Clinical trial NCT03254056: 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
Overall status: COMPLETED
Phase: NA
Conditions: Post-operative Pain
Fascial Closure
Keywords: fascial closure device
laparoscopic surgery
postoperative pain
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
First posted: 2017-08-18
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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'.

Eligibility criteria: 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

Primary outcomes:
measure: Post-operative incisional pain
timeFrame: 24 hours after fascial closure closure
measure: Post-operative incisional pain
timeFrame: 7 days after fascial closure closure
Secondary outcomes:
measure: Time for fascial closure
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zekai Tahir Burak Women Health Education and Research Hospital
Study officials:
affiliation: University of Health Sciences, Zekai Tahir Burak Women's Health Health Research and Practice Center
name: Yaprak Üstün, Prof
role: STUDY_CHAIR
References:
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.
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.
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.