Gallbladder DiseaseNCT01772745
The Comparison of Single Incision Laparoscopic Cholecystectomy and Three Port Laparoscopic Cholecystectomy
A study testing SILS cholecystectomy and TPCL cholecystectomy in people with Gallbladder Disease, run by Maltepe University.
Trial summary
Laparoscopic techniques have allowed surgeons to perform complicated intrabdominal surgery with minimal trauma. Laparoscopic cholecystectomy has been recognized since 1987 as the gold standard procedure for gallbladder surgery. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Gallbladder Disease
- What is being tested?
- SILS cholecystectomy and TPCL cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Jan 2013
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Required laparoscopic cholecystectomy for gallbladder disease.
Who cannot join
- American Society of Anesthesiologists score (ASA) more than III,
- Patients had prior abdominal surgery,
- Patients admitted outside working hours with acute cholecystitis,
- Patients have choledocolithiasis,
- pregnancy,
- ongoing peritoneal dialysis,
- lack of written informed consent.
About this study
Laparoscopic techniques have allowed surgeons to perform complicated intrabdominal surgery with minimal trauma. Laparoscopic cholecystectomy has been recognized since 1987 as the gold standard procedure for gallbladder surgery. Single incision laparoscopic surgery (SILS) was developed with the aim of reducing the invasiveness of conventional laparoscopy. In this study we aimed to compare results of SILS cholecystectomy and three port conventional laparoscopic (TPCL) cholecystectomy prospectively
Read the detailed description
Single-incision laparoscopic procedures have evolved gradually to include a multitude of various surgeries. The current literature documents the use of a single-incision or single-port access surgery for cholecystectomies, adrenalectomies, splenectomies, appendectomies, herniorrhaphies, bariatrics, and colon surgery.
Total of 100 patients who undergoing laparoscopic cholecystectomy for gallbladder disorders will randomly assign to undergo SILS cholecystectomy group (n = 50) or TPCL cholecystectomy group (n= 50) according to a computer-generated table of random numbers. Demographics (ie, age, gender, body mass index (BMI), American Society of Anesthesiology (ASA) score, indication for operation, need for conversion to a standard or three port laparoscopic cholecystectomy, need for conversion to an open cholecystectomy will be recorded. Outcome measures include operative morbidity, operative time, pain score, hospital stay. Morbidity will be evaluated by rates of bile leak, wound infection, hospital readmission, and hernia.
- Conditions
- Gallbladder Disease
- Being tested
- SILS cholecystectomy, TPCL cholecystectomy
- Keywords
- single incision, cholecystectomy, laparoscopy
- Medical subject headings
- Gallbladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SILS cholecystectomyProcedure or surgery
Single incision laparoscopic cholecystectomy will be performed
TPCL cholecystectomyProcedure or surgery
Three port laparoscopic cholecystectomy will br performed
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | SILS cholecystectomy Receives: Procedure: SILS cholecystectomy |
| Group 2 | Active comparator | TPCL cholecystectomy Receives: Procedure: TPCL cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score
Postoperative pain will be assessed according Visual analog scale from 0 (no pain) to 10 (worst pain imaginable. Postoperative six hour VAS (POSH-VAS) and postoperative first day VAS (POFD-VAS) will be recorded and compared.
Measured: Postoperative first 24 hours
Intraoperative complications
Per operative complications will be recorded.
- Bleeding
- Gallbladder perforation
- Bile leakage
- Bowel perforation
- Complications associated with increased intra-abdominal pressure
Measured: Average of 70 minutes
Secondary outcomes (1)
Operating time
The operating time will be defined as the time from the first incision to the last suture's placement.
Measured: Average of 70 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2013 (estimated)
- Study startJan 2010
- Primary completionJan 2013
- Study completionJan 2013
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 Gallbladder DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maltepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, manuk norayk manukyan, Maltepe University
- Investigators
- Uğur Deveci, Ass. Prof., Principal investigator, Maltepe University, School of Medicine , General Surgery DepartmentManuk N. Manukyan, Ass.Prof., Study director, Maltepe University, School of Medicine, General Surgery DepartmentUmut Barbaros, Ass.Prof., Principal investigator, Istanbul University, Istanbul Medical School, General Surgery DepartmentAbut Kebudi, Prof., Study chair, Maltepe University, School of Medicine, General Surgery DepartmentSertan Kapakli, Ass.Prof., Principal investigator, Maltepe University, School of Medicine, General Surgery Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01772745
- Sponsor's protocol ID
- mütf3
- Status last verified
- Jan 2013
- First submitted
- 16 Jan 2013
- Last updated
- 21 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Deveci U, Barbaros U, Kapakli MS, Manukyan MN, Simsek S, Kebudi A, Mercan S. The comparison of single incision laparoscopic cholecystectomy and three port laparoscopic cholecystectomy: prospective randomized study. J Korean Surg Soc. 2013 Dec;85(6):275-82. doi: 10.4174/jkss.2013.85.6.275. Epub 2013 Nov 26.
