The Sealıng Effect Of A Fıbrın Tıssue Patch On The Esophageal Perforatıon Area In Prımary Repaır
THE SEALING EFFECT OF A FIBRIN TISSUE PATCH ON THE ESOPHAGEAL PERFORATION AREA IN PRIMARY REPAIR
Authors:
1) Abdullah Erdogan1, MD, Associated Professor,
2) Gulsum Gurses1, MD, Physician,
3) Hakan Keskin1, MD,
4) Abid Demircan1, MD, Professor, Head of Department,
1Institution and Affiliations: Akdeniz University School of Medicine, Department of Thoracic Surgery, Antalya, Turkey
Correspondence Address:
Dr. Abdullah Erdogan
Akdeniz University, School of Medicine
Department of Thoracic Surgery
07070 Antalya, Turkey
Phone number: + 90 242 2496815
Fax number: +90 242 2274490
e-mail: erdogana@akdeniz.edu.tr
Running Head: Primary reinforcement repair for esophageal perforation
Abstract
Background: We aimed to investigate the efficacy of the fibrin tissue patch and to analyze patients having esophageal perforation in this study.
Methods: We analyzed 28 patients, diagnosed with esophageal perforation, between January 1990 and January 2006 at Akdeniz University Hospital. Sixteen (57.14%) were male, the others female. The average age was 59±9 years. We performed surgery and primary repair reinforcement even if the diagnosis was late.
Results: Twenty-three (82.14%) perforations were due to endoscopic instruments, spontaneous perforations occurred in 3 (10.71%) patients. Postoperative complication (Heller myotomy) caused one perforation (3.57%) and blunt trauma in one (3.57%) patient. A total of 3 (10.71%) patients had cervical perforation, and the other 25 (89.29%) patients had thoracic esophageal perforation. Twelve (42.86%) patients underwent emergency surgery (within the first 24 hours). Ten (35.71%) patients underwent surgery within 48 hours, and the remaining 6 (21.43%) patients underwent surgery very late (after 48 hours).
Nine (32.14%) patients had primary repair, 7 (25%) patients had the reinforcement of the primary repair with fibrin tissue patch, 7 (25%) patients had esophagectomy and gastric pull-up, and 2 (7.14%) patients had drainage and metallic stents.
In 4 patients of the 9 who had primary repair, fistula complication was detected, whereas, in only one patient of the 7 who had reinforcement of the primary repair with fibrin tissue patch were fistula detected.
Three patients (10.71%), two of them with Boerhaave’s syndrome, died.
Conclusions: Surgical primary repair with fibrin tissue patch is the most successful treatment option in the management of esophageal perforation.
Key Words: Esophageal perforation, primary repair, fibrin tissue patch
Introduction
Esophageal perforation still continues to carry a significant risk of mortality and morbidity [1]. The mortality rate rises steeply if there is a delay in diagnosis and in the initiation of optimum treatment. The reported mortality from treated esophageal perforation is between nearly 4% and 20% when therapy is initiated within 24 hours of perforation, but it could rise to more than double this mortality rate when the treatment is delayed beyond 48 hours [2,3].
The rate of perforation of the esophagus by medical apparatus has increased a consequence of the recent and rapid development in esophagoscopy [4]. In the last 2 decades, advances in surgery, anesthesia, postoperative care, hyper alimentation, and powerful and selective antibiotics have caused substantial improvements in the outcome of the treatment of esophageal perforation [5].
Regarding the choice of treatment option for a delayed or a missed rupture of the esophagus, this is not very clear and is still controversial. The fact that many procedures have been described in the literature is indicative that no single surgical procedure can be considered a gold standard for the treatment of esophageal perforation [6]. Different procedures described for delayed esophageal perforation include primary repair with or without reinforcement [7], simple drainage of the thoracic cavity [8], exclusion diversion operation [9], occlusion of the perforation site with prosthesis such as expandable metallic stents [10], and single stage esophageal resection with or without primary reconstruction [11].
