Integration of Intraoperative Neuromonitoring Into Decompression Surgery

NCT06009640 | Completed

• 1 other identifier: 2022/514/220/8
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Nerve Entrapments; Pelvic Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Intraoperative neurophysiological monitoring for decompression surgery

EXPERIMENTAL

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. These areas can be accesed more easily with by laparoscopy, which provides better magnification and visualization. Sacral and sciatic nerves might be damaged when performing decompression surgery in these deep pelvic areas. Patients who gave informed consent and underwent surgical treatment for a proven diagnosis of lumbosacral plexus nerve entrapment were included in the study.

Device: Intraoperative neurophysiological monitoring with Nicolet Endeavor IOM Machine

Interventions

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.

Also known as: Nicolet Endeavor IOM Machine

Intraoperative neurophysiological monitoring for decompression surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Dr. Lutfi Kirdar Kartal Training and Research Hospital: lead

Study Sites (1)

Kartal Dr. Lutfi Kirdar City Hospital

Istanbul, Kartal, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Nerve Compression Syndromes; Pelvic Pain

Interventions

Intraoperative Neurophysiological Monitoring

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Monitoring, Intraoperative; Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Neurophysiological Monitoring; Surgical Procedures, Operative

Study Officials

• Elif Gundogdu, M.D.Dr

  Kartal Dr. Lutfi Kirdar City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist doctor

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 24, 2023
• Study Start: December 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: March 1, 2022
• Last Updated: August 25, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)