The Drainage Dilemma in Thyroid Surgeries: A Randomized Controlled Trial to Evaluate Necessity of Drain Following Thyroidectomy

Abstract

Background:

Draining the thyroid bed after thyroid surgery is a matter of apprehension and anxiety for the operating surgeon rather than its necessity. This study aims to evaluate the evidence-based evaluation of the necessity of a drain following thyroidectomy.

Materials and Methods:

A randomized-controlled trial was conducted at a tertiary care center in Central India for 2 years with a sample size of 80 patients undergoing thyroidectomy, with 40 patients in both thyroidectomy with drain and thyroidectomy without drain group each. The postoperative protocol and standard of care were similar in both groups. The patients were assessed for pain, seroma formation, and wound infection on postoperative day 1, 3, and 5, and patient-rated satisfaction scoring was done using a 5-point Likert scoring.

Results:

The age distribution in both the groups was comparable with a mean age of presentation in Group A was 42.1 ± 11.6 years and for Group B was 43.4 ± 14.2 years. Patients with a drain experienced significantly more pain (P < 0.00001) and increased length of hospital stay (P < 0.0001). The patients in the group without a drain were significantly more satisfied (significant P < 0.022). Only 4 patients in the group without a drain developed seroma. None of the patients had hematoma or surgical site infection in the postoperative period.

Conclusion:

Drain placement after thyroid surgeries has no additional benefits in preventing postoperative risk of seroma/hematoma formation or occurrence of surgical site infection. Rather, the use of drains is usually associated with postoperative discomfort, increased length of hospital stays, and leaves an additional scar affecting overall esthetics for patients.

Introduction

Palpable thyroid nodules are present in approximately 4%–7% of the adult population, with a higher prevalence in women than in men.[1] While most nodules are benign, 5%–15% may represent malignancies.[2] Surgery is recommended for malignant, suspicious, or symptomatic nodules, with the extent of thyroidectomy-lobectomy, subtotal, near-total, or total; depending on tumor characteristics, intraoperative finding, and surgeon experience.[3] Thyroidectomy carries inherent risks of complications such as hemorrhage, seroma, surgical site infections, recurrent laryngeal nerve (RLN) palsy, and hypoparathyroidism due to parathyroid injury.[4] Postoperative hematoma at the thyroid bed, though less frequent, is considered a surgical emergency due to the risk of airway obstruction. To minimize such complications, surgeons often employ closed-suction drains postoperatively that can be used to evacuate blood and serous fluid, reduce dead space, and theoretically prevent the formation of hematomas and seromas.[5] Multiple randomized controlled trials and meta-analyses have questioned the necessity of routine drainage after thyroid surgery. Some studies have reported no significant difference in rates of hematoma or seroma formation between patients with or without drains.[6] Moreover, the use of drains has been associated with increased postoperative pain, delayed mobilization, higher infection rates, and longer hospital stays.[7] Improved surgical techniques, such as meticulous haemostasis, use of energy devices, and intraoperative nerve monitoring, have further reduced intraoperative and postoperative risks, challenging the rationale for routine drainage. In addition, drains can negatively affect patient comfort and may cause psychological distress, especially when their presence delays discharge or creates anxiety about complications.[7] Given these conflicting findings and a lack of consensus among surgeons, this randomized controlled trial aims to assess the utility of drain placement following thyroidectomy, focusing on key outcomes such as postoperative hematoma, infection rates, pain levels, duration of hospital stay, and overall patient satisfaction. By evaluating these variables, this study seeks to contribute to evidence-based surgical decision-making and to improve recovery protocols for patients undergoing thyroid surgery.

