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OpenTrials
Completed

NCT Number: NCT04765306

Fascial Closure Technique After Gynecologic Laparoscopic Surgery and Postoperative Pain

Our study aims to determine postoperative pain outcomes when comparing port site > 10 mm fascial closure with traditional direct closure versus use of laparoscopic fascial closure device in patients undergoing minimally invasive gynecologic surgery via laparoscopic or robotic techniques. Pain outcomes will be measured using the visual analog scale.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Erlanger Baroness Hospital

Chattanooga, Tennessee, 37403, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients aged 18 or older.
  • Any patient undergoing laparoscopic gynecologic surgery with one left upper quadrant port site > 10 mm via either robotic or traditional laparoscopic techniques for any indication including abnormal bleeding, pelvic pain, gynecologic cancer, uterine fibroids, etc. Procedures performed will include but not be limited to hysterectomy, bilateral or unilateral salpingoophorectomy, ovarian cystectomy, and pelvic floor support procedures.
  • Patients willing and able to give informed consent.
  • Patients capable and willing to return for follow up and complete pain diaries.

Exclusion criteria

  • Patients unable to return for follow up.
  • Patients undergoing laparoscopic surgery that requires conversion to laparotomy.
  • Patients undergoing laparoscopic surgery that does not require a port site >10 mm.

Treatment and study plan

Traditional Direct Fascial Closure

Device

Fascial closure using traditional surgical instruments and suture without laparoscopic guidance.

Fascial Closure Device

Device

Fascial closure using a fascial closure device under direct laparoscopic guidance.

Primary outcomes

  1. Postoperative pain scores via Visual Analog Scale

    Time frame: Through 2 weeks postoperatively

    A 20 mm difference in VAS score and a 2-unit difference on a 10-point pain scale have been described as a clinically significant difference between treatment groups.

Secondary outcomes

  1. Quantity of narcotics consumed in postoperative period

    Time frame: Through 2 weeks postoperatively

    Number of tablets of narcotics consumed in postoperative period

  2. Length of hospital stay

    Time frame: Through study completion, up to 6 months

    Length of hospital stay in days from day of surgery until discharge home

  3. Postoperative complication

    Time frame: Through 6 weeks postoperatively

    Postoperative incisional infection, postoperative incisional hernia

  4. Fascial closure operating time

    Time frame: Duration of fascial closure operating time

    Timing of fascial closure will start when the surgeon or surgical assistant reports s/he is beginning the fascial closure and stop after the suture is cut after tying.

Sponsors and collaborators

Lead sponsor

Jessica G Putman

Other

Registry information

Official study title

Fascial Closure Technique After Gynecologic Laparoscopic Surgery and Postoperative Pain: a Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 21, 2021
Registry last updated
May 12, 2022

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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