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

Primary Purpose

Cicatrix

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Ten mm trocar
Sponsored by
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cicatrix

Eligibility Criteria

20 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Participant with eligible for laparoscopic surgery

Exclusion Criteria:

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

Sites / Locations

  • Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Supraumbilical entry group

Intraumbilical entry group

Infraumbilical group

Arm Description

Umbilical port will be insert to supra umbilical area.

Umbilical port will be insert to intra umbilical area.

Umbilical port will be insert to infra umbilical area.

Outcomes

Primary Outcome Measures

The results of vancouver scar scale

Secondary Outcome Measures

Full Information

First Posted
January 21, 2016
Last Updated
March 13, 2022
Sponsor
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02672956
Brief Title
Comparison of Different Umbilical Port Entry Techniques in Terms of Cosmetic Results
Official Title
Comparison of Different Umbilical Port Entry Techniques in Terms of Cosmetic Results
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zeynep Kamil Maternity and Pediatric Research and Training Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cicatrix

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supraumbilical entry group
Arm Type
Experimental
Arm Description
Umbilical port will be insert to supra umbilical area.
Arm Title
Intraumbilical entry group
Arm Type
Experimental
Arm Description
Umbilical port will be insert to intra umbilical area.
Arm Title
Infraumbilical group
Arm Type
Experimental
Arm Description
Umbilical port will be insert to infra umbilical area.
Intervention Type
Procedure
Intervention Name(s)
Ten mm trocar
Primary Outcome Measure Information:
Title
The results of vancouver scar scale
Time Frame
One month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participant with eligible for laparoscopic surgery Exclusion Criteria: Participant with umbilical scar due to previous surgery, burn eg.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehmet Baki Şentürk, MD
Organizational Affiliation
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
City
Istanbul
ZIP/Postal Code
34668
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
18839082
Citation
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.
Results Reference
background
PubMed Identifier
21856076
Citation
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.
Results Reference
result
PubMed Identifier
21150398
Citation
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.
Results Reference
result
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/21856076
Description
Related Info
URL
http://www.ncbi.nlm.nih.gov/pubmed/?term=Longitudinal+Incision+of+the+Umbilicus+for+Laparoendoscopic+Single+Site+Adrenalectomy%3A+A+Particular+Intraumbilical+Technique
Description
Related Info
URL
http://www.ncbi.nlm.nih.gov/pubmed/?term=Minimal-Scar+Laparoscopic+Adjustable+Gastric+Banding+(LAGB)
Description
Related Info

Learn more about this trial

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

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