The purpose of this study is to review the etiology, management, and outcome of 28 esophageal perforations and to analyze the patients’ treated with reinforcement material, a fibrin tissue patch, named TachoComb (manufacturer: NYCOMED; Austria GmbH A-4020 Linz, Austria).
Materials and Methods
We treated 28 patients who had esophageal perforation at our clinic in the period between January 1990 and January 2006. There were 16 (57.14%) males and 12 (42.86%) females. The average age was 59±9 years (Range 19-78 years). We analyzed the patients according to the perforation area, the causes of the perforation, the time taken in diagnosis, the type of therapy methods for esophageal perforation and the results of these therapy methods (Table 1). Esophageal perforation was diagnosed from physical examination, chest x-ray, and water soluble contrast esophagogram (Iopamiro).
We categorized those patients who obtained early diagnosis and who underwent primary repair surgery into two categories. The first category included 9 (32.14%) patients who were treated with only primary repair without reinforcement, between 1990 and 2002. The second category included 7 (25%) patients who were treated with reinforcement of the primary repair with a fibrin tissue patch between 2003 and 2006 (Table 2). We used a fibrin tissue patch on the area of esophageal perforation after the primary repair operation, even if the diagnosis was late (within 48 hours), after 2003 (Figure 1). The fibrin tissue patch employed is a collagen derived material produced from horses’ equine and it adheres to the tissue when wet with tissue fluid. Therefore, it is wrapped circumferentially, without stitching, over the area of primary repair after the perforation area was managed through sewn two steps suture. The perforated mucosal layer was closed with 3/0 polyglactin 910 (Coated Vicryl; Johnson & Johnson Professional Export Company Ethicon Limited, Edinburgh, England). And the muscle layer was closed with 3/0 silk sutures (Doğsan; atraumatic silk, Gazipaşa Cad. 13. Trabzon, Türkiye).
During the operation we inserted a nasogastric tube in all operated patients. It was removed on the 8th day postoperatively if there were no complications, and the patients took a normal diet. We confirmed the swallow function of the operated patients with barium swallow postoperatively within two weeks.
Moderate to severe pain was the hallmark for all patients. Emphysema and crepitating of the subcutaneous, in neck palpation, was present in 3 patients.
Statistical Analysis
Continuous variables such as age were expressed as the mean ± standard deviation (SD) and analyzed by the t-test or Mann-Whitney U test. Categorical variables such as gender were presented by frequency (%) and analyzed by the c2 tests (SPSS 10 for Windows, SPSS Institute, Chicago, IL). A p value of less than 0.05 was regarded as significant.
Results
The cause of esophageal perforations included endoscopic bougginage, in 12 (42.86%) patients, endoscopic balloon dilatation in 11 (39.29%) patients, spontaneous rupture (Boerhaave’s syndrome) in 3 (10.71%) patients, postoperative complication (after Heller myotomy) in one (3.57%) patient, and external blunt trauma in one (3.57%) patient. Some other demographic variables are demonstrated in Table 1 such as; clinical presentation, perforation area, gender, diagnosis time, type of operation, etc.
Chest pain, the most common presenting symptom, was observed in 23 (82.14%) of the 28 patients. Other symptoms were: dyspnea 19 (67.86%), dysphagia 12 (42.86%), fever 6 (21.43%) and back pain 4 (14.29%). For patients who had cervical esophageal perforations subcutaneous emphysema was the most common sign and was detected in 3 (10.71) patients.
Chest x-rays were performed for all patients and revealed hydropneumothorax in 9 (32.14%), pleural effusion in 8 (28.57%), mediastinal widening in 5 (17.86%), mediastinal air in 4 (14.29%), and pneumothorax in 2 (7.14%) patients. Diagnosis was confirmed by water soluble contrast esophagography (Iopamiro) in 11 (39.29%) patients, and by endoscopy in all patients. Perforations were detected in the cervical esophagus in 3 (10.71%) patients, and of the thoracic esophagus in 25 (89.29%) patients. The three patients (10.71%) who had cervical esophageal perforation were managed through non operative treatment. The remaining 25 (89.29%) patients were treated surgically. The interval between rupture and initial treatment was less than 24 hours in 12 (42.86%), within the second day in 10 (35.71%), and longer than the second day in 6 (21.43%) cases.
