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

NCT ID: NCT02672956

Last Updated: 2022-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cicatrix

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Supraumbilical entry group

Umbilical port will be insert to supra umbilical area.

Group Type EXPERIMENTAL

Ten mm trocar

Intervention Type PROCEDURE

Intraumbilical entry group

Umbilical port will be insert to intra umbilical area.

Group Type EXPERIMENTAL

Ten mm trocar

Intervention Type PROCEDURE

Infraumbilical group

Umbilical port will be insert to infra umbilical area.

Group Type EXPERIMENTAL

Ten mm trocar

Intervention Type PROCEDURE

Interventions

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Ten mm trocar

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Participant with eligible for laparoscopic surgery

Exclusion Criteria

* Participant with umbilical scar due to previous surgery, burn eg.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Zeynep Kamil Maternity and Pediatric Research and Training Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mehmet Baki Senturk

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mehmet Baki Şentürk, MD

Role: PRINCIPAL_INVESTIGATOR

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Locations

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Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 18839082 (View on PubMed)

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.

Reference Type RESULT
PMID: 21856076 (View on PubMed)

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.

Reference Type RESULT
PMID: 21150398 (View on PubMed)

Other Identifiers

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129

Identifier Type: -

Identifier Source: org_study_id

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