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A systematic review and meta-analysis of Harmonic Focus in thyroidectomy compared to conventional techniques.

Cheng H, Soleas I, Ferko NC, Clymer JW, Amaral JF - Thyroid Res (2015)

Bottom Line: Meta-analysis was performed using random effects models with the inverse-variance method for mean differences of continuous variables and the Mantel-Haenszel method for risk ratios of dichotomous variables.A total of 14 studies met the inclusion criteria.This is the first meta-analysis of Harmonic Focus in thyroid surgery.

View Article: PubMed Central - PubMed

Affiliation: Ethicon Inc, 4545 Creek Rd, Cincinnati, OH 45242 USA.

ABSTRACT

Introduction: Several meta-analyses have been performed comparing the use of a variety of ultrasonic devices in thyroidectomy to conventional procedures. These studies have shown the superiority of ultrasonic devices for most outcomes studied including faster operative time and less blood loss, and equivalent or better safety for recurrent laryngeal nerve paresis and hypocalcemia. The current work is the first to examine a single ultrasonic device specifically designed for thyroid surgery, the Harmonic Focus, in order to confirm its efficacy and safety in thyroidectomy.

Methods: A comprehensive literature search without language restrictions was performed for randomized clinical trials comparing Harmonic Focus and conventional clamp, cut and tie in thyroidectomy. Outcome measures included operating time, blood loss, post-operative pain, length of hospital stay, hypocalcemia and recurrent laryngeal nerve paresis. Risk of bias was analyzed for all studies. Meta-analysis was performed using random effects models with the inverse-variance method for mean differences of continuous variables and the Mantel-Haenszel method for risk ratios of dichotomous variables.

Results: A total of 14 studies met the inclusion criteria. Harmonic Focus reduced operative time by 29 min, a 31 % decrease (p < 0.001), intra-operative blood loss by 45 ml (p < 0.001), post-operative pain (p < 0.001), length of hospital stay by 0.68 days (p = 0.005), drainage volume by 29 ml (p = 0.01), and occurrence of transient hypocalcemia by 40 % (p = 0.001). There were no significant differences between Harmonic Focus and conventional procedures in rate of persistent hypocalcemia, or rates of transient and persistent recurrent laryngeal nerve paresis.

Conclusion: This is the first meta-analysis of Harmonic Focus in thyroid surgery. In agreement with meta-analyses previously performed on ultrasonic devices, use of the Harmonic Focus has been shown to be a more effective surgical procedure compared to conventional methods in thyroidectomy. The low occurrence of hypocalcemia and recurrent laryngeal nerve paresis confirms that Harmonic Focus can improve thyroidectomy efficiency without increasing the risk of complications.

No MeSH data available.


Related in: MedlinePlus

Risk of bias assessment for studies meeting inclusion criteria
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Related In: Results  -  Collection

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Fig2: Risk of bias assessment for studies meeting inclusion criteria

Mentions: The risk of bias varied across the included studies. The overall results of the risk of bias assessments are reported in Fig. 2 and individual study quality assessments are summarized in Table 3. Randomization method was known in nine studies [8–10, 12, 16, 17, 19–22]. Three studies described randomization through the use of envelopes [10, 12, 17], two used a random permuted block design [9, 22], and two described the use of a drawing technique [8, 21]. One study used a computer-generated schedule [19] and one described a fixed simple randomization method [20]. Six studies [9, 10, 12, 17, 19, 22] described concealment of the randomization sequence. Blinding of patients to the surgical technique was reported in six studies [8–10, 14, 15, 20], one study [22] reported blinding of the surgeon to the surgical technique, and three studies [9, 10, 19] described blinding of outcome assessors. Risk of performance bias was deemed low in non-blinded studies, as outcomes were considered objective and unlikely to be affected by a lack of blinding. There were no patient withdrawals in seven studies [8, 9, 12, 16–18, 20] and one study [22] reported exclusions, but was assumed to have no clinically relevant impact. Reporting of attritions or exclusions was insufficient in six studies [10, 13–15, 19, 21]. Selective reporting remained unclear in nine studies [9, 10, 14–18, 20, 21], while three studies were deemed to have a high risk of bias as certain outcomes noted in protocol were not included in the results [8, 12, 13].Fig. 2


A systematic review and meta-analysis of Harmonic Focus in thyroidectomy compared to conventional techniques.

