CLIVIT Trial: Comparing Clips and Ligatures in Thyroid Surgery
Author Information
Author(s): Seiler CM, Fröhlich BE, Veit JA, Gazyakan E, Wente MN, Wollermann C, Deckert A, Witte S, Victor N, Buchler MW, Knaebel HP
Primary Institution: Study Center of the German Surgical Society (SDGC), University of Heidelberg, Germany
Hypothesis
Does the use of vascular clips in thyroid surgery significantly reduce operating time compared to traditional ligatures?
Conclusion
The CLIVIT trial aims to determine if using clips instead of ligatures can reduce the time taken for thyroid surgery.
Supporting Evidence
- Over 90,000 thyroid surgeries are performed annually in Germany.
- The current standard for vessel occlusion in thyroid surgery is ligatures.
- Vascular clips may provide a faster and safer alternative for hemostasis.
- The trial aims to recruit 420 patients to ensure adequate power for the study.
- Surgeon expertise will be documented and analyzed to minimize bias.
- Randomization is performed intraoperatively to ensure unbiased allocation.
- The trial is registered and follows Good Clinical Practice guidelines.
- Results may influence future surgical practices in thyroid surgery.
Takeaway
This study is trying to find out if using clips instead of ties during thyroid surgery can make the surgery faster and safer.
Methodology
A multicenter, patient-blinded, two-group parallel randomized controlled trial comparing clips and ligatures in thyroid surgery.
Potential Biases
Potential biases include selection bias, randomization bias, and surgeon's expertise bias.
Limitations
The trial may face biases related to surgeon expertise and the difficulty of blinding in surgical trials.
Participant Demographics
Patients scheduled for elective resection of at least two-thirds of the thyroid gland for benign disease.
Digital Object Identifier (DOI)
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