Pain, PostoperativeUMBI-CHOLNCT01268748
Single Port Versus Four Ports Laparoscopic Cholecystectomy and Early Postoperative Pain
A study testing Conventional laparoscopic procedure and Experimental laparoscopic procedure in people with Pain, Postoperative and Postoperative Nausea and Vomiting, run by Bispebjerg Hospital at 3 sites in Denmark.
Trial summary
This is a trial to evaluate if single port laparoscopic cholecystectomy causes less pain than conventional laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Pain, Postoperative, Postoperative Nausea and Vomiting, Postoperative Complications
- What is being tested?
- Conventional laparoscopic procedure and Experimental laparoscopic procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesDenmark
- Study dates
- Sep 2010to Jun 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-III
- Planned elective laparoscopic cholecystectomy because of biliary pain or uncomplicated biliary pancreatitis
Who cannot join
- Expected poor compliance
- History of cholecystitis or severe pancreatitis
- Earlier open upper abdominal surgery, pregnancy or lactation, chronic pain or conversion to open surgery
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites, 3 recruiting
- Recruiting
Dept. of Surgery K, Bispebjerg Hospital
Copenhagen NV, DK-2400
Lars N Jorgensen, MD, DrMSc, +45 35316441, larsnjorgensen@hotmail.com
Lars N Jorgensen, MD, DrMSc
- Recruiting
Gentofte Hospital, University of Copenhagen
Gentofte Municipality, DK-2920
Jacob Rosenberg, MD, DrMSc, +45 44883433, jaro@heh.regionh.dk
Jacob Rosenberg, MD, DrMSc
- Recruiting
Dept. of Surgery, Koege Hospital, University of Copenhagen
Koege, DK-4600
Thue Bisgaard, MD, DrMSc, +45 47323224, thuebisgaard@tdcadsl.dk
Thue Bisgaard, MD, DrMSc
About this study
Official title: Efficacy of Transumbilical Versus Standard Laparoscopic Cholecystectomy on Postoperative Pain
This is a trial to evaluate if single port laparoscopic cholecystectomy causes less pain than conventional laparoscopic cholecystectomy.
Read the detailed description
This study is a randomized, two-arm, double-blinded three-center trial to compare single-port transumbilical laparoscopic cholecystectomy with conventional 4-port laparoscopic cholecystectomy. 120 patients are included with a 1:1 randomization. Three centers participate in the trial.
Inclusion criteria: Female patients, ASA I-III, age between 18 and 75 years, elective laparoscopic cholecystectomy because of biliary pain or recent uncomplicated biliary pancreatitis.
Exclusion criteria: Expected poor compliance, history of cholecystitis or severe pancreatitis, previous open upper abdominal surgery, pregnancy or lactation, preoperative chronic pain or conversion from laparoscopic to open surgery.
Pain and nausea is measured on VAS before the operation and 3 hrs, 1 day, 2 days and 3 days after the operation.
Cosmesis is evaluated after 28 days.
Patients are telephone-interviewed after 12 months and asked about port hernia formation. If hernia is suspected patients are called in for an abdominal ultrasonography.
