Trial Outcomes & Findings for Minimal Access Surgical Technique (MAST) in Obese Patients in Degenerative Lumbar Disease (NCT NCT01195584)

NCT ID: NCT01195584

Last Updated: 2015-04-03

Results Overview

Postoperative complications related to the operation within the body mass index groups. A complication is any harmful event occuring during the surgery until hospital discharge.

• Recruitment status: COMPLETED
• Target enrollment: 72 participants
• Primary outcome timeframe: at hospital discharge
• Results posted on: 2015-04-03

Participant Flow

All patients fulfilling in- and exclusion criteria were enrolled into the retrospecitve study. All consecutive 72 patients who signed the patient informed consent were included. Patients were stratified in three groups according to their body mass index (BMI) established by WHO. Enrollment period from January 2009 - August 2010

Participant milestones

Measure	BMI < 25 Body Mass Index (BMI) according to WHO definition. BMI \< 25 is defined as 'normal weight'.	25 <= BMI < 30 Body Mass Index (BMI) according to WHO definition. BMI \>= 25 and \< 30 is defined as 'overweight'.	BMI >= 30 Body Mass Index (BMI) according to WHO definition. BMI \>= 30 is defined as 'obese'.
Overall Study STARTED	20	25	27
Overall Study COMPLETED	20	25	27
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Minimal Access Surgical Technique (MAST) in Obese Patients in Degenerative Lumbar Disease

Baseline characteristics by cohort

Measure	BMI < 25 n=20 Participants Body Mass Index (BMI) according to WHO definition. BMI \< 25 is defined as 'normal weight'.	25 <= BMI < 30 n=25 Participants Body Mass Index (BMI) according to WHO definition. BMI \>= 25 and \< 30 is defined as 'overweight'.	BMI >= 30 n=27 Participants Body Mass Index (BMI) according to WHO definition. BMI \>= 30 is defined as 'obese'.	Total n=72 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants	40 Participants n=4 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	16 Participants n=7 Participants	10 Participants n=5 Participants	32 Participants n=4 Participants
Age, Continuous	53.5 years STANDARD_DEVIATION 12.1 • n=5 Participants	67.2 years STANDARD_DEVIATION 12.7 • n=7 Participants	62.8 years STANDARD_DEVIATION 11.3 • n=5 Participants	61.8 years STANDARD_DEVIATION 13.1 • n=4 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	15 Participants n=7 Participants	18 Participants n=5 Participants	42 Participants n=4 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	10 Participants n=7 Participants	9 Participants n=5 Participants	30 Participants n=4 Participants
Region of Enrollment Austria	20 participants n=5 Participants	25 participants n=7 Participants	27 participants n=5 Participants	72 participants n=4 Participants

PRIMARY outcome

Timeframe: at hospital discharge

Population: Analysis per protocol

Postoperative complications related to the operation within the body mass index groups. A complication is any harmful event occuring during the surgery until hospital discharge.

Outcome measures

Measure	Complications n=72 Participants Postoperative complications; complications include fever, subfebrile temerature, neurogenic deficit, temorary meningism, pulmonary embolism, TIA, cardiac ischemia, urinary tract infection, respiratory infection and pneumonia
Postoperative Complications in the BMI Groups During Post Operative Hospitalization. BMI < 25	8 Events during hospitalization
Postoperative Complications in the BMI Groups During Post Operative Hospitalization. 25 >= BMI < 30	9 Events during hospitalization
Postoperative Complications in the BMI Groups During Post Operative Hospitalization. BMI >= 30	20 Events during hospitalization

SECONDARY outcome

Timeframe: after surgery

Population: analysis per protocol

Duration of the operation in minutes.