We performed aggressive surgical therapy even if the diagnosis was late. In operation, primary closure was performed in 9 (32.14%) patients, and reinforcement with a fibrin tissue patch after primary closure was performed in 7 (25%) patients. In addition, we performed esophagectomy and gastric pull-up in 7 (25%) patients and esophageal self expandable metallic stents were placed in 2 (7.14%) patients. If very late diagnosis occurred (after 48 hours), we performed esophageal resection or the implementation of self expandable esophageal stents.
No deaths were observed from cervical esophageal perforation, while 3 patients died from thoracic esophageal perforation in the postoperative period. Two of the deaths were from Boerhaave’s syndrome and thoracic esophageal spontaneous perforations were detected. The detected causes of deaths were acute metabolic and respiratory failure in the early postoperative period (first and third days). The other death, of a 78 years old man having chronic obstructive pulmonary disease, was diagnosed after the 8th day of perforation. He underwent left thoracotomy and drainage but died due to acute respiratory failure postoperatively after 5 days.
Complications were detected in 12 (42.86%) patients and were as follows: anastomotic leakage and fistula in 5 (17.86%) patients, respiratory failure in one (3.57%) patient, atelectasis in two (7.14%) patients, wound infection in one (3.57%) patient, empyema in one (3.57%) patient, and arrhythmia in one (%) patient.
We divided the patients who underwent primary repair into two groups. The first group included 9 patients who had only primary closure. The second group included 7 patients who had reinforcement of the primary repair with the fibrin tissue patch (Figure 1). We preferred primary repair if diagnosis was obtained within 24 hours (n=8), but, we preferred reinforcement of the primary repair with the fibrin tissue patch if diagnosis was late, within the second day, (n=6). We used the fibrin tissue patch when it became available in 2003. We preferred using the fibrin tissue patch for all primary repairs after 2003. We compared the two groups according to the complication rate and the date of the operation.
We detected one fistula in 5 patients who were diagnosed within the first day, and 3 fistulas in 4 patients who were diagnosed late (within the second day), who underwent primary repair between 1990 and 2002. Whereas we did not detect any fistula diagnosed within the first day, and only one fistula in 4 patients who were diagnosed late (within the second day) who underwent reinforcement of the primary repair with the fibrin tissue patch, between 2003 and 2006 (Table 2). But, this result-the comparison of the postoperative fistula rate for the reinforcement of the primary closure with a fibrin tissue patch and only primary closure operations-was not statistically valuable (p=0.092). Due to the very small number of patients the results were statistically invalid.
We implanted self expandable metallic stents in 5 patients who underwent anastomotic leakage and fistula after the first operation.
The mean hospital stay was 17.5±9.3 days (range, 5-37 days). When the patients were discharged all the patients were on a normal diet and none of the patients had dysphagia. Follow-up information was available from phone, mail, and email for 11 (44%) of the 25 survivors. The mean follow up period was 14 months (7 days-60 months). No patient required re-operation on the esophagus in the follow up period.
Discussion
There is no clear consensus concerning the treatment of esophageal perforation, discussions related to therapy methods for esophageal perforation continue [12]. But many surgeons recommended surgical intervention should be performed, even if the diagnosis is obtained in the late period [12,13]. Various factors have important impacts on the choice of treatment approach, they are as follows: the cause and location of the perforation, the presence of underlying esophageal disease, the time interval between perforation and diagnosis, and the age and general status and any additional diseases of the patient. The treatment options include medical or surgical interventions. In our series, we performed non-operative therapy on 10 (35.71%) patients. Three of these patients had esophageal stents, as these patients had cervical esophageal perforation and all of these patients were treated through non-operative therapy.
