Scalpel vs Electrocautery for Thyroid Surgery

Overseen By Kaye Ong, BSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dr. Sam M. Wiseman

Disqualifiers: Prior incisions, Connective disorders, Keloid, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: Surgery day

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two methods for making the initial incision during thyroid surgery: a scalpel and electrocautery, which uses heat to cut. The researchers aim to determine which method results in a more aesthetically pleasing scar post-surgery. Participants will have their scars evaluated at 6 and 12 months after surgery to assess appearance and personal satisfaction. This trial is open to patients scheduled for thyroid surgery with Dr. Sam Wiseman at St. Paul's Hospital who have not previously undergone surgery in the same area. As an unphased trial, it provides patients the chance to contribute to enhancing surgical outcomes and scar appearance.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinator or your doctor.

What prior data suggests that these surgical incision methods are safe for thyroid surgery?

Research shows that electrocautery, which uses electricity to cut and seal tissue, is safe for surgeries. Studies have found that it can reduce post-surgery pain compared to traditional methods. It may also lead to fewer issues, such as bleeding, during thyroid surgeries. Electrocautery has been used in various surgeries, often yielding good results and a similar appearance to other methods.

Using a scalpel is the traditional way to make cuts in surgery. It has been used for many years and is generally well-accepted. No specific evidence suggests safety concerns with using a scalpel for thyroid surgery, as it is a common practice.

Both methods have proven effective and safe in surgeries. Participants in clinical trials can feel confident about the safety of these options, as both have been used successfully for a long time. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about comparing scalpels and electrocautery in thyroid surgery because these tools offer different benefits for making the first incision. A scalpel, the traditional tool, provides precision and control, which can be crucial in delicate surgeries like thyroid operations. Electrocautery, on the other hand, uses heat to cut tissue and simultaneously seal blood vessels, potentially reducing bleeding and speeding up the procedure. By comparing these methods, researchers hope to find out which technique offers better outcomes for patients in terms of safety and recovery.

What evidence suggests that these surgical incision methods are effective for thyroid surgery?

This trial will compare the use of electrocautery and scalpel for thyroid surgery. Research has shown that electrocautery, a tool that uses heat, can achieve cosmetic results similar to those of a scalpel, a surgical knife. One study found that both methods produced similar-looking scars six months post-surgery. However, electrocautery is associated with fewer blood clots after surgery. While some early issues may arise with electrocautery, the overall surgical and cosmetic outcomes are comparable to those with a scalpel. Both methods are effective, with only slight differences in early recovery. ^{2 3 5 6 7}

Who Is on the Research Team?

Sam M Wiseman, MD

Principal Investigator

University of British Columbia and St. Paul's Hospital

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are scheduled for conventional thyroid surgery with Dr. Sam Wiseman at St. Paul's Hospital in Vancouver, BC. Participants must consent to the study and be willing to follow up on their surgical scar appearance.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo thyroid surgery using either scalpel or electrocautery incision methods

Surgery day

1 visit (in-person)

Follow-up

Participants are monitored for cosmetic outcomes, wound infection, and postoperative pain at 6 and 12 months post-surgery

12 months

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Electrocautery
• Scalpel

Trial Overview The study compares two methods of making surgical incisions during thyroid surgery: using a scalpel or electrocautery. Patients will be randomly assigned to one method without knowing which one, and their scar appearance will be evaluated at 6 and 12 months post-surgery.

How Is the Trial Designed?

Group I: Electrocautery Experimental Treatment 1 Intervention

Use of an electrocautery as a first incision during thyroid operation.

Group II: Scalpel Active Control 1 Intervention

Use of a scalpel as a first incision during thyroid operation.

Electrocautery is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Electrocautery for:

• General surgical procedures
• Including but not limited to thyroid surgery

Approved in United States as Electrocautery for:

• General surgical procedures
• Including but not limited to thyroid surgery

Approved in Canada as Electrocautery for:

• General surgical procedures
• Including but not limited to thyroid surgery

Who Is Running the Clinical Trial?

Dr. Sam M. Wiseman

Lead Sponsor

Trials

1

Recruited

60+

Published Research Related to This Trial

In a multicenter randomized controlled trial involving 261 patients, the use of an ultrasonic scalpel during total thyroidectomy resulted in a 17% reduction in operative time compared to conventional techniques.

The ultrasonic scalpel demonstrated similar safety profiles to traditional methods, with no significant differences in postoperative complications, while also leading to lower postoperative drainage volumes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Total thyroidectomy with ultrasonic scalpel: a multicenter, randomized controlled trial. Kowalski, LP., Sanabria, A., Vartanian, JG., et al.[2022]

In a study of 60 patients undergoing total thyroidectomy, the bipolar radiofrequency ablation device significantly reduced the mean operative time by 15.35 minutes compared to the ultrasonic scalpel, making it a more time-efficient option.

Both devices showed no significant differences in complication rates or other outcomes, indicating that the bipolar radiofrequency device is a safe and effective alternative to the more expensive ultrasonic scalpel for thyroid surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Bipolar Radiofrequency Ablation Device in Hemostasis during Thyroidectomy in Comparison with Ultrasonic Scalpel: A Comparative Study. Kadem, SG., Alabbood, MH.[2022]

Cutting electrocautery significantly reduces blood loss, incisional time, and postoperative pain compared to scalpel incisions, based on a meta-analysis of 41 studies involving 6422 participants.

