GallstonePhase 2/3NCT01383031
Safety and Efficacy Study of Transumbilical Laparoendoscopic Single Site Cholecystectomy
A Phase 2/3 study testing CLC and TU-LESSC in people with Gallstone and Gallbladder Polyps, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
The purpose of this study is to scientifically evaluate the safety, efficacy and cosmetic results of transumbilical laparoendoscopic single site cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gallstone, Gallbladder Polyps
- What is being tested?
- CLC and TU-LESSC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Oct 2010to Dec 2012
- Phase
- Phase 2/3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 Years to 5 Years
- Benign gallbladder diseases
- KPS ≥ 70
- informed consent
Who cannot join
- Obstructive jaundice
- Broadening of the common bile duct
- Gallstone pancreatitis
- Serious heart,brain,lung, metabolic diseases history
- History of upper abdominal surgery
- Pregnancy or breast-feeding women
- Refuse TU-LESSC
- BMI(Body Mass Index)≥ 30
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Bejing Friendship Hospital
Beijing, Bejing, 100050
Zhang Z Tao, Doctor
About this study
Official title: Randomized Controlled Trial Of Transumbilical Laparoendoscopic Single Site Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy
The purpose of this study is to scientifically evaluate the safety, efficacy and cosmetic results of transumbilical laparoendoscopic single site cholecystectomy.
Read the detailed description
As the natural orifice during embryonic, the transumbilical surgery not only can mask the abdominal scar and avoid infection produced by puncturing stomach, vagina or rectum in NOTES,but also can be played by the conventional laparoscopic instruments. TU-LESS (transumbilical laparoendoscopic single site surgery), is considered to be the most feasible NOTES(natural orifice transluminal endoscopic surgery)technology at present. Researches about TU-LESS mostly are case reports and small samples or the control experiments up to now,there are not persuasive randomized controlled trail between TU-LESS and conventional laparoscopic cholecystectomy. So the investigators design this prospective randomized controlled trail to scientifically evaluate the safety, efficacy and cosmetic results of transumbilical laparoendoscopic single site cholecystectomy .
- Conditions
- Gallstone, Gallbladder Polyps
- Being tested
- CLC, TU-LESSC
- Keywords
- laparoscopic cholecystectomy, single site, randomized controlled trail
- Medical subject headings
- Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLCProcedure or surgery
Also called conventional laparoscopic cholecystectomy
CLC（4 ports or 3 ports）will be performed in a routine fashion by one full time faculty member with fellowship training in laparoscopy.
TU-LESSCProcedure or surgery
Also called Transumbilical laparoendoscopic single site cholecystectomy
TU-LESSC will be performed in a routine fashion which is same to CLC by one full time faculty member with fellowship training in laparoscopy through the conventional laparoscopic instruments.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Cholecystectomy | Active comparator | Laparoscopic cholecystectomy（4 ports or 3 ports）will be performed in a routine fashion by one full time faculty member with fellowship training in laparoscopy. Receives: Procedure: CLC |
| TU-LESSC | Active comparator | TU-LESSC will be performed in a routine fashion which is same to CLC（conventional laparoscopic cholecystetomy）by one full time faculty member with fellowship training in laparoscopy through the conventional laparoscopic instruments. Receives: Procedure: TU-LESSC |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of surgical complications
The primary outcome messures are the incidence of surgical complications caused by the two surgeries.Bleeding,bile duct injury and bile leakage during operation.Wound infection，umbilical hernia，poke holes hernia and biliary fistula after operation.
Measured: up to 12 weeks
Secondary outcomes (7)
transfer rate
TU-LESSC（transumbilical laparoendoscopic single site cholecystectomy）is converted to LC（laparoscopic cholecystectomy）or open sugery;LC is converted to open sugery.
Measured: participants will be followed for the duration of hospital stay, an expected average of 5 days
quality of life scores
Count patients' quality of life scores before sugery and at several time points after operation.
Measured: up to 12 weeks
pain scores
Use VAS（Visual Analogue Score）to count patients' pain scores at several time points after operation.
Measured: up to 12 weeks
length of hospital stay
Measured: participants will be followed for the duration of hospital stay, an expected average of 5 days
total cost of hospitalization
Measured: participants will be followed for the duration of hospital stay, an expected average of 5 days
Cosmetic results
Through the incision length and patients' satisfaction to assess cosmetic results.
