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NCT06009640 Clinical Trial

Integration of Intraoperative Neuromonitoring Into Decompression Surgery

Pelvic Pain Clinical Trial

Official title:
Integration of Intraoperative Neuromonitoring Into Laparoscopic Pelvic Nerve Decompression Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06009640
Other study ID # 2022/514/220/8
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2021
Est. completion date March 1, 2022

Study information
Verified date August 2023
Source Dr. Lutfi Kirdar Kartal Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date March 1, 2022
Est. primary completion date February 1, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Intraoperative neurophysiological monitoring with Nicolet Endeavor IOM Machine
Integration of intraoperative neurophysiological monitoring (IONM) into laparoscopic decompression surgery to protect pelvic nerves by continuously monitoring when they are at risk during surgery.

Locations
Country Name City State
Turkey Kartal Dr. Lutfi Kirdar City Hospital Istanbul Kartal

Sponsors (1)
Lead Sponsor Collaborator
Dr. Lutfi Kirdar Kartal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain score assessment with visual Analogic Scale (VAS) Pain symptoms (Dysmenorrhea, dyspareunia, dyschezia, sciatic pain, chronic pelvic pain) were evaluated preoperatively , and re-evaluated at the postoperative first month. 1 month
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