Uncomplicated CholelithiasisPhase 4NCT01211743
Oxidative Stress in Standard Laparoscopic vs Single Port Cholecystectomy
A Phase 4 study testing Laparoscopic cholecystectomy and Single incision laparoscopic cholecystectomy in people with Uncomplicated Cholelithiasis and Cholecystectomy, run by G. Hatzikosta General Hospital at 1 site in Greece.
Trial summary
Study of Oxidative Stress Markers in order to assess whether there are differences between standard laparoscopic cholecystectomy vs single port cholecystectomy for uncomplicated cholelithiasis Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Uncomplicated Cholelithiasis, Cholecystectomy, Laparoscopy
- What is being tested?
- Laparoscopic cholecystectomy and Single incision laparoscopic cholecystectomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGreece
- Study dates
- Jun 2010to Sep 2010
- Phase
- Phase 4
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:Uncomplicated cholelithiasis American Society of Anesthesiologists (ASA) I or II No previous operations in upper abdomen Body mass index (BMI) -
Exclusion Criteria:Cholecystitis ASA > II BMI>30 Previous operations in upper abdomen Previous operations in intestine Smokers Alcohol Drugs
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Oxidative Stress in Standard Laparoscopic vs Single Port Cholecystectomy for Uncomplicated Cholelithiasis (Lap vs SILS)
Study of Oxidative Stress Markers in order to assess whether there are differences between standard laparoscopic cholecystectomy vs single port cholecystectomy for uncomplicated cholelithiasis
- Conditions
- Uncomplicated Cholelithiasis, Cholecystectomy, Laparoscopy, Standard Technique, Single Port Laparoscopy
- Being tested
- Laparoscopic cholecystectomy, Single incision laparoscopic cholecystectomy
- Keywords
- SILS, Oxidative Stress, 8-epiPGF2a, SILS vs standard laparoscopic cholecystectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic cholecystectomyOther
Standard 4 port laparoscopic cholecystectomy
Single incision laparoscopic cholecystectomyOther
One port placed through the umbilicus
| 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; Other: Single incision 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 posted29 Sep 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2010
- Study completionSep 2010
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 Uncomplicated 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- G. Hatzikosta General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Demokrition University of Thrace, University of Ioannina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01211743
- Sponsor's protocol ID
- GH-1948-06
- Status last verified
- Sep 2010
- First submitted
- 28 Sep 2010
- Last updated
- 29 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pappas-Gogos G, Tellis CC, Trypsianis G, Tsimogiannis KE, Tsimoyiannis EC, Simopoulos CE, Pitiakoudis M, Tselepis AD. Oxidative stress in multi-port and single-port cholecystectomy. J Surg Res. 2015 Mar;194(1):101-6. doi: 10.1016/j.jss.2014.09.020. Epub 2014 Sep 28.
PubMed 25438954
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Oxidative Stress in Standard Laparoscopic vs Single Port Cholecystectomy for Uncomplicated Cholelithiasis (Lap vs SILS)
- ClinicalTrials.gov ID
- NCT01211743
- Acronym / sponsor ID
- GH-1948-06
- Conditions
- Uncomplicated Cholelithiasis, Cholecystectomy, Laparoscopy, Standard Technique, Single Port Laparoscopy
- Keywords
- SILS, Oxidative Stress, 8-epiPGF2a, SILS vs standard laparoscopic cholecystectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- G. Hatzikosta General HospitalUniversity, hospital or other
- Collaborators
- Demokrition University of Thrace, University of Ioannina
- Study start
- Jun 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 29 Sep 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.
Study of Oxidative Stress Markers in order to assess whether there are differences between standard laparoscopic cholecystectomy vs single port cholecystectomy for uncomplicated cholelithiasis
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lap Group | Active comparator | Other: Laparoscopic cholecystectomy, Other: Single incision 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
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 cholecystectomyStandard 4 port laparoscopic cholecystectomy | Other | Lap Group |
| Single incision laparoscopic cholecystectomyOne port placed through the umbilicus | Other | Lap Group, SILS 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 29 Sep 2010.
- Derived from this study: PubMed 25438954Pappas-Gogos G, Tellis CC, Trypsianis G, Tsimogiannis KE, Tsimoyiannis EC, Simopoulos CE, Pitiakoudis M, Tselepis AD. Oxidative stress in multi-port and single-port cholecystectomy. J Surg Res. 2015 Mar;194(1):101-6. doi: 10.1016/j.jss.2014.09.020. Epub 2014 Sep 28.
Related trials for Uncomplicated Cholelithiasis
RecruitingObservational study
The Pro-Chol Study
Gallstones, Gallstone Attack
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 Phase 4 study testing Laparoscopic cholecystectomy and Single incision laparoscopic cholecystectomy in people with Uncomplicated Cholelithiasis and Cholecystectomy, 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?
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 29 Sep 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01211743, 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 29 Sep 2010.