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Fascial Closure Techniques Post-Operative Pain Laparoscopy

Primary Purpose

Post-operative Pain, Fascial Closure

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Conventional technique
Berci technique
Sponsored by
Zekai Tahir Burak Women's Health Research and Education Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post-operative Pain focused on measuring fascial closure device, laparoscopic surgery, postoperative pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Zekai Tahir Burak Women Health Education and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Conventional Technique

Berci Technique

Arm Description

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.

This instrument facilitates full thickness abdominal wall closure under the view of laparoscopic optic.

Outcomes

Primary Outcome Measures

Post-operative incisional pain
Visual Analog Scale
Post-operative incisional pain
Visual Analog Scale

Secondary Outcome Measures

Time for fascial closure
Minutes

Full Information

First Posted
August 14, 2017
Last Updated
June 25, 2018
Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03254056
Brief Title
Fascial Closure Techniques Post-Operative Pain Laparoscopy
Official Title
The Effects of Fascial Closure Techniques on Post-Operative Pain in Gynecologic Laparoscopic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
October 3, 2017 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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'.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain, Fascial Closure
Keywords
fascial closure device, laparoscopic surgery, postoperative pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional Technique
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Berci Technique
Arm Type
Active Comparator
Arm Description
This instrument facilitates full thickness abdominal wall closure under the view of laparoscopic optic.
Intervention Type
Procedure
Intervention Name(s)
Conventional technique
Intervention Description
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
Intervention Name(s)
Berci technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
Post-operative incisional pain
Description
Visual Analog Scale
Time Frame
24 hours after fascial closure closure
Title
Post-operative incisional pain
Description
Visual Analog Scale
Time Frame
7 days after fascial closure closure
Secondary Outcome Measure Information:
Title
Time for fascial closure
Description
Minutes
Time Frame
Intraoperative

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 18-65 years Ability to understand the inform consent No conversion from laparoscopy to laparotomy Exclusion Criteria: No-ability to understand the inform consent Conversion to laparotomy from laparoscopy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaprak Üstün, Prof
Organizational Affiliation
University of Health Sciences, Zekai Tahir Burak Women's Health Health Research and Practice Center
Official's Role
Study Chair
Facility Information:
Facility Name
Zekai Tahir Burak Women Health Education and Research Hospital
City
Ankara
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28757438
Citation
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.
Results Reference
result
PubMed Identifier
19036733
Citation
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.
Results Reference
result
PubMed Identifier
8843262
Citation
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.
Results Reference
result

Learn more about this trial

Fascial Closure Techniques Post-Operative Pain Laparoscopy

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