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OpenTrials
Completed

NCT Number: NCT06009640

Integration of Intraoperative Neuromonitoring Into Decompression Surgery

To describe a novel technique by integrating the intraoperative neurophysiological monitoring (IONM) into laparoscopy to protect pelvic nerves by continuously monitoring when they are at risk during surgery.

Completed

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kartal Dr. Lutfi Kirdar City Hospital

Istanbul, Kartal, Turkey (Türkiye)

About this study

We integrated intraoperative neuromonitoring system into laparoscopic lumbosacral plexus nerve decompression surgery and simultaneusly recorded nerve roots from lumbar 5 to sacral 4 during the operation. Diseases that cause pelvic nerve compression such as abnormal vascular conflict, aberrant priformis muscle, and endometriosis have settled in hard-to-reach deep areas of the pelvis. Sacral and sciatic nerves might be damaged when performing decompression surgery in these deep pelvic areas. We described a novel technique by integrating the intraoperative neurophysiological monitoring (IONM) into laparoscopy to protect pelvic nerves by continuously monitoring when they are at risk during surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with symptoms of chronic pelvic pain , dyspareunia, dysmenorrhea and severe, burning sharp pain on the lower extremity dermatomes, which had been present for at least one year were included.

Exclusion criteria

  • Patients who underwent laparoscopic decompression surgery but did not give informed consent were not included in the study.

Treatment and study plan

Intraoperative neurophysiological monitoring with Nicolet Endeavor IOM Machine

Device

Integration of intraoperative neurophysiological monitoring (IONM) into laparoscopic decompression surgery to protect pelvic nerves by continuously monitoring when they are at risk during surgery.

Other names: Nicolet Endeavor IOM Machine

Primary outcomes

  1. Pain score assessment with visual Analogic Scale (VAS)

    Time frame: 1 month

    Pain symptoms (Dysmenorrhea, dyspareunia, dyschezia, sciatic pain, chronic pelvic pain) were evaluated preoperatively , and re-evaluated at the postoperative first month.

Sponsors and collaborators

Lead sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Other Gov

Registry information

Official study title

Integration of Intraoperative Neuromonitoring Into Laparoscopic Pelvic Nerve Decompression Surgery

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 24, 2023
Registry last updated
Aug 25, 2023

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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