Keywords
otorhinolaryngologic surgical procedure - thyroglossal cyst - drainage - postoperative
complications - surgical wound infection
Introduction
Thyroglossal duct cyst (TDC) is a common abnormality of the neck region and can occur
at any age, though it is much more common in the pediatric population.[1] The most definitive, efficacious management is achieved through the Sistrunk procedure,
a widely accepted and choice surgical technique, which effectively removes the cystic
lesion and reduces recurrence rates.[2]
[3]
[4]
[5] Common postoperative complications associated with the technique include wound-related
infection, pus/abscess, and hematoma/seroma (H-S) formation, with subsequent airway
compromise.[3]
[6] Surgical drains are placed in patients undergoing the Sistrunk procedure to prevent
these postoperative complications, but hardly any studies have overtly assessed if
drain placement is actually necessary. A recent case series in a pediatric population
suggests that routine drain placement may not be necessary.[7] As drain placement in the Sistrunk procedure may often necessitate postoperative
hospitalization, leading to increased cost and patient discomfort, it is important
to understand if drain placement offers any substantial advantage.
The rationale of our study was to assess if drain placement in the Sistrunk procedure
makes any significant difference in the prognosis of postoperative complications.
The issue assumes significance as a focus of head and neck surgeries (including the
Sistrunk procedure) now is shifting toward outpatient, same-day, and ambulatory surgeries.[5]
[8]
[9] Studies demonstrate same-day surgery to be a safer, less costly, and reasonable
alternative to admission surgery, without increased patient risk.[8]
[9] With a general tendency to reduce hospital stays and with the Sistrunk technique
being increasingly performed in same-day, outpatient settings, evaluating the impact
of drain placement with the technique on postoperative complications and patient morbidity
is essential.[5]
[7]
With this objective, we conducted a retrospective study at our hospital to explore
if same-day, outpatient Sistrunk procedure performed without drain placement was a
safe alternative versus the same procedure with drain placement. The study focused
on postsurgical complications of the Sistrunk procedure in both groups (those with
or without drain placement) and evaluated whether surgical drain offered any substantial
benefit in the Sistrunk procedure, and if it was necessary.
Methods
Records of all patients who underwent the Sistrunk procedure for TDC surgery in the
preceding 10 years (2004 to 2014) were retrieved, and data were searched and extracted.
In total, 80 patient records of the Sistrunk procedure could be retrieved and were
reviewed. Certain patients were excluded to standardize the patient population and
avoid any bias in the study. All patients who had a bleeding disorder were excluded.
All those who had active infection and pus in cyst requiring incision and drainage
of the cyst along with Sistrunk procedure were also excluded. Patients who had incomplete
surgery like removal of just the cyst without the tract including the body of the
hyoid (which were documented as Sistrunk but were not actually Sistrunk) were also
not included. Patients who in addition to Sistrunk procedure also underwent other
surgical procedures were excluded (e.g., those who underwent papillary carcinoma surgery
and proceeded to the Sistrunk procedure, or thyroidectomy/lymph node biopsies along
with Sistrunk procedure, among others). Moreover, cases with missing data like no
mention of placement or nonplacement of drain were also not included. Records missing
follow-up information or clues regarding complications after the Sistrunk procedure
were also not included.
Based on inclusion-exclusion criteria, of 80 records, only 58 patients were deemed
fit for analysis, and the remaining 22 were excluded due to either missing data or
inclusion-exclusion criteria. Patients who were found suitable for analysis (n = 58) were separated into two groups: patients who did not have a drain placed (n = 38) during the Sistrunk procedure, and those who had a drain placed (n = 20). Of these 58 patients, 38 were males (65.5%) and 20 (35.5%) were females. The
age of the patients varied from 1 to 53 years, with the mean and median age of patients
being 18.1 and 13.5 years, respectively. Patient demographics are summarized in [Table 1].
