Acute CholecystitisNCT03122054
Early Versus Delayed Cholecystectomy
A study testing laparoscopic cholecystectomy in people with Acute Cholecystitis, run by Sisli Hamidiye Etfal Training and Research Hospital.
Trial summary
This study examines complications, mortality rates, cost-effectiveness and safety of early laparoscopic cholecystectomy (ELC) versus delayed laparoscopic cholecystectomy (DLC). Group L (n:88) patients treated surgically with laparoscopic cholecystectomy immediately or Group D (n:88) patients first treated medically… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Cholecystitis
- What is being tested?
- laparoscopic cholecystectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2015to 15 Feb 2017
- 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
- patients suffering acute cholecystitis in their first 72 hours of pain
Who cannot join
- clinical duration longer than 72 hours, complicated acute cholecystitis (bilirubin >2gr/dl, elevated transaminases (>100 u/l), and cholestatic enzymes (gamma glutamyl transferase >50 u/l), ultrasonographically confirmed dilated intrahepatic or extrahepatic bile ducts, and elevated amylase levels three times more than normal range
About this study
Official title: Should Surgical Experience Change Our Treatment Strategy on Acute Cholecystitis? Early Versus Delayed Cholecystectomy
This study examines complications, mortality rates, cost-effectiveness and safety of early laparoscopic cholecystectomy (ELC) versus delayed laparoscopic cholecystectomy (DLC). Group L (n:88) patients treated surgically with laparoscopic cholecystectomy immediately or Group D (n:88) patients first treated medically and than treated surgically with delayed (4-8 weeks later) laparoscopic cholecystectomy.
Read the detailed description
There is only few knowledge about the comparison of early laparoscopic cholecystectomy (ELC) versus delayed laparoscopic cholecystectomy (DLC) for the treatment of acute cholecystitis considering the surgeon's work experience. This study examines complications, mortality rates, cost-effectiveness and safety of DLC versus ELC. This prospective randomized clinical trial was performed between November 2015-2016 in our General Surgery Clinic. Patients suffering acute cholecystitis in their first 72 hours of pain were enrolled in one of the two study groups: Group L (n:88) patients treated surgically with laparoscopic cholecystectomy immediately or Group D (n:88) patients first treated medically and than treated surgically with delayed (4-8 weeks later) laparoscopic cholecystectomy. All operations and medical treatments were done by surgeons having work experience <2 years.
- Conditions
- Acute Cholecystitis
- Being tested
- laparoscopic cholecystectomy
- Keywords
- Laparoscopic Cholecystectomy, Delayed Cholecystectomy
- Medical subject headings
- Cholecystitis, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic cholecystectomyProcedure or surgery
First trocar was inserted with Hasson method (Subumbilical 1 cm vertical incision was made and first 10-mm trocar (VersaportTM plus V2, Covidien, USA) inserted under direct vision) and pneumoperitoneum was created with 12 mm Hg pressure. Second 10-mm trocar was inserted from subxyphoid area. Two 5-mm trocars were inserted in the right upper quadrant area. After general intrabdominal exploration, dissection was started to ensure safe-view of Calot triangle. In case of quite tough gallbladder for griping, gallbladder was drained with a gray intravenous cannula. Cystic artery and cystic duct were separately dissected and twice ligated with Endo Clip™ II ML (Covidien, USA). Gallbladder was dissected from liver bed carefully. Gallbladder was taken out from abdomen through the subumbilical incision.
| Study group | Role | What they receive |
|---|---|---|
| Group L (n:88) | Other | patients treated surgically with laparoscopic cholecystectomy immediately Receives: Procedure: laparoscopic cholecystectomy |
| Group D (n:88) | Other | patients first treated medically and than treated surgically with delayed (4-8 weeks later) laparoscopic cholecystectomy Receives: Procedure: laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital stay
time spent totally in the hospital; time from admission to discharge from hospital in days
Measured: 4 to 8 weeks
Secondary outcomes (1)
Costs of treatment
costs of treatment spent for surgery and hospital stay in days; costs of treatment from admission to discharge from hospital in USD
Measured: 4 to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2017
- Study start1 Nov 2015
- Primary completion1 Nov 2016
- Study completion15 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute CholecystitisStudies 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
- Model description
- patients suffering acute pain because of acute cholecystitis
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Canan Tulay ISIL, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- Riza Gurhan Isil, MD, Principal investigator, Sağlık Bilimleri Üniversitesi Şişli Hamidiye Etfal Eğitim ve Araştırma Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03122054
- Sponsor's protocol ID
- SHEEAH 12.04.2016/1141
- Status last verified
- Apr 2017
- First submitted
- 28 Mar 2017
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I can share study data only without sharing patient names and protocol numbers.
Publications
Stinton LM, Shaffer EA. Epidemiology of gallbladder disease: cholelithiasis and cancer. Gut Liver. 2012 Apr;6(2):172-87. doi: 10.5009/gnl.2012.6.2.172. Epub 2012 Apr 17.
PubMed 22570746Gurusamy K, Samraj K, Gluud C, Wilson E, Davidson BR. Meta-analysis of randomized controlled trials on the safety and effectiveness of early versus delayed laparoscopic cholecystectomy for acute cholecystitis. Br J Surg. 2010 Feb;97(2):141-50. doi: 10.1002/bjs.6870.
