Integration of Intraoperative Neuromonitoring Into Decompression Surgery

Sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT06009640

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nerve Entrapments Pelvic Pain	Device: Intraoperative neurophysiological monitoring with Nicolet Endeavor IOM Machine	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Integration of Intraoperative Neuromonitoring Into Laparoscopic Pelvic Nerve Decompression Surgery

Actual Study Start Date :

Dec 1, 2021

Actual Primary Completion Date :

Feb 1, 2022

Actual Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intraoperative neurophysiological monitoring for decompression surgery 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 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

Arm

Intervention/Treatment

Experimental: Intraoperative neurophysiological monitoring for decompression surgery

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

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

Outcome Measures

Primary Outcome Measures

Pain score assessment with visual Analogic Scale (VAS) [1 month]
Pain symptoms (Dysmenorrhea, dyspareunia, dyschezia, sciatic pain, chronic pelvic pain) were evaluated preoperatively , and re-evaluated at the postoperative first month.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kartal Dr. Lutfi Kirdar City Hospital	Istanbul	Kartal	Turkey

Sponsors and Collaborators

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Investigators

Principal Investigator: Elif Gundogdu, M.D.Dr, Kartal Dr. Lutfi Kirdar City Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Elif Cansu Gundogdu, Specialist doctor, Dr. Lutfi Kirdar Kartal Training and Research Hospital

ClinicalTrials.gov Identifier:

NCT06009640

Other Study ID Numbers:

2022/514/220/8

First Posted:

Aug 24, 2023

Last Update Posted:

Aug 25, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Nerve Compression Syndromes

Pelvic Pain

Study Results

No Results Posted as of Aug 25, 2023