Materials and Methods

It was a prospective Randomized Controlled Non-Inferiority study carried out at the Department of Surgery, All India Institute of Medical Sciences, Nagpur between February 2024 and May 2025, after obtaining the Institutional Ethics Committee’s (IEC) approval and registering the study under Clinical Trial Registry India vide Reg. No. CTRI/2024/02/062365 dated February 7, 2024. All patients of 16 years and above with benign, indeterminate, or differentiated thyroid carcinomas, clinically euthyroid status, or presenting with solitary or multiple nodules undergoing thyroidectomy were included in the study. Patients undergoing completion thyroidectomy, recurrent thyroid surgery, modified radical neck dissections, or patients with prior radiation exposure were excluded from the study.

Sample size was calculated based on previous randomized controlled trial, considering the parameters such as incidence of hematoma, seroma, wound infection, postoperative pain, length of stay and patient satisfaction, and 10% attrition rate, the formula being: n = f (α, β) × (πs × [100− πs] + πe × [100 – πe])/(πs − πe − d)².

Here, π₈ and π_e are the true percent “success” in the standard and experimental treatment group, respectively, d = 10%, f (α, β) = (Φ⁻¹ [α] + Φ⁻¹ [β])² and Φ⁻¹ is the cumulative distribution function of a standardized normal deviate. The sample size calculated was 80 subjects, with 40 subjects in each allocated group.

Randomization was done using the envelope method. All subjects meeting with the inclusion criteria underwent relevant investigations, imaging, indirect laryngoscopy, and preanesthetic check-up. All cases underwent thyroidectomy and were operated by the same team of surgeons. Drains were placed as per allocated group: Group A - Patients with drain (negative suction no. 12 Romovac drain) and Group B - Patients without drain.

The postoperative protocol for both groups was similar, with subjects from both groups received injection Ceftriaxone 1 g IV 12 hourly for 2 days, followed by Tablet Cefixime 200 mg BD for 5 days, injection Diclofenac aqueous 1cc 12 hourly for 2 days, followed by Tablet Diclofenac 50 mg + Tablet, Serratiopeptidase 10 mg twice daily for 5 days. Early neck range of motion exercise was started on postoperative day (POD) 1. Standard care was followed for postoperative dressings and drain emptying. Drains were removed when output was <10 ml for 24 h. Patients were assessed for pain using the Visual Analogue Scale (VAS), seroma formation, and wound infection on POD 1 (day 3 and 5 as well, when patient was not discharged). Patient-rated satisfaction scoring was done using a 5-point Likert scoring.

The quantitative data, such as pain score and length of hospital stay, were reported as mean and standard deviation and tested with Student’s t-test. The incidence of hematoma and wound infection, patient satisfaction scoring was reported as numbers and percentages, and data were analyzed using Fisher’s exact test and Chi-square test.

Results

Eighty subjects were recruited after following the inclusion criteria, with 40 subjects in each group. The age distribution in both the groups was comparable, with a mean age of presentation in Group A was 42.1 ± 11.6 and for Group B was 43.4 ± 14.2 years. The maximum number of patients undergoing thyroidectomy was in the middle age group of 40–59 years (47%), with a mean age of 42.8 ± 12.9. The gender distribution across both groups was also comparable, with a total female-to-male ratio of patients undergoing thyroidectomy was 12.4:1. Out of the 80 patients enrolled, 36 patients (45%) had multinodular goiter, 35 patients (43.7%) had solitary thyroid nodule, 3 patients (3.7%) had Follicular neoplasm and 6 patients (7.5%) had malignant lesion. The type of lesion and their distribution among both the groups are shown in Table 1.

Table 1.

Distribution of types of thyroid lesions among both groups

Group	Type of lesion					Total
	Benign		Indeterminate	Malignant
	MNG	STN	Follicular neoplasm	Papillary	Follicular
Group A	21	13	2	4	0	40
Group B	15	22	1	1	1	40
Total	36	35	3	5	1	80

STN: Solitary thyroid nodule; MNG: Multinodular goiter

Postoperative pain was assessed using VAS on POD 1 and day 3. Patients with drain experienced significantly more pain on both POD-1 and POD-3 (P<0.00001) [Table 2]. Patients also experienced more discomfort with the drain in situ.

