y, Dalenback J, Edlund G, Israelsson LA, Janes A, Moller M, Thorell A. Improved outcome after laparoscopic cholecystectomy with ultrasonic dissection: a randomized multicenter trial. Surg Endosc. 2010 Mar;24(3):624-30. doi: 10.1007/s00464-009-0649-2. Epub 2009 Aug 18.
PubMed 19688393
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Day Case Laparoscopic Cholecystectomy: Comparison of Fundus First With Ultrasonic Dissection or Conventional Diathermy Hook, Randomized Trial
- ClinicalTrials.gov ID
- NCT01553331
- Acronym / sponsor ID
- KSSHPB10208
- Conditions
- Cholecystolithiasis
- Keywords
- laparoscopic cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Central Finland Hospital DistrictUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 14 Mar 2012 (estimated)
- 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. Ultrasonic dissection starting from the gallbladder fundus is another option. The aim is to test the hypothesis that with ultrasonic dissection technique a better same day discharge and a shorter operative time can be achieved.
Detailed description
After initiation of general anesthesia patients are randomized either to conventional or ultrasonic 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 |
| ultrasonic dissection | Active comparator | Procedure: dissection of gallbladder in laparoscopic cholecystectomyLaparoscopic cholecystectomy made with ultrasonic dissection starting from gallbladder fundus |
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 | conventional diathermy hook |
| dissection of gallbladder in laparoscopic cholecystectomylaparoscopic cholecystectomy with ultrasonic scissors starting from fundus | Procedure or surgery | ultrasonic dissection |
Primary outcome
same day discharge
Time frame: 30 days
operative time
Time frame: 30 days
intraoperative complications
Time frame: 30 days
4 secondary outcomes
analgetic use
Time frame: 30 days
postoperative nausea and vomiting
Time frame: 30 days
readmission
Time frame: 30 days
morbidity
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2014.
- Background: PubMed 15880649Cengiz Y, Janes A, Grehn A, Israelsson LA. Randomized trial of traditional dissection with electrocautery versus ultrasonic fundus-first dissection in patients undergoing laparoscopic cholecystectomy. Br J Surg. 2005 Jul;92(7):810-3. doi: 10.1002/bjs.4982.
- Background: PubMed 19688393Cengiz Y, Dalenback J, Edlund G, Israelsson LA, Janes A, Moller M, Thorell A. Improved outcome after laparoscopic cholecystectomy with ultrasonic dissection: a randomized multicenter trial. Surg Endosc. 2010 Mar;24(3):624-30. doi: 10.1007/s00464-009-0649-2. Epub 2009 Aug 18.
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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.
Ilmo Kellokumpu, Docent study director
Jyvaskyla Central Hospital
Anne K Mattila, MD principal investigator
Jyvaskyla Central Hospital
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 Cholecystolithiasis, run by Central Finland Hospital District at 1 site in Finland.
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: finished, as of the sponsor's last update on 11 Dec 2014. 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 Finland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
same day discharge (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?
On the ClinicalTrials.gov record for NCT01553331, which also lists 2 linked publications.
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 11 Dec 2014.