Tonsillectomy Using BiZact™ - a Randomized Side-controlled Clinical Trial
Condition: Tonsillitis Chronic; Tonsillectomy; Hemorrhage; Postoperative Pain; Postoperative Hemorrhage; Surgery--Complications; Handling; Otorhinolaryngologic Diseases
MeSH terms: Tonsillitis; Otorhinolaryngologic Diseases; Hemorrhage; Postoperative Hemorrhage
Study type: Interventional

Summary: 
      Tonsillectomies are frequently followed by severe postoperative pain, hence high analgetics
      consumption and prolonged hospitalization. Also, postoperative hemorrhages can be hazardous.
      Constant evaluation of surgical techniques is paramount to improve safety and
      cost-effectiveness. Frequently tonsillectomies are performed in cold steel technique. Aim of
      this study will be the evaluation of handling, surgical time, postoperative pain and
      postoperative hemorrhage rates using the BiZactTM-Device in comparison to traditional
      techniques on the contralateral side. In one patient, two different techniques will be used.

      The primary objective will be the surgical time. Regardless of surgeon handedness, surgeons
      will randomly be assigned to either start with the left or right tonsil, and randomly either
      to start with the BiZact™ Device or with "cold steel" methods.

      Additionally, time to stop bleeding, intraoperative blood loss, tonsil mobility, device
      handling, as well as wound healing will be assessed.
    

Detailed description: 
      Although stricter indication criteria have been implanted (especially in Austria since 2008),
      tonsillectomies are still performed very frequently. Post-surgical bleeding can potentially
      be life-threatening, and occur within 3 weeks after tonsillectomy. A broad survey in Great
      Britain revealed a postoperative hemorrhage rate in 33.921 patients between 1.5 and 5.4 %,
      varying on hospital size. Small collectives also showed rates up to 21.7%.

      Worldwide, different techniques are used. Generally, "cold" steel and "hot" techniques can be
      distinguished, although often current-carrying ("hot") and "cold" instruments are used
      alternately. Postoperative pain seems to be uninfluenced by technique, whereas postoperative
      hemorrhage rates seem to be higher in "hot" techniques.

      LigaSure® is a bipolar "current-carrying" device, which is able to seal vessels.
      Simultaneously tissue impedance is measured to control energy application. In this way only
      the required energy levels are applied. Therefore LigaSure® can also be referred as a
      "softened hot" technique.

      In 2005 Lachanas et al. compared the LigaSure®-technique with the "cold" steel technique in
      200 patients and found significantly less postoperative pain in favor of the
      LigaSure®-technique. Postoperative hemorrhage rates were not higher with LigaSure®. Based on
      the LigaSure®-scissors, Medtronic introduced a device specifically developed and licensed for
      tonsillectomies (BiZactTM).

      Aim of this study will be the evaluation of handling, surgical time, postoperative pain and
      postoperative hemorrhage rates in comparison to traditional techniques on the contralateral
      side. In one patient, two different techniques will be used. This side-controlled evaluation
      of surgical techniques in tonsillectomies has been proven successfully in previous studies.
    

Intervention name(s): BiZactTM Open Sealer/Divider
Intervention type(s): Device
Intervention description(s): The BiZactTM Open Sealer/Divider creates a seal by application of radiofrequency (RF) electrosurgical energy to blood and lymphatic vessels or tissue bundles interposed between the jaws of the instrument. A cutting blade within the instrument is surgeon-activated to divide tissue. It is a single-use device and will not be reused in other patients.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Cross-over block design with block sizes of 12, such that after 12 patients every group was chosen three times. 48 patients in 4 groups (BiZactTM first / BiZactTM second, BiZactTM right / BiZactTM left side).
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment