RESEARCH PROTOCOL

Comparison of Mean Operative Time Between LigaSure and Conventional Suture Ligation in Total Thyroidectomy: A Randomized Controlled Trial Protocol

Specialty: Surgery  |  Category: Research Methods

Tags: FCPS; Thyroidectomy; LigaSure; Operative Time; Randomized Controlled Trial; Surgical Techniques

Abstract

Background: Total thyroidectomy requires careful control of bleeding because the thyroid gland has a rich blood supply. Conventional suture ligation is an established method of hemostasis, while LigaSure uses an energy-based vessel-sealing mechanism. The relative effect of these techniques on operative duration is relevant to surgical workflow and operating-room efficiency.

Objective: To compare mean operative time between the LigaSure vessel-sealing system and conventional suture ligation in patients undergoing total thyroidectomy.

Methods: This planned randomized controlled trial will be conducted in the Department of General Surgery at Bakhtawar Amin Trust Teaching Hospital, Multan, over six months after approval of the synopsis. The planned sample is 70 adults aged 18–60 years, with 35 participants allocated to each group. After consecutive recruitment, allocation will be performed using block randomization and sealed opaque envelopes. Operative time will be measured from the initial skin-collar incision to final skin closure. Data are planned to be analyzed in IBM SPSS version 26.0 using an independent-samples t-test, with p ≤ 0.05 considered statistically significant.

Protocol status: This article describes a planned study. The submitted synopsis does not report completed patient data or study results; therefore, no comparative result is presented here.

Keywords: thyroidectomy; LigaSure; suture ligation; operative time; randomized controlled trial; surgical hemostasis.

Introduction

Thyroid disorders, including multinodular goiter and thyroid malignancies, are an important part of the workload in general surgery. Total thyroidectomy involves removal of both thyroid lobes and the isthmus and may be indicated for bilateral benign disease or selected malignant conditions. Because the thyroid gland is highly vascular, meticulous hemostasis is essential. Inadequate control of bleeding can obscure the operative field and may contribute to serious complications, including neck hematoma, recurrent laryngeal nerve injury, and hypoparathyroidism.

Conventional hemostasis commonly involves vessel ligation with surgical ties and clips. Although effective, repeated ligation and knot-tying can add time to an operation. LigaSure is an energy-based vessel-sealing device that combines bipolar radiofrequency energy with mechanical pressure to seal vessels. Previous studies have compared LigaSure with conventional techniques in thyroid surgery, including assessments of safety, cost, complications, and operative outcomes [1–5].

In busy surgical services, operative-room capacity and anesthesia time are important practical considerations. However, results from international studies may not directly reflect local workflows and patient populations. A structured comparison in a local tertiary-care setting can provide context-specific evidence about operative duration. This protocol therefore proposes a comparison of mean operative time between LigaSure and conventional suture ligation during total thyroidectomy.

Study objective

To compare the mean operative time between the LigaSure vessel-sealing system and the conventional suture-ligation technique in patients undergoing total thyroidectomy.

Research hypotheses

Null hypothesis (H₀): There is no statistically significant difference in mean operative time between LigaSure and conventional suture ligation during total thyroidectomy.

Alternative hypothesis (H₁): Total thyroidectomy performed using LigaSure has a shorter mean operative time than surgery performed using conventional suture ligation.

Operational definitions

Mean operative time: The duration, measured in minutes, from the initial skin-collar incision to final skin closure.

LigaSure method: Hemostasis of thyroid pedicles primarily using the LigaSure bipolar vessel-sealing device, without primary reliance on silk ties or clips.

Conventional method: Hemostasis using standard surgical silk ties, transfixion suture ligatures, and metallic clips.

Materials and methods

Study design: Randomized controlled trial.

Setting: Department of General Surgery, Bakhtawar Amin Trust Teaching Hospital, Multan, Pakistan.

Duration: Six months after approval of the research synopsis and required permissions.

Sample size: 70 patients in total, with 35 participants planned for Group A (LigaSure) and 35 for Group B (conventional suture ligation). The synopsis reports that the sample size was calculated using the WHO sample-size calculator for two independent means, with a 95% confidence level and 80% statistical power.