Table 1
Patient demographics
|
Without drain
|
With drain
|
|
Total no. of patients (%)
|
38 (65.5%)
|
20 (34.5%)
|
|
Males (%)
|
24 (41.4%)
|
14 (24.1%)
|
|
Females (%)
|
14 (24.1%)
|
6 (10.3%)
|
|
Age group distribution (y)
|
|
|
|
≤15 (%)
|
23 (39.7%)
|
10(17.2%)
|
|
16–30 (%)
|
8 (13.8%)
|
5 (8.6%)
|
|
>30 (%)
|
7(12.1%)
|
5(8.6%)
|
|
Age (y)
|
|
|
|
Mean
|
16.9 (14.7)
|
20.4 (15.2)
|
|
Median
|
12.5
|
15.5
|
|
Minimum
|
1
|
1
|
|
Maximum age
|
53
|
49
|
|
No. of patients admitted overnight
|
7 (12.1%)
|
6 (10.3%)
|
Abbreviation: SD, standard deviation.
Note: All percent values are absolute percentages. Overall mean age (SD) was 18.1
(14.8) y and median age, 13.5 y.
All patients had same-day surgery under general anesthesia. The patients came in the
morning, were operated upon, and were discharged by evening after their condition
stabilized. Of the 58 patients, 13 (6 from the drain group and 7 from the no-drain
group) were admitted for 1 night and discharged the next day but for reasons unrelated
to complications, apparently based on patient or surgeon preference. Patient preference
included those who had come from distant places and had late evening surgery, those
who felt nauseous and had possibly not recovered well from anesthesia, and those who
had anticipatory anxiety and reported feeling “uncomfortable” or “not feeling well.”
Patients who were admitted due to surgeon preference included one patient who had
sickle cell anemia (who did not have a drain) for optimization and another patient
(who had a drain) to observe for any anticipatory H-S.
Postoperatively, all patients were given antibiotics along with analgesics. Both groups
of patients had homeostasis secured at time of surgery, and no major complication
was noted. None of the patients developed any major complication like damage to great
vessels, nerve damage, hypothyroidism, perforation of pharynx/esophagus, or injury
to airway. None of the patients required any surgical exploration post–Sistrunk procedure,
except minor wound exploration or incision and drainage of pus.
Both groups of patients were reviewed, and data were extracted for various postoperative
Sistrunk-related complications, like presence of H-S (and if the patients required
aspiration for H-S or were managed conservatively), wound infection, and pus formation.
Data on number of follow-up visits by each patient was also extracted. Of the 58 patients,
3 did not return for follow-up and were assumed to be doing fine.
The extracted data were stored and analyzed using SPSS version 16 (Armonk, NY, IBM
Corp). Pearson chi-square test was used to see the association of drain or no drain
with gender, age, H-S, aspiration, wound infection, pus, and number of follow-up visits.
The t test was used to compare if there was any significant difference in mean age of patients
in both groups. The parametric nature of the data was accessed statistically, and
normality assumption was checked before application of t test.
Results
Sistrunk procedure–related complications were minimal in both groups. Overall, about
10% of patients had H-S, 6.9% of whom needed aspiration for H-S and the rest were
managed conservatively; 3.4% had wound infections; and 1.7% had pus collection that
required wound exploration or incision and drainage. The comparative overall gross
percentages of complications in both groups (drain versus no drain) did not show any
significant difference (H-S, 0 versus 15.8%; aspiration needed, 0 versus 10.5%; wound
infection, 5.0 versus 2.6%; pus formation, 5 versus 0%; respectively). None of the
patients who were admitted overnight (patient or surgeon preference) developed any
of the complications discussed.
The chi-square test compared both group of patients in terms of any Sistrunk procedure-related
complications (H-S, aspiration required, wound infection, pus, and number of follow-up
visits). The groups did not show any statistical significant difference in Sistrunk-related
complications in the Fisher exact (two-sided) test: H-S (p = 0.08), aspiration required (p = 0.29), wound infection (p > 0.99), and pus formation (p = 0.35; [Table 2]). The chi-square (two-sided) test also did not show any statistically significant
difference in number of follow-ups for both group of patients (p = 0.81; [Table 2]). No significant difference between groups could be found with respect to gender.
The t test compared mean age difference between patients with and without drain, and no
significant difference in mean age could be seen (p = 0.34; [Table 2]).
