Fascial Closure Techniques Post-Operative Pain Laparoscopy

Study Overview
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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'.

Official Title
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The Effects of Fascial Closure Techniques on Post-Operative Pain in Gynecologic Laparoscopic Surgery

Conditions
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Post-operative Pain, Fascial Closure

Intervention / Treatment
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* Procedure: Conventional technique
* Procedure: Berci technique


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Technique<br>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. | Procedure: Conventional technique<br>* 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.<br>|
| Active Comparator: Berci Technique<br>This instrument facilitates full thickness abdominal wall closure under the view of laparoscopic optic. | Procedure: Berci technique<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative incisional pain | Visual Analog Scale | 24 hours after fascial closure closure | 
| Post-operative incisional pain | Visual Analog Scale | 7 days after fascial closure closure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time for fascial closure | Minutes | Intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fascial closure device, laparoscopic surgery, postoperative pain