Outcome measures

Measure	Complications n=72 Participants Postoperative complications; complications include fever, subfebrile temerature, neurogenic deficit, temorary meningism, pulmonary embolism, TIA, cardiac ischemia, urinary tract infection, respiratory infection and pneumonia
Operation Duration BMI < 25	156.8 Minutes Standard Deviation 41.6
Operation Duration 25 >= BMI < 30	186.2 Minutes Standard Deviation 67.8
Operation Duration BMI >= 30	205.4 Minutes Standard Deviation 76.0

SECONDARY outcome

Timeframe: after surgery

Population: analysis per protocol

Loss of blood during surgical procedure in milliliters.

Outcome measures

Measure	Complications n=72 Participants Postoperative complications; complications include fever, subfebrile temerature, neurogenic deficit, temorary meningism, pulmonary embolism, TIA, cardiac ischemia, urinary tract infection, respiratory infection and pneumonia
Blood Loss BMI < 25	165.4 ml Standard Deviation 306.5
Blood Loss 25 >= BMI < 30	284.4 ml Standard Deviation 375.1
Blood Loss BMI >= 30	169.8 ml Standard Deviation 175.0

SECONDARY outcome

Timeframe: peri operative

Population: analysis per protocol

Number of affected spine segments. One spine segment is defined as 2 vertebral bodies and the intervertebral disc (between the 2 vertebral bodies). For this study the number fo affected spine segments is identical to the number of operated intervertebral discs.

Outcome measures

Measure	Complications n=72 Participants Postoperative complications; complications include fever, subfebrile temerature, neurogenic deficit, temorary meningism, pulmonary embolism, TIA, cardiac ischemia, urinary tract infection, respiratory infection and pneumonia
Number of Spine Segments BMI < 25	1.9 spine segments Standard Deviation 0.8
Number of Spine Segments 25 >= BMI < 30	2.3 spine segments Standard Deviation 1.4
Number of Spine Segments BMI >= 30	2.2 spine segments Standard Deviation 1.1

SECONDARY outcome

Timeframe: at hospital discharge

Population: analysis per protocol

Drainage during hospitalization. The drainage was placed during the surgery and has been removed prior to hospital discharge. The amount of drainage in milliliters has been measured.

Outcome measures

Measure	Complications n=72 Participants Postoperative complications; complications include fever, subfebrile temerature, neurogenic deficit, temorary meningism, pulmonary embolism, TIA, cardiac ischemia, urinary tract infection, respiratory infection and pneumonia
Drainage BMI < 25	165.6 ml Standard Deviation 246.8
Drainage 25 >= BMI < 30	150.4 ml Standard Deviation 125.6
Drainage BMI >= 30	152.0 ml Standard Deviation 141.5

SECONDARY outcome

Timeframe: at hospital discharge

Population: analysis per protocol

Total time of hospitalization.

Outcome measures

Measure	Complications n=72 Participants Postoperative complications; complications include fever, subfebrile temerature, neurogenic deficit, temorary meningism, pulmonary embolism, TIA, cardiac ischemia, urinary tract infection, respiratory infection and pneumonia
Days of Hospitalization BMI < 25	8.4 Days Standard Deviation 2.17
Days of Hospitalization 25 >= BMI < 30	11.2 Days Standard Deviation 8.67
Days of Hospitalization BMI >= 30	10.7 Days Standard Deviation 3.51

