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

Completed

• Conditions: Degenerative Lumbar Disease

• Registration Number: NCT01195584
• Lead Sponsor: General Hospital Amstetten

Brief Summary

The study concerns a retrospective analysis of all subjects operated as of 1st Jan 2008 using Minimal Access Surgical Technique (MAST). The study is descriptive in nature and will present the observation of all cumulated patients operated with MAST.

The study data will include the general health information of the subjects prior to surgery, information on the surgery such as OP time, blood loss, and the postoperative wound healing process (until discharge), which is on average the 10th postoperative day.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Study First Submitted: 2010-09-03
• Study First Submitted QC: 2010-09-03
• Study First Posted: 2010-09-06
• Results First Submitted: 2011-08-16
• Results First Submitted QC: 2011-08-16
• Results First Posted: 2011-09-21
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-16
• Last Update Posted: 2015-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Not provided

Exclusion Criteria

• all patients who underwent minimal access spinal surgery for degenerative lumbar disease fusion surgery
• patient older than 18 years
• all products have been used within intended use

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative Complications in the BMI Groups During Post Operative Hospitalization.	at hospital discharge	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.

Secondary Outcome Measures

Name	Time	Method
Blood Loss	after surgery	Loss of blood during surgical procedure in milliliters.
Drainage	at hospital discharge	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.
Operation Duration	after surgery	Duration of the operation in minutes.
Number of Spine Segments	peri operative	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.
Days of Hospitalization	at hospital discharge	Total time of hospitalization.

Trial Locations

Locations (1)

General Hospital Amstetten; 🇦🇹 Amstetten, Austria