Abstract
Tonsillectomy is a common procedure performed globally. It is associated with morbidities like hemorrhage and pain. Various methods are employed to reduce them. The present study is aimed to evaluate the role of Feracrylum (1%) in traditional cold steel tonsillectomy and to measure the outcomes in terms of intra-operative bleed, intra-operative time and post operative pain and recovery. A prospective study was conducted in Department of ENT, ESI Medical College, Kalburgi Karnataka, India, for a period of two years between January 2019 to December 2020 In this study, a total of 60 patients were involved and divided them into two groups after fulfilling the inclusion and exclusion criteria. Thirty patients each undergoing tonsillectomy with the use of Feracrylum considered as Group I and without the use of Feracrylum in the tonsillar fossae considered as Group II. The study has been approved by Ethics committee and informed consent was obtained from all the study subjects. The amount of blood loss is calculated. Post operative pain based on VAS (Visual Analogue Scale) is assessed in both the groups. Assessment of recovery in days is estimated in both groups by reduced pain, gaining normal activity and normal food intake. In this study, intra-operative time in group I was 19.83 ± 3.93 min and in group II 27.16 ± 3.35 min (P < 0.001). The intra-operative blood loss in group I was 26.67 ± 4.81 ml and in group II 44.70 ± 7.59 ml (P < 0.001). Patients recovered from pain, resumed normal activity and food intake within 2–3 days in Group I and in contrast it took about 3–5 days on an average in group II. In this study, majority of the patients experienced mild pain in Group I when Feracrylum was used during hemostasis. In our study, the time taken by the patients to recover from pain, resume their normal activity and also with regard to normal food intake was rapid. On an average of 2–3 days was seen in Group I. Group II patients required 3–5 days to recover from pain and resuming normal activity and food intake. The P value of < 0.001 was highly significant. Our study has stressed that use of Feracrylum in cold steel tonsillectomy is relatively safe. Its use is associated with a significant decrease in surgical time and blood loss. Rapid recovery makes it favourable to be used in cold steel tonsillectomy.
Keywords: Feracrylum, Primary and secondary hemorrhage, Tonsillectomy
Introduction
Tonsillectomy remains the most common surgical procedure performed globally [1]. In general practice tonsillectomy is a major surgical procedure. In Hindu medicine the surgery has been mentioned about 3000 years ago [2]. During the first century BC., Cornelio Celcus described tonsillectomy. He applied milk and vinegar to the surgical specimen to achieve hemostasis [3, 4]. Galen (121-200AD) described tonsillectomy by the use of snare. During 625–690 AD, Paulus Aegineta described the detailed tonsillectomy procedure and controlling the post operative bleeding [2].
Tonsillectomy is performed for various etiologies like chronic tonsillitis, peritonsillar abscess, suspicion of malignancy and sleep disordered breathing. The most common complication encountered following tonsillectomy is hemorrhage from the tomnsillar fossae called post tonsillar hemorrhage. On an average 2–4% patients suffer from hemorrhage [5, 6].
Hemorrhage has two peak modes, primary post tonsillar hemorrhage which occurs within the first 24 h and secondary post tonsillar hemorrhage which occurs between 24 h to 2 weeks after surgery [5, 7]. Fatal post operative hemorrhage is reported from 0.2 to 1 for every 10,000 surgeries performed. It is on an average of 0.9 for every 10,000 surgeries [5].
The other morbidity associated with tonsillectomy is the pain. Pain is an unpleasant sensory and emotional experience. Tonsillectomy has become a daycare procedure and is associated with significant postoperative pain. It is intense on its first day and needs to be addressed. The pain is the result of the disrupted mucosa with glossopharyngeal and vagal nerve fibre irritation followed by inflammation and spasm of pharyngeal muscles which leads to ischemia and pain [8].
During the previous 40 years various techniques are being used to decrease the morbidity in terms of hemorrhage, pain, duration of surgery and days of recovery. Electro dissection, Microscopic tonsillectomy, Bovie or coblation, Microdebrider, Laser assisted tonsillectomy, Radio frequency, Harmonic scalpel, Trans oral robotic radical tonsillectomy and Cryo-tonsillectomy. Cold steel technique is still considered the Gold standard technique [5]. This study is designed to determine the efficacy of use of 1% Feracrylum citrate in tonsillectomy in terms of reducing the hemorrhage, duration of surgery, post operative pain and days of recovery.
