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Clinical Trials/NCT06009640
NCT06009640
Completed
Not Applicable

Integration of Intraoperative Neuromonitoring Into Laparoscopic Pelvic Nerve Decompression Surgery

Dr. Lutfi Kirdar Kartal Training and Research Hospital1 site in 1 country10 target enrollmentDecember 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Nerve Entrapments
Sponsor
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Enrollment
10
Locations
1
Primary Endpoint
Pain score assessment with visual Analogic Scale (VAS)
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2021
End Date
March 1, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Elif Cansu Gundogdu

Specialist doctor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Study Sites (1)

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