- Being tested
- Conventional laparoscopic procedure, Experimental laparoscopic procedure
- Keywords
- single site surgery, laparoscopic surgery, pain, nausea
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting, Postoperative Complications, Pain, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional laparoscopic procedureProcedure or surgery
Also called Versaport 12 mm, Versaport 5 mm
Patients allocated to this group will undergo laparoscopic cholecystectomy using two 12 mm ports and two 5 mm ports
Experimental laparoscopic procedureProcedure or surgery
Also called SILS port
Patients allocated to this group will undergo laparoscopic cholecystectomy using only a transumbilical SILS port
| Study group | Role | What they receive |
|---|---|---|
| 4 ports laparoscopic cholecystectomy | Other | Not described Receives: Procedure: Conventional laparoscopic procedure |
| One port transumb. laparoscopic surgery | Other | Not described Receives: Procedure: Experimental laparoscopic procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores on the Visual Analog Scale before surgery
Measured: Before surgery
Pain scores on the Visual Analog Scale 3 hours after surgery
Measured: 3 hrs after surgery
Pain scores on the Visual Analog Scale 1 day after surgery
Measured: 1 day after surgery
Pain scores on the Visual Analog Scale 2 days after surgery
Measured: 2 days after surgery
Pain scores on the Visual Analog Scale 3 days after surgery
Measured: 3 days after surgery
Secondary outcomes (12)
Nausea scores on a 4 point scale before surgery
The 4 point scale: none, light, moderate, and severe
Measured: Before surgery
Nausea scores on a 4 point scale 3 hours after surgery
The 4 point scale: none, light, moderate, and severe
Measured: 3 hours after surgery
Nausea scores on a 4 point scale 1 day surgery
The 4 point scale: none, light, moderate, and severe
Measured: 1 day after surgery
Nausea scores on a 4 point scale 2 days after surgery
The 4 point scale: none, light, moderate, and severe
Measured: 2 days after surgery
Nausea scores on a 4 point scale 3 days after surgery
The 4 point scale: none, light, moderate, and severe
Measured: 3 days after surgery
Well being scores on the Visual Analog Scale before surgery
Measured: Before surgery
Well being scores on the Visual Analog Scale 3 hours after surgery
Measured: 3 hours after surgery
Well being scores on the Visual Analog Scale 1 day after surgery
Measured: 1 day after surgery
Well being scores on the Visual Analog Scale 2 days after surgery
Measured: 2 days after surgery
Well being scores on the Visual Analog Scale 3 days after surgery
Measured: 3 days after surgery
Number of participants with adverse events as a measure of safety and tolerability
Adverse events include all complications related to surgery
Measured: Within 30 days after surgery
Patient-assessed cosmesis on the Visual Analog Scale 30 days after surgery
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2010 (estimated)
- Study startSep 2010
- Primary completionJun 2011 (estimated)
- Study completionJun 2012 (estimated)
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 Pain, PostoperativeStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Gentofte, Copenhagen, University of Copenhagen
- Investigators
- Haytham Al-Tayar, MD, Principal investigator, Dept. of Surgery, Bispebjerg Hospital, University of CopenhagenSami Assaadzadeh, MD, Principal investigator, Dept. of Surgery, Gentofte Hospital, University of CopenhagenJacob Rosenberg, MD, DrMSc, Principal investigator, Dept. of Surgery, Herlev Hospital, University of CopenhagenFlemming Hjørne, MD, Principal investigator, Dept. of Surgery, Køge Hospital, University of CopenhagenThue Bisgaard, MD, DrMSc, Principal investigator, Dept. of Surgery, Køge Hospital, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01268748
- Sponsor's protocol ID
- H-3-2010-064
- Acronym
- UMBI-CHOL
- Status last verified
- Sep 2010
- First submitted
- 20 Sep 2010
- Last updated
- 31 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Jorgensen LN, Rosenberg J, Al-Tayar H, Assaadzadeh S, Helgstrand F, Bisgaard T. Randomized clinical trial of single- versus multi-incision laparoscopic cholecystectomy. Br J Surg. 2014 Mar;101(4):347-55. doi: 10.1002/bjs.9393.
PubMed 24536008
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Transumbilical Versus Standard Laparoscopic Cholecystectomy on Postoperative Pain
- ClinicalTrials.gov ID
- NCT01268748
- Acronym / sponsor ID
- UMBI-CHOL / H-3-2010-064
- Keywords
- single site surgery, laparoscopic surgery, pain, nausea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Gentofte, Copenhagen, University of Copenhagen
- Study start
- Sep 2010
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 31 Dec 2010 (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.
This is a trial to evaluate if single port laparoscopic cholecystectomy causes less pain than conventional laparoscopic cholecystectomy.
Detailed description
This study is a randomized, two-arm, double-blinded three-center trial to compare single-port transumbilical laparoscopic cholecystectomy with conventional 4-port laparoscopic cholecystectomy. 120 patients are included with a 1:1 randomization. Three centers participate in the trial.
Inclusion criteria: Female patients, ASA I-III, age between 18 and 75 years, elective laparoscopic cholecystectomy because of biliary pain or recent uncomplicated biliary pancreatitis.
Exclusion criteria: Expected poor compliance, history of cholecystitis or severe pancreatitis, previous open upper abdominal surgery, pregnancy or lactation, preoperative chronic pain or conversion from laparoscopic to open surgery.
