Back to resultsIntegration of Intraoperative Neuromonitoring Into Decompression Surgery
Primary Purpose
Nerve Entrapments, Pelvic Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Intraoperative neurophysiological monitoring with Nicolet Endeavor IOM Machine
Sponsored by
About this trial
This is an interventional treatment trial for Nerve Entrapments
Eligibility Criteria
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.
Sites / Locations
- Kartal Dr. Lutfi Kirdar City Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intraoperative neurophysiological monitoring for decompression surgery
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT06009640
First Posted
August 11, 2023
Last Updated
August 23, 2023
Sponsor
Dr. Lutfi Kirdar Kartal Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06009640
Brief Title
Integration of Intraoperative Neuromonitoring Into Decompression Surgery
Official Title
Integration of Intraoperative Neuromonitoring Into Laparoscopic Pelvic Nerve Decompression Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
March 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. Lutfi Kirdar Kartal Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nerve Entrapments, Pelvic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intraoperative neurophysiological monitoring for decompression surgery
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Intraoperative neurophysiological monitoring with Nicolet Endeavor IOM Machine
Other Intervention Name(s)
Nicolet Endeavor IOM Machine
Intervention Description
Integration of intraoperative neurophysiological monitoring (IONM) into laparoscopic decompression surgery to protect pelvic nerves by continuously monitoring when they are at risk during surgery.
Primary Outcome Measure Information:
Title
Pain score assessment with visual Analogic Scale (VAS)
Description
Pain symptoms (Dysmenorrhea, dyspareunia, dyschezia, sciatic pain, chronic pelvic pain) were evaluated preoperatively , and re-evaluated at the postoperative first month.
Time Frame
1 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elif Gundogdu, M.D.Dr
Organizational Affiliation
Kartal Dr. Lutfi Kirdar City Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kartal Dr. Lutfi Kirdar City Hospital
City
Istanbul
State/Province
Kartal
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Integration of Intraoperative Neuromonitoring Into Decompression Surgery
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