Table 2
Comparison of Sistrunk procedure patient groups (with drain versus without drain)
|
Aspect of comparison
|
No drain (n = 38)
|
With drain (n = 20)
|
p Value (significance)
|
|
Complications
|
|
|
|
|
H-S (%)
|
6 (15.8%)
|
0 (0%)
|
0.084 (NS)[a]
|
|
Aspiration need (%)
|
4 (10.5%)
|
0 (0%)
|
0.28 (NS)[a]
|
|
Wound infection (%)
|
1 (2.6%)
|
1 (5%)
|
>0.05 (NS)[a]
|
|
Pus (%)
|
0 (0%)
|
1 (5%)
|
0.345 (NS)[a]
|
|
Number of follow-up visits
|
|
|
|
|
One (%)
|
24 (68.6%)
|
13 (72.2%)
|
0.80 (NS)[b]
|
|
Two (%)
|
10 (28.6%)
|
4 (22.2%)
|
|
Three (%)
|
1 (2.9%)
|
1 (5.6%)
|
|
Mean age (SD)
|
16.87 (14.69)
|
20.40 (15.22)
|
0.394 (NS)[c]
|
|
Sex
|
|
|
|
|
Male (%)
|
24 (63.2%)
|
14 (70%)
|
>0.05 (NS)[a]
|
|
Female (%)
|
12 (36.8%)
|
6 (30%)
|
Abbreviations: H-S, hematoma/seroma; NS, not significant; SD, standard deviation.
Note: All percent values are within group percentages. Overall mean age (SD) of participants
was 18.09 ± 14.84.
a Fisher exact test
b Chi-square test (chi-square value 0.43, df-2).
c Independent samples t text.
Discussion
Analysis of data suggests that there is no significant difference in complications
post–Sistrunk procedure (infection, pus/abscess, or H-S) between the drain and no-drain
groups. Furthermore, no patient admitted overnight developed any of the complications
discussed, which supports our methodology because the patients were admitted for reasons
not related to complications and admissions were apparently due to patient and surgeon
preferences. The findings of our study resonate with that of another recently published
case series, which tried to ascertain if drain placement is at all necessary with
the Sistrunk procedure for treating TDCs in the pediatric population.[7] The case series evaluated 30 consecutive pediatric patients (mean age 7.4 years)
who underwent the Sistrunk procedure without drain placement (study group). Importantly,
the first 10 patients were hospitalized, despite no drain placement, to observe for
any complications in terms of hematomas, seromas, and subsequent airway compromise.
However, when no major complications were seen, the next 20 patients undergoing the
Sistrunk procedure without drain placement were treated with same-day, outpatient
surgery. The study also had 21 age-matched controls (mean age 7.5 years) who underwent
the Sistrunk procedure with drain placement.[7] Interestingly, the study did not find any statistical difference in the complication
rates between the study (no drain) and the control (drain) group (paired t test, p = 0.85). Conclusively, the author stated that surgical drain placement was not necessary
in pediatric patients who underwent the Sistrunk procedure.[7] Our study (which included both children and adults) reinforces the same finding
in a pediatric population and extends the generalizability of similar outcome in the
Sistrunk procedure performed in an adult population.
With hardly any studies exploring the need for drain placement in the Sistrunk procedure,
no protocol recommendation or consensus seems to exist to place the drain or not.
In fact, use of drains in thyroid/parathyroid surgery has been considered controversial
and debatable and may be even contraindicated.[10]
[11] It has been suggested that use of drains is not justified as drains cannot substitute
for meticulous use of surgical technique and adequate hemostasis, in which noncompliance
would eventually still lead to H-S. Rather, it has been contended that in noncomplicated
surgeries with minimal drainage, placement of a drain could lead to a possible infection.[12]
[13] Hence, nonusage of drains in the Sistrunk procedure is not only related to reduced
hospital stay, less cost, and improved patient comfort, but also has implications
in terms of decreased chance of postoperative infections.
Though not specific to the Sistrunk procedure, Hurtado-López et al tried to analyze
the actual value and effectiveness of a drain in thyroid surgery settings and found
that presence or absence of drains did not affect the incidence of seroma or hematoma
postsurgery.[14] It is worth mentioning that although routine use of drains does not seem to be indicated
in uncomplicated thyroid surgery cases, in complicated cases or when dead space is
large, drains do have a use.[15] The same may be applicable while using the Sistrunk procedure to surgically excise
and manage TDCs, and the surgeon preference for drain placement should depend on merits
of its use and not on routine use in the Sistrunk procedure.
