CholecystectomyNCT00689663
Laparoscopic Cholecystectomy - Fundus First and Harmonic Ace Compared With Conventional Technique
A study testing Laparoscopic cholecystectomy in people with Cholecystectomy, run by Sundsvall Hospital at 1 site in Sweden.
Trial summary
Laparoscopic cholecytectomy can be by starting the dissection at the triangle of calots or as a fundus first dissection. Dissection can be with electrocutery or ultrasonic. The optimal technique or the optimal way of dissection has to be established. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cholecystectomy
- What is being tested?
- Laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 233 participants
- Where
- 1 siteSweden
- Study dates
- May 2006to Dec 2007
- 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
- laparoscopic cholecystectomy
Who cannot join
- age >Z65
- ASA >3
- obesity
- previous extensive gastrointestinal surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Multicentre Trial: Comparison of Harmonic Ace and Eletrocautery; Comparison of Fundus First and Conventional Dissection
Laparoscopic cholecytectomy can be by starting the dissection at the triangle of calots or as a fundus first dissection.
Dissection can be with electrocutery or ultrasonic. The optimal technique or the optimal way of dissection has to be established. Patients are at 4 hospitals randomised to the different techniques and the different methods of dissection.
Read the detailed description
Patients at the participating hospitals are randomized to:
- dissection starting at the triangle of Calots with electrocautery.
- dissection by fundus first technique with electrocautery.
- dissection by fundus first technique with ultrasonic dissection.
- Conditions
- Cholecystectomy
- Being tested
- Laparoscopic cholecystectomy
- Keywords
- cholecystectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic cholecystectomyProcedure or surgery
Also called Randomised study.
Randomized to three arm.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Dissection staring at the triangle of calots. Dissection with electrocautery. Receives: Procedure: Laparoscopic cholecystectomy |
| 2 | Active comparator | Dissection as fundus first with electrocautery. Receives: Procedure: Laparoscopic cholecystectomy |
| 3 | Active comparator | Dissection as fundus first with ultrasonic dissection. Receives: Procedure: Laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operation time, bleeding, pain, nausea, quality of life, analgetics, sick leave, surgical complications, conversion rate
Measured: 30 days
Secondary outcomes (1)
surgical complications
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study startMay 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sundsvall Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Leif A Israelsson, MD,PhD, Study chair, Umea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00689663
- Sponsor's protocol ID
- YC11
- Status last verified
- May 2008
- First submitted
- 26 May 2008
- Last updated
- 3 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
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 15880649
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Multicentre Trial: Comparison of Harmonic Ace and Eletrocautery; Comparison of Fundus First and Conventional Dissection
- ClinicalTrials.gov ID
- NCT00689663
- Acronym / sponsor ID
- YC11
- Conditions
- Cholecystectomy
- Keywords
- cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Sundsvall HospitalUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 3 Jun 2008 (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.
Laparoscopic cholecytectomy can be by starting the dissection at the triangle of calots or as a fundus first dissection.
Dissection can be with electrocutery or ultrasonic. The optimal technique or the optimal way of dissection has to be established. Patients are at 4 hospitals randomised to the different techniques and the different methods of dissection.
Detailed description
Patients at the participating hospitals are randomized to:
- dissection starting at the triangle of Calots with electrocautery.
- dissection by fundus first technique with electrocautery.
- dissection by fundus first technique with ultrasonic dissection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Laparoscopic cholecystectomyDissection staring at the triangle of calots. Dissection with electrocautery. |
| 2 | Active comparator | Procedure: Laparoscopic cholecystectomyDissection as fundus first with electrocautery. |
| 3 | Active comparator | Procedure: Laparoscopic cholecystectomyDissection as fundus first with ultrasonic dissection. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- laparoscopic cholecystectomy
Key exclusion criteria (4 listed)
- age >Z65
- ASA >3
- obesity
- previous extensive gastrointestinal surgery
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 |
|---|---|---|
| Laparoscopic cholecystectomyAlso: Randomised study.Randomized to three arm. | Procedure or surgery | 1, 2, 3 |
Primary outcome
Operation time, bleeding, pain, nausea, quality of life, analgetics, sick leave, surgical complications, conversion rate
Time frame: 30 days
1 secondary outcome
surgical complications
Time frame: 3 months
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 3 Jun 2008.
- 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.
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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.
Leif A Israelsson, MD,PhD study chair
Umea University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic cholecystectomy in people with Cholecystectomy, run by Sundsvall Hospital at 1 site in Sweden.
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 1 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 3 Jun 2008. 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 Sweden. 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?
Operation time, bleeding, pain, nausea, quality of life, analgetics, sick leave, surgical complications, conversion rate (time frame: 30 days). 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 NCT00689663, which also lists 1 linked publication.
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 3 Jun 2008.