Methods
A prospective study was conducted in Department of ENT, ESI Medical College, Kalburgi, Karnataka, India for a period of two years between January 2019 to December 2020. In this study, a total of 60 patients were involved and divided them into two groups. Thirty patients each undergoing tonsillectomy with the use of Feracrylum considered as Group I and without the use of Feracrylum in the tonsillar fossae considered as Group II. The study has been approved by Ethics committee and informed consent was obtained from all the study subjects. The diagnosis is made on the basis of detailed history, clinical examination and investigations.
Recurrent tonsillitis (5–6 episodes per year), previous episodes of peritonsillar abscess and sleep disordered breathing were included in the study. The patients with age less than 5 years, anaemia, bleeding diathesis, craniofacial disorders, cervical spine deformities, suspected malignancy of tonsil, acute or chronic tonsillitis, peritonsillar abscess, patient with co-morbidities and Immuno-compromised patients were excluded from the study.
Detailed physical and clinical examination done for all the subjects. Admitted patients underwent routine preoperative assessment. Every patient on the day of surgery was given preoperative dose of antibiotics and underwent surgery under general anaesthesia. Our sample size was 60 patients.Group I included 30 patients who underwent tonsillectomy by dissection and snare technique with use of 1% Feracrylum citrate in the tonsillar fossa for achieving hemostasis. 2 ml of Feracrylum soaked guaze was applied with pressure in the tonsillar fossa. After 1–2 min the tonsillar fossa is observed for the presence or absence of primary hemorrhage. After achieving complete hemostasis patient is extubated.
Group II consists of 30 subjects who too underwent tonsillectomy by dissection and snare technique.In this group of patients, saline soaked guaze is applied with pressure in the tonsillar fossa and after 1–2 min the fossa is observed for the presence or absence of bleeding. Bipolar diathermy and ligation was used as a method to achieve hemostasis during uncontrolled bleeding intra-operatively. Patient is extubated after achieving complete hemostasis. In both the goups on table intra-operative time, intra-operative bleeding are noted. Intra-operative time is noted from the time of incision to the removal of Boyle-Davis mouth gag. Immediate postoperative pain and complications noted. Post operatively all patients were given I.V., antibiotics for 3 days.
The amount of blood loss is calculated by the amount of blood collected in the suction bottle. The soaked guaze balls which were used for pressure hemostasis are weighed pre and post operatively (1gram = 1 ml).The total volume blood loss in the suction bottle and the weight of guaze gives the intra-operative blood loss. Post operative pain based on VAS (Visual Analogue Scale) is assessed in both the groups. It is an objective scoring technique which is inferred by patients or parents and categorized into mild (0–4), moderate (5–8) and severe pain (9,10).Assessment of recovery in days is estimated in both groups by reduced pain, gaining normal activity normal food intake.
Statistical analysis
Results on continuous measurements are presented on Mean ± SD and results on categorical measurements are presented in Number (%). Chi-square/Fisher Exact test has been used to find the significance of study parameters on categorical scale between two groups. P value < 0.05 considered as significant.
Results
Our study comprised of 60 patients and were divided into two groups, each containing 30 patients arranged on random basis. Group I, patients underwent tonsillectomy by dissection and snare technique and the hemostasis is achieved by the use of Feracrylum. Group II patients too underwent tonsillectomy by dissection and snare technique and the Feracrylum was not used.
In this, study, overall, 40 (66.7%) patients were under the age of 11–20 years. The 13 (21.7%) were in 21–30 years of age group whereas 4 (6.7%) were in 5–10 years age group. Younger age group had higher incidence of recurrent tonsillitis. Decrease in incidence is noted with advancing age (Table 1). Among 60 patients, 37 (61.7%) were males and 23 (38.3%) were females.
Table 1.
