CicatrixNCT02672956
Comparison of Different Umbilical Port Entry Techniques in Terms of Cosmetic Results
A study testing Ten mm trocar in people with Cicatrix, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Investigators selected participants who operated by laparoscopic technique due to any gynecologic indication according to random number table. The ten mm trocar was inserted supraumbilical, infraumbilical and intraumbilical. The verres needle was not used in all of patients. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cicatrix
- What is being tested?
- Ten mm trocar
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2015to Dec 2017
- 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 20 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant with eligible for laparoscopic surgery
Who cannot join
- Participant with umbilical scar due to previous surgery, burn eg.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Istanbul, 34668
About this study
Investigators selected participants who operated by laparoscopic technique due to any gynecologic indication according to random number table. The ten mm trocar was inserted supraumbilical, infraumbilical and intraumbilical. The verres needle was not used in all of patients. One month after we evaluated umbilical scar by used vancouver scar scale and compared results of vancouver scar scale.
- Conditions
- Cicatrix
- Being tested
- Ten mm trocar
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ten mm trocarProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Supraumbilical entry group | Experimental | Umbilical port will be insert to supra umbilical area. Receives: Procedure: Ten mm trocar |
| Intraumbilical entry group | Experimental | Umbilical port will be insert to intra umbilical area. Receives: Procedure: Ten mm trocar |
| Infraumbilical group | Experimental | Umbilical port will be insert to infra umbilical area. Receives: Procedure: Ten mm trocar |
What is being measured
The primary outcome is the main question the study is designed to answer.
The results of vancouver scar scale
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study startSep 2015
- Primary completionSep 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CicatrixStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Baki Senturk, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Investigators
- Mehmet Baki Şentürk, MD, Principal investigator, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02672956
- Sponsor's protocol ID
- 129
- Status last verified
- Mar 2022
- First submitted
- 21 Jan 2016
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim E, Kim D, Lee S, Lee H. Minimal-scar laparoscopic adjustable gastric banding (LAGB). Obes Surg. 2009 Apr;19(4):500-3. doi: 10.1007/s11695-008-9713-6. Epub 2008 Oct 7.
PubMed 18839082Park SK, Olweny EO, Best SL, Tracy CR, Mir SA, Cadeddu JA. Patient-reported body image and cosmesis outcomes following kidney surgery: comparison of laparoendoscopic single-site, laparoscopic, and open surgery. Eur Urol. 2011 Nov;60(5):1097-104. doi: 10.1016/j.eururo.2011.08.007. Epub 2011 Aug 12.
PubMed 21856076Nozaki T, Ichimatsu K, Watanabe A, Komiya A, Fuse H. Longitudinal incision of the umbilicus for laparoendoscopic single site adrenalectomy: a particular intraumbilical technique. Surg Laparosc Endosc Percutan Tech. 2010 Dec;20(6):e185-8. doi: 10.1097/SLE.0b013e3181f70a2a.
PubMed 21150398
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Umbilical Port Entry Techniques in Terms of Cosmetic Results
- ClinicalTrials.gov ID
- NCT02672956
- Acronym / sponsor ID
- 129
- Conditions
- Cicatrix
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training HospitalUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 3 Feb 2016 (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.
Investigators selected participants who operated by laparoscopic technique due to any gynecologic indication according to random number table. The ten mm trocar was inserted supraumbilical, infraumbilical and intraumbilical. The verres needle was not used in all of patients. One month after we evaluated umbilical scar by used vancouver scar scale and compared results of vancouver scar scale.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Supraumbilical entry group | Experimental | Procedure: Ten mm trocarUmbilical port will be insert to supra umbilical area. |
| Intraumbilical entry group | Experimental | Procedure: Ten mm trocarUmbilical port will be insert to intra umbilical area. |
| Infraumbilical group | Experimental | Procedure: Ten mm trocarUmbilical port will be insert to infra umbilical area. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participant with eligible for laparoscopic surgery
Key exclusion criteria (1 listed)
- Participant with umbilical scar due to previous surgery, burn eg.
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 |
|---|---|---|
| Ten mm trocar | Procedure or surgery | Infraumbilical group, Intraumbilical entry group, Supraumbilical entry group |
Primary outcome
The results of vancouver scar scale
Time frame: One 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 29 Mar 2022.
- Background: PubMed 18839082Kim E, Kim D, Lee S, Lee H. Minimal-scar laparoscopic adjustable gastric banding (LAGB). Obes Surg. 2009 Apr;19(4):500-3. doi: 10.1007/s11695-008-9713-6. Epub 2008 Oct 7.
- Results publication: PubMed 21856076Park SK, Olweny EO, Best SL, Tracy CR, Mir SA, Cadeddu JA. Patient-reported body image and cosmesis outcomes following kidney surgery: comparison of laparoendoscopic single-site, laparoscopic, and open surgery. Eur Urol. 2011 Nov;60(5):1097-104. doi: 10.1016/j.eururo.2011.08.007. Epub 2011 Aug 12.
- Results publication: PubMed 21150398Nozaki T, Ichimatsu K, Watanabe A, Komiya A, Fuse H. Longitudinal incision of the umbilicus for laparoendoscopic single site adrenalectomy: a particular intraumbilical technique. Surg Laparosc Endosc Percutan Tech. 2010 Dec;20(6):e185-8. doi: 10.1097/SLE.0b013e3181f70a2a.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
Mehmet Baki Şentürk, MD principal investigator
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ten mm trocar in people with Cicatrix, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 1 site in Turkey (Türkiye).
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 1 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 29 Mar 2022. 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 Turkey (Türkiye). 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.
What does the primary outcome measure?
The results of vancouver scar scale (time frame: One 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 NCT02672956, which also lists 3 linked publications.
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 Mar 2022.