Comparison of two surgical methods, limited and agressive
Design
Two arm parallel group randomized trial (each group 40 patients) with two different type of surgery with blinded collecting and analyzing process
Settings and conduct
Patients were selected between admitted ones in neurosurgery ward of Arak's valiasr hospital and correlated outcomes with blinded data collector and analizor (without knowledge about the type of surgery on patients) were collected one day before and a day and six month after surgery
Participants/Inclusion and exclusion criteria
age under 60, single level disc herniation, no diabetes, no heavy smoking
Intervention groups
first group: limited discectomy with just sequestrectomy and removing pressure on nerve root
second group: maximal effort to evacuate disc space after pressure removal on nerve root
Main outcome variables
pain score a day before surgery
pain score a day after surgery
pain score, discitis, steomyelitis and recurrent disc herniation during 6 months after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190413043261N1
Registration date:2019-05-25, 1398/03/04
Registration timing:retrospective
Last update:2019-05-25, 1398/03/04
Update count:0
Registration date
2019-05-25, 1398/03/04
Registrant information
Name
Alireza Lotfipour fard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7745 2311
Email address
alireza.lotfipour@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2018-11-21, 1397/08/30
Actual recruitment start date
2018-03-21, 1397/01/01
Actual recruitment end date
2018-11-21, 1397/08/30
Trial completion date
2019-03-19, 1397/12/28
Scientific title
A comparative study on surgical outcome between limited discectomy and aggressive discectomy method
Public title
Role of type of discectomy surgey in patients outcomes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Single level disc herniation
Exclusion criteria:
Diabetes mellitus
Heavy smokers
age over 60
Age
To 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Based on random patient's admission dates
Blinding (investigator's opinion)
Double blinded
Blinding description
All participants, clinical observer and researcher, data collector and analysor didn't know about the type of procedure that was done on patient