Fascial Closure Techniques Post-Operative Pain Laparoscopy

Not Applicable

Completed

• Conditions: Post-operative Pain; Fascial Closure
• Interventions: Procedure: Conventional technique; Procedure: Berci technique

• Registration Number: NCT03254056
• Lead Sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital

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'.

Study Timeline

• Study First Submitted: 2017-08-14
• Study First Submitted QC: 2017-08-15
• Study First Posted: 2017-08-18
• Study Start: 2017-10-03
• Status Verified: 2018-06
• Primary Completion: 2018-06-01
• Study Completion: 2018-06-01
• Last Update Submitted: 2018-06-25
• Last Update Posted: 2018-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Technique	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.
Berci Technique	Berci technique	This instrument facilitates full thickness abdominal wall closure under the view of laparoscopic optic.

Primary Outcome Measures

Name	Time	Method
Post-operative incisional pain	7 days after fascial closure closure	Visual Analog Scale

Secondary Outcome Measures

Name	Time	Method
Time for fascial closure	Intraoperative	Minutes

Trial Locations

Locations (1)

Zekai Tahir Burak Women Health Education and Research Hospital; 🇹🇷 Ankara, Turkey