Minimal Invasive Surgery Versus Interlaminar Decompression in Lumbar Canal Stenosis

• Sponsor: Assiut University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05147064
• Collaborator: (none)
• Enrollment: 40
• Arms: 2
• Anticipated Duration (Months): 24

Study Details

Study Description

Brief Summary

Conventional open surgery has been shown to be an effective procedure for LCS decompression. Minimally invasive surgery (MIS) through tubular retractors is a recently introduced alternative procedure for decompression of LCS.

The current study aims at evaluating the efficacy of minimally invasive surgery as a decompressive procedure in comparison to conventional open surgery for the treatment of patients with LCS.

Condition or Disease	Intervention/Treatment	Phase
Lumbar Spinal Stenosis	Procedure: minimally invasive surgery; Procedure: conventional open surgery	N/A

Detailed Description

Lumbar canal stenosis (LCS) is defined as narrowing of the spinal canal, the vertebral foramina, and/or the lateral recesses, causing compression on the nearby neurologic structures. Degenerative LCS is one of the most common reasons for old patients to undergo spinal surgery. Neurogenic claudication is the most common symptom for LCS patients. The patients complain of pain or discomfort that radiates to the buttock, thigh and lower limb after walking for a certain distance, therefore leading to functional disability and decreased walking capacity. Conservative management is the first line of treatment in the absence of progressive neurologic deficit or intractable pain, consisting of physical therapy, medications (analgesics, steroids) and pain management procedures. Surgical intervention is recommended if the symptoms are persistent or worsening.

Various techniques are currently used for direct decompression of LCS. Conventional open surgery involves laminectomy that has been shown to be an effective procedure for LCS decompression. However, wide laminectomies disturbs the stability of bony and ligamentous structures and may exacerbate preexisting spondylolisthesis. Minimally invasive surgery (MIS) through tubular retractors is a recently introduced alternative procedure for decompression of LCS. This technique avoids detachment of the paraspinal muscles and may promote preservation of stabilizing ligamentous and bony spinal structures.

The current study aims at evaluating the efficacy of minimally invasive surgery as a decompressive procedure in comparison to conventional open surgery for the treatment of patients with LCS.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Minimally Invasive Surgery Versus Conventional Open Interlaminar Decompression in Treatment of Degenerative Lumbar Canal Stenosis
• Anticipated Study Start Date: Dec 1, 2021
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: group A randomly allocated	Procedure: minimally invasive surgery; using (tubular dilators, surgical microscope, and/ or endoscope). the other group will be operated by conventional inter laminar decompression.
Experimental: group B randomly allocated	Procedure: conventional open surgery; open interlaminar lumbar decompression

Outcome Measures

Primary Outcome Measures

1. Functional outcome [Change of ODI is being assessed immediate pre operatively, after 3, 6,and 12 months post operatively.]

   Change of Oswestry disability index (ODI) is being assessed to compare the pre and post operative values. This outcome measure is designed to assess function in activities of daily living for those with acute or chronic back pain. The ODI consists of 10 patient-completed questions in which the response options are presented as 6-point Likert scales. Scores range from 0% (no disability) to 100% (most severe disability).

2. back pain and lower limb pain [using visual analogue scale change of the values is being assessed immediate pre operatively, after 3, 6,and 12 months post operatively.]

   Change of visual analogue scale (VAS) is being assessed to compare the pre and post operative values. VAS is a continuous scale comprised of a horizontal line, usually 10 centimeters in length. For pain intensity, "no pain" (score of 0) or "worst imaginable pain" (score of 10).

Secondary Outcome Measures

1. Intraoperative blood loss [intraoperative]

   amount of intraoperative blood loss

2. Operative time [intraoperative]

   in minutes

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• all patient with lumbar canal stenosis From 18_70 years old

Exclusion Criteria:

• instability Infection Tumours of vertebrae

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mahmoud Garamoun Abd El Zaher, Assistant lecturer, Assiut University
• ClinicalTrials.gov Identifier: NCT05147064
• Other Study ID Numbers: Minimal invasive surgery LCS
• First Posted: Dec 7, 2021
• Last Update Posted: Dec 7, 2021
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mahmoud Garamoun Abd El Zaher, Assistant lecturer, Assiut University: minimally invasive surgery; interlaminar decompression
• Additional relevant MeSH terms: Spinal Stenosis; Constriction, Pathologic

Study Results

No Results Posted as of Dec 7, 2021