CholelithiasisPhase 1SILCNCT00678873
Single Incision Laparoscopic Cholecystectomy
A Phase 1 study testing Single Incision Laparoscopic Cholecystectomy in people with Cholelithiasis, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The investigators aim to investigate the safety, feasibility and short-term outcomes of Single Incision Laparoscopic Cholecystectomy. The investigators hypothesize that Single Incision Laparoscopic Cholecystectomy is safe and feasible. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholelithiasis
- What is being tested?
- Single Incision Laparoscopic Cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Dec 2009
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults male and female(>18 years old)
- Capable of giving informed consent
- Ultrasound proven cholelithiasis
- Symptomatic cholelithiasis
- Elective cholecystectomy
Who cannot join
- Pregnancy
- Contraindications for general anesthesia
- Morbid obesity
- Multiple previous abdominal surgeries
- Uncontrolled medical conditions
- Acute cholecystitis
Trial locations and contacts
1 site in 1 country.
About this study
The investigators aim to investigate the safety, feasibility and short-term outcomes of Single Incision Laparoscopic Cholecystectomy.
The investigators hypothesize that Single Incision Laparoscopic Cholecystectomy is safe and feasible.
Read the detailed description
Laparoscopic cholecystectomy is the standard approach for the treatment of gallbladder disease. Laparoscopic cholecystectomy is now performed as an outpatient procedure and it commonly requires the use of 4 separate small incisions. Single incision or single access trans-umbilical surgery may provide less pain, scarring and may improve patient's overall satisfaction.
In this phase I trial we aim to evaluate the safety, feasibility and short-term outcomes of Single Incision Laparoscopic Cholecystectomy for the treatment of symptomatic cholelithiasis (gallstones).
- Conditions
- Cholelithiasis
- Being tested
- Single Incision Laparoscopic Cholecystectomy
- Keywords
- Single Incision, Single Access, Surgery, Cholecystectomy
- Medical subject headings
- Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Incision Laparoscopic CholecystectomyProcedure or surgery
Also called Single incision surgery, Single access surgery, Single incision laparoscopy, Single access laparoscopy
A single trans-umbilical incision laparoscopic cholecystectomy will be performed by standard fashion and under general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Surgical group | Experimental | Patients with ultrasound proven symptomatic cholelithiasis (gallstones). Receives: Procedure: Single Incision Laparoscopic Cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and feasibility
Measured: 12 months
Secondary outcomes (1)
Short-term clinical outcomes
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholelithiasisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Homero Rivas, MD, Principal investigator, UTSouthwestern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00678873
- Sponsor's protocol ID
- 8843
- Acronym
- SILC
- Status last verified
- Aug 2008
- First submitted
- 14 May 2008
- Last updated
- 15 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Incision Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT00678873
- Acronym / sponsor ID
- SILC / 8843
- Conditions
- Cholelithiasis
- Keywords
- Single Incision, Single Access, Surgery, Cholecystectomy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 16 May 2008 (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 investigators aim to investigate the safety, feasibility and short-term outcomes of Single Incision Laparoscopic Cholecystectomy.
The investigators hypothesize that Single Incision Laparoscopic Cholecystectomy is safe and feasible.
Detailed description
Laparoscopic cholecystectomy is the standard approach for the treatment of gallbladder disease. Laparoscopic cholecystectomy is now performed as an outpatient procedure and it commonly requires the use of 4 separate small incisions. Single incision or single access trans-umbilical surgery may provide less pain, scarring and may improve patient's overall satisfaction.
In this phase I trial we aim to evaluate the safety, feasibility and short-term outcomes of Single Incision Laparoscopic Cholecystectomy for the treatment of symptomatic cholelithiasis (gallstones).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical group | Experimental | Procedure: Single Incision Laparoscopic CholecystectomyPatients with ultrasound proven symptomatic cholelithiasis (gallstones). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults male and female(>18 years old)
- Capable of giving informed consent
- Ultrasound proven cholelithiasis
- Symptomatic cholelithiasis
- Elective cholecystectomy
Key exclusion criteria (6 listed)
- Pregnancy
- Contraindications for general anesthesia
- Morbid obesity
- Multiple previous abdominal surgeries
- Uncontrolled medical conditions
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 |
|---|---|---|
| Single Incision Laparoscopic CholecystectomyAlso: Single incision surgery, Single access surgery, Single incision laparoscopy, Single access laparoscopyA single trans-umbilical incision laparoscopic cholecystectomy will be performed by standard fashion and under general anesthesia. | Procedure or surgery | Surgical group |
Primary outcome
Safety and feasibility
Time frame: 12 months
1 secondary outcome
Short-term clinical outcomes
Time frame: 12 months
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 15 Dec 2009.
Related trials for Cholelithiasis
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Timing of CHolecystectomy In Severe PAncreatitis
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Time to Loss of Consciousness With Remimazolam Versus Propofol for Anesthetic Induction in Laparoscopic Cholecystectomy
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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.
Homero Rivas, MD principal investigator
UTSouthwestern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Single Incision Laparoscopic Cholecystectomy in people with Cholelithiasis, run by University of Texas Southwestern Medical Center at 1 site in United States.
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 5 inclusion and 6 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 15 Dec 2009. 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Safety and feasibility (time frame: 12 months). 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 15 Dec 2009.