CholecystitisNCT03909360
Drainage or Not for Laparoscopic Cholecystetomy
A study testing drainage tube in people with Cholecystitis and Cholecystolithiasis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Surgeons usually choosing drainage tube for laparoscopic cholecystectomy according to their experiences but not guidelines. The investigators design a RCT to evaluate the role of drainage in LC surgery and compare the clinical results between drainage and no drainage. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cholecystitis, Cholecystolithiasis, Polyps Gallbladder
- What is being tested?
- drainage tube
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 14 Mar 2019to 1 Mar 2020
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age:18-75 years old
- indicated and planed to receive laparoscopic cholecystectomy
Who cannot join
- cirrohosis Child Grading B and C
- upper abdominal surgery history
- adjustment of surgical name intraoperative
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The second affiliated hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Huanbing Zhu, 15857174159, juvanbn@msn.com
About this study
Official title: Role of Abdominal Drainage for Laparoscopic Cholecystectomy a Prospective Randomised Study
Surgeons usually choosing drainage tube for laparoscopic cholecystectomy according to their experiences but not guidelines. The investigators design a RCT to evaluate the role of drainage in LC surgery and compare the clinical results between drainage and no drainage.
Read the detailed description
The investigators design a RCT to evaluate the role of drainage in LC surgery and compare the clinical results between drainage and no drainage.
Compare complications as below betwwen drainage and no drainage groups.
- VAS
- Nause and vomiting
- infection
- bleeding
- bile leakage
- puncture drainage
- readmission
- reoperation
- hospital stay
- hospital expense
- Being tested
- drainage tube
- Medical subject headings
- Cholecystitis, Cholecystolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drainage tubeProcedure or surgery
sub-hepatic drainage tube for laparoscopic cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| drainage | Experimental | Placement of subhepatic drainage tube for laparoscopic cholecytetomy Receives: Procedure: drainage tube |
| no drainage | No intervention | no placement of subhepatic drainage tube for laparoscopic cholecytetomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
bleeding Bile leakage
the morbidity of bleeding
the morbidity of bile leakage
Measured: day 1 to one month post LC operation
bile leakage
the morbidity of bile leakage
Measured: day 1 to one month post LC operation
Puncture drainage Puncture drainage
the percentage of puncture drainage
Puncture drainage
Puncture drainage
Measured: day 1 to one month post LC operation
reoperation Reoperation
the percentage of reoperation
Measured: day 1 to one month post LC operation
readmission
the percentage of readmission
Measured: day 1 to one month post LC operation
Secondary outcomes (5)
hospital stay
hospital stay
Measured: day 1 to discharge post LC operation
Hospitalization expenses
Hospitalization expenses
Measured: day 1 to discharge post LC operation
VAS score
VAS score
Measured: day 1 to discharge post LC operation
Nausea and vomiting
the morbidity of Nausea and vomiting
Measured: day 1 to discharge post LC operation
infection
the morbidity of infection (abdominal, incision,pulmonary,et al)
Measured: day 1 to discharge post LC operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start14 Mar 2019
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Mar 2020 (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 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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiangtao Li, MD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909360
- Sponsor's protocol ID
- zyeyLCdrainage
- Status last verified
- Apr 2019
- First submitted
- 17 Mar 2019
- Last updated
- 16 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhu H, Liu D, Zhou D, Wu J, Yu Y, Jin Y, Ye D, Ding C, Zhang X, Huang B, Peng S, Li J. Effectiveness of no drainage after elective day-case laparoscopic cholecystectomy, even with intraoperative gallbladder perforation: a randomized controlled trial. Langenbecks Arch Surg. 2023 Mar 1;408(1):112. doi: 10.1007/s00423-023-02846-z.
PubMed 36856748
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Abdominal Drainage for Laparoscopic Cholecystectomy a Prospective Randomised Study
- ClinicalTrials.gov ID
- NCT03909360
- Acronym / sponsor ID
- zyeyLCdrainage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 14 Mar 2019 (actual)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 10 Apr 2019 (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.
Surgeons usually choosing drainage tube for laparoscopic cholecystectomy according to their experiences but not guidelines. The investigators design a RCT to evaluate the role of drainage in LC surgery and compare the clinical results between drainage and no drainage.
Detailed description
The investigators design a RCT to evaluate the role of drainage in LC surgery and compare the clinical results between drainage and no drainage.
Compare complications as below betwwen drainage and no drainage groups.
- VAS
- Nause and vomiting
- infection
- bleeding
- bile leakage
- puncture drainage
- readmission
- reoperation
- hospital stay
- hospital expense
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| drainage | Experimental | Procedure: drainage tubePlacement of subhepatic drainage tube for laparoscopic cholecytetomy |
| no drainage | No intervention | –no placement of subhepatic drainage tube for laparoscopic cholecytetomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age:18-75 years old
- indicated and planed to receive laparoscopic cholecystectomy
Key exclusion criteria (3 listed)
- cirrohosis Child Grading B and C
- upper abdominal surgery history
- adjustment of surgical name intraoperative
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 |
|---|---|---|
| drainage tubesub-hepatic drainage tube for laparoscopic cholecystectomy | Procedure or surgery | drainage |
Primary outcome
bleeding Bile leakage
Time frame: day 1 to one month post LC operation
the morbidity of bleeding the morbidity of bile leakage
bile leakage
Time frame: day 1 to one month post LC operation
the morbidity of bile leakage
Puncture drainage Puncture drainage
Time frame: day 1 to one month post LC operation
the percentage of puncture drainage Puncture drainage Puncture drainage
reoperation Reoperation
Time frame: day 1 to one month post LC operation
the percentage of reoperation
readmission
Time frame: day 1 to one month post LC operation
the percentage of readmission
5 secondary outcomes
hospital stay
Time frame: day 1 to discharge post LC operation
Hospitalization expenses
Time frame: day 1 to discharge post LC operation
VAS score
Time frame: day 1 to discharge post LC operation
Nausea and vomiting
Time frame: day 1 to discharge post LC operation
infection
Time frame: day 1 to discharge post LC operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Derived from this study: PubMed 36856748Zhu H, Liu D, Zhou D, Wu J, Yu Y, Jin Y, Ye D, Ding C, Zhang X, Huang B, Peng S, Li J. Effectiveness of no drainage after elective day-case laparoscopic cholecystectomy, even with intraoperative gallbladder perforation: a randomized controlled trial. Langenbecks Arch Surg. 2023 Mar 1;408(1):112. doi: 10.1007/s00423-023-02846-z.
- Individual participant dataSharing planned: No
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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.
Jiangtao Li, MD principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing drainage tube in people with Cholecystitis and Cholecystolithiasis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 16 Apr 2019. 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 China. 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 Huanbing Zhu, MD (15857174159, juvanbn@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bleeding Bile leakage (time frame: day 1 to one month post LC operation). 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 NCT03909360, 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 16 Apr 2019.