Laparoscopic Surgical ProceduresNCT02417857
Comparison of Single İncision Laparoscopic Cholecystectomy Versus Laparoscopic Cholecystectomy
A study testing Laparoscopic Cholecystectomy (Single Incision) and Laparoscopic Cholecystectomy (Conventional) in people with Laparoscopic Surgical Procedures, run by Ankara Mevki Military Hospital.
Trial summary
The aim of this study is to compare outcomes of quality-of-life measures and evaluate the body image and cosmesis between Single Incision Laparoscopic Cholecystectomy (SILC) and Conventional Laparoscopic Cholecystectomy (CLC).Twenty eight patients underwent SILC and 30 underwent LC.Fifty-eight patients were included… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Surgical Procedures
- What is being tested?
- Laparoscopic Cholecystectomy (Single Incision) and Laparoscopic Cholecystectomy (Conventional)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Mar 2014
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patients who were scheduled for elective cholecystectomy were included in the study
Who cannot join
- pregnancy
- acute cholecystitis
- ASA 3-4 (American Society of Anesthesiologists)
- history of bile duct stone migration
- biller pancreatitis
- upper laparatomy
Show all 9Show fewer
- any ventral hernia repair
- chronic systemic disease or
- with allergic attitude to any agent
About this study
Official title: Quality-of-life, Body Image and Cosmesis After Single Incision Laparoscopic Cholecystectomy (SILC) Versus Conventional Laparoscopic Cholecystectomy (CLC)
The aim of this study is to compare outcomes of quality-of-life measures and evaluate the body image and cosmesis between Single Incision Laparoscopic Cholecystectomy (SILC) and Conventional Laparoscopic Cholecystectomy (CLC).Twenty eight patients underwent SILC and 30 underwent LC.Fifty-eight patients were included the study and divided into two groups. The results of the questionnaires were statistically compared.
Read the detailed description
Recently, single incision laparoscopic cholecystectomy (SILC) is one of the minimally invasive technique, developed to reduce the need of multiple ports and has become popular among the surgeons. This study was conducted with fifty eight patients between January 2011 and March 2013 in Turkey. Fifty-eight patients were included the study and divided into two groups. Quality-of-life measures was evaluated by the EuroQol EQ-5D questionnaire.Cosmesis and body image were evaluated with the Body Image Questionnaire. All statistical analyses were performed by IBM Statistics 21.0 and MS-Excel 2007. A value of p<0.05 was accepted as statistically significant.
- Conditions
- Laparoscopic Surgical Procedures
- Being tested
- Laparoscopic Cholecystectomy (Single Incision), Laparoscopic Cholecystectomy (Conventional)
- Keywords
- Single İncision Laparoscopic Surgery, Conventional Laparoscopic Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Cholecystectomy (Single Incision)Procedure or surgery
We performed Single Incision Laparoscopic Cholecystectomy (SILC) operation to the group-1
Laparoscopic Cholecystectomy (Conventional)Procedure or surgery
We performed Conventional Laparoscopic Cholecystectomy (CLC) to group-2
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Cholecystectomy (SILC) | Experimental | Group 1: Single Incision Laparoscopic Cholecystectomy (Intervention) Receives: Procedure: Laparoscopic Cholecystectomy (Single Incision) |
| Laparoscopic Cholecystectomy (CLC) | Experimental | Group 2: Conventional Laparoscopic Cholecystectomy (Intervention) Receives: Procedure: Laparoscopic Cholecystectomy (Conventional) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life measure
Measured: We had performed the questionnaire at postoperative 6 th month
Secondary outcomes (1)
Body Image Questionnaire measure
Measured: We had performed the questionnaire at postoperative 6 th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2015 (estimated)
- Study startJan 2011
- Primary completionMar 2013
- Study completionMar 2014
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 Surgical ProceduresStudies 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
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Mevki Military Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MD. Mehmet SAYDAM (General Surgeon), Ankara Mevki Military Hospital
- Investigators
- Huseyin SINAN, Prof. M.D., Study director, VAN MILITARY HOSPITAL, GENERAL SURGERY DEPARTMENT, VAN, TURKEY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02417857
- Sponsor's protocol ID
- GMMA-LEC-1648.4-70
- Status last verified
- Apr 2015
- First submitted
- 8 Apr 2015
- Last updated
- 16 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Abd Ellatif ME, Askar WA, Abbas AE, Noaman N, Negm A, El-Morsy G, El Nakeeb A, Magdy A, Amin M. Quality-of-life measures after single-access versus conventional laparoscopic cholecystectomy: a prospective randomized study. Surg Endosc. 2013 Jun;27(6):1896-906. doi: 10.1007/s00464-012-2625-5. Epub 2012 Dec 27.