Cheng H, Soleas I, Ferko NC, Clymer JW, Amaral JF - Thyroid Res (2015)

Risk of bias assessment for studies meeting inclusion criteria
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4589949&req=5

Fig2: Risk of bias assessment for studies meeting inclusion criteria
Mentions: The risk of bias varied across the included studies. The overall results of the risk of bias assessments are reported in Fig. 2 and individual study quality assessments are summarized in Table 3. Randomization method was known in nine studies [8–10, 12, 16, 17, 19–22]. Three studies described randomization through the use of envelopes [10, 12, 17], two used a random permuted block design [9, 22], and two described the use of a drawing technique [8, 21]. One study used a computer-generated schedule [19] and one described a fixed simple randomization method [20]. Six studies [9, 10, 12, 17, 19, 22] described concealment of the randomization sequence. Blinding of patients to the surgical technique was reported in six studies [8–10, 14, 15, 20], one study [22] reported blinding of the surgeon to the surgical technique, and three studies [9, 10, 19] described blinding of outcome assessors. Risk of performance bias was deemed low in non-blinded studies, as outcomes were considered objective and unlikely to be affected by a lack of blinding. There were no patient withdrawals in seven studies [8, 9, 12, 16–18, 20] and one study [22] reported exclusions, but was assumed to have no clinically relevant impact. Reporting of attritions or exclusions was insufficient in six studies [10, 13–15, 19, 21]. Selective reporting remained unclear in nine studies [9, 10, 14–18, 20, 21], while three studies were deemed to have a high risk of bias as certain outcomes noted in protocol were not included in the results [8, 12, 13].Fig. 2

Bottom Line: Meta-analysis was performed using random effects models with the inverse-variance method for mean differences of continuous variables and the Mantel-Haenszel method for risk ratios of dichotomous variables.A total of 14 studies met the inclusion criteria.This is the first meta-analysis of Harmonic Focus in thyroid surgery.

View Article: PubMed Central - PubMed

Affiliation: Ethicon Inc, 4545 Creek Rd, Cincinnati, OH 45242 USA.

ABSTRACT

Introduction: Several meta-analyses have been performed comparing the use of a variety of ultrasonic devices in thyroidectomy to conventional procedures. These studies have shown the superiority of ultrasonic devices for most outcomes studied including faster operative time and less blood loss, and equivalent or better safety for recurrent laryngeal nerve paresis and hypocalcemia. The current work is the first to examine a single ultrasonic device specifically designed for thyroid surgery, the Harmonic Focus, in order to confirm its efficacy and safety in thyroidectomy.

Methods: A comprehensive literature search without language restrictions was performed for randomized clinical trials comparing Harmonic Focus and conventional clamp, cut and tie in thyroidectomy. Outcome measures included operating time, blood loss, post-operative pain, length of hospital stay, hypocalcemia and recurrent laryngeal nerve paresis. Risk of bias was analyzed for all studies. Meta-analysis was performed using random effects models with the inverse-variance method for mean differences of continuous variables and the Mantel-Haenszel method for risk ratios of dichotomous variables.

Results: A total of 14 studies met the inclusion criteria. Harmonic Focus reduced operative time by 29 min, a 31 % decrease (p < 0.001), intra-operative blood loss by 45 ml (p < 0.001), post-operative pain (p < 0.001), length of hospital stay by 0.68 days (p = 0.005), drainage volume by 29 ml (p = 0.01), and occurrence of transient hypocalcemia by 40 % (p = 0.001). There were no significant differences between Harmonic Focus and conventional procedures in rate of persistent hypocalcemia, or rates of transient and persistent recurrent laryngeal nerve paresis.

Conclusion: This is the first meta-analysis of Harmonic Focus in thyroid surgery. In agreement with meta-analyses previously performed on ultrasonic devices, use of the Harmonic Focus has been shown to be a more effective surgical procedure compared to conventional methods in thyroidectomy. The low occurrence of hypocalcemia and recurrent laryngeal nerve paresis confirms that Harmonic Focus can improve thyroidectomy efficiency without increasing the risk of complications.

No MeSH data available.


Related in: MedlinePlus