Open Discectomy Versus Microscopic Discectomy for Lumbar Disc Herniation

May 8, 2020 updated by: Sherwan Ahmed Ali Hamawandi, Hawler Medical University

Open Discectomy Versus Microscope Assisted Discectomy for Treatment of Symptomatic Lumbar Disc Herniation: a Comparative Study

60 patients involved were divided into two matched groups; Group A: 30 patients were treated with conventional fenestration laminectomy and discectomy and Group B: 30 patients were treated with microdiscectomy. The age of the patients involved in this study ranged from 19 years old to 46 years old

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

60 patients involved were divided into two matched groups; Group A: 30 patients were treated with conventional fenestration laminectomy and discectomy and Group B: 30 patients were treated with microdiscectomy. The age of the patients involved in this study ranged from 19 years old to 46 years old. All the patient was suffering from symptomatic lumbar disc herniation L4-5. Each patient was assessed clinically and MRI was done for all the patients to prove clinically, the symptomatic lumbar disc herniation which was present in all patients.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults who are symptomatic lumbar disc herniation L4-5. Each patient was assessed clinically and MRI was done for all the patients to prove clinically, the symptomatic lumbar disc herniation which was present in all patients. Conservative treatment for 6weeks was failed

Exclusion Criteria:

  • smoking, previous lumbar spine surgery, Diabetes Melitus (DM) and neuromuscular disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Open discectomy
This group of patients are treated by open discectomy
Procedure: Microdiscectomy
Other Names:
  • Open discectomy
Other: Microdiscectomy
This group of patients are treated by Microdiscectomy
Procedure: Microdiscectomy
Other Names:
  • Open discectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue score
Time Frame: Visua analogue score was assessed preoperatively and postoperatively to see how much change in pain can occurred after open discectomy and after Microdiscectomy for 1 year
Visual analogue score of back pain and leg pain which represent a score from 0-10 so if patient has no pain so gives 0 and if has severe pain gives 10
Visua analogue score was assessed preoperatively and postoperatively to see how much change in pain can occurred after open discectomy and after Microdiscectomy for 1 year
Oswestry disability index
Time Frame: Oswestry disability index was assessed preoperatively and postoperatively to assess how much changes can occur after open discectomy and Microdiscectomy for 1 year after surgery
Oswestry disability index in a measurement of functional ability of patients regarding pain and daily activities
Oswestry disability index was assessed preoperatively and postoperatively to assess how much changes can occur after open discectomy and Microdiscectomy for 1 year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hawler Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2015

Primary Completion (Actual)

August 15, 2019

Study Completion (Actual)

August 20, 2019

Study Registration Dates

First Submitted

September 27, 2019

First Submitted That Met QC Criteria

September 30, 2019

First Posted (Actual)

October 2, 2019

Study Record Updates

Last Update Posted (Actual)

May 11, 2020

Last Update Submitted That Met QC Criteria

May 8, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMU/Sherwan3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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