Introduction
Post-operative haemorrhage following thyroid and parathyroid surgery is an uncommon but serious complication with the potential for life-threatening airway compromise necessitating urgent intervention.Reference Iliff, El-Boghdadly, Ahmad, Davis, Harris and Khan1 Reported re-operation rates for bleeding vary between 0.3 per cent and 4.3 per cent, and no patient group can be considered entirely free of risk.Reference Iliff, El-Boghdadly, Ahmad, Davis, Harris and Khan1–Reference Godballe, Madsen, Pedersen, Sørensen, Pedersen and Frisch5 This unpredictability has historically limited the adoption of day-case thyroidectomy, with the British Association of Endocrine and Thyroid Surgeons initially discouraging same-day discharge due to concerns about post-operative haematoma.Reference Rajeev, Sutaria, Ezzat, Mihai and Sadler6 More recent evidence, however, supports the safety of day-case thyroid and parathyroid procedures in selected patients.Reference Rajeev, Sutaria, Ezzat, Mihai and Sadler6
While consensus guidelines now exist for the recognition and management of post-operative haematoma,Reference Iliff, El-Boghdadly, Ahmad, Davis, Harris and Khan1 there remains limited evidence on preventive intra-operative strategies. Traditional haemostatic techniques, including clamp-and-tieReference Materazzi, Ambrosini, Fregoli, De Napoli, Frustaci and Matteucci7 or energy devices, reduce operative time but have not consistently been shown to alter bleeding risk.Reference Yao, Wang, Wang and Ruan8, Reference Pons, Gauthier, Ukkola-Pons, Clément, Roguet and Poncet9 Similarly, haemostatic agents such as Surgicel and FloSeal have not demonstrated significant impact on post-operative haematoma rates.Reference Amit, Binenbaum, Cohen and Gil10, Reference Testini, Marzaioli, Lissidini, Lippolis, Logoluso and Gurrado11 In contrast, a retrospective review from our own unit reported a re-operation for bleeding rate of 1.3 per cent across 1913 patients, with no clear predictive patient factors identified.Reference Edafe, Cochrane and Balasubramanian12
Based on this, a structured closure protocol – “ITSRED Fred” (Irrigation, Time, Systolic blood pressure greater than 100 mmHg, Relief of neck extension, Elevation of venous pressure, Drain avoidance, Flap evaluation) – was developed and implemented (Fig. 1). This mnemonic provides a reproducible set of steps designed to optimise haemostasis before wound closure. Beyond its potential to reduce bleeding, the structured format offers value as a training tool, enabling junior surgeons to adopt systematic habits during wound closure.
The ITSRED Fred protocol for prevention of bleed after thyroid and/or parathyroid surgery.
Figure 1 Long description
The infographic presents the ITSRED Fred protocol for post-operative bleeding prevention. It includes six steps: 1. Irrigate the wound, illustrated with a syringe releasing drops of liquid. 2. Time, with a clock showing a wait of 3 to 5 minutes. 3. Systolic blood pressure should be greater than 100 millimeters of mercury, depicted with an arm and blood pressure cuff. 4. Relieve neck extension, shown with a person lying down. 5. Elevate venous pressure using Valsalva maneuver, illustrated with a person holding their breath. 6. Drain to be avoided, marked with a red cross over a drain image. The final step, Fred, involves flap evaluation before closure, depicted with hands evaluating a surgical site.
The aim of this study was to evaluate the effectiveness of the ITSRED Fred protocol in reducing re-operation for bleeding after thyroid and parathyroid surgery in a single tertiary endocrine surgical unit.
Materials and Methods
Study design
An observational retrospective cohort study was undertaken, with a nested case–control analysis comparing patients requiring re-operation for bleeding with a randomly selected control group.
Setting and protocol implementation
The study was conducted in a tertiary endocrine surgical unit comprising two consultant endocrine surgeons. The ITSRED Fred protocol was introduced in March 2017 and incorporated into routine practice. Both consultants were instructed on parameters and asked to document its use in the operative note. The mnemonic was also used in theatre teaching to provide a reproducible framework for trainees during wound closure.
Participants
All consecutive patients undergoing thyroid and/or parathyroid surgery between March 2017 and June 2022 were included. The cohort comprised primary and redo operations, as well as cases with lymph node dissection in conjunction with thyroidectomy/ parathyroidectomy. Patients undergoing thymic cyst excision, lymph node biopsy or excision of isolated lymph nodes or lipomata were excluded.
Outcomes
The primary outcome was the rate of significant post-operative bleeding requiring re-operation, defined as evacuation of haematoma either immediately after wound closure or as a separate return to theatre. Secondary outcomes included recurrent laryngeal nerve palsy, temporary and permanent hypoparathyroidism and length of stay. The management of patients requiring re-exploration was analysed descriptively.
Data collection and analysis
Data were extracted from electronic patient records, operative notes and clinic correspondence. Readmissions were reviewed. Data were anonymised and analysed using SPSS. Associations between categorical variables and bleeding were assessed with chi-squared or Fisher’s exact test; continuous variables were compared using t-test or Mann–Whitney U test. A p-value of less than 0.05 was considered statistically significant.
