Department of Surgery, Shalamar Medical and Dental College, Lahore, Pakistan
Mr Talat Waseem FRCS Eng, FACS,Consultant Surgeon Shalamar Medical and Dental College, Lahore
Contrary to significant clinical evidence, many surgeons still use drains following a thyroidectomy for several reasons, including intent to prevent postoperative hemorrhage and seroma formation. Quality of hemostasis, size of gland, quality of thyroid tissue and its dissection, presence of adhesions and extent of surgery may all influence surgeon’s decision to use a drain. The aim of this study is to qualitatively explore the reasons for use of drains in thyroidectomy, to evaluate given reasons in a clinical setting and finally, to develop a consensus decision tree.
We conducted a thematic analysis following a focused group discussion among panel of endocrine surgical experts (n=8) to explore the factors which influence the decision to place a drain following thyroidectomy. To validate these findings, we conducted a prospective randomized clinical trial on patients undergoing thyroid surgery. Patients were randomly assigned to a drain group (
Thematic analysis of the focused group discussion of panel of endocrine surgeons revealed various factors involved in the decision of placing or not placing a drain. Reasons included quality of dissection, size of gland, extent of dissection, thyrotoxicosis associated tissue friability and thyroiditis or cancer associated fibrosis. Technique of dissection and experience were considered to be the most important determinant of postoperative hemorrhage. Purpose of drain placement was not to prevent hemorrhage, but to provide a sense of comfort to the operating surgeon. Clinical trials revealed no significant impact of drains in prevention of hemorrhage, however, drain placement was significantly associated with lower rates of postoperative seroma formation. Subgroup analysis showed a higher association of seroma formation to extent of surgery, size of gland and thyrotoxicosis. A decision tree to aid decision making for drain placement during thyroidectomy is being proposed here.
The decision to place the drain should be selective. Size of the gland, extent of dissection, thyrotoxicosis and quality of hemostasis are important determinants for the decision of drain placement justifying the selective use of drains. The frequency of life-threatening post-thyroidectomy bleeds remains low and drain placement might not be required for smaller thyroid nodules. Short term drain placement for 12-24 hours reduces seroma formation and, thus, need for needle aspiration in patients undergoing thyroidectomy.
Emerging evidence challenges routine use of drains in many surgical procedures because of higher infection rates, discomfort and prolonged hospital stays
This discrepancy between literature recommendations and prevalent practices potentiates the need for randomized trials but despite many randomized trials, many aspects of the drain placement decision still remain unexplored. To explore reasons for drain placement we here employ the qualitative approach and examine the perceptions and their scientific justification. To further corroborate our qualitative findings, we conducted a randomized controlled trial. The objective of the study is to critically probe the reasons for placing a drain following neck surgery and with the eventual aim to minimize the gap between theory and practice.
Ethical approval for the study was obtained through institutional review board. Mixed method study design was chosen, with stage 1 comprising a qualitative approach and stage 2 comprising quantitative data collection in clinical setting, where findings of the first stage were validated in quantitative fashion. In stage 3, based on the data, a proposed decision tree was circulated among the panel of experts to build consensus through e-Delphi technique as described previously
Focus group discussion was conducted in standard fashion with the point of saturation as described previously by Strauss
In stage 2 of the study, a prospective randomized clinical trial was conducted following principles of the CONSORT flow diagram. The trial involved patients undergoing elective thyroidectomy with or without drain. The patients having small and moderate sized glands were included in the study and the patients with large or huge glands were excluded from the study. General demographics of the participants, disease, gland size, clinical status and clinical diagnosis parameters were recorded as per norms. The randomization was through the lottery method. The primary study end point was seroma formation and hemorrhage necessitating re-exploration. Secondary end points included postoperative pain (assessed by visual analgia scoring and analgesia requirements according to the WHO analgesia ladder system) at 24 hours, drain output and length of hospital stay. Patients requiring extensive surgery like sternotomy, thyroidectomy for huge glands, neck dissection and with history of any bleeding disorder were excluded. Both surgeons and the patients were blinded to randomization. Two surgeons employed the same operative technique to provide uniformity. Meticulous hemostasis was ensured prior to closure. Suction drain was used prior to closure for the drain group. Preoperative analgesia was standardized. Type and length of surgery recorded. Operative time, blood loss, postoperative drain volume, analgesia requirements, histological diagnosis and recurrence over a period of at least 6 months recorded. Postoperative pain was assessed through visual analogue scoring ranging from 0-10. Postoperative complications like acute life-threatening post-thyroidectomy bleed, neck hematoma and symptoms of hypocalcemia, were recorded both throughout the hospital stay and at the first scheduled clinic appointment after surgery (6 weeks postoperatively). A wound infection was diagnosed if purulent discharge exuded from the wound or a painful, spreading erythema indicative of cellulitis existed. At six weeks, patient satisfaction with scarring was assessed by subjective patient ranking on a scale from 0 to 10.
In Stage 3, e-Delphi technique was used as described previously to build expert consensus on proposed decision tree for drain placement in 2 rounds.
The data was analyzed using SPSS version 21 (SPSS, Inc, Chicago, IL, USA). Data normality was tested using the Kolmogorov-Smirnov test. Fisher’s exact test or Pearson Chi
The study consists of three stages: first stage encompasses qualitative portion and the second stage is a quantitative study in form of a randomized controlled trial. Figure 1 shows the flow of the study and its two stages. In third stage we propose a consensus decision tree based on data. Extensive preliminary literature review was done, based on which themes and subthemes were identified to understand the reasons of drain placement. A discussion guide was formulated to standardize the discussion. Eight experts in endocrine surgery participated in Focus Group Discussion (FGD). The themes explored have been summarized in the Table 1.
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Factors influencing Placement of Drain |
Hemorrhage & Apprehension of Bleed Size & Extent of Dissection Friability & Fibrosis Adhesions Seroma Formation |
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Prevention of Hemorrhage |
Technique & Quality of Hemostasis |
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Advantages of Drain Placement |
Reassurance Possible Prevention of Hemorrhage Reduction of Seroma Formation |
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Disadvantages of Drain Placement |
Discomfort & Pain Hospital Stay |
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Avoiding Drain Placement |
Smaller Glands- Minimal Dissection |
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Need or Reassurance? |
Reassurance Prevention of Seroma Formation |
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Factors influencing the decision of drain placement were explored. Contrary to what the literature states, the fear and apprehension of neck hematoma needing evacuation still has some role to play in decision making. This varies between surgeons and few believe in the literature evidence but would still like to decide on case to case basis. One participant said:
Gland size and extent of dissection play an important role in terms of apprehension about hemorrhage and the seroma formation as well as described by one participant:
Third salient determinant for placement of drain that emerged was friability and the fibrosis of gland or adhesions to the surrounding structures. According to one participant,
The size of the gland and extent of dissection and quality of hemostasis also correlate positively to postoperative seroma formation.
Quality of hemostasis would often dictate surgeons to use or not to use the drain following thyroid surgery as explained by one endocrine surgeon this way:
Frequent advantages outlined by the participants included personal reassurance, possible prevention or early detection of hemorrhage, reduction in the incidence of seroma formation and reduction in postoperative pain and discomfort.
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Factors influencing Placement of Drain |
Hemorrhage & Apprehension of Bleed Size & Extent of Dissection Friability & Fibrosis Adhesions Seroma Formation |
|
Prevention of Hemorrhage |
Technique & Quality of Hemostasis |
|
Advantages of Drain Placement |
Reassurance Possible Prevention of Hemorrhage Reduction of Seroma Formation |
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Disadvantages of Drain Placement |
Discomfort & Pain Hospital Stay |
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Avoiding Drain Placement |
Smaller Glands- Minimal Dissection |
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Need or Reassurance? |
Reassurance Prevention of Seroma Formation |
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The representative statements have been outlined in the Table 1. Similarly, postoperative discomfort and potential lengthening of the hospital stay were considered as the potential disadvantages. One participant concluded by illuminating:
To further expand the findings of qualitative analysis and to put them to clinical perspective, we ran a randomized controlled trial. CONSORT protocol was followed and eventually 112 patients were randomized to drain group and 100 to the no-drain group. The general characteristics of the patients have been summarized in Table 2.
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Per-operative mean blood loss |
39.86±24.75 |
42.95±25.06 |
0.135 |
Postoperative Drain Output |
50.17±41.50 |
- |
- |
Mean length of postoperative stay (Hours) |
25.91±9.87 |
21.82±3.57 |
0.773 |
Mean pain score (maximum = 10) |
3.1±1.1 |
2.3±0.4 |
0.051* |
Median postoperative analgesic requirements as per WHO pain ladder |
Level II |
Level II |
0.341 |
Complications |
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Wound infection |
0.9% |
1.2% |
0.063 |
Hematoma requiring drainage |
0.5% |
0.9% |
0.472 |
Seroma formation requiring drainage |
1.4% |
11.3% |
0.000* |
Transient hypocalcemia |
0.9% |
1.1% |
0.936 |
Permanent hypocalcemia |
0% |
0% |
- |
Transient recurrent laryngeal Nerve compromise |
2.8% |
3.2% |
0.265 |
Permanent recurrent laryngeal nerve compromise |
0% |
0% |
- |
Recurrence (Over period of at least 6 months-7 years) |
0% |
0% |
- |
Others (RTI) |
0.3% |
0.02% |
0.634 |
Mean satisfaction with scar (maximum = 10) |
7.9 |
8.3 |
0.640 |
Satisfaction with overall hospital stay (maximum = 10) |
8.1 |
8.7 |
0.982 |
The primary endpoints included postoperative hemorrhage and neck hematoma formation, pain scoring, hospital stay and seroma formation (Table 3). Rest of the complications including hypocalcemia, recurrent laryngeal nerve compromise, recurrence over a period of at least 6 months and wound infection were also assessed.