Table 2.

Visual Analog Scale for pain in both the groups on postoperative day 1 and postoperative day 3

Group	Pain score (on VAS)
	POD 1, mean±SD	POD 3, mean±SD
Group A	6.25±0.63	5.5±0.50
Group B	5.18±0.76	4.48±0.56
P	<0.00001	<0.00001

VAS: Visual Analogue Scale; SD: Standard deviation; POD: Postoperative day

Only four patients (5%) developed seroma, out of which 3 patients were belonging to group where drain placement was not done (Group B), with an insignificant P = 0.6. These patients were otherwise asymptomatic and were managed by aseptic needle aspiration and compression dressings. There was no incidence of hematoma formation, and neither any patient developed surgical site infection in both the groups.

The average length of hospital stay in Group A was 4.9 ± 0.72 days, significantly more (P = 0.0001, by student t-test) as compared to Group B with a mean length of stay 3.4 ± 0.43 days. Drains were associated with a longer length of hospital stay.

Patient satisfaction was assessed using a 5-point Likert scale, rated in terms of postoperative pain and discomfort, scar appearance, neck mobility, and overall quality of care received [Figures 1 and 2].

Figure 1.

Thyroidectomy with drain placement

Figure 2.

Thyroidectomy without drain placement

The assessment was patient rated which included 5 questions with 5 ratings each, from very good to very bad scoring from 5 to 1 respectively. Total of 25 points which was summed up into three categories: Good (>20 points), Moderate (10–20 points), and Bad (<10 points). The patients in the group without drain were significantly more satisfied with the overall treatment received (significant P < 0.022, by Chi-square test) as shown in Table 3.

Table 3.

Patient satisfaction as assessed by 5-point Likert Scale for both groups

Scoring	Group A, n (%)	Group B, n (%)	Total, n (%)
Good >20	17 (8.05)	29 (5.95)	46 (57.5)
Mod 10–20	22 (14.95)	10 (11.05)	32 (40)
Bad <10	1	1	2 (2.5)
Total	40	40	80

Discussion

The insertion of surgical drains after thyroid surgery remains a widely practiced method aimed at eliminating fluid accumulation and reducing the risk of complications such as hematoma and seroma. Drains promote tissue apposition and gradual collapse of dead space by providing an exit route for accumulated blood, lymph, or serous fluid from the wound site.[8] However, the use of drains in thyroid surgery remains a topic of debate. The necessity of putting a drain is more of a traditionally followed step, rather than evidence based.[7] The common belief of drain serving as alarms for possible hematomas or collections compromising the upper respiratory tract and the need for urgent exploration is not true[9] as the incidence of hematoma after thyroid surgeries is reported as 0.3%–1% in the literature.[10] The occurrence of hematoma is seen maximally at around 2–6 h postoperatively.[11] Improper cauterization of bleeders, slipping of ligatures, and spasms of smaller vessels contribute to the development of postoperative hematoma in the neck. A surgeon’s meticulous dissection of anatomical planes, judicial use of bipolar cautery, use of vessel sealants, and above all, the surgical skills are important elements in the prevention of hematomas. Drains should not be regarded as substitutes for these fundamentals.[12]

On the contrary, use of drain in thyroid surgeries can act as foreign body, that may initiate a local inflammatory response, prevents apposition of surfaces or it may itself gets blocked due to blood clots rendering it nonfunctional.[11] In addition, the drain acts as a source of ascending infection and thereby increasing the risk of surgical site infection. Drain can cause discomfort to the patients, increased hospital stays and cost, and jeopardize cosmesis by incorporating another scar on the neck.[12,13] These drains can impinge on vascular-compromised parathyroid gland or RLN, thereby increasing the chances of postoperative hypothyroidism or change in voice, respectively.[11]