Age (years) distribution of patients in two groups studied
| Age (years) | Group I | Group II | Total |
|---|---|---|---|
| 5–10 | 2 (6.7%) | 2 (6.7%) | 4 (6.7%) |
| 11–20 | 18 (60%) | 22 (73.3%) | 40 (66.7%) |
| 21–30 | 8 (26.7%) | 5 (16.7%) | 13 (21.7%) |
| 31–40 | 1 (3.3%) | 0 (0%) | 1 (1.7%) |
| 41–50 | 1 (3.3%) | 1 (3.3%) | 2 (3.3%) |
| Total | 30 (100%) | 30 (100%) | 60 (100%) |
| Mean ± SD | 18.93 ± 7.93 | 17.80 ± 7.95 | 18.36 ± 7.89 |
Intra-operative time
In this study, intra-operative time in group I was 19.83 ± 3.93 min and in group II 27.16 ± 3.35 min (P < 0.001). The results showed a lesser intra-operative time when Feracrylum was used for hemostasis (Table 2).
Table 2.
Comparison of intra-op time and blood loss in two groups studied
| Variables | Group I | Group II | Total | P Value |
|---|---|---|---|---|
| Intra operative time in minutes | 19.83 ± 3.93 | 27.16 ± 3.35 | 23.50 ± 5.17 | < 0.001 |
| Intra-operative blood loss in ml | 26.67 ± 4.81 | 44.70 ± 7.59 | 35.68 ± 11.06 | < 0.001 |
Intra-operative blood loss
The intra-operative blood loss in group I was 26.67 ± 4.81 ml and in group II 44.70 ± 7.59 ml (P < 0.001). The results showed less blood loss in group I (Table 2).
Severity of pain
Assessment of severity of pain was done by using Visual Analogue Scale. It was an objective scoring given by parents or patients and categorized into mild (0–4), moderate (5–8) and severe pain (9–10) (Table 3).
Table 3.
Pain distribution of patients in two groups studied
| Pain | Group I | Group II | Total | % Difference |
|---|---|---|---|---|
| Post-operative day 1 | ||||
| Mild pain | 10 (33.3%) | 0 (0%) | 10 (16.7%) | − 16.6% |
| Moderate pain | 19 (63.3%) | 23 (76.7%) | 42 (70%) | 6.6% |
| Severe pain | 1 (3.3%) | 7 (23.3%) | 8 (13.3%) | 10.0% |
| Post-operative day 2 | ||||
| Mild pain | 28 (93.3%) | 20 (66.7%) | 48 (80%) | − 13.3% |
| Moderate pain | 2 (6.7%) | 9 (30%) | 11 (18.3%) | 11.6% |
| Severe pain | 0 (0%) | 1 (3.3%) | 1 (1.7%) | 1.7% |
| Post-operative day 3 | ||||
| Mild pain | 29 (96.7%) | 20 (66.7%) | 49 (81.7%) | − 15.0% |
| Moderate pain | 0 (0%) | 10 (33.3%) | 10 (16.7%) | 16.7% |
| Severe pain | 1 (3.3%) | 0 (0%) | 1 (1.7%) | − 1.6% |
| Total | 30 (100%) | 30 (100%) | 60 (100%) | – |
In Group I, during 1st post-operative day 10 (33.3%) patients had mild pain, 19 (63.3%) had moderate pain and 1 (3.3%) had severe pain. In Group II, majority of the patients 23 (76.7%) had moderate pain and 7 (23.3%) had severe pain. In the second post operative day none of the patients experienced severe pain. 28 (93.3%) had mild pain and 2 (6.7%) had moderate pain. In Group II only 20 (66.7%) had mild pain while 9 (30%) patients still experienced moderate pain and 1 patient (3.3%) had severe pain. In the third postoperative day 29 (96.7%) patients had mild pain and one patient with severe pain in Group I, while in Group II 20 (66.7%) had mild pain and 10 (33.3%) had moderate pain. We noticed that the majority of the patients experienced mild pain in Group I when Feracrylum was used during hemostasis (Table 4).
Table 4.