Group without drain had significantly lower postoperative pain and discomfort as opposed to drain group (3.1±1.1 vs. 2.3±0.4; p<0.05) however postoperative analgesia requirement was not statistically different. Similarly, rate of seroma formation in postoperative period was significantly higher in the group receiving no drains (1.4% vs. 11.3%; p value <0.00). Despite a good quality hemostasis, average drain output was 50.17±41.50 ml in drain group probably forming the impetus for subsequent seroma formation.
Rest of the parameters like operative time, per-operative blood loss, hematoma requiring draining, would infection, postoperative hypocalcemia, RLN compromise and recurrence were not statistically different between two groups. Mean satisfaction with scar or overall hospital stay were not statistically different either (Table 3).
To explore the reasons of the higher seroma rate in no drain group, sub group analysis was done which showed size of the gland, extent of dissection and toxicity of the gland to be related to higher rates of seroma formation (Table 4). The size of the gland was the strongest predictor of seroma formation with Pearson Chi2 value of 11.99 and p<0.002.
In stage 3 of the study, the above data was shared in form of a report along with a proposed decision tree for the drain placement during thyroidectomy. The consensus was developed through 2 rounds on the decision tree with Fleiss’s kappa value of 0.83. Figure 2, shows a proposed algorithm for the drain placement in thyroidectomy.
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ASA Status |
0.759 |
0.859 |
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Toxicity |
4.289 |
0.04* |
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Fibrosis |
6.634 |
0.07 |
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Histological Diagnosis |
5.963 |
0.11 |
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Size of Gland |
11.99 |
0.002* |
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Extent of Surgery |
6.402 |
0.05* |
Hematoma rates are generally low ranging from 0-2.6% and the ones requiring intervention are even less than 1.5%. Most hematomas develop in early postoperative period i.e. 75% within first 6 hours and rest in 6-24 hours. Though the incidence of the hematomas is low but they can be potentially life threatening; thus, creating a reason for drain placement. Placement of drain though may be assuring for some, does not prevent the need for exploration if the patients really develop postoperative neck hematoma. Extensive literature review persistently shows that drain placement does not prevent hemorrhage
Drain placement, however, does reduce the incidence of postoperative seroma formation and has thus been proposed to have selective use of drain by Saha et al. This study further strengthens the literature evidence and propagates for placement of short-term drain for 12-24 hours as quoted by one endocrine surgeon in this study.
This study has explored the reasons for higher incidence of seroma formation whom did not have drain. Quality of hemostasis and expertise in securing hemostasis can be a significant factor in preventing postoperative hemorrhage as well as seroma formation
Instead of advocating no drains for all thyroidectomies, it appears prudent to commend for selective drainage following thyroidectomy. The algorithm, here proposed, promotes the decision of putting drain on the bases of quality of hemostasis, size of gland, extent of dissection and vascularity of gland. For large and huge glands (WHO Class IV and beyond), it would be probably be more prudent to place a drain as there would be higher chances of seroma formation and higher probability of life-threatening hematoma formation in neck.
There are certain limitations in this study. The study has primarily enrolled smaller and moderate size glands in clinical trial; hence the quantitative data is not sufficient enough to predict the rates of hemorrhage and seroma formation in those individuals. Moreover, qualitative data by principle is based on opinions and experiences and may not sufficiently prove exclusively that surgeon experience or perceptions are reflections of reality.
In conclusion, intent of earlier detection of hemorrhage, fear of postoperative hemorrhage and seroma formation were found to be the most common reasons for drain placement. The decision of placing a drain or not should be individualized and should correlate with extent of dissection, size of gland, quality of hemostasis, extent of adhesions either related to any inflammatory condition or malignancy and the vascularity of the gland. It remains safe to skip drain placement in small to moderate size glands provided the quality of hemostasis is superb and risk factors for seroma formation are not present.
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