The risk for the development of seroma is similar whether a drain is placed or not.[11] Most of the seroma does not pose any life-threatening complications and usually resolve in few days. If not, then it can be aspirated under radiological guidance. Although no hematoma or SSI formation occurred in either group in our study, seroma developed in 7.5% of the non-drained group and 2.5% in the drained group, with no significant difference between the two groups, which was consistent with the findings from the meta-analysis by Portinari and Carcoforo.[6]

Sanabria et al.,[14] in an earlier meta-analysis, reported a minor benefit of drainage in seroma control but acknowledged no benefit in preventing major complications such as hematoma. In contrast, Schietroma et al.[11] and Maroun et al.,[15] in their randomized controlled trial, stated no statistically significant difference in hematoma or seroma rates between drained and nondrained groups, but noted longer hospital stay and increased pain scores in the drain group. Their results echoed in our study too, as the average length of hospitalization for patients with a drain was significantly greater (4.80 ± 1.87 days) compared to those without a drain (3.40 ± 1.18 days) with a significant P = 0.0003.

In a meta-analysis study by Zhang et al.,[7], inserting drains during thyroid surgery did not lead to a significant reduction in postoperative wound hematoma formation (odds ratio: 0.86; 95% confidence interval: 0.54–1.36; P = 0.52). On the other hand, patients who received intraoperative drains experienced a significantly higher rate of wound infections after surgery.

In our study, pain assessment using the VAS indicated a statistically significant difference in pain levels between the two groups on both POD 1 and day 3, with a P < 0.00001 in both days, showing that placement of a drain increased the pain and discomfort in postoperative recovery, and the results were comparable with the studies of Schietroma et al.[11] and Wang et al.[16]

The size of thyroid gland also does not mandate the use of a drain, although a study by Dunlap et al.,[17] advocated for drain use, particularly in cases involving large thyroid glands or extensive dissection to reduce the need for emergent reoperation due to compressive hematomas. We assessed patient satisfaction using a 5-point Likert scale, which measured factors such as postoperative pain and discomfort, scar appearance, neck mobility, and overall quality of care received. Patients in the no-drain group reported greater satisfaction with their overall treatment. This is likely due to the reduced pain and discomfort in the absence of a drain, along with better neck mobility and the avoidance of an extra scar at the drain insertion site. In the study by Schietroma et al.,[11] patients in the nondrain group reported significantly higher satisfaction 1 week after surgery (P = 0.0001). In terms of operative efficiency and patient satisfaction, avoiding routine drain placement has been shown to reduce surgical duration, improve postoperative mobility, and enhance aesthetic outcomes, as supported by a study conducted by Sarmast Shoushtari et al.[18] These benefits are increasingly relevant in modern healthcare systems where patient experience and resource optimization are key performance indicators.

However, this study was of short duration and had a limited sample size. Large samples and randomized studies are essential to evaluate the necessity of drain placement in thyroidectomy.

The novelty of this study lies in its prospective Indian randomized control trial design, standardized operative protocol, and inclusion of patient satisfaction metrics, which remain underexplored in previous literature. The findings contribute meaningful evidence toward evidence-based thyroid surgery and support selective rather than routine use of drains after uncomplicated thyroidectomy.

Conclusion

Drain placement after thyroid surgeries has no additional benefits in preventing post-operative risk of seroma/hematoma formation or occurrence of surgical site infection. Rather, the use of drain is usually associated with postoperative discomfort, increased length of hospital stays, and leaves an additional scar affecting overall aesthetics for patients. A higher sense of positive feeling is seen in patients with no drain placement.

Ethical clearance

The study was approved by the IEC of All India Institute of Medical Sciences, Nagpur, Maharashtra, India; Ref No: IEC/Pharmac/2024/721.

The study was registered under Clinical Trial Registry India vide Reg. No. CTRI/2024/02/062365 dated February 7, 2024.

Informed and written consent was taken from all the participants and from the guardians of minor patients.

Conflicts of interest

There are no conflicts of interest.

Funding Statement

Nil.