Postoperative PainMC-UsDNCT01723540
A Comparison of Laparoscopic Cholecystectomy Versus Ultrasonic Dissection Assisted Minilaparotomy Cholecystectomy
A study testing Minilaparotomy vs laparoscopy in people with Postoperative Pain, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
Minilaparatomy cholecystectomy with ultrasonic dissection (UsD) is rarely considered and therefore we investigate here the contributions of UsD in early recovery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Minilaparotomy vs laparoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2010to Apr 2012
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Pregnancy or lactating
- common bile-duct stones
- acute cholecystitis
- previous upper abdominal operation
- Chirrosis
- Renal disease
Show all 10Show fewer
- Pancreatitis
- ASA 4-5
- Participation of any other clinical trial within 30 days before the start of the screening period
- History of uncontrolled cardiovascular, epileptic disorder, psychosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Ultrasonic Dissection Assisted Minilaparotomy Cholecystectomy Versus Laparoscopic Cholecystectomy; a Randomised Two-center Study.
Minilaparatomy cholecystectomy with ultrasonic dissection (UsD) is rarely considered and therefore we investigate here the contributions of UsD in early recovery.
- Conditions
- Postoperative Pain
- Being tested
- Minilaparotomy vs laparoscopy
- Keywords
- Cholecystectomy,minilaparotomy,laparascopy,ultrasonic dissection
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minilaparotomy vs laparoscopyProcedure or surgery
MC-group will undergo ultrasonic dissection assisted minilaparotomy cholecystectomy ans patients in the LC-grout will undergo laparoscopic cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| Minilaparotomy cholecystectomy with ultrasonic scissors | Experimental | Minilaparotomy vs laparoscopy Receives: Procedure: Minilaparotomy vs laparoscopy |
| Laparoscopic cholecystectomy | Active comparator | Minilaparotomy vs laparoscopy Receives: Procedure: Minilaparotomy vs laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early recovery
Post operative pain, wound infections, bile leak, mean length of sick leave days, use of analgesics the success of day-surgery
Measured: One month
Secondary outcomes (1)
Peroperative outcome
Operative time, time at the operation theatre, bleeding, length of skin incision
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2012 (estimated)
- Study startSep 2010
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01723540
- Sponsor's protocol ID
- KUH5204520
- Acronym
- MC-UsD
- Status last verified
- Nov 2012
- First submitted
- 6 Nov 2012
- Last updated
- 8 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Ultrasonic Dissection Assisted Minilaparotomy Cholecystectomy Versus Laparoscopic Cholecystectomy; a Randomised Two-center Study.
- ClinicalTrials.gov ID
- NCT01723540
- Acronym / sponsor ID
- MC-UsD / KUH5204520
- Conditions
- Postoperative Pain
- Keywords
- Cholecystectomy,minilaparotomy,laparascopy,ultrasonic dissection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 8 Nov 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.
Minilaparatomy cholecystectomy with ultrasonic dissection (UsD) is rarely considered and therefore we investigate here the contributions of UsD in early recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minilaparotomy cholecystectomy with ultrasonic scissors | Experimental | Procedure: Minilaparotomy vs laparoscopyMinilaparotomy vs laparoscopy |
| Laparoscopic cholecystectomy | Active comparator | Procedure: Minilaparotomy vs laparoscopyMinilaparotomy vs laparoscopy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Pregnancy or lactating
- common bile-duct stones
- acute cholecystitis
- previous upper abdominal operation
- Chirrosis
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 |
|---|---|---|
| Minilaparotomy vs laparoscopyMC-group will undergo ultrasonic dissection assisted minilaparotomy cholecystectomy ans patients in the LC-grout will undergo laparoscopic cholecystectomy | Procedure or surgery | Laparoscopic cholecystectomy, Minilaparotomy cholecystectomy with ultrasonic scissors |
Primary outcome
Early recovery
Time frame: One month
Post operative pain, wound infections, bile leak, mean length of sick leave days, use of analgesics the success of day-surgery
1 secondary outcome
Peroperative outcome
Time frame: 24 hours
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 8 Nov 2012.
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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 Minilaparotomy vs laparoscopy in people with Postoperative Pain, run by Kuopio University Hospital 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 0 inclusion and 10 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 8 Nov 2012. 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?
Early recovery (time frame: One month). 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 8 Nov 2012.