There were no significant differences in wound infection rates or cosmetic outcomes between electrocautery and scalpel techniques, suggesting that electrocautery is a safe and effective option for surgical incisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cutting electrocautery versus scalpel for surgical incisions: a systematic review and meta-analysis. Ismail, A., Abushouk, AI., Elmaraezy, A., et al.[2023]

In a study of 239 patients undergoing thyroidectomy, the use of electrocautery for cutaneous flap creation was found to be as safe as using scissors, with no significant difference in post-operative wound complication rates (7.9% for electrocautery vs 10.6% for scissors).

Factors such as age, body mass index (BMI), cutaneous tissue depth, and tissue weight were identified as significant risk factors for wound complications, with a BMI over 27.5 kg/m2 increasing the risk by 13.7 times.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrocautery for cutaneous flap creation during thyroidectomy: a randomised, controlled study. Barbaros, U., Erbil, Y., Aksakal, N., et al.[2022]

In a study of 100 patients undergoing thyroidectomy, electrocautery resulted in greater tissue damage and postoperative discomfort compared to scalpel use, particularly noted 7 days after surgery.

Despite the increased early complications associated with electrocautery, both methods yielded similar clinical and cosmetic outcomes 6 months post-surgery, indicating that electrocautery can be used effectively without compromising long-term results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wound complications and clinical results of electrocautery versus a scalpel to create a cutaneous flap in thyroidectomy: a prospective randomized trial. Uludag, M., Yetkin, G., Ozel, A., et al.[2022]

In a study of 197 patients, electrocautery for skin incisions resulted in significantly shorter incision times and less blood loss compared to traditional scalpel incisions, indicating its efficiency in surgical procedures.

Patients who underwent electrocautery reported lower postoperative pain levels, while there was no significant difference in wound infection rates or healing times between the two methods, suggesting electrocautery is a safe alternative to scalpel incisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diathermy versus Scalpel Incision in a Heterogeneous Cohort of General Surgery Patients in a Nigerian Teaching Hospital. Ayandipo, OO., Afuwape, OO., Irabor, D., et al.[2020]

The use of an ultrasonic scalpel (Harmonic scalpel) during open-heart reoperation is presented as a safe alternative to electrocautery for patients with implanted pacemakers, reducing the risk of pacemaker dysfunction.

This case demonstrates the efficacy of the ultrasonic scalpel in a high-risk surgical setting, suggesting it may be a preferable option for similar patients in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of an ultrasonic scalpel in the open-heart reoperation of a patient with pacemaker. Ozeren, M., Doğan, OV., Düzgün, C., et al.[2019]

Using a diathermy blade for surgical incisions can lead to quicker procedures and reduced blood loss compared to traditional knives.

Patients experience less postoperative pain with diathermy blades, and there are no negative impacts on wound healing or cosmetic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical incision by high frequency cautery. Vedbhushan, ST., Mulla, MA., Haroonrasid, ., et al.[2021]

A controlled clinical study indicates that skin incisions made with scalpels and electrosurgical instruments have minimal differences in outcomes.

This suggests that both methods are equally effective for surgical procedures, providing flexibility in choosing the appropriate tool based on the surgeon's preference or specific clinical situation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrosurgical skin incision. Mann, W., Klippel, CH.[2019]

A systematic review of 6 randomized controlled trials involving 1234 participants found that electrocautery for skin incisions does not increase the risk of wound infections or negatively affect scar appearance compared to traditional scalpels.

Electrocautery significantly reduces incision time and postoperative wound pain, suggesting it is a safe and effective alternative for surgical skin incisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of electrocautery versus scalpel for surgical skin incisions. Aird, LN., Brown, CJ.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11336783/

Comparison of thyroid surgery techniques - PubMed Central This study compared intra- and postoperative parameters of thyroid surgery for thyroidectomy or thyroid cancer.

2. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/397263

Use of a Diathermy System in Thyroid Surgery Use of the LigaSure in thyroid surgery did not significantly reduce operative time, blood loss, or complication rates compared with conventional knot tying.

3. nature.com nature.com/articles/s41598-021-01953-5

Alternative sources of cautery may improve post-operative ... There was a statistically significant decrease in post-operative hematoma risk using alternative sources of cautery compared to conventional cautery.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7347829/

Thyroidectomy with energy-based devices: surgical outcomes ... The aim of this study was to compare Harmonic Focus (HF), LigaSure Small Jaw (LSJ) and Thunderbeat Open Fine Jaw (TB) in terms of surgical outcomes and ...

5. withpower.com withpower.com/trial/phase-2-2015-b101a

Scalpel vs Electrocautery for Thyroid Surgery Despite the increased early complications associated with electrocautery, both methods yielded similar clinical and cosmetic outcomes 6 months post-surgery, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12282559/

A Single‐Blind, Randomized, Clinical Trial Comparing ... In randomized control trials (RCT) on laparotomy incisions, cosmetic outcomes were equivalent and postoperative pain reduced by EC when compared ...

7. frontiersin.org frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2021.793431/full

Improving Voice Outcomes After Thyroid Surgery This article reviews relevant medical literatures of conventional electrocauteries and different mechanisms of current EBDs, and compares two safety parameters.