Fascial Closure Techniques Post-Operative Pain Laparoscopy

Zekai Tahir Burak Women's Health Research and Education Hospital

Status: Completed

Conditions: Post-operative Pain; Fascial Closure

Treatments: Procedure: Berci technique; Procedure: Conventional technique

Study type: Interventional

Funder types: Other

Identifiers

NCT03254056

ZTB1

Details and patient eligibility

About

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).

Full 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'.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Conventional Technique

Active Comparator group

Description:

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.

Treatment:

Procedure: Conventional technique

Berci Technique

Active Comparator group

Description:

This instrument facilitates full thickness abdominal wall closure under the view of laparoscopic optic.

Treatment:

Procedure: Berci technique