Days for recovery from pain
| Days for recovery from pain | Group I | Group II | Total |
|---|---|---|---|
| 1–2 Days | 20 (66.7%) | 7 (23.3%) | 27 (45%) |
| 3–4 Days | 10 (33.3%) | 20 (66.7%) | 30 (50%) |
| > 5 Days | 0 (0%) | 3 (10%) | 3 (5%) |
| Total | 30 (100%) | 30 (100%) | 60 (100%) |
We noticed that the time taken by the patients to recover from pain, resume their normal activity (Table 5) and also with regard to normal food intake was rapid (Table 6). On an average of 2–3 days was seen in Group I. Group II patients required 3–5 days to recover from pain and resuming normal activity and food intake (Table 7).
Table 5.
Days to resume to normal activity
| Days to resume to normal activity | Group I | Group II | Total |
|---|---|---|---|
| 1 | 1 (3.3%) | 0 (0%) | 1 (1.7%) |
| 2 | 24 (80%) | 5 (16.7%) | 29 (48.3%) |
| 3 | 5 (16.7%) | 16 (53.3%) | 21 (35%) |
| 4 | 0 (0%) | 7 (23.3%) | 7 (11.7%) |
| 5 | 0 (0%) | 2 (6.7%) | 2 (3.3%) |
| Total | 30 (100%) | 30 (100%) | 60 (100%) |
Table 6.
Days for intake of normal food
| Days for intake of normal food | Group I | Group II | Total |
|---|---|---|---|
| 1 | 4 (13.3%) | 0 (0%) | 4 (6.7%) |
| 2 | 21 (70%) | 7 (23.3%) | 28 (46.7%) |
| 3 | 4 (13.3%) | 10 (33.3%) | 14 (23.3%) |
| 4 | 1 (3.3%) | 10 (33.3%) | 11 (18.3%) |
| > 5 | 0 (0%) | 3 (10%) | 3 (5%) |
| Total | 30 (100%) | 30 (100%) | 60 (100%) |
Table 7.
Comparison of days of recovery from pain, days to resume to normal activity and days for intake of normal food in two groups
| Variables | Group I | Group II | Total | P Value |
|---|---|---|---|---|
| Days for recovery from pain | 2.33 ± 0.47 | 3.30 ± 0.95 | 2.81 ± 0.89 | < 0.001 |
| Days to resume to normal activity | 2.13 ± 0.43 | 3.20 ± 0.80 | 2.66 ± 0.83 | < 0.001 |
| Days for intake of normal food | 2.06 ± 0.63 | 3.40 ± 1.16 | 2.73 ± 1.14 | < 0.001 |
Discussion
Tonsillectomy though commonly performed surgeries globally, surgeon always experience dreaded complication of hemorrhage which leads to aspiration and shock. The intra-operative blood loss exceeding more than 10% of patients blood volume is around 18% and post operative hemorrhage occurs in 0–10% cases. Mortality is between 1 per 1100 and 1 per 16,000 cases [9]. To make tonsillectomy an ideal procedure, it should be quick, painless and with minimum blood loss. A wide variety of hemostatic agents are used in an attempt to reduce intra-operative blood loss and post tonsillectomy hemorrhage. Topical use of astringents like silver nitrate, tannic acid, adrenalin, tranexemic acid have been tried to control hemorrhage [9].
In the current study, we used 1% Feracrylum citrate, a novel hemostatic agent [10]. It is an effective, safe, reliable topical agent which is used in various surgeries for control of diffuse oozing from the surgical site [11].
Feracrylum is a water soluble mixture of incomplete ferrous salt II and III of polyacrylic acid containing 0.05–0.5% of iron. It is biodegradable and hygroscopic. The molecular weight is about 5,00,000–8,00,000 Daltons, due to which there is no systemic absorption. No noted side effects on major organs like liver, kidney, adrenal gland, cardiovascular system and hemopoietic system. It has antimicrobial and wound healing properties [11].