Ethics
The study was registered with the Clinical Effectiveness Unit within the tertiary hospital. As an observational study, formal ethical approval was not required.
Results
A total of 1525 operations were included: 946 (62 per cent) thyroid, 542 (35 per cent) parathyroid and 38 (2.5 per cent) combined procedures. The cohort had a female to male ratio of 4:1 (n = 1216 vs. 309) with a median age of 53 years. Most cases were first-time procedures, with 27 (1.8 per cent) re-operations. Among thyroid procedures (n = 984), 177 (18 per cent) involved a neck dissection. The ITSRED Fred mnemonic was documented in all operative notes. Demographic features were comparable to the pre-protocol cohort (Table 1).
Demographic and clinical characteristics of patients before and after introduction of the ITSRED Fred protocol
Table 1 Long description
The table compares demographic and clinical characteristics of patients before and after the introduction of the ITSRED Fred protocol. Both groups have a median age of 53, with interquartile ranges of 27 and 26, and a p-value of 1.0, indicating no significant age difference. Gender distribution is similar, with 1221 females and 316 males after the protocol, and 1454 females and 459 males before, also showing no significant difference (p = 1.0). The nature of surgery shows a slight difference in thyroid surgeries, with 946 after and 1253 before, but the p-value of 0.1 suggests this is not statistically significant. Parathyroid and combined surgeries have similar distributions across both groups. Overall, the data suggests that the ITSRED Fred protocol did not significantly alter the demographic or clinical characteristics of the patient groups.
IQR = interquartile range.
Twelve patients (0.79 per cent) required re-operation for bleeding, compared with 1.3 per cent in the pre-protocol group (p = 0.14). The bleed group included five females and seven males, median age 45 years. Bleeding rates were higher following thyroidectomy (1.05 per cent) compared with parathyroidectomy (0.37 per cent), with no events after combined surgery (p = 0.26). All bleeds occurred in first-time operations, and two cases followed neck dissection (1.1 per cent) (Table 2).
Demographic and clinical characteristics of patients with and without bleed after thyroid and/or parathyroid surgery
Table 2 Long description
The table compares demographic and clinical characteristics of patients with and without bleeding after thyroid and/or parathyroid surgery. Among patients who required reoperation for bleeding, 1.1% had thyroid surgery, 0.4% had parathyroid surgery, and none had both surgeries. The median age of patients with bleeding was 45 years, younger than those without bleeding at 51 years. Gender distribution shows a higher percentage of males (2.2%) requiring reoperation compared to females (0.4%). These findings suggest a higher risk of bleeding in thyroid surgeries and among younger patients and males.
Note: Values are n (%) unless stated otherwise.
IQR = interquartile range.
Timing of re-operation was intra-operative or immediately post-extubation in four cases, within 6 hours in six cases and after 6 hours in two cases (7 and 9 hours, respectively). Of the eight patients who bled after theatre, only three had documented wound opening prior to reintubation. A drain was inserted at re-exploration in four cases. A clear bleeding point was recorded in six patients (50 per cent), including slipped venous clips, muscle edge bleeding and pre-tracheal/general ooze. No patient required transfusion, tracheostomy or high-dependency or intensive care, and there was no mortality.
Nested case–control analysis (12 bleed cases vs 120 controls) showed no significant association between bleeding and age, hypertension or anticoagulant/antiplatelet use. Length of stay did not differ between groups (median 1 day). Male sex (p=0.018) and thyroid surgery (p=0.046) were associated with higher risk of re-operation. Recurrent laryngeal nerve palsy was rare (two cases, both controls). Transient hypoparathyroidism occurred in one bleed case and three controls, with only one instance of permanent hypoparathyroidism (control group) (Table 3).
Comparison of demographic and detailed clinical characteristics in the nested case–control analysis
Table 3 Long description
The table compares demographic and clinical characteristics between patients who underwent reoperation for bleeding and those who did not. Females had fewer reoperations compared to males, with a significant p-value of 0.018. Total thyroidectomy patients had a higher reoperation rate than those who had hemithyroidectomy, with a p-value of 0.046. Other factors like neck dissection, redo surgery, anticoagulation, drain use, hypertension, and length of stay showed no significant differences between the groups. The median age was similar across both groups, and the length of stay was consistently one day for both. The data suggests gender and type of operation are significant factors in reoperation rates for bleeding.
Note: Values are n (%) unless stated otherwise. Fisher’s exact test was used to calculate the p values stated above except for length of stay where a t-test was used.
Discussion
This study evaluated the introduction of a structured closure protocol, ITSRED Fred, for the prevention of post-operative haemorrhage after thyroid and parathyroid surgery. The re-operation rate for bleeding fell from 1.3 per cent in a prior institutional cohort to 0.79 per cent after protocol adoption.Reference Edafe, Cochrane and Balasubramanian12 Although this reduction did not reach statistical significance, it is clinically important given the life-threatening nature of neck haematoma.
