Minimal Invasive Surgery Versus Interlaminar Decompression in Lumbar Canal Stenosis

NCT05147064 | Unknown

• 1 other identifier: Minimal invasive surgery LCS
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lumbar Spinal Stenosis

Keywords

minimally invasive surgery; interlaminar decompression

Outcome Measures

Primary Outcomes (2)

• Functional outcome

  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).

  Change of ODI is being assessed immediate pre operatively, after 3, 6,and 12 months post operatively.

• back pain and lower limb pain

  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).

  using visual analogue scale change of the values is being assessed immediate pre operatively, after 3, 6,and 12 months post operatively.

Secondary Outcomes (2)

• Intraoperative blood loss

  intraoperative

• Operative time

  intraoperative

Study Arms (2)

group A

EXPERIMENTAL

randomly allocated

Procedure: minimally invasive surgery

group B

EXPERIMENTAL

randomly allocated

Procedure: conventional open surgery

Interventions

minimally invasive surgery PROCEDURE

using (tubular dilators, surgical microscope, and/ or endoscope). the other group will be operated by conventional inter laminar decompression.

group A

conventional open surgery PROCEDURE

open interlaminar lumbar decompression

group B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• instability Infection Tumours of vertebrae

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Minimally Invasive Surgical Procedures

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: December 7, 2021
• Study Start: December 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 7, 2021

Record last verified: 2021-12