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
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Nerve Compression Syndromes
• Pelvic Pain

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