PubMed 23269370
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality-of-life, Body Image and Cosmesis After Single Incision Laparoscopic Cholecystectomy (SILC) Versus Conventional Laparoscopic Cholecystectomy (CLC)
- ClinicalTrials.gov ID
- NCT02417857
- Acronym / sponsor ID
- GMMA-LEC-1648.4-70
- Conditions
- Laparoscopic Surgical Procedures
- Keywords
- Single İncision Laparoscopic Surgery, Conventional Laparoscopic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Ankara Mevki Military HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 16 Apr 2015 (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 aim of this study is to compare outcomes of quality-of-life measures and evaluate the body image and cosmesis between Single Incision Laparoscopic Cholecystectomy (SILC) and Conventional Laparoscopic Cholecystectomy (CLC).Twenty eight patients underwent SILC and 30 underwent LC.Fifty-eight patients were included the study and divided into two groups. The results of the questionnaires were statistically compared.
Detailed description
Recently, single incision laparoscopic cholecystectomy (SILC) is one of the minimally invasive technique, developed to reduce the need of multiple ports and has become popular among the surgeons. This study was conducted with fifty eight patients between January 2011 and March 2013 in Turkey. Fifty-eight patients were included the study and divided into two groups. Quality-of-life measures was evaluated by the EuroQol EQ-5D questionnaire.Cosmesis and body image were evaluated with the Body Image Questionnaire. All statistical analyses were performed by IBM Statistics 21.0 and MS-Excel 2007. A value of p<0.05 was accepted as statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Cholecystectomy (SILC) | Experimental | Procedure: Laparoscopic Cholecystectomy (Single Incision)Group 1: Single Incision Laparoscopic Cholecystectomy (Intervention) |
| Laparoscopic Cholecystectomy (CLC) | Experimental | Procedure: Laparoscopic Cholecystectomy (Conventional)Group 2: Conventional Laparoscopic Cholecystectomy (Intervention) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The patients who were scheduled for elective cholecystectomy were included in the study
Key exclusion criteria (9 listed)
- pregnancy
- acute cholecystitis
- ASA 3-4 (American Society of Anesthesiologists)
- history of bile duct stone migration
- biller pancreatitis
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 Cholecystectomy (Single Incision)We performed Single Incision Laparoscopic Cholecystectomy (SILC) operation to the group-1 | Procedure or surgery | Laparoscopic Cholecystectomy (SILC) |
| Laparoscopic Cholecystectomy (Conventional)We performed Conventional Laparoscopic Cholecystectomy (CLC) to group-2 | Procedure or surgery | Laparoscopic Cholecystectomy (CLC) |
Primary outcome
Quality of life measure
Time frame: We had performed the questionnaire at postoperative 6 th month
1 secondary outcome
Body Image Questionnaire measure
Time frame: We had performed the questionnaire at postoperative 6 th month
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 16 Apr 2015.
- Results publication: PubMed 23269370Abd Ellatif ME, Askar WA, Abbas AE, Noaman N, Negm A, El-Morsy G, El Nakeeb A, Magdy A, Amin M. Quality-of-life measures after single-access versus conventional laparoscopic cholecystectomy: a prospective randomized study. Surg Endosc. 2013 Jun;27(6):1896-906. doi: 10.1007/s00464-012-2625-5. Epub 2012 Dec 27.
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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.
Huseyin SINAN, Prof. M.D. study director
VAN MILITARY HOSPITAL, GENERAL SURGERY DEPARTMENT, VAN, TURKEY
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Cholecystectomy (Single Incision) and Laparoscopic Cholecystectomy (Conventional) in people with Laparoscopic Surgical Procedures, run by Ankara Mevki Military Hospital.
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 9 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 16 Apr 2015. 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?
Quality of life measure (time frame: We had performed the questionnaire at postoperative 6 th month). 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 NCT02417857, 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 16 Apr 2015; AzTrials last refreshed its copy on 7 Nov 2026.