Pain and nausea is measured on VAS before the operation and 3 hrs, 1 day, 2 days and 3 days after the operation.
Cosmesis is evaluated after 28 days.
Patients are telephone-interviewed after 12 months and asked about port hernia formation. If hernia is suspected patients are called in for an abdominal ultrasonography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4 ports laparoscopic cholecystectomy | Other | Procedure: Conventional laparoscopic procedure |
| One port transumb. laparoscopic surgery | Other | Procedure: Experimental laparoscopic procedure |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I-III
- Planned elective laparoscopic cholecystectomy because of biliary pain or uncomplicated biliary pancreatitis
Key exclusion criteria (3 listed)
- Expected poor compliance
- History of cholecystitis or severe pancreatitis
- Earlier open upper abdominal surgery, pregnancy or lactation, chronic pain or conversion to open 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 |
|---|---|---|
| Conventional laparoscopic procedureAlso: Versaport 12 mm, Versaport 5 mmPatients allocated to this group will undergo laparoscopic cholecystectomy using two 12 mm ports and two 5 mm ports | Procedure or surgery | 4 ports laparoscopic cholecystectomy |
| Experimental laparoscopic procedureAlso: SILS portPatients allocated to this group will undergo laparoscopic cholecystectomy using only a transumbilical SILS port | Procedure or surgery | One port transumb. laparoscopic surgery |
Primary outcome
Pain scores on the Visual Analog Scale before surgery
Time frame: Before surgery
Pain scores on the Visual Analog Scale 3 hours after surgery
Time frame: 3 hrs after surgery
Pain scores on the Visual Analog Scale 1 day after surgery
Time frame: 1 day after surgery
Pain scores on the Visual Analog Scale 2 days after surgery
Time frame: 2 days after surgery
Pain scores on the Visual Analog Scale 3 days after surgery
Time frame: 3 days after surgery
12 secondary outcomes
Nausea scores on a 4 point scale before surgery
Time frame: Before surgery
Nausea scores on a 4 point scale 3 hours after surgery
Time frame: 3 hours after surgery
Nausea scores on a 4 point scale 1 day surgery
Time frame: 1 day after surgery
Nausea scores on a 4 point scale 2 days after surgery
Time frame: 2 days after surgery
Nausea scores on a 4 point scale 3 days after surgery
Time frame: 3 days after surgery
Well being scores on the Visual Analog Scale before surgery
Time frame: Before surgery
Well being scores on the Visual Analog Scale 3 hours after surgery
Time frame: 3 hours after surgery
Well being scores on the Visual Analog Scale 1 day after surgery
Time frame: 1 day after surgery
Well being scores on the Visual Analog Scale 2 days after surgery
Time frame: 2 days after surgery
Well being scores on the Visual Analog Scale 3 days after surgery
Time frame: 3 days after surgery
Number of participants with adverse events as a measure of safety and tolerability
Time frame: Within 30 days after surgery
Patient-assessed cosmesis on the Visual Analog Scale 30 days after surgery
Time frame: 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2010.
- Derived from this study: PubMed 24536008Jorgensen LN, Rosenberg J, Al-Tayar H, Assaadzadeh S, Helgstrand F, Bisgaard T. Randomized clinical trial of single- versus multi-incision laparoscopic cholecystectomy. Br J Surg. 2014 Mar;101(4):347-55. doi: 10.1002/bjs.9393.
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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.
Haytham Al-Tayar, MD principal investigator
Dept. of Surgery, Bispebjerg Hospital, University of Copenhagen
Sami Assaadzadeh, MD principal investigator
Dept. of Surgery, Gentofte Hospital, University of Copenhagen
Jacob Rosenberg, MD, DrMSc principal investigator
Dept. of Surgery, Herlev Hospital, University of Copenhagen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional laparoscopic procedure and Experimental laparoscopic procedure in people with Pain, Postoperative and Postoperative Nausea and Vomiting, run by Bispebjerg Hospital at 3 sites in Denmark.
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 2 inclusion and 3 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 31 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. 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?
Contact Lars N Jorgensen, MD, DrMSc (+45 35316441, larsnjorgensen@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores on the Visual Analog Scale before surgery (time frame: Before surgery). The study lists 5 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 NCT01268748, 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 31 Dec 2010.