Fascial Closure Techniques Post-Operative Pain Laparoscopy

Post-operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03254056
• Other study ID #: ZTB1
• Status: Completed
• Phase: N/A
• Start date: October 3, 2017
• Est. completion date: June 1, 2018

Study information

• Verified date: June 2018
• Source: Zekai Tahir Burak Women's Health Research and Education Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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'.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fascial Closure
• Pain, Postoperative
• Post-operative Pain

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Turkey	Zekai Tahir Burak Women Health Education and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Zekai Tahir Burak Women's Health Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative incisional pain	Visual Analog Scale	24 hours after fascial closure closure
Primary	Post-operative incisional pain	Visual Analog Scale	7 days after fascial closure closure
Secondary	Time for fascial closure	Minutes	Intraoperative