Fascial Closure Techniques Post-Operative Pain Laparoscopy

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03254056

Enrollment

Registered

2017-08-18

Start date

2017-10-03

Completion date

2018-06-01

Last updated

2018-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-operative Pain, Fascial Closure

Keywords

fascial closure device, laparoscopic surgery, postoperative pain

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'.

Interventions

PROCEDUREConventional 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.

PROCEDUREBerci 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Post-operative incisional pain	24 hours after fascial closure closure	Visual Analog Scale

Secondary

Measure	Time frame	Description
Time for fascial closure	Intraoperative	Minutes

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026