- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02672956
Comparison of Different Umbilical Port Entry Techniques in Terms of Cosmetic Results
March 13, 2022 updated by: Mehmet Baki Senturk, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
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 Overview
Study Type
Interventional
Enrollment (Actual)
105
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Istanbul, Turkey, 34668
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Participant with eligible for laparoscopic surgery
Exclusion Criteria:
- Participant with umbilical scar due to previous surgery, burn eg.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Supraumbilical entry group
Umbilical port will be insert to supra umbilical area.
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Experimental: Intraumbilical entry group
Umbilical port will be insert to intra umbilical area.
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Experimental: Infraumbilical group
Umbilical port will be insert to infra umbilical area.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The results of vancouver scar scale
Time Frame: One month
|
One month
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mehmet Baki Şentürk, MD, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Park 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.
- Nozaki 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2015
Primary Completion (Actual)
September 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
January 21, 2016
First Submitted That Met QC Criteria
January 29, 2016
First Posted (Estimate)
February 3, 2016
Study Record Updates
Last Update Posted (Actual)
March 29, 2022
Last Update Submitted That Met QC Criteria
March 13, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 129
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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