PubMed 20035546
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Should Surgical Experience Change Our Treatment Strategy on Acute Cholecystitis? Early Versus Delayed Cholecystectomy
- ClinicalTrials.gov ID
- NCT03122054
- Acronym / sponsor ID
- SHEEAH 12.04.2016/1141
- Conditions
- Acute Cholecystitis
- Keywords
- Laparoscopic Cholecystectomy, Delayed Cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 1 Nov 2016 (actual)
- Study completion
- 15 Feb 2017 (actual)
- First posted
- 20 Apr 2017 (actual)
- 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 study examines complications, mortality rates, cost-effectiveness and safety of early laparoscopic cholecystectomy (ELC) versus delayed laparoscopic cholecystectomy (DLC). Group L (n:88) patients treated surgically with laparoscopic cholecystectomy immediately or Group D (n:88) patients first treated medically and than treated surgically with delayed (4-8 weeks later) laparoscopic cholecystectomy.
Detailed description
There is only few knowledge about the comparison of early laparoscopic cholecystectomy (ELC) versus delayed laparoscopic cholecystectomy (DLC) for the treatment of acute cholecystitis considering the surgeon's work experience. This study examines complications, mortality rates, cost-effectiveness and safety of DLC versus ELC. This prospective randomized clinical trial was performed between November 2015-2016 in our General Surgery Clinic. Patients suffering acute cholecystitis in their first 72 hours of pain were enrolled in one of the two study groups: Group L (n:88) patients treated surgically with laparoscopic cholecystectomy immediately or Group D (n:88) patients first treated medically and than treated surgically with delayed (4-8 weeks later) laparoscopic cholecystectomy. All operations and medical treatments were done by surgeons having work experience <2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- patients suffering acute pain because of acute cholecystitis
| Arm | Type | Receives |
|---|---|---|
| Group L (n:88) | Other | Procedure: laparoscopic cholecystectomypatients treated surgically with laparoscopic cholecystectomy immediately |
| Group D (n:88) | Other | Procedure: laparoscopic cholecystectomypatients first treated medically and than treated surgically with delayed (4-8 weeks later) laparoscopic cholecystectomy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients suffering acute cholecystitis in their first 72 hours of pain
Key exclusion criteria (1 listed)
- clinical duration longer than 72 hours, complicated acute cholecystitis (bilirubin >2gr/dl, elevated transaminases (>100 u/l), and cholestatic enzymes (gamma glutamyl transferase >50 u/l), ultrasonographically confirmed dilated intrahepatic or extrahepatic bile ducts, and elevated amylase levels three times more than normal range
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 cholecystectomyFirst trocar was inserted with Hasson method (Subumbilical 1 cm vertical incision was made and first 10-mm trocar (VersaportTM plus V2, Covidien, USA) inserted under direct vision) and pneumoperitoneum was created with 12 mm Hg pressure. Second 10-mm trocar was inserted from subxyphoid area. Two 5-mm trocars were inserted in the right upper quadrant area. After general intrabdominal exploration, dissection was started to ensure safe-view of Calot triangle. In case of quite tough gallbladder for griping, gallbladder was drained with a gray intravenous cannula. Cystic artery and cystic duct were separately dissected and twice ligated with Endo Clip™ II ML (Covidien, USA). Gallbladder was dissected from liver bed carefully. Gallbladder was taken out from abdomen through the subumbilical incision. | Procedure or surgery | Group D (n:88), Group L (n:88) |
Primary outcome
Hospital stay
Time frame: 4 to 8 weeks
time spent totally in the hospital; time from admission to discharge from hospital in days
1 secondary outcome
Costs of treatment
Time frame: 4 to 8 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 25 Apr 2017.
- Background: PubMed 22570746Stinton LM, Shaffer EA. Epidemiology of gallbladder disease: cholelithiasis and cancer. Gut Liver. 2012 Apr;6(2):172-87. doi: 10.5009/gnl.2012.6.2.172. Epub 2012 Apr 17.
- Results publication: PubMed 20035546Gurusamy K, Samraj K, Gluud C, Wilson E, Davidson BR. Meta-analysis of randomized controlled trials on the safety and effectiveness of early versus delayed laparoscopic cholecystectomy for acute cholecystitis. Br J Surg. 2010 Feb;97(2):141-50. doi: 10.1002/bjs.6870.
- Individual participant dataSharing planned: No. I can share study data only without sharing patient names and protocol numbers.
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Percutaneous Drainage Versus EUS-guided Gallbladder Drainage in Poor Surgical Patients With Cholecystitis
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RecruitingObservational study
Influence of Gut Microbiome in Gallstone Disease
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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.
Riza Gurhan Isil, MD principal investigator
Sağlık Bilimleri Üniversitesi Şişli Hamidiye Etfal Eğitim ve Araştırma Hastanesi
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic cholecystectomy in people with Acute Cholecystitis, run by Sisli Hamidiye Etfal Training and Research Hospital.
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 1 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 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Hospital stay (time frame: 4 to 8 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 NCT03122054, which also lists 2 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 25 Apr 2017.