Acute CholecystitisPhase 3NCT01625247
Drainage is Not Necessary Procedure After Laparoscopic Cholecystectomy Due to Severe Acute Cholecystitis
A Phase 3 study testing Surgical drainage in people with Acute Cholecystitis and Empyema, run by Yonsei University at 1 site in South Korea.
Trial summary
Laparoscopic cholecystectomy (LC) is the current preferred method of cholecystectomy. The role of routine drainage after LC to decrease postoperative morbidity is still an issue of considerable debate. The goal of this study was to assess to role of drains in LC, performed for acute inflamed gallbladder. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Cholecystitis, Empyema
- What is being tested?
- Surgical drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2009to Dec 2012
- 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
- Acute cholecystis
- Laparoscopic cholecystectomy
- KAROFSKY PERFORMANCE SCALE > 70
- No history of major operation
Who cannot join
- NYHA class > 3
- Open cholecystectomy
- No- compliance
- Intraoperative injuries
- Inadequate hemostasis
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Gangnam Severance hospital
Seoul, Seoul, 135-720
Dong Sup Yoon, MD, 82-2-2019-2444, yds1660@yuhs.ac
Dong Sup Yoon, MD
About this study
Laparoscopic cholecystectomy (LC) is the current preferred method of cholecystectomy. The role of routine drainage after LC to decrease postoperative morbidity is still an issue of considerable debate. The goal of this study was to assess to role of drains in LC, performed for acute inflamed gallbladder.
- Conditions
- Acute Cholecystitis, Empyema
- Being tested
- Surgical drainage
- Medical subject headings
- Cholecystitis, Acute, Empyema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical drainageProcedure or surgery
Postoperative abdominal drainage were connected to a 200-mL closed suction reservoir. The drainage was removed if there are drainage amount less than 20 mL and color was serous color.
| Study group | Role | What they receive |
|---|---|---|
| 1 arm | Experimental | Patients under LC. Allocated to drain placement . Drainage was removed if the drainage amount was less than 20cc. Receives: Procedure: Surgical drainage |
| 2 arm | Active comparator | Patients under LC. Allocation to sham drain, Receives: Procedure: Surgical drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of postoperative complication occurrence
Measured: whinin 1 week and 8 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2012 (estimated)
- Study startJun 2009
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute CholecystitisStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01625247
- Sponsor's protocol ID
- 3-2008-0140
- Status last verified
- Jun 2012
- First submitted
- 12 Jun 2012
- Last updated
- 21 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drainage is Not Necessary Procedure After Laparoscopic Cholecystectomy Due to Severe Acute Cholecystitis
- ClinicalTrials.gov ID
- NCT01625247
- Acronym / sponsor ID
- 3-2008-0140
- Conditions
- Acute Cholecystitis, Empyema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 21 Jun 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.
Laparoscopic cholecystectomy (LC) is the current preferred method of cholecystectomy. The role of routine drainage after LC to decrease postoperative morbidity is still an issue of considerable debate. The goal of this study was to assess to role of drains in LC, performed for acute inflamed gallbladder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 arm | Experimental | Procedure: Surgical drainagePatients under LC. Allocated to drain placement . Drainage was removed if the drainage amount was less than 20cc. |
| 2 arm | Active comparator | Procedure: Surgical drainagePatients under LC. Allocation to sham drain, |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Acute cholecystis
- Laparoscopic cholecystectomy
- KAROFSKY PERFORMANCE SCALE > 70
- No history of major operation
Key exclusion criteria (5 listed)
- NYHA class > 3
- Open cholecystectomy
- No- compliance
- Intraoperative injuries
- Inadequate hemostasis
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 |
|---|---|---|
| Surgical drainagePostoperative abdominal drainage were connected to a 200-mL closed suction reservoir. The drainage was removed if there are drainage amount less than 20 mL and color was serous color. | Procedure or surgery | 1 arm, 2 arm |
Primary outcome
frequency of postoperative complication occurrence
Time frame: whinin 1 week and 8 weeks postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 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.
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 Surgical drainage in people with Acute Cholecystitis and Empyema, run by Yonsei University at 1 site in South Korea.
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 4 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: status not confirmed, as of the sponsor's last update on 21 Jun 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dong Sup Yoon, MD (82-2-2019-2444, yds1660@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of postoperative complication occurrence (time frame: whinin 1 week and 8 weeks postoperatively). 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 21 Jun 2012.