PubMed 24368985
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Single Incision Laparoscopic Cholecystectomy and Three Port Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT01772745
- Acronym / sponsor ID
- mütf3
- Conditions
- Gallbladder Disease
- Keywords
- single incision, cholecystectomy, laparoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Maltepe UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 21 Jan 2013 (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.
Laparoscopic techniques have allowed surgeons to perform complicated intrabdominal surgery with minimal trauma. Laparoscopic cholecystectomy has been recognized since 1987 as the gold standard procedure for gallbladder surgery. Single incision laparoscopic surgery (SILS) was developed with the aim of reducing the invasiveness of conventional laparoscopy. In this study we aimed to compare results of SILS cholecystectomy and three port conventional laparoscopic (TPCL) cholecystectomy prospectively
Detailed description
Single-incision laparoscopic procedures have evolved gradually to include a multitude of various surgeries. The current literature documents the use of a single-incision or single-port access surgery for cholecystectomies, adrenalectomies, splenectomies, appendectomies, herniorrhaphies, bariatrics, and colon surgery.
Total of 100 patients who undergoing laparoscopic cholecystectomy for gallbladder disorders will randomly assign to undergo SILS cholecystectomy group (n = 50) or TPCL cholecystectomy group (n= 50) according to a computer-generated table of random numbers. Demographics (ie, age, gender, body mass index (BMI), American Society of Anesthesiology (ASA) score, indication for operation, need for conversion to a standard or three port laparoscopic cholecystectomy, need for conversion to an open cholecystectomy will be recorded. Outcome measures include operative morbidity, operative time, pain score, hospital stay. Morbidity will be evaluated by rates of bile leak, wound infection, hospital readmission, and hernia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: SILS cholecystectomySILS cholecystectomy |
| Group 2 | Active comparator | Procedure: TPCL cholecystectomyTPCL cholecystectomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Required laparoscopic cholecystectomy for gallbladder disease.
Key exclusion criteria (7 listed)
- American Society of Anesthesiologists score (ASA) more than III,
- Patients had prior abdominal surgery,
- Patients admitted outside working hours with acute cholecystitis,
- Patients have choledocolithiasis,
- pregnancy,
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 |
|---|---|---|
| SILS cholecystectomySingle incision laparoscopic cholecystectomy will be performed | Procedure or surgery | Group 1 |
| TPCL cholecystectomyThree port laparoscopic cholecystectomy will br performed | Procedure or surgery | Group 2 |
Primary outcome
pain score
Time frame: Postoperative first 24 hours
Postoperative pain will be assessed according Visual analog scale from 0 (no pain) to 10 (worst pain imaginable. Postoperative six hour VAS (POSH-VAS) and postoperative first day VAS (POFD-VAS) will be recorded and compared.
Intraoperative complications
Time frame: Average of 70 minutes
Per operative complications will be recorded. * Bleeding * Gallbladder perforation * Bile leakage * Bowel perforation * Complications associated with increased intra-abdominal pressure
1 secondary outcome
Operating time
Time frame: Average of 70 minutes
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 Jan 2013.
- Derived from this study: PubMed 24368985Deveci U, Barbaros U, Kapakli MS, Manukyan MN, Simsek S, Kebudi A, Mercan S. The comparison of single incision laparoscopic cholecystectomy and three port laparoscopic cholecystectomy: prospective randomized study. J Korean Surg Soc. 2013 Dec;85(6):275-82. doi: 10.4174/jkss.2013.85.6.275. Epub 2013 Nov 26.
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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.
Uğur Deveci, Ass. Prof. principal investigator
Maltepe University, School of Medicine , General Surgery Department
Manuk N. Manukyan, Ass.Prof. study director
Maltepe University, School of Medicine, General Surgery Department
Umut Barbaros, Ass.Prof. principal investigator
Istanbul University, Istanbul Medical School, General Surgery Department
Questions about this trial
What is this clinical trial studying?
A study testing SILS cholecystectomy and TPCL cholecystectomy in people with Gallbladder Disease, run by Maltepe University.
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 1 inclusion and 7 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 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
pain score (time frame: Postoperative first 24 hours). The study lists 2 primary outcomes in all. 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 NCT01772745, 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 21 Jan 2013.