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Completed

NCT Number: NCT01195584

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

General Hospital Amstetten

Amstetten, 3300, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion and 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

Treatment and study plan

Primary outcomes

  1. Postoperative Complications in the BMI Groups During Post Operative Hospitalization.

    Time frame: 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 outcomes

  1. Operation Duration

    Time frame: after surgery

    Duration of the operation in minutes.

  2. Blood Loss

    Time frame: after surgery

    Loss of blood during surgical procedure in milliliters.

  3. Number of Spine Segments

    Time frame: 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.

  4. Drainage

    Time frame: 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.

  5. Days of Hospitalization

    Time frame: at hospital discharge

    Total time of hospitalization.

Sponsors and collaborators

Lead sponsor

General Hospital Amstetten

Other

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Sep 6, 2010
Registry last updated
Apr 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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