Surgical interventions may include an esophageal resection or exclusion, or chest drainage with or without esophageal repair. The primary repair of the perforation of the esophagus within 24 hours, in the absence of pre-existing esophageal disease, remains the gold standard of therapy, and it is the approach most commonly advocated in the literature [14-16]. The perforation area was closed primarily and separately after muscular and mucosal debridmant, and the reinforcement of the primary repair has been advocated by many surgeons, even if diagnosis was obtained in the late period [17,18].
In our series, we preferred to reinforce the primary repair with a fibrin tissue patch within the first 48 hours. And we found a 14.29% complication rate, anastomotic leakage, in patients who had reinforcement. But we did not detect the same success rate for those patients who had repair without the fibrin tissue patch. We observed a 44.44% fistula complication rate in those patients who had repair without the fibrin tissue patch. When we compared the two groups, primary repair with a fibrin tissue patch and primary repair without the fibrin tissue patch, the complication rate for the patients who had primary repair with a fibrin tissue patch was far less, but this outcome was not valuable statistically (p=0.092), due to the very small number of patients.
Of course, reinforcement primary repair can be performed with autologous tissue patches such as the pleura, diaphragm or pericardial fat in surgical intervention; additionally it would be cheaper than prosthetic reinforcement material such as fibrin tissue patch, because of its cost. When the autologous material can not be feasible or available, fibrin tissue patch as a reinforcement material is a good alternative choose. Fibrin tissue patch is not a persistent material into the body; it will be absorbed from the body within 3 weeks. Consequently, our series recommended that fibrin tissue patch for the management of esophageal perforation can be a good alternative reinforcement prosthetic material in selective esophageal perforation patients.
In our series, the mortality rate was only one (4%) patient from instrumental injury but 2 (66.6%) patients from spontaneous perforation (Boerhaave’s syndrome). The total mortality was 3 patients, a rate of 10.71%. This result is similar to those of previously reported papers [2,3].
From these results, we continue to support aggressive, definitive surgery, the reinforcement of the primary repair with the fibrin tissue patch in those patients with thoracic esophageal perforations that are diagnosed early (within 24 hours) or moderate late (within 48 hours).
In summary, esophageal perforation is a serious disorder that is difficult to diagnose and manage. Early diagnosis and treatment are essential to reduce mortality rates. The most successful therapy option in the management of esophageal perforation is surgical reinforcement of the primary repair with reinforcement material such as autologous (pleura etc.) or non-autologous (fibrin tissue patch). Non-operative therapy is appropriate in certain well-defined situations, frequently for cervical esophageal perforation. Additionally, performing metallic stents is an alternative therapy method when fistula is detected in the late period.
Acknowledgement
We record our appreciation of TMP Duggan, for editing this article for language.
This study was supported by the Akdeniz University Research Fund.
References
1. Jones WG, Ginsberg RJ. Esophageal perforation: a continuing challenge. Ann Thorac Surg 1992;53:534-543.
2. Port JL, Kent MS, Korst RJ, et al. Thoracic esophageal perforations: a decate of experience. Ann Thorac Surg 2003;75:1071-1074.
3. Brinster CJ, Singhal S, Lee L, et al. Evolving options in the management of esophageal perforation. Ann Thorac Surg 2004;77:1475-1483.
4. Wesdorp IC, Bartelsman JF, Huibregtse K, et al. Treatment of instrumental esophageal perforation. Gut 1984;25:398-404.
5. Attar S, Hankins JR, Suter CM, et al. Esophageal perforation: a therapeutic challenge. Ann Thorac Surg 1990;50:45-51.
6. Eroglu A, Kurkcuoglu IC, Karaoglanoglu N, et al. Esophageal perforation: the importance of early diagnosis and primary repair. Dis Esoph 2004;17:91-94.
