GallstonesNCT01190280
Indications for Gallbladder Surgery in Gallstone Disease
An observational study of Gallstones, run by Haraldsplass Deaconess Hospital at 1 site in Norway.
Trial summary
The aim of the study is to identify patients with gallstone disease that should be operated and those that may potentially be observed. This selection was based on symptoms and clinical presentation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gallstones
- What is being tested?
- Cholecystectomy operation
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteNorway
- Study dates
- Oct 1991to Aug 2010
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to a hospital for either acute cholecystitis or uncomplicated symptomatic gallstone disease randomized to observation or operation. Patients from a population screening study for gallstones performed in 1983. Patients operated for gallstone disease in 1983.
Who may be able to join
- Symptomatic gallstone disease (SGBS):
- Episodes of pain in the right subcostal or midline epigastric area lasting more than 30 min, with ultrasonography signs of gallstones.
- Ultrasonographic: echo with an acoustic shadow in a visible gallbladder, or an echo with positional change and size <3 mm or, alternatively no demonstrable gallbladder but a strong echo with an acoustic shadow in the position of the gallbladder
- Acute abdominal pain
- Duration of more than 8-12 h
- Tenderness on clinical examination in the upper right quadrant
Show all 9Show fewer
- Presence of gallbladder stones and signs of inflammation on ultrasonography and in clinical biochemistry data, including an elevated temperature
- Participation in a screening study for gallstones in 1983
- Operated for symptomatic gallstone disease in Bergen, Norway in 1983
Who cannot join
- Infrequent and/or minimal pain that need only very occasional medication
- Age below 18 or above 80
- Not willing to participate
- Severe concomitant disease
- Suspected Common Bile Duct stone
- Acalculous cholecystitis
- Localized peritonitis suggesting gallbladder perforation or gangrenous cholecystitis
Trial locations and contacts
1 site in 1 country.
Norway1 site
Haraldsplass Deaconal Hospital, Department of Surgery
Bergen, 5009
About this study
The aim of the study is to identify patients with gallstone disease that should be operated and those that may potentially be observed. This selection was based on symptoms and clinical presentation. The consequences that may arise for the patient if observation is chosen compared with outcome after cholecystectomy has been markers of outcome.
Read the detailed description
- Randomized clinical trial (RCT) of observation versus surgery for uncomplicated gallstone disease
- RCT of observation versus operation for acute cholecystitis
- Study of outcome after cholecystectomy in patients from 1. and 2.
- Study of symptoms in gallstone disease and symptom relief after cholecystectomy
- Long-term morbidity and mortality, including cancer, after cholecystectomy
- Long-term follow-up of patients with silent gallstones
- Conditions
- Gallstones
- Being tested
- Cholecystectomy operation
- Medical subject headings
- Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cholecystectomy operationProcedure or surgery
Also called Removal of gallbladder
Cholecystectomy after randomization
| Study group | Role | What they receive |
|---|---|---|
| AC - operation | Patients admitted with acute cholecystitis randomized to operation Receives: Procedure: Cholecystectomy operation | |
| AC - observation | Patients admitted with acute cholecystitis randomized to observation | |
| SGBS - operation | Patients admitted with uncomplicated gallstone disease randomized to operation Receives: Procedure: Cholecystectomy operation | |
| SGBS - observation | Patients admitted with uncomplicated gallstone disease randomized to observation | |
| 1983 - stones | Patients that in 1983 were diagnosed with gallstones in a population screening | |
| 1983 - operation | Patients that were operated for gallstone disease at Haukeland University Hospital, Bergen, Norway, in 1983 | |
| 1983 - controls | Patients that were shown not to have gallstones in a 1983 population screening | |
| Gallstone patients | Patients with symptoms from gallstone disease |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2010 (estimated)
- Study startOct 1991
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for GallstonesStudies 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
- Observational
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haraldsplass Deaconess Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen
- Investigators
- Karl Søndenaa, MD, PhD, Study chair, Haraldsplass Deaconal Hospital, University of Bergen, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01190280
- Sponsor's protocol ID
- GS06
- Status last verified
- Aug 2010
- First submitted
- 26 Aug 2010
- Last updated
- 27 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Sondenaa K, Nesvik I, Solhaug JH, Soreide O. Randomization to surgery or observation in patients with symptomatic gallbladder stone disease. The problem of evidence-based medicine in clinical practice. Scand J Gastroenterol. 1997 Jun;32(6):611-6. doi: 10.3109/00365529709025108.
