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Comparison of Different Umbilical Port Entry Techniques in Terms of Cosmetic Results

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02672956
Recruitment Status : Unknown
Verified October 2016 by Mehmet Baki Senturk, Zeynep Kamil Maternity and Pediatric Research and Training Hospital.
Recruitment status was:  Recruiting
First Posted : February 3, 2016
Last Update Posted : November 1, 2016
Sponsor:
Information provided by (Responsible Party):
Mehmet Baki Senturk, Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Brief 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. One month after we evaluated umbilical scar by used vancouver scar scale and compared results of vancouver scar scale.

Condition or disease Intervention/treatment Phase
Cicatrix Procedure: Ten mm trocar Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparison of Different Umbilical Port Entry Techniques in Terms of Cosmetic Results
Study Start Date : September 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cosmetics Scars

Arm Intervention/treatment
Experimental: Supraumbilical entry group
Umbilical port will be insert to supra umbilical area.
Procedure: Ten mm trocar
Experimental: Intraumbilical entry group
Umbilical port will be insert to intra umbilical area.
Procedure: Ten mm trocar
Experimental: Infraumbilical group
Umbilical port will be insert to infra umbilical area.
Procedure: Ten mm trocar



Primary Outcome Measures :
  1. The results of vancouver scar scale [ Time Frame: One month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participant with eligible for laparoscopic surgery

Exclusion Criteria:

  • Participant with umbilical scar due to previous surgery, burn eg.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672956


Contacts
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Contact: Mehmet Baki Şentürk, MD +90 541 773 71 76 dr.baki77@gmail.com
Contact: Çetin Kılıççı, MD +90 505 644 94 85 cetinkilicci@hotmail.com

Locations
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Turkey
Zeynep Kamil Maternity and Pediatric Research and Training Hospital Recruiting
Istanbul, Turkey, 34668
Sponsors and Collaborators
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Investigators
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Principal Investigator: Mehmet Baki Şentürk, MD Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Mehmet Baki Senturk, Principal investigator, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
ClinicalTrials.gov Identifier: NCT02672956    
Other Study ID Numbers: 129
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Cicatrix
Fibrosis
Pathologic Processes