Cholecystectomy, LaparoscopicPhase 3NCT00892879
A Trial of Single Port Laparoscopic Cholecystectomy Versus Four Port Laparoscopic Cholecystectomy
A Phase 3 study testing Laparoscopic cholecystectomy surgery in people with Cholecystectomy, Laparoscopic, run by Providence Health & Services at 1 site in United States.
Trial summary
This is a single-institution, prospective, one-to-one randomized controlled research study. Subjects medically determined to need a cholecystectomy will be consented for surgery and study participation prior to enrolment in this study. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cholecystectomy, Laparoscopic
- What is being tested?
- Laparoscopic cholecystectomy surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Dec 2010
- Phase
- Phase 3
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pre-operative diagnosis of one of the following:
- Pancreatic cholecystitis
- Biliary cholic
- Biliary dyskinesia
- Choledocholithiasis status post endoscopic retrograde cholangiopancreatography/sphincterotomy
- Gallbladder polyps
- Other diagnosis at the discretion of the surgeon
Who cannot join
- Acute cholecystitis
- Gallstones > 2.5cm in length on ultrasound
- Suspected presence of common duct stones
- History of jaundice
- History of gallstone pancreatic
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence Portland Medical Center
Portland, Oregon, 97213
About this study
Official title: A Randomized Trial of Single Port Laparoscopic Cholecystectomy Versus Four Port Laparoscopic Cholecystectomy
This is a single-institution, prospective, one-to-one randomized controlled research study. Subjects medically determined to need a cholecystectomy will be consented for surgery and study participation prior to enrolment in this study. Patients will then be randomized to receive either a single port laparoscopic cholecystectomy or a four port laparoscopic cholecystectomy.
- Conditions
- Cholecystectomy, Laparoscopic
- Being tested
- Laparoscopic cholecystectomy surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic cholecystectomy surgeryDevice
Also called ACS Triport, Advanced Surgical Concepts, Ireland
Single port laparoscopic cholecystectomy surgery versus a standard four port device.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Single port laparoscopic device Receives: Device: Laparoscopic cholecystectomy surgery |
| 2 | Active comparator | Four-port laparoscopic device Receives: Device: Laparoscopic cholecystectomy surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain scores (visual analogue pain scale from 0-10)assessed on post-operative day 1 and at the post-operative follow up visit in clinic. The mean pain scores will be compared using student's t-test.
Measured: 3-6 weeks
Secondary outcomes (1)
The postoperative infection rate will be monitored and compared for patients undergoing single port laparoscopic cholecystectomy and four port laparoscopic cholecystectomy.
Measured: 3-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2009 (estimated)
- Study startFeb 2009
- Primary completionDec 2010
- Study completionDec 2010
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 Cholecystectomy, LaparoscopicStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Investigators
- Paul D Hansen, MD, Principal investigator, Providence Health & Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00892879
- Sponsor's protocol ID
- PHS IRB # 09-14A
- Status last verified
- May 2011
- First submitted
- 27 Apr 2009
- Last updated
- 18 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Ma J, Cassera MA, Spaun GO, Hammill CW, Hansen PD, Aliabadi-Wahle S. Randomized controlled trial comparing single-port laparoscopic cholecystectomy and four-port laparoscopic cholecystectomy. Ann Surg. 2011 Jul;254(1):22-7. doi: 10.1097/SLA.0b013e3182192f89.
PubMed 21494123
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Single Port Laparoscopic Cholecystectomy Versus Four Port Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT00892879
- Acronym / sponsor ID
- PHS IRB # 09-14A
- Conditions
- Cholecystectomy, Laparoscopic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 5 May 2009 (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 single-institution, prospective, one-to-one randomized controlled research study. Subjects medically determined to need a cholecystectomy will be consented for surgery and study participation prior to enrolment in this study. Patients will then be randomized to receive either a single port laparoscopic cholecystectomy or a four port laparoscopic cholecystectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Laparoscopic cholecystectomy surgerySingle port laparoscopic device |
| 2 | Active comparator | Device: Laparoscopic cholecystectomy surgeryFour-port laparoscopic device |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pre-operative diagnosis of one of the following:
Key exclusion criteria (5 listed)
- Acute cholecystitis
- Gallstones > 2.5cm in length on ultrasound
- Suspected presence of common duct stones
- History of jaundice
- History of gallstone pancreatic
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 cholecystectomy surgeryAlso: ACS Triport, Advanced Surgical Concepts, IrelandSingle port laparoscopic cholecystectomy surgery versus a standard four port device. | Device | 1, 2 |
Primary outcome
Post-operative pain scores (visual analogue pain scale from 0-10)assessed on post-operative day 1 and at the post-operative follow up visit in clinic. The mean pain scores will be compared using student's t-test.
Time frame: 3-6 weeks
1 secondary outcome
The postoperative infection rate will be monitored and compared for patients undergoing single port laparoscopic cholecystectomy and four port laparoscopic cholecystectomy.
Time frame: 3-6 weeks
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 18 May 2011.
- Derived from this study: PubMed 21494123Ma J, Cassera MA, Spaun GO, Hammill CW, Hansen PD, Aliabadi-Wahle S. Randomized controlled trial comparing single-port laparoscopic cholecystectomy and four-port laparoscopic cholecystectomy. Ann Surg. 2011 Jul;254(1):22-7. doi: 10.1097/SLA.0b013e3182192f89.
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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.
Paul D Hansen, MD principal investigator
Providence Health & Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Laparoscopic cholecystectomy surgery in people with Cholecystectomy, Laparoscopic, run by Providence Health & Services at 1 site in United States.
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 7 inclusion and 5 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 18 May 2011. 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 United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Post-operative pain scores (visual analogue pain scale from 0-10)assessed on post-operative day 1 and at the post-operative follow up visit in clinic. The mean pain scores will be compared using student's t-test. (time frame: 3-6 weeks). 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 NCT00892879, 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 18 May 2011.