Previous literature has reported male sex as a risk factor for post-thyroidectomy bleeding,Reference Promberger, Ott, Kober, Koppitsch, Seemann and Freissmuth3, Reference Godballe, Madsen, Pedersen, Sørensen, Pedersen and Frisch5, Reference Yao, Wang, Wang and Ruan8, Reference Dehal, Abbas, Hussain and Johna13, Reference Talutis, Drake, Sachs, Rao and McAneny14 a finding replicated in our dataset. In contrast, no association was observed with age, comorbidity or anticoagulant use, despite some reports linking these variables to increased bleeding risk.Reference Dehal, Abbas, Hussain and Johna13, Reference Oltmann, Alhefdhi, Rajaei, Schneider, Sippel and Chen15 The rarity of the outcome limits definitive conclusions, but our findings support the importance of modifiable intra-operative measures rather than patient selection alone.
The majority of bleeds in this study occurred within 10 hours of surgery, consistent with published reports.Reference Rosenbaum, Haridas and McHenry16, Reference Farooq, Nouraei, Kaddour and Saharay17 These data support the safety of carefully selected day-case thyroid and parathyroid surgery, particularly in procedures with lower baseline bleeding risk such as parathyroidectomy and hemi-thyroidectomy.Reference Yao, Wang, Wang and Ruan8, Reference Yakhlef, Marboeuf, Piquard and Saint Marc18, Reference Flynn, Quayyum, Goldstein and Bumpous19 Importantly, adherence to post-operative algorithms such as the SCOOP protocol remains essential for prompt recognition and management should a haematoma occur.Reference Iliff, El-Boghdadly, Ahmad, Davis, Harris and Khan1
In half of the re-explored cases, no discrete bleeding point was identified, with general ooze commonly described. Other studies report higher rates of identifiable sources,Reference Burkey, van Heerden, Thompson, Grant, Schleck and Farley2, Reference Promberger, Ott, Kober, Koppitsch, Seemann and Freissmuth3 suggesting that routine use of structured haemostatic checks, as captured by ITSRED Fred, may help identify bleeding points intra-operatively before wound closure.
Beyond clinical outcome, a notable strength of ITSRED Fred is its utility as an educational tool. Surgical training increasingly emphasises structured, reproducible processes to reduce variability and improve safety. Similar to the WHO surgical safety checklist and the SCOOP protocol, ITSRED Fred provides a simple mnemonic that can be taught to trainees, reinforcing systematic haemostatic assessment at closure. By embedding such tools in training, junior surgeons can develop habits that enhance both patient safety and surgical education.
What is already known on the subject
• Post-thyroid/ parathyroid haemorrhage is rare but potentially life-threatening, requiring urgent intervention
• Protocols exist for the identification and treatment of post-thyroid/parathyroid haematomas, but there is no standardised advice for prevention
What this paper adds
• Implementation of the ITSRED Fred protocol reduced re-operation for bleeding from 1.3 per cent to 0.79 per cent following thyroid and parathyroid surgery
• Protocol steps include irrigation, systolic blood pressure greater than 100 mmHg, neck extension relief, venous pressure elevation and flap evaluation prior to wound closure
• No significant associations were found between bleeding and age, anticoagulant use or operation type
• ITSRED Fred improves safety and provides a structured educational and training tool for haemostatic assessment
Limitations
This study shares the limitations of a retrospective observational design. The primary outcome was rare, making it difficult to demonstrate statistical significance, though the absolute reduction is clinically relevant. Selection bias was minimised through inclusion of consecutive patients, although post-discharge bleeds presenting to other hospitals may have been missed. The low incidence of secondary complications such as recurrent laryngeal nerve injury or hypoparathyroidism limits comparison between groups. Finally, the findings reflect practice in a high-volume unit in a tertiary centre with potentially more complex workload, which may affect generalisability.
Conclusion
The ITSRED Fred protocol was associated with a lower rate of re-operation for bleeding after thyroid and parathyroid surgery. While statistical significance was not reached, the clinical relevance is clear given the severity of this complication. Crucially, ITSRED Fred offers a structured, reproducible framework that not only supports patient safety but also serves as a valuable training tool for surgical education.
Contributions
Nurhan Abbud was involved in all aspects from conception, study design, data collection and analysis and manuscript write up. Georgia Kirby involved in data collection and part of original draft write up. Ovie Edafe involved in conception and manuscript editing. Saba P.Balasubramanian involved as supervisor in all aspects from conception, study design and manuscript review.
Acknowledgements
The following work was approved by the clinical effectiveness unit at Sheffield Teaching hospital. Some of the patient data has been submitted to the UKRETS registry run by the British Association of Endocrine and Thyroid Surgeons. This work is an original article, not published beforehand and is not being considered for publication elsewhere in its final form, in either printed or electronic media. No artificial intelligence was used at any stage of data analysis or writing of this article. Artificial intelligence image software was used in creation of the figure included in this article.
Competing interests
There is no conflict of interest, financial interest or other competing interest associated with the authors or subject of this paper.
Funding statement
No funding was obtained.
