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Completed

NCT Number: NCT03254056

Fascial Closure Techniques Post-Operative Pain Laparoscopy

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).

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Key information

Conditions

Post-operative Pain Fascial Closure Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zekai Tahir Burak Women Health Education and Research Hospital

Ankara, 06100, Turkey (Türkiye)

About this study

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'.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18-65 years
  • Ability to understand the inform consent
  • No conversion from laparoscopy to laparotomy

Exclusion criteria

  • No-ability to understand the inform consent
  • Conversion to laparotomy from laparoscopy

Treatment and study plan

Conventional technique

Procedure

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

Procedure

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.

Primary outcomes

  1. Post-operative incisional pain

    Time frame: 24 hours after fascial closure closure

    Visual Analog Scale

  2. Post-operative incisional pain

    Time frame: 7 days after fascial closure closure

    Visual Analog Scale

Secondary outcomes

  1. Time for fascial closure

    Time frame: Intraoperative

    Minutes

Sponsors and collaborators

Lead sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 18, 2017
Registry last updated
Jun 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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