PubMed 9200296Glambek I, Kvaale G, Arnesjo B, Soreide O. Prevalence of gallstones in a Norwegian population. Scand J Gastroenterol. 1987 Nov;22(9):1089-94. doi: 10.3109/00365528708991963.
PubMed 3321395Vetrhus M, Soreide O, Solhaug JH, Nesvik I, Sondenaa K. Symptomatic, non-complicated gallbladder stone disease. Operation or observation? A randomized clinical study. Scand J Gastroenterol. 2002 Jul;37(7):834-9.
PubMed 12190099Vetrhus M, Soreide O, Nesvik I, Sondenaa K. Acute cholecystitis: delayed surgery or observation. A randomized clinical trial. Scand J Gastroenterol. 2003 Sep;38(9):985-90. doi: 10.1080/00365520310004056.
PubMed 14531537Vetrhus M, Berhane T, Soreide O, Sondenaa K. Pain persists in many patients five years after removal of the gallbladder: observations from two randomized controlled trials of symptomatic, noncomplicated gallstone disease and acute cholecystitis. J Gastrointest Surg. 2005 Jul-Aug;9(6):826-31. doi: 10.1016/j.gassur.2005.01.291.
PubMed 15985239Schmidt M, Smastuen MC, Sondenaa K. Increased cancer incidence in some gallstone diseases, and equivocal effect of cholecystectomy: a long-term analysis of cancer and mortality. Scand J Gastroenterol. 2012 Dec;47(12):1467-74. doi: 10.3109/00365521.2012.719928. Epub 2012 Sep 5.
PubMed 22946484
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indications for Gallbladder Surgery in Gallstone Disease
- ClinicalTrials.gov ID
- NCT01190280
- Acronym / sponsor ID
- GS06
- Conditions
- Gallstones
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Haraldsplass Deaconess HospitalUniversity, hospital or other
- Collaborators
- University of Bergen
- Study start
- Oct 1991
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 27 Aug 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.
The aim of the study is to identify patients with gallstone disease that should be operated and those that may potentially be observed. This selection was based on symptoms and clinical presentation. The consequences that may arise for the patient if observation is chosen compared with outcome after cholecystectomy has been markers of outcome.
Detailed description
- Randomized clinical trial (RCT) of observation versus surgery for uncomplicated gallstone disease
- RCT of observation versus operation for acute cholecystitis
- Study of outcome after cholecystectomy in patients from 1. and 2.
- Study of symptoms in gallstone disease and symptom relief after cholecystectomy
- Long-term morbidity and mortality, including cancer, after cholecystectomy
- Long-term follow-up of patients with silent gallstones
Study design
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| AC - operation | – | Procedure: Cholecystectomy operationPatients admitted with acute cholecystitis randomized to operation |
| AC - observation | – | –Patients admitted with acute cholecystitis randomized to observation |
| SGBS - operation | – | Procedure: Cholecystectomy operationPatients admitted with uncomplicated gallstone disease randomized to operation |
| SGBS - observation | – | –Patients admitted with uncomplicated gallstone disease randomized to observation |
| 1983 - stones | – | –Patients that in 1983 were diagnosed with gallstones in a population screening |
| 1983 - operation | – | –Patients that were operated for gallstone disease at Haukeland University Hospital, Bergen, Norway, in 1983 |
| 1983 - controls | – | –Patients that were shown not to have gallstones in a 1983 population screening |
| Gallstone patients | – | –Patients with symptoms from gallstone disease |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to a hospital for either acute cholecystitis or uncomplicated symptomatic gallstone disease randomized to observation or operation. Patients from a population screening study for gallstones performed in 1983. Patients operated for gallstone disease in 1983.