Due to the increasing burden of extensive head and neck surgeries requiring mandatory
hospitalization, smaller surgeries like the Sistrunk procedure be managed as same-day,
outpatient treatment. As drain placement in the Sistrunk procedure may often require
in-patient admission and increased hospital stay, it should not be performed if it
does not offer any considerable advantage in decreasing postoperative complications.
This would also have positive implications on reduced treatment expenditure and minimized
patient distress.
Bratu and Laberge evaluated same-day TDC surgery (which included Sistrunk procedure)
in 100 children in a retrospective review and found that outpatient surgery was a
safe alternative to postoperative admission surgery in uncomplicated cases (no comorbidity,
congenital defect, or bleeding disorders).[5] Interestingly, drain placement was one of the factors that prolonged the length
of hospital stay in patients. Another point worth emphasizing is that 38% patients
had drains placed at surgeon discretion with no further details.[5] Bratu and Laberge also stated that outpatient, same-day surgery was safe for routine
TDC excision (including the Sistrunk procedure), but surgeons who were reluctant to
use same-day surgery due to fear of complications needed a shift in behavior to increase
outpatient TDC surgery.[5] This further emphasizes the rationale of performing the Sistrunk procedure as same-day,
outpatient surgery and emphasizes that the unnecessary routine use of drain placement
with the Sistrunk procedure would necessitate admission surgery leading to waste of
health resources.
The fact that very few complications were observed in our study even after discharge
suggests that if homeostasis is adequately achieved, drain placement in Sistrunk procedure
may not be necessary. However, to take care of any unprecedented postoperative hematoma
and/or edema and subsequent airway compromise in patients undergoing same-day, outpatient
Sistrunk procedure without any drain placement, the surgeon should take all precautions.
All patients with TDC having same-day Sistrunk procedure should be asked to report
any postoperative abnormality like swelling, purulent discharge, or fever postdischarge,
as soon as possible and irrespective of the scheduled follow-up. This not only would
ensure optimal utilization of health care resources to manage any adverse complication
(if any arise) but also would provide cost-benefit information and improved comfort
to the patient, ensuring greater patient satisfaction and better overall management
of TDCs.
The observational nature is an important limitation of our study. Smaller sample size
is another limitation, as complications of H-S in the Sistrunk procedure are relatively
rare. Due to the retrospective, observational study design, with no randomization
possible, there may be a risk of selection bias. Although, to the best of our effort,
we could not find any clinical or surgical variable to be associated with placement
or nonplacement of a drain, its possibility cannot be completely ruled out. Furthermore,
because all surgeries were performed by the consultant and residents under direct
supervision of the consultant (and consultant as first assistant), there does not
seem to be any performance bias. Apparently, drain placement with the Sistrunk procedure
does not seems to be determined by the person performing the surgery or the surgeon's
expertise, and rather appears to be governed by patient and surgeon preference. However,
we cannot deny it in absolute terms.
A study with a larger sample population would further confirm the findings of our
study. Ideally, however, a randomized trial comparing the Sistrunk procedure, with
or without drain, should be performed to definitively understand if placing a drain
is at all necessary in the Sistrunk procedure. This would help create a protocol recommendation
and consensus among surgeons managing TDCs, with respect to deciding whether or not
a drain should be placed during the Sistrunk procedure. To best of our knowledge,
ours is the first study that has compared drain or no-drain Sistrunk procedure across
all age groups; more comparative studies are needed in both pediatric as well as nonpediatric
population.
Conclusion
Surgical placement of a drain did not seem to offer any advantage in patients undergoing
the Sistrunk procedure at our hospital in terms of reduced postoperative complications.
Hence, there does not seem to be any apparent need for drain placement when performing
the Sistrunk procedure in patients with TDCs. Moreover, because no major complications
were observed in surgically managing uncomplicated cases of TDCs by same-day, outpatient
Sistrunk procedure without drain placement, it could be considered a safe alternative
to the Sistrunk procedure with drain placement, which may require overnight hospitalization/admission.
This would translate into better patient comfort, greater satisfaction, and reduced
surgical costs in patients of TDCs undergoing the Sistrunk procedure.
