CholelithiasisLap vs SILSNCT01116492
Study of the Inflammatory Reaction in Standard vs Single Port Cholecystectomy for Uncomplicated Cholelithiasis
A study testing Single incision laparoscopic cholecystectomy and Laparoscopic cholecystectomy in people with Cholelithiasis and Inflammatory Response, run by G. Hatzikosta General Hospital at 1 site in Greece.
Trial summary
This is a study of the inflammatory reaction in standard 4 port laparoscopic cholecystectomy vs Single Port Laparoscopic (SIL) cholecystectomy. It is assumed that the reduced trauma in SIL Cholecystectomy causes reduced inflammatory reaction compared to the 4 port laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cholelithiasis, Inflammatory Response
- What is being tested?
- Single incision laparoscopic cholecystectomy and Laparoscopic cholecystectomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2010to May 2010
- 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 Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Uncomplicated cholelithiasis
- American Society of Anesthesiologists (ASA) I or II
- No previous operations in upper abdomen
- Body mass index (BMI) <30
Who cannot join
- Cholecystitis
- ASA > II
- BMI>30
- Previous operations in upper abdomen
- Previous operations in intestine
Trial locations and contacts
1 site in 1 country.
About this study
This is a study of the inflammatory reaction in standard 4 port laparoscopic cholecystectomy vs Single Port Laparoscopic (SIL) cholecystectomy. It is assumed that the reduced trauma in SIL Cholecystectomy causes reduced inflammatory reaction compared to the 4 port laparoscopic cholecystectomy.
Read the detailed description
Two groups of 20 patients each are included in this study. Pre operatively, 6 and 24 hours postoperatively, blood is taken from these patients, it is centrifuged and the plasma is taken. IL-6, a-defensins and CRP are measured for each sample.
- Conditions
- Cholelithiasis, Inflammatory Response
- Being tested
- Single incision laparoscopic cholecystectomy, Laparoscopic cholecystectomy
- Keywords
- SILS, Inflammatory reaction, a-defensins, SILS vs standard laparoscopic cholecystectomy
- Medical subject headings
- Cholelithiasis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single incision laparoscopic cholecystectomyOther
One port placed through the umbilicus
Laparoscopic cholecystectomyOther
Standard 4 port laparoscopic cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| Lap Group | Active comparator | Patients in this group are operated for uncomplicated cholelithiasis with standard 4 port laparoscopic cholecystectomy Receives: Other: Laparoscopic cholecystectomy |
| SILS group | Active comparator | Patients in this group are operated for uncomplicated cholelithiasis with Single Incision Laparoscopic Cholecystectomy Receives: Other: Single incision laparoscopic cholecystectomy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study startJan 2010
- Primary completionMay 2010
- Study completionMay 2010
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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- G. Hatzikosta General Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01116492
- Sponsor's protocol ID
- GH-1948-05
- Acronym
- Lap vs SILS
- Status last verified
- May 2010
- First submitted
- 4 May 2010
- Last updated
- 21 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Inflammatory Reaction in Standard vs Single Port Cholecystectomy for Uncomplicated Cholelithiasis
- ClinicalTrials.gov ID
- NCT01116492
- Acronym / sponsor ID
- Lap vs SILS / GH-1948-05
- Conditions
- Cholelithiasis, Inflammatory Response
- Keywords
- SILS, Inflammatory reaction, a-defensins, SILS vs standard laparoscopic cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- G. Hatzikosta General HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 5 May 2010 (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.
This is a study of the inflammatory reaction in standard 4 port laparoscopic cholecystectomy vs Single Port Laparoscopic (SIL) cholecystectomy. It is assumed that the reduced trauma in SIL Cholecystectomy causes reduced inflammatory reaction compared to the 4 port laparoscopic cholecystectomy.
Detailed description
Two groups of 20 patients each are included in this study. Pre operatively, 6 and 24 hours postoperatively, blood is taken from these patients, it is centrifuged and the plasma is taken. IL-6, a-defensins and CRP are measured for each sample.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lap Group | Active comparator | Other: Laparoscopic cholecystectomyPatients in this group are operated for uncomplicated cholelithiasis with standard 4 port laparoscopic cholecystectomy |
| SILS group | Active comparator | Other: Single incision laparoscopic cholecystectomyPatients in this group are operated for uncomplicated cholelithiasis with Single Incision Laparoscopic Cholecystectomy |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Uncomplicated cholelithiasis
- American Society of Anesthesiologists (ASA) I or II
- No previous operations in upper abdomen
- Body mass index (BMI) <30
Key exclusion criteria (5 listed)
- Cholecystitis
- ASA > II
- BMI>30
- Previous operations in upper abdomen
- Previous operations in intestine
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 cholecystectomyOne port placed through the umbilicus | Other | SILS group |
| Laparoscopic cholecystectomyStandard 4 port laparoscopic cholecystectomy | Other | Lap Group |
Primary outcome
Not reported in the source record.
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 21 May 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single incision laparoscopic cholecystectomy and Laparoscopic cholecystectomy in people with Cholelithiasis and Inflammatory Response, run by G. Hatzikosta General Hospital at 1 site in Greece.
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: finished, as of the sponsor's last update on 21 May 2010. 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 Greece. 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?
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.
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 May 2010.