Adverse Events

BMI < 25

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

25 <= BMI < 30

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

BMI >= 30

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	BMI < 25 n=20 participants at risk Body Mass Index (BMI) according to WHO definition. BMI \< 25 is defined as 'normal weight'.	25 <= BMI < 30 n=25 participants at risk Body Mass Index (BMI) according to WHO definition. BMI \>= 25 and \< 30 is defined as 'overweight'.	BMI >= 30 n=27 participants at risk Body Mass Index (BMI) according to WHO definition. BMI \>= 30 is defined as 'obese'.
Infections and infestations Fever	15.0% 3/20 • Number of events 3 • Events have been recorded at hospital discharge for each patient Patients enrolled consecutively. Only patients who signed patient informed consent have been included. The study describes the method of minimally invasive surgery and records complications related to the operation, adverse events are not linked to medical device.	12.0% 3/25 • Number of events 3 • Events have been recorded at hospital discharge for each patient Patients enrolled consecutively. Only patients who signed patient informed consent have been included. The study describes the method of minimally invasive surgery and records complications related to the operation, adverse events are not linked to medical device.	33.3% 9/27 • Number of events 9 • Events have been recorded at hospital discharge for each patient Patients enrolled consecutively. Only patients who signed patient informed consent have been included. The study describes the method of minimally invasive surgery and records complications related to the operation, adverse events are not linked to medical device.
Infections and infestations Subfebrile temperature	15.0% 3/20 • Number of events 3 • Events have been recorded at hospital discharge for each patient Patients enrolled consecutively. Only patients who signed patient informed consent have been included. The study describes the method of minimally invasive surgery and records complications related to the operation, adverse events are not linked to medical device.	24.0% 6/25 • Number of events 6 • Events have been recorded at hospital discharge for each patient Patients enrolled consecutively. Only patients who signed patient informed consent have been included. The study describes the method of minimally invasive surgery and records complications related to the operation, adverse events are not linked to medical device.	33.3% 9/27 • Number of events 9 • Events have been recorded at hospital discharge for each patient Patients enrolled consecutively. Only patients who signed patient informed consent have been included. The study describes the method of minimally invasive surgery and records complications related to the operation, adverse events are not linked to medical device.
Nervous system disorders Neurogenic deficit	0.00% 0/20 • Events have been recorded at hospital discharge for each patient Patients enrolled consecutively. Only patients who signed patient informed consent have been included. The study describes the method of minimally invasive surgery and records complications related to the operation, adverse events are not linked to medical device.	4.0% 1/25 • Number of events 1 • Events have been recorded at hospital discharge for each patient Patients enrolled consecutively. Only patients who signed patient informed consent have been included. The study describes the method of minimally invasive surgery and records complications related to the operation, adverse events are not linked to medical device.	0.00% 0/27 • Events have been recorded at hospital discharge for each patient Patients enrolled consecutively. Only patients who signed patient informed consent have been included. The study describes the method of minimally invasive surgery and records complications related to the operation, adverse events are not linked to medical device.
Nervous system disorders Temporary meningism	5.0% 1/20 • Number of events 1 • Events have been recorded at hospital discharge for each patient Patients enrolled consecutively. Only patients who signed patient informed consent have been included. The study describes the method of minimally invasive surgery and records complications related to the operation, adverse events are not linked to medical device.	0.00% 0/25 • Events have been recorded at hospital discharge for each patient Patients enrolled consecutively. Only patients who signed patient informed consent have been included. The study describes the method of minimally invasive surgery and records complications related to the operation, adverse events are not linked to medical device.	0.00% 0/27 • Events have been recorded at hospital discharge for each patient Patients enrolled consecutively. Only patients who signed patient informed consent have been included. The study describes the method of minimally invasive surgery and records complications related to the operation, adverse events are not linked to medical device.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/20 • Events have been recorded at hospital discharge for each patient Patients enrolled consecutively. Only patients who signed patient informed consent have been included. The study describes the method of minimally invasive surgery and records complications related to the operation, adverse events are not linked to medical device.	0.00% 0/25 • Events have been recorded at hospital discharge for each patient Patients enrolled consecutively. Only patients who signed patient informed consent have been included. The study describes the method of minimally invasive surgery and records complications related to the operation, adverse events are not linked to medical device.	3.7% 1/27 • Number of events 1 • Events have been recorded at hospital discharge for each patient Patients enrolled consecutively. Only patients who signed patient informed consent have been included. The study describes the method of minimally invasive surgery and records complications related to the operation, adverse events are not linked to medical device.
