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Integration of Intraoperative Neuromonitoring Into Decompression Surgery

R

Republic of Turkey Ministry of Health

Status

Completed

Conditions

Nerve Entrapments
Pelvic Pain

Treatments

Device: Intraoperative neurophysiological monitoring with Nicolet Endeavor IOM Machine

Study type

Interventional

Funder types

Other

Identifiers

NCT06009640
2022/514/220/8

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

Female

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Intraoperative neurophysiological monitoring for decompression surgery
Experimental group
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. 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.
Treatment:
Device: Intraoperative neurophysiological monitoring with Nicolet Endeavor IOM Machine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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