NCT02672956

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 3, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 29, 2022

Status Verified

March 1, 2022

Enrollment Period

2 years

First QC Date

January 21, 2016

Last Update Submit

March 13, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • The results of vancouver scar scale

    One month

Study Arms (3)

Supraumbilical entry group

EXPERIMENTAL

Umbilical port will be insert to supra umbilical area.

Procedure: Ten mm trocar

Intraumbilical entry group

EXPERIMENTAL

Umbilical port will be insert to intra umbilical area.

Procedure: Ten mm trocar

Infraumbilical group

EXPERIMENTAL

Umbilical port will be insert to infra umbilical area.

Procedure: Ten mm trocar

Interventions

Ten mm trocarPROCEDURE
Infraumbilical groupIntraumbilical entry groupSupraumbilical entry group

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participant with eligible for laparoscopic surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Istanbul, 34668, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 18839082BACKGROUND
  • 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.

Related Links

MeSH Terms

Conditions

Cicatrix

Interventions

Surgical Instruments

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical EquipmentEquipment and Supplies

Study Officials

  • Mehmet Baki Şentürk, MD

    Zeynep Kamil Maternity and Pediatric Research and Training Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 21, 2016

First Posted

February 3, 2016

Study Start

September 1, 2015

Primary Completion

September 1, 2017

Study Completion

December 1, 2017

Last Updated

March 29, 2022

Record last verified: 2022-03

Locations