Blood and lymphatic system disorders Transient Ischemic Attack	0.00% 0/20 • Events have been recorded at hospital discharge for each patient Patients enrolled consecutively. Only patients who signed patient informed consent have been included. The study describes the method of minimally invasive surgery and records complications related to the operation, adverse events are not linked to medical device.	4.0% 1/25 • Number of events 1 • Events have been recorded at hospital discharge for each patient Patients enrolled consecutively. Only patients who signed patient informed consent have been included. The study describes the method of minimally invasive surgery and records complications related to the operation, adverse events are not linked to medical device.	3.7% 1/27 • Number of events 1 • Events have been recorded at hospital discharge for each patient Patients enrolled consecutively. Only patients who signed patient informed consent have been included. The study describes the method of minimally invasive surgery and records complications related to the operation, adverse events are not linked to medical device.
Cardiac disorders Cardiac Ischemia	0.00% 0/20 • Events have been recorded at hospital discharge for each patient Patients enrolled consecutively. Only patients who signed patient informed consent have been included. The study describes the method of minimally invasive surgery and records complications related to the operation, adverse events are not linked to medical device.	0.00% 0/25 • Events have been recorded at hospital discharge for each patient Patients enrolled consecutively. Only patients who signed patient informed consent have been included. The study describes the method of minimally invasive surgery and records complications related to the operation, adverse events are not linked to medical device.	3.7% 1/27 • Number of events 1 • Events have been recorded at hospital discharge for each patient Patients enrolled consecutively. Only patients who signed patient informed consent have been included. The study describes the method of minimally invasive surgery and records complications related to the operation, adverse events are not linked to medical device.
Renal and urinary disorders Urinary Tract Infection	5.0% 1/20 • Number of events 1 • Events have been recorded at hospital discharge for each patient Patients enrolled consecutively. Only patients who signed patient informed consent have been included. The study describes the method of minimally invasive surgery and records complications related to the operation, adverse events are not linked to medical device.	0.00% 0/25 • Events have been recorded at hospital discharge for each patient Patients enrolled consecutively. Only patients who signed patient informed consent have been included. The study describes the method of minimally invasive surgery and records complications related to the operation, adverse events are not linked to medical device.	7.4% 2/27 • Number of events 2 • Events have been recorded at hospital discharge for each patient Patients enrolled consecutively. Only patients who signed patient informed consent have been included. The study describes the method of minimally invasive surgery and records complications related to the operation, adverse events are not linked to medical device.
Respiratory, thoracic and mediastinal disorders Respiratory Infection	0.00% 0/20 • Events have been recorded at hospital discharge for each patient Patients enrolled consecutively. Only patients who signed patient informed consent have been included. The study describes the method of minimally invasive surgery and records complications related to the operation, adverse events are not linked to medical device.	4.0% 1/25 • Number of events 1 • Events have been recorded at hospital discharge for each patient Patients enrolled consecutively. Only patients who signed patient informed consent have been included. The study describes the method of minimally invasive surgery and records complications related to the operation, adverse events are not linked to medical device.	0.00% 0/27 • Events have been recorded at hospital discharge for each patient Patients enrolled consecutively. Only patients who signed patient informed consent have been included. The study describes the method of minimally invasive surgery and records complications related to the operation, adverse events are not linked to medical device.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/20 • Events have been recorded at hospital discharge for each patient Patients enrolled consecutively. Only patients who signed patient informed consent have been included. The study describes the method of minimally invasive surgery and records complications related to the operation, adverse events are not linked to medical device.	0.00% 0/25 • Events have been recorded at hospital discharge for each patient Patients enrolled consecutively. Only patients who signed patient informed consent have been included. The study describes the method of minimally invasive surgery and records complications related to the operation, adverse events are not linked to medical device.	3.7% 1/27 • Number of events 1 • Events have been recorded at hospital discharge for each patient Patients enrolled consecutively. Only patients who signed patient informed consent have been included. The study describes the method of minimally invasive surgery and records complications related to the operation, adverse events are not linked to medical device.

Additional Information

Wolfgang Senker, MD

General Hospital Amstetten

Phone: +43 7472 6040

Email: wolfgang.senker@aon.at

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place