It activates thrombin, converting soluble fibrinogen into insoluble strands of fibrin. This results in formation of clot and catalyses coagulation related reactions. Feracrylum combines with blood protein like albumin and forms a gel like substance which acts as a barrier on the raw surface which halts the capillary ooze and bleeding [5, 12]. Recurrent tonsillitis is a problem of younger age group. The incidence decreases with increasing age. In a study conducted by Karan Sharma et al., 32% were from the age group of 11–20 years and 20% were in the age group of 21–30 years and 10% were in the age group of 31–40. Similarly in our study 66.7% contributed to the age group of 11–20, 13 (21.7%) were in the age group of 21–30 and only 5% in the age group of 31–50 had episodes of recurrent tonsillitis [9]. The common morbidity associated with tonsillectomy is the hemorrhage. Conventional techniques like ligation and or cauterization control major bleeding vessels, there could be diffuse bleeding and capillary ooze which poses a challenge to locate bleeders leading to inefficient hemostasis and increase the intra-operative blood loss and prolong the duration of surgery. Tonsil has a robust vascular supply and tonsillectomy is the “ultimate test of hemostasis”.
In our current study when Feracrylum was used the intra-operative blood loss was 26.67 ± 4.81 ml as compared to the other group wherein the blood loss was 44.70 ± 7.59 ml when Feracrylum was not used. Sathyaki et al. compared the use of Feracrylum with that of tranexemic acid in the tonsillar fossa as a hemostatic agent none of the patients required ligation or bipolar diathermy to achieve hemostasis intra-operatively [5]. In this study, intra-operatively patient did not require ligation or bipolar diathermy and blood loss was significantly less than the comparative group.
Our results were also in concordance with the results obtained by Sathyaki et al. compared the use of Feracrylum with that of adrenalin and did not require ligation of vessels after tonsillectomy when Feracrylum was used [13].
Ideally tonsillectomy should be quick and with minimum blood loss. In this study, the time taken to achieve hemostasis was faster with the use of Feracrylum and opting with use of bipolar diathermy and ligation as a method of hemostasis in Group II resulted in increase in intra-operative duration. In Group I, the intra-operative time was 19.83 ± 3.93 min as compared to Group II the time was 27.16 ± 3.35 min. We observed improvement in time required for achieving hemostasis with the use of Feracrylum.
Pain is an unpleasant and distressing complex with emotional experience. Emotional and psychological set up of the patient also affects the pain threshold. Pain in children is comparatively less compared to adults. Increased scar tissue and more injury in adults make the pain worse than children. Pain after tonsillectomy results in significant morbidity [14].
Pain is at the peak immediately after procedure and continuous for next three days [15]. Lot of debate has been found in literature regarding pain management. Various techniques are also employed to reduce the pain. Topical application is considered to be the simplest and the safest to be used during the procedure. Feracrylum has wound healing capacity and its antibacterial properties help in faster recovery of the raw surface.
In the present study, on the first post operative day 33.3% from Group I experienced mild pain and 63.3% had moderate pain in Group II. Use of bipolar diathermy causes of charring of tissue and increased scar tissue formation which leads to increase in intensity of pain. Significant differences were found when the pain scores were obtained on different days after surgery.
Tonsillectomy is associated with morbidity. Morbidity in terms of hemorrhage, pain, fever, poor oral intake and increased duration of hospitalisation. Patients from group I were able to recover from pain, resuming normal activity and normal diet intake in 2–3 days. In contrast, patients from group II took around 3–5 days to recover from surgery. We did not encounter any postoperative hemorrhage owing to meticulous dissection and proper control of hemostasis intra-operatively.
Our study has demonstrated that the use of Feracrylum in tonsillectomy is safe and effective in controlling the intra-operative blood loss. It also reduced the intra-operative time and faster post- operative recovery. However other methods can also be used in tonsillectomy with a favourable outcome.
Conclusion
The present study, results may conclude that lesser intra-operative time and also less blood loss when Feracrylum was used. Patients recovered from pain, resumed normal activity and food intake within 2–3 days in Group I and about 3–5 days in Group II. In this study, majority of the patients experienced mild pain in Group I when Feracrylum was used during hemostasis. The time taken by the patients to recover from pain, resume their normal activity and also with regard to normal food intake was rapid. Feracrylum application as a hemostatic agent during tonsillectomy is effective in reducing intra-operative blood loss and also reducing operative time. Post op recovery was quick with no side effects or complications. Further, studies are recommended with large sample size to confirm these findings.
Funding
None.
Declaration
Conflict of Interest
The authors declare that they have no conflict of interest.
Footnotes
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