7. Bufkin BL, Miller JI Jr, Mansour KA. Esophageal perforation: emphasis on management. Ann Thorac Surg 1996;61:1447-1452.
8. Flynn AE, Verrier ED, Way LW, et al. Esophageal perforation. Arch Surg 1989;124:1211-1215.
9. Urschel HC JR, Razzuk MA, Wood RE, et al. Improved management of esophageal perforation: exclusion and diversion in continuity. Ann Surg 1974;179:587-591.
10. Johnsson E, Lundell L, Liedman B. Sealing of esophageal perforation or ruptures with expandable metallic stents: a prospective controlled study on treatment efficacy and limitation. Dis Esoph 2005;18:262-266.
11. Kiernan PD, Sheridan MJ, Hettrick V, et al. Thoracic esophageal perforation: one surgeon’s experience. Dis Esoph 2006;19:24-30.
12. Okten I, Cangır AK, Ozdemir N, et al. Management of esophageal perforation. Surg Today 2001;31:36-39.
13. Chao YK, Liu YH, Ko PJ, et al. Treatment of esophageal perforation in a referral center in Taiwan. Surg Today 2005;35:828-832.
14. Khan AA, Shah SW, Alam A, et al. Sixteen years follow up of achalasia: A prospective study of graded dilatation using Rigiflex balloon. Dis Esoph 2005;18:41-45.
15. Richardson JD. Management of esophageal perforations: the value of aggressive surgical treatment. Am J Surg. 2005;190:161-165.
16. Bladergroen MR, Lowe JE, Postlethwait RW. Diagnosis and recommended management of esophageal perforation and rupture. Ann Thorac Surg 1986;42:235-239.
17. Sung SW, Park JJ, Kim YT, et al. Surgery in thoracic esophageal perforation: primary repair is feasible. Dis Esoph 2002;15:204-209.
18. Wright CD, Mathisen DJ, Wain JC, et al. Reinforced primary repair of thoracic esophageal perforation. Ann Thorac Surg 1995;60:245-249.
Table 1. Patients Characteristics
Characteristics
N (Number of patient) (%)
Gender
Male
17 (60.71%)
Female
11 (39.29%)
Location of Perforation
Cervical
3 (10.71%)
Thoracic
25 (89.29%)
Initial esophageal disease
Corrosive esophagitis
13 (46.43%)
Achalasia
11 (39.26%)
Esophageal Carcinoma
3 (10.71%)
Foreign body extraction
1 (3.57%)
Etiologic factors
Endoscopic bougginage
12 (42.86%)
Endoscopic balloon dilatation
11 (39.29%)
Spontaneously (Boerhaave’s Syndrome)
3 (10.71%)
Traumatic
1 (3.57%)
Postoperative complication (Heller myotomy)
1 (3.57%)
Time Before Diagnosis
Within 24 hours
12 (42.86%)
Within 48 hours
10 (35.71%)
After 48 hours
6 (21.43%)
Therapy Options
Nonoperative
3 (10.71%)
Surgical therapy
25 (89.29%)
Type of surgical options
Primary closure (only)
9 (32.14%)
Primary repair (reinforcement with fibrin tissue patch)
7 (25%)
Esophagectomy+gastric pull-up
7 (25%)
Stents+drainage
2 (7.14%)
Table 2. Complications rates and number of fistula according to operation type and date
Years
1990 - 2002
2003 - 2006
Diagnosis time
First day
Second day
First day
Second day
Primary closure only
5
4
1
0
Anastomotic leakage(fistula)
1
3
0
0
Reinforcement of the primary repair
0
0
2
4
Anastomotic leakage(fistula)
0
0
0
1
Other complications (1990-2006)
N (Number of patients)
%
Atelectasis
2
7.14
Respiratory failure
1
3.57
Empyema
1
3.57
Wound infection
1
3.57
Arrhythmia
1
3.57
Bleeding
1
3.57
Figure 1. Reinforcement of the primary repair with the fibrin tissue patch on the esophagus, following the primary repair, at the perforation site.
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