Comparison of macroscopic and microscopic surgical procedures in patients undergoing anterior cervical discectomy In Besat Hospital of Hamadan from 1399 to 1400
Design
A clinical trial with a control group, with parallel groups, singe blinded, randomized phase 3 on 60 patients, Rand function of Excel software will be used for randomization.
Settings and conduct
The study will be conducted on patients with cervical discopathy under the age of 70 years old in Besat Hospita in Hamadan. Patients who are eligible to enter the study will be randomly assigned to two intervention groups A and B. Group A will undergo cervical discectomy surgery by macroscopic method and group B will undergo cervical discectomy surgery by microscopic method. In this study, the person who assesses the surgical outcomes will be blinded of the surgical method used (single blind).
Participants/Inclusion and exclusion criteria
inclusion criteria: suffering from non-traumatic cervical discopathy, the number of discopathy levels less than three levels and conditions for not entering the study: age over 70 years, presence of calcification of the posterior ligament
Intervention groups
One group of patients will undergo cervical discectomy surgery by macroscopic method and another group will undergo cervical discectomy surgery by microscopic method.
Main outcome variables
The main outcomes of the study are: pain severity, amount of analgesic and narcotic drugs need, dysphagia complications, septicemia, bleeding during and after the operation, length of hospital stay.
General information
Reason for update
Acronym
دیسکتومی
IRCT registration information
IRCT registration number:IRCT20151123025202N27
Registration date:2023-01-02, 1401/10/12
Registration timing:prospective
Last update:2023-01-02, 1401/10/12
Update count:0
Registration date
2023-01-02, 1401/10/12
Registrant information
Name
Abbas Moradi
Name of organization / entity
Hamedan University of Medical Of Science
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0097
Email address
a.moradi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-05, 1401/10/15
Expected recruitment end date
2023-09-21, 1402/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of macroscopic and microscopic surgical methods in patients undergoing anterior cervical discectomy
Public title
Cervical disc surgery by macroscopic and microscopic methods
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Non-traumatic cervical discopathy
Discopathy less than three levels
Exclusion criteria:
Presence of posterior ligament calcification
Age > 70 years
Age
To 70 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
We made 60 cards and write letters MA on 30 for macroscopy and on the other 30 letters MI for the microscopy group. Then put them inside the envelope with aluminum wrap and put in a box. At the time of patient arrival, randomly select one of the envelopes and open it, based on selected letter ( MA or MI) patients assign it to the macroscopy or microscopy discectomy .
Blinding (investigator's opinion)
Single blinded
Blinding description
The person who will assess the pain score and other outcomes of the surgery will be blinded of the surgical procedure
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan Univercity of Medical Science
Street address
shahid fahmideh avenue
City
Hamadan
Province
Hamadan
Postal code
6517789971
Approval date
2022-12-03, 1401/09/12
Ethics committee reference number
IR.UMSHA.REC.1401.747
Health conditions studied
1
Description of health condition studied
cervical disc
ICD-10 code
M50
ICD-10 code description
Cervical disc disorders
Primary outcomes
1
Description
pain severity change
Timepoint
24 4 hours after surgery
Method of measurement
Neck pain Visual Analog Scale (NP-VAS)
2
Description
Analgesic consumption
Timepoint
during 24 hours postoperative
Method of measurement
Extract from the patient's medical record
3
Description
Complications of bleeding, septicemia, dysphagia
Timepoint
During the operation and up to 24 hours after the operation
Method of measurement
Surgeon's report, clinical examination and review of patients' medical records
Secondary outcomes
1
Description
Hospitalization period
Timepoint
at discharge time
Method of measurement
Interval time between hospitalization and discharge
Intervention groups
1
Description
Intervention group: They will undergo macroscopic surgery.In the macroscopic method, the cervical spine is accessed through the front. The skin and platysma muscle will be opened and the vertebral column is accessed from the space between the sternocleidomastoid on the side and the mid-cervical structures (trachea and esophagus) in the middle. In this method, the entire injured disc and the osteophytes will be removed, and a bone graft is placed in the space of the removed disc.
Category
Treatment - Surgery
2
Description
Control group: They will undergo microscopic surgery. In this procedure, first, a small incision is made at the back of the neck (midline). By removing the muscle, access to the desired vertebra will be provided. In order to ensure the exact location of the surgery, an X-ray is performed before removing the disc. Then, in order to determine the root of the nerve, a part of the facet joint is removed, finally, using a microscope, the disc under the root is identified and the herniated disc is removed. The nerve root will be returned. The muscles will move back and the incision will be sutured.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Mahdi Arjipour
Street address
Shahid Beheshti Blv
City
Hamadan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3264 0020
Email
besat@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokohi
Street address
Shahid Fahmide Ave
City
Hamadan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 0717
Fax
+98 81 3838 0130
Email
vc_research@umsha.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Shahid fahmideh street Medical school
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0097
Fax
+98 81 3838 0208
Email
a.moradi@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mahdi Arjipour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Hamedan shahid fahmideh street medicine school
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0572
Fax
+98 81 3838 0208
Email
m.arjipour@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Shahid fahmideh street medicine school
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0097
Fax
+98 81 3838 0208
Email
a.moradi@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available