Fascial Closure Techniques Post-Operative Pain Laparoscopy

NCT ID: NCT03254056

Last Updated: 2018-06-26

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-03

Study Completion Date

2018-06-01

Brief Summary

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This study compares post-operative incisional pain on post-operative days 1 and 7 who will undergo gynecologic laparoscopic operations. Half of participants will undergo conventional fascial closure, while the other will undergo fascial closure by Berci Fascial Closure (Karl Storz, Belgium).

Detailed Description

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Studies have demonstrated that laparoscopic surgery has numerous advantages over laparotomy. The patients who undergo laparoscopic surgery acquired fewer doses of analgesics than who undergo laparotomy. This point is also one of the advantages of the laparoscopic surgery. The fascia closure in fascial defects larger than 10 mm diameters in laparoscopic surgery is an important issue. Incisional hernias may occur after laparoscopic surgery. The surgeons prefer the techniques in fascial closure which is more safe and cause less pain. In current study, investigators aim to compare the post-operative incisional pain in two different techniques in gynecologic laparoscopic surgery; conventional versus by 'Berci Fascial Closure'.

Conditions

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Post-operative Pain Fascial Closure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

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.

Group Type ACTIVE_COMPARATOR

Conventional technique

Intervention Type PROCEDURE

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.

Group Type ACTIVE_COMPARATOR

Berci technique

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Aged 18-65 years
2. Ability to understand the inform consent
3. No conversion from laparoscopy to laparotomy

Exclusion Criteria

1. No-ability to understand the inform consent
2. Conversion to laparotomy from laparoscopy
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Zekai Tahir Burak Women's Health Research and Education Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hasan Onur Topçu

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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)

Site Status

Countries

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Turkey (Türkiye)

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.

Reference Type RESULT
PMID: 28757438 (View on PubMed)

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.

Reference Type RESULT
PMID: 19036733 (View on PubMed)

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.

Reference Type RESULT
PMID: 8843262 (View on PubMed)

Other Identifiers

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ZTB1

Identifier Type: -

Identifier Source: org_study_id

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