Measured: 1 month
The incidence of adverse events
The adverse events occurred after surgery，regardless of whether they are caused by the tow operations。 Such as nausea, dizziness, urinary retention, vomiting and so on.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2011 (estimated)
- Study startOct 2010
- 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 GallstoneStudies of the same condition, open and under way.
- More trials run by Beijing 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Zhongtao Zhang, doctor, Study chair, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01383031
- Sponsor's protocol ID
- BFH-007
- Status last verified
- Oct 2010
- First submitted
- 17 Jun 2011
- Last updated
- 7 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Of Transumbilical Laparoendoscopic Single Site Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT01383031
- Acronym / sponsor ID
- BFH-007
- Conditions
- Gallstone, Gallbladder Polyps
- Keywords
- laparoscopic cholecystectomy, single site, randomized controlled trail
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 28 Jun 2011 (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 purpose of this study is to scientifically evaluate the safety, efficacy and cosmetic results of transumbilical laparoendoscopic single site cholecystectomy.
Detailed description
As the natural orifice during embryonic, the transumbilical surgery not only can mask the abdominal scar and avoid infection produced by puncturing stomach, vagina or rectum in NOTES,but also can be played by the conventional laparoscopic instruments. TU-LESS (transumbilical laparoendoscopic single site surgery), is considered to be the most feasible NOTES(natural orifice transluminal endoscopic surgery)technology at present. Researches about TU-LESS mostly are case reports and small samples or the control experiments up to now,there are not persuasive randomized controlled trail between TU-LESS and conventional laparoscopic cholecystectomy. So the investigators design this prospective randomized controlled trail to scientifically evaluate the safety, efficacy and cosmetic results of transumbilical laparoendoscopic single site cholecystectomy .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Cholecystectomy | Active comparator | Procedure: CLCLaparoscopic cholecystectomy（4 ports or 3 ports）will be performed in a routine fashion by one full time faculty member with fellowship training in laparoscopy. |
| TU-LESSC | Active comparator | Procedure: TU-LESSCTU-LESSC will be performed in a routine fashion which is same to CLC（conventional laparoscopic cholecystetomy）by one full time faculty member with fellowship training in laparoscopy through the conventional laparoscopic instruments. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 Years to 5 Years
- Benign gallbladder diseases
- KPS ≥ 70
- informed consent
Key exclusion criteria (8 listed)
- Obstructive jaundice
- Broadening of the common bile duct
- Gallstone pancreatitis
- Serious heart,brain,lung, metabolic diseases history
- History of upper abdominal surgery
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 |
|---|---|---|
| CLCAlso: conventional laparoscopic cholecystectomyCLC（4 ports or 3 ports）will be performed in a routine fashion by one full time faculty member with fellowship training in laparoscopy. | Procedure or surgery | Laparoscopic Cholecystectomy |
| TU-LESSCAlso: Transumbilical laparoendoscopic single site cholecystectomyTU-LESSC will be performed in a routine fashion which is same to CLC by one full time faculty member with fellowship training in laparoscopy through the conventional laparoscopic instruments. | Procedure or surgery | TU-LESSC |
Primary outcome
the incidence of surgical complications
Time frame: up to 12 weeks
The primary outcome messures are the incidence of surgical complications caused by the two surgeries.Bleeding,bile duct injury and bile leakage during operation.Wound infection，umbilical hernia，poke holes hernia and biliary fistula after operation.
7 secondary outcomes
transfer rate
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 days
quality of life scores
Time frame: up to 12 weeks
pain scores
Time frame: up to 12 weeks
length of hospital stay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 days
total cost of hospitalization
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 days
Cosmetic results
Time frame: 1 month
The incidence of adverse events
Time frame: up to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2011.
Related trials for Gallstone
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Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)
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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.
Zhongtao Zhang, doctor study chair
Beijing Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing CLC and TU-LESSC in people with Gallstone and Gallbladder Polyps, run by Beijing 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 8 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 7 Jul 2011. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Yang Liu, master (+8615001284594, liuyangzhanglina@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of surgical complications (time frame: up to 12 weeks). 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 7 Jul 2011.