Sampling and allocation: Eligible patients will be recruited consecutively and then allocated to the two study groups using block randomization. According to the synopsis, allocation will be performed using sealed opaque envelopes.

Eligibility criteria

Inclusion criteria:

·         Adult patients aged 18–60 years, of either sex.

·         Euthyroid status before surgery, confirmed by T3, T4, and TSH assessment.

·         An indication for elective total thyroidectomy, such as multinodular goiter, benign adenoma, or selected early non-invasive thyroid malignancy.

Exclusion criteria:

·         Previous neck surgery or neck radiotherapy.

·         Giant or substernal goiter extending into the mediastinum.

·         Advanced invasive thyroid carcinoma requiring concurrent radical neck dissection.

·         Pre-existing vocal-cord palsy or a severe bleeding diathesis.

Data collection procedure

After the required ethics review and approval, eligible participants will be informed about the study and asked to provide informed consent. Participants will then be assigned to Group A (LigaSure) or Group B (conventional suture ligation) using the stated randomization procedure. Surgeries will be performed by experienced surgical teams according to standard protocols.

Operative duration will be recorded with a digital timer, starting at the skin incision and ending at final skin closure. Information recorded on the structured proforma will include patient age, gender, hospital registration number, contact details, preoperative diagnosis, assigned study group, incision-start time, closure-completion time, and total operative time.

Outcome measure

The primary outcome is mean operative time, in minutes, compared between the LigaSure and conventional suture-ligation groups.

Statistical analysis

Data will be analyzed using IBM SPSS version 26.0. Quantitative variables, including age and operative time, will be summarized as mean and standard deviation. Qualitative variables, including gender and preoperative diagnosis, will be summarized as frequencies and percentages. Mean operative time between the two independent groups will be compared using the independent-samples t-test. A p-value of 0.05 or less will be considered statistically significant, as specified in the synopsis.

Ethical considerations

The synopsis states that the study will begin after the required ethics review and approvals and that informed consent will be obtained from eligible participants. Before publication or implementation, the researcher should confirm the exact name of the approving committee/body and ensure that the final protocol follows the institution’s approved procedures for participant information, consent, privacy, and data handling.

Expected contribution and protocol considerations

The study is intended to estimate whether mean operative time differs between LigaSure and conventional suture ligation in the specified hospital setting. Its findings, once collected and analyzed, may help local surgical teams assess the practical role of each technique in operating-room workflow. This protocol itself does not establish that either technique is faster or safer; that conclusion must depend on the completed study data.

The provided synopsis defines operative time as the primary outcome. Other outcomes, such as postoperative complications, blood loss, length of stay, or cost, are not specified as planned study endpoints in the synopsis and should not be reported as study findings unless they are prospectively added to an approved protocol.

Conclusion

This protocol outlines a randomized controlled comparison of mean operative time between LigaSure vessel sealing and conventional suture ligation in patients undergoing total thyroidectomy at Bakhtawar Amin Trust Teaching Hospital, Multan. The planned analysis will compare operative duration between 35 participants in each group. Conclusions about differences between the techniques should be made only after the study has been completed and the data analyzed.

References

1.    Bhettani MK, Rehman M, Khan MS. Safety and cost-effectiveness of LigaSure® in total thyroidectomy in comparison with conventional suture tie technique. Cureus. 2019;11(12):e6368.

2.    Latif S, Altaf HN, Waseem S, Farooqui F, Altaf OS, Amir M. A retrospective study of complications of total thyroidectomy; is it a safe approach for benign thyroid conditions. J Pak Med Assoc. 2019;69(11):1470–1473.

3.    Bibi S, Tabassam S, Mahmood S, Saqib K, Rana MH, Irfan I. Comparison of two different techniques used for thyroidectomies. J Univ Med Dent Coll. 2022;13(2):646–650.

4.    Amin HS, Mahmood A, Khan RA. Comparison of outcome of conventional suture ligation versus LigaSure vessel sealing in total thyroidectomy. Professional Med J. 2023;30(10):1240–1245.

5.    Himayoun Z, Khan AU, Chaudhry A. LigaSure versus conventional ligation of vessels by knot tying in total thyroidectomy. Pak J Health Sci. 2025;6(2):45–50.