Key inclusion criteria (9 listed)
- Symptomatic gallstone disease (SGBS):
- Episodes of pain in the right subcostal or midline epigastric area lasting more than 30 min, with ultrasonography signs of gallstones.
- Ultrasonographic: echo with an acoustic shadow in a visible gallbladder, or an echo with positional change and size <3 mm or, alternatively no demonstrable gallbladder but a strong echo with an acoustic shadow in the position of the gallbladder
- Acute abdominal pain
- Duration of more than 8-12 h
Key exclusion criteria (7 listed)
- Infrequent and/or minimal pain that need only very occasional medication
- Age below 18 or above 80
- Not willing to participate
- Severe concomitant disease
- Suspected Common Bile Duct stone
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 |
|---|---|---|
| Cholecystectomy operationAlso: Removal of gallbladderCholecystectomy after randomization | Procedure or surgery | AC - operation, SGBS - operation |
Primary outcome
Not reported in the source record.
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 27 Aug 2010.
- Background: PubMed 9200296Sondenaa K, Nesvik I, Solhaug JH, Soreide O. Randomization to surgery or observation in patients with symptomatic gallbladder stone disease. The problem of evidence-based medicine in clinical practice. Scand J Gastroenterol. 1997 Jun;32(6):611-6. doi: 10.3109/00365529709025108.
- Background: PubMed 3321395Glambek I, Kvaale G, Arnesjo B, Soreide O. Prevalence of gallstones in a Norwegian population. Scand J Gastroenterol. 1987 Nov;22(9):1089-94. doi: 10.3109/00365528708991963.
- Background: PubMed 12190099Vetrhus M, Soreide O, Solhaug JH, Nesvik I, Sondenaa K. Symptomatic, non-complicated gallbladder stone disease. Operation or observation? A randomized clinical study. Scand J Gastroenterol. 2002 Jul;37(7):834-9.
- Background: PubMed 14531537Vetrhus M, Soreide O, Nesvik I, Sondenaa K. Acute cholecystitis: delayed surgery or observation. A randomized clinical trial. Scand J Gastroenterol. 2003 Sep;38(9):985-90. doi: 10.1080/00365520310004056.
- Background: PubMed 15985239Vetrhus M, Berhane T, Soreide O, Sondenaa K. Pain persists in many patients five years after removal of the gallbladder: observations from two randomized controlled trials of symptomatic, noncomplicated gallstone disease and acute cholecystitis. J Gastrointest Surg. 2005 Jul-Aug;9(6):826-31. doi: 10.1016/j.gassur.2005.01.291.
- Derived from this study: PubMed 22946484Schmidt M, Smastuen MC, Sondenaa K. Increased cancer incidence in some gallstone diseases, and equivocal effect of cholecystectomy: a long-term analysis of cancer and mortality. Scand J Gastroenterol. 2012 Dec;47(12):1467-74. doi: 10.3109/00365521.2012.719928. Epub 2012 Sep 5.
Related trials for Gallstones
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
Active, not recruiting
Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)
Gallstones, Pain
Recruiting
Timing of CHolecystectomy In Severe PAncreatitis
Acute Pancreatitis, Cholelithiasis
RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
Cholelithiasis
RecruitingPhase 4
Time to Loss of Consciousness With Remimazolam Versus Propofol for Anesthetic Induction in Laparoscopic Cholecystectomy
Intravenous Anesthesia, Cholelithiasis
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.
Karl Søndenaa, MD, PhD study chair
Haraldsplass Deaconal Hospital, University of Bergen, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gallstones, run by Haraldsplass Deaconess Hospital at 1 site in Norway.
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 9 inclusion and 7 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 27 Aug 2010. 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 Norway. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01190280, which also lists 6 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 27 Aug 2010.