Gallbladder StoneNCT02185586
A Prospective Randomized Controlled Trial of Lower Abdominal Three-port Laparoscopic Cholecystectomy
A study testing laparoscopic cholecystectomy in people with Gallbladder Stone and Gallbladder Polyp, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
We have designed a new method which could be used in laparoscopic cholecy- stectomy.Account to this new method, the three incisions are all located on the lower abdominal, theoretically it could get more beautiful outlook and less stress response than traditional laparoscopic cholecystectomy(two of the three incisions… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gallbladder Stone, Gallbladder Polyp
- What is being tested?
- laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteChina
- Study dates
- May 2014to Nov 2015
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age from 18 to 70 years old
- benign diseases of gallbladder
- selective cholecystectomy
- Capable to read and write
Who cannot join
- accept upper abdominal operation before
- acute cholecystitis
- with serious heart or pulmonary diseases
- with diseases of immune system
- Pregnant women
- can not understand the research purposes
- relatives of researchers
Trial locations and contacts
1 site in 1 country.
China1 site
Department of hepatobiliary surgery,China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
About this study
Official title: A Prospective Randomized Controlled Trial of Traditional Three-port Laparoscopic Cholecystectomy Versus Lower Abdominal Three-port Laparoscopic Cholecystectomy
We have designed a new method which could be used in laparoscopic cholecy- stectomy.Account to this new method, the three incisions are all located on the lower abdominal, theoretically it could get more beautiful outlook and less stress response than traditional laparoscopic cholecystectomy(two of the three incisions located on upper abdomen) or single port laparoscopic cholecystectomy(one large incision located on umbilicus).
We plan to conduct a randomized controlled trial to compare those there methods of laparoscopic cholecystectomy, in order to find out if there will be some advantages of this new method,such as in lowering the stress response,reducing impact on respiration, relieving post-operation pain and improving appearance.
- Conditions
- Gallbladder Stone, Gallbladder Polyp
- Being tested
- laparoscopic cholecystectomy
- Medical subject headings
- Cholecystolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic cholecystectomyProcedure or surgery
Also called lower abdominal three-port laparoscopic cholecystectomy, single port laparoscopic cholecystectomy, upper abdominal three-port laparoscopic cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| LALC | Experimental | lower abdominal laparoscopic cholecystectomy Receives: Procedure: laparoscopic cholecystectomy |
| SLC | Experimental | single laparoscopic cholecystectomy Receives: Procedure: laparoscopic cholecystectomy |
| UALC | Placebo comparator | upper abdominal laparoscopic cholecystectomy Receives: Procedure: laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systematic inflammatory response caused by the surgical trauma
Blood IL-6,TNF-α,and CRP levels determined by ELISA at different time-points,
Measured: one day before the operation,8 hours after the operation,one day after the operation
Secondary outcomes (4)
Cosmesis and body image score
Measured: 1 and 3 months after the operation
pulmonary function
Measured: one day before the operation, one day after the operation
Post-operation pain score (visual analog scale, VAS)
Measured: 12 and 24 hours after the operation
36-item health survey
Measured: 3 months after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startMay 2014
- Primary completionAug 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gallbladder StoneStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Xu, China-Japan Friendship Hospital
- Investigators
- Chen Wang, MD, Principal investigator, China-Japan Friednship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02185586
- Sponsor's protocol ID
- 2014-21
- Other IDs
- 2014-21
- Status last verified
- Jan 2020
- First submitted
- 6 Jul 2014
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial of Traditional Three-port Laparoscopic Cholecystectomy Versus Lower Abdominal Three-port Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT02185586
- Acronym / sponsor ID
- 2014-21
- Conditions
- Gallbladder Stone, Gallbladder Polyp
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 9 Jul 2014 (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.
We have designed a new method which could be used in laparoscopic cholecy- stectomy.Account to this new method, the three incisions are all located on the lower abdominal, theoretically it could get more beautiful outlook and less stress response than traditional laparoscopic cholecystectomy(two of the three incisions located on upper abdomen) or single port laparoscopic cholecystectomy(one large incision located on umbilicus).
We plan to conduct a randomized controlled trial to compare those there methods of laparoscopic cholecystectomy, in order to find out if there will be some advantages of this new method,such as in lowering the stress response,reducing impact on respiration, relieving post-operation pain and improving appearance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LALC | Experimental | Procedure: laparoscopic cholecystectomylower abdominal laparoscopic cholecystectomy |
| SLC | Experimental | Procedure: laparoscopic cholecystectomysingle laparoscopic cholecystectomy |
| UALC | Placebo comparator | Procedure: laparoscopic cholecystectomyupper abdominal laparoscopic cholecystectomy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age from 18 to 70 years old
- benign diseases of gallbladder
- selective cholecystectomy
- Capable to read and write
Key exclusion criteria (7 listed)
- accept upper abdominal operation before
- acute cholecystitis
- with serious heart or pulmonary diseases
- with diseases of immune system
- Pregnant women
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 cholecystectomyAlso: lower abdominal three-port laparoscopic cholecystectomy, single port laparoscopic cholecystectomy, upper abdominal three-port laparoscopic cholecystectomy | Procedure or surgery | LALC, SLC, UALC |
Primary outcome
Systematic inflammatory response caused by the surgical trauma
Time frame: one day before the operation,8 hours after the operation,one day after the operation
Blood IL-6,TNF-α,and CRP levels determined by ELISA at different time-points,
4 secondary outcomes
Cosmesis and body image score
Time frame: 1 and 3 months after the operation
pulmonary function
Time frame: one day before the operation, one day after the operation
Post-operation pain score (visual analog scale, VAS)
Time frame: 12 and 24 hours after the operation
36-item health survey
Time frame: 3 months after the operation
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 23 Jan 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Gallbladder Stone
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Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)
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Recruiting
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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.
Chen Wang, MD principal investigator
China-Japan Friednship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic cholecystectomy in people with Gallbladder Stone and Gallbladder Polyp, run by China-Japan Friendship Hospital 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 4 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 23 Jan 2020. 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. Some participants in this study may receive a placebo. 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?
Systematic inflammatory response caused by the surgical trauma (time frame: one day before the operation,8 hours after the operation,one day after the operation). 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 23 Jan 2020.