Fascial Closure Techniques Post-Operative Pain Laparoscopy
NCT ID: NCT03254056
Last Updated: 2018-06-26
Study Results
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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COMPLETED
NA
60 participants
INTERVENTIONAL
2017-10-03
2018-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Conventional Technique
The edges of the fascia will be hold by the surgical instruments. The fascial defect will be repaired by using devices which are generated for laparotomy operations.
Conventional technique
Conventional technique: In this group; S-retractors will be used to visualize the fascia and a single interrupted stitch will be placed using 0-vicryl suture.
Berci Technique
This instrument facilitates full thickness abdominal wall closure under the view of laparoscopic optic.
Berci technique
Berci group: In this group; the fascial incision will be closed with the fascial closure device, (Berci Fascial Closure instrument) using 1 interrupted stitch with 0-vicryl suture.
Interventions
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Conventional technique
Conventional technique: In this group; S-retractors will be used to visualize the fascia and a single interrupted stitch will be placed using 0-vicryl suture.
Berci technique
Berci group: In this group; the fascial incision will be closed with the fascial closure device, (Berci Fascial Closure instrument) using 1 interrupted stitch with 0-vicryl suture.
Eligibility Criteria
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Inclusion Criteria
2. Ability to understand the inform consent
3. No conversion from laparoscopy to laparotomy
Exclusion Criteria
2. Conversion to laparotomy from laparoscopy
18 Years
65 Years
FEMALE
Yes
Sponsors
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Zekai Tahir Burak Women's Health Research and Education Hospital
OTHER
Responsible Party
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Hasan Onur Topçu
Associate Professor
Principal Investigators
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Yaprak Üstün, Prof
Role: STUDY_CHAIR
University of Health Sciences, Zekai Tahir Burak Women's Health Health Research and Practice Center
Locations
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Zekai Tahir Burak Women Health Education and Research Hospital
Ankara, , Turkey (Türkiye)
Countries
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References
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Lyapis A, Ulrich A, LaMonica R, Kuo CL, Kaye L, Luciano D. Does the Difference in Fascial Closure Technique Affect Postoperative Pain? J Minim Invasive Gynecol. 2017 Nov-Dec;24(7):1190-1194. doi: 10.1016/j.jmig.2017.07.020. Epub 2017 Jul 27.
Williams CP, Rosen MJ, Jin J, McGee MF, Schomisch SJ, Ponsky J. Objective analysis of the accuracy and efficacy of a novel fascial closure device. Surg Innov. 2008 Dec;15(4):307-11. doi: 10.1177/1553350608327168.
Elashry OM, Nakada SY, Wolf JS Jr, Figenshau RS, McDougall EM, Clayman RV. Comparative clinical study of port-closure techniques following laparoscopic surgery. J Am Coll Surg. 1996 Oct;183(4):335-44.
Other Identifiers
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ZTB1
Identifier Type: -
Identifier Source: org_study_id
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