Laparoscopic CholecystectomyPhase 4NCT00872287
Pain in Single Incision Laparoscopic Surgery Cholecystectomy
A Phase 4 study testing Laparoscopic Cholecystectomy and SILS in people with Laparoscopic Cholecystectomy, run by G. Hatzikosta General Hospital at 1 site in Greece.
Trial summary
The attempt to further reduce the operative trauma in laparoscopic cholecystectomy led in new techniques, as Natural Orifice Transluminal Endoscopic Surgery (NOTES) and Single Incision Laparoscopic Surgery (SILS). Read more about this study
- Who is it for?
- Ages 28 to 75 years
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- Laparoscopic Cholecystectomy and SILS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- Sep 2008to Dec 2008
- 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 28 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body Mass Index less than 30
- Attacks of cholelithiasis
Who cannot join
- Body Mass Index more than 30
- Signs of acute cholecystitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Study of Different Pain Scores in Single Transumbilical Incision Laparoscopic Cholecystectomy Versus Classic Laparoscopic Cholecystectomy
The attempt to further reduce the operative trauma in laparoscopic cholecystectomy led in new techniques, as Natural Orifice Transluminal Endoscopic Surgery (NOTES) and Single Incision Laparoscopic Surgery (SILS). These new techniques are considered as painless procedures, but there are not any publications to study a possible different pain score in new techniques versus classic laparoscopic cholecystectomy. In this randomized controlled study the researchers have investigated the pain scores, the incidence of nausea and vomiting and analgesics request after the procedure.
- Conditions
- Laparoscopic Cholecystectomy
- Being tested
- Laparoscopic Cholecystectomy, SILS
- Keywords
- minimally invasive surgery, scarless cholecystectomy, new techniques in laparoscopy, invisible scar, single port access, abdominal pain, shoulder pain
- Medical subject headings
- Abdominal Pain, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic CholecystectomyProcedure or surgery
Four ports classic laparoscopic cholecystectomy
SILSProcedure or surgery
Single transumbilical incision laparoscopic cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Cholecystectomy | Active comparator | Four ports classic laparoscopic cholecystectomy Receives: Procedure: Laparoscopic Cholecystectomy |
| SILS | Active comparator | Single transumbilical incision laparoscopic cholecystectomy Receives: Procedure: SILS |
What is being measured
The primary outcome is the main question the study is designed to answer.
SILS cholecystectomy, except the invisible scar, has significantly less abdominal and shoulder pain scores
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2009 (estimated)
- Study startSep 2008
- Primary completionDec 2008
- Study completionDec 2008
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 Laparoscopic CholecystectomyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- G. Hatzikosta General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Evangelos C. Tsimoyiannis, M.D., Study chair, G. Hatzikosta General Hospital, Ioannina, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00872287
- Sponsor's protocol ID
- GH-1948-01
- Other IDs
- GHDS-12345-1
- Status last verified
- Mar 2009
- First submitted
- 30 Mar 2009
- Last updated
- 31 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Tsimoyiannis EC, Tsimogiannis KE, Pappas-Gogos G, Farantos C, Benetatos N, Mavridou P, Manataki A. Different pain scores in single transumbilical incision laparoscopic cholecystectomy versus classic laparoscopic cholecystectomy: a randomized controlled trial. Surg Endosc. 2010 Aug;24(8):1842-8. doi: 10.1007/s00464-010-0887-3. Epub 2010 Feb 20.
PubMed 20174950
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study of Different Pain Scores in Single Transumbilical Incision Laparoscopic Cholecystectomy Versus Classic Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT00872287
- Acronym / sponsor ID
- GH-1948-01
- Conditions
- Laparoscopic Cholecystectomy
- Keywords
- minimally invasive surgery, scarless cholecystectomy, new techniques in laparoscopy, invisible scar, single port access, abdominal pain, shoulder pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- G. Hatzikosta General HospitalUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 31 Mar 2009 (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 attempt to further reduce the operative trauma in laparoscopic cholecystectomy led in new techniques, as Natural Orifice Transluminal Endoscopic Surgery (NOTES) and Single Incision Laparoscopic Surgery (SILS). These new techniques are considered as painless procedures, but there are not any publications to study a possible different pain score in new techniques versus classic laparoscopic cholecystectomy. In this randomized controlled study the researchers have investigated the pain scores, the incidence of nausea and vomiting and analgesics request after the procedure.
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: Laparoscopic CholecystectomyFour ports classic laparoscopic cholecystectomy |
| SILS | Active comparator | Procedure: SILSSingle transumbilical incision laparoscopic cholecystectomy |
Who may qualify
- Ages
- 28 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body Mass Index less than 30
- Attacks of cholelithiasis
Key exclusion criteria (2 listed)
- Body Mass Index more than 30
- Signs of acute cholecystitis
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 CholecystectomyFour ports classic laparoscopic cholecystectomy | Procedure or surgery | Laparoscopic Cholecystectomy |
| SILSSingle transumbilical incision laparoscopic cholecystectomy | Procedure or surgery | SILS |
Primary outcome
SILS cholecystectomy, except the invisible scar, has significantly less abdominal and shoulder pain scores
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 31 Mar 2009.
- Derived from this study: PubMed 20174950Tsimoyiannis EC, Tsimogiannis KE, Pappas-Gogos G, Farantos C, Benetatos N, Mavridou P, Manataki A. Different pain scores in single transumbilical incision laparoscopic cholecystectomy versus classic laparoscopic cholecystectomy: a randomized controlled trial. Surg Endosc. 2010 Aug;24(8):1842-8. doi: 10.1007/s00464-010-0887-3. Epub 2010 Feb 20.
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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.
Evangelos C. Tsimoyiannis, M.D. study chair
G. Hatzikosta General Hospital, Ioannina, Greece
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 SILS in people with Laparoscopic 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?
The sponsor lists 2 inclusion and 2 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 31 Mar 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 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.
What does the primary outcome measure?
SILS cholecystectomy, except the invisible scar, has significantly less abdominal and shoulder pain scores. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00872287, 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 31 Mar 2009.