Ozone Therapy For The Management Of Postoperative Enterocutaneous Fistula:Clinical Analysis

BackgroundEnterocutaneous fistula (ECF) is the physical channel between the inside of intestine and the outside of skin, which is a serious complication after abdominal surgery and may lead to leakage of intestinal contents, and consequent infection, fluid loss, malnutrition, organ dysfunction and a series of other pathophysiological changes. Once enterocutaneous fistula occurred,its symptoms and influence on the whole body depend on the size and location of the fistula and the original diseases. In less severe cases, only a small amount of intestinal contents fluid from the fistula outlet. While in more serious cases, there will be a series of pathophysiology change, involving in homeostasis, nutrition, infection, and organ dysfunction,etc.And those will lead to circulatory failure, systemic bacterial infection, abdominal cavity infection and multiple organ dysfunction syndrome. Also a series of symptom such as hypoalbuminemia, vitamin deficiency and the decline in immune function and so on are caused by various of absent nutrient elements. And these factors influence each other, forming a vicious circle. Otherwise, infection is the leading cause of death in patients who suffered with enterocutaneous fistula. Therefore, controlling of infection is the key to improve the external intestinal fistula patients survival rate. Nowadays the principles of ECF treatment have been clearly delineated and generally accepted.They include early drainage, treatment of infection, nutritional support, etc, aiming at improving spontaneous closure rates. Otherwise a definitive surgical intervention will be done. However, under such circumstances the hospital stays will be prolonged and there will be more complications and suffering as well as heavier economic burden. Still, the management of ECF continues to be a challenging surgical problem. With the development of aging society, the incidence of diabetes,tumor, organ transplantation and immune dysfunction will increase and the incidence of intestinal fistula will also significantly increased as well. Thus, it is high time that a more effective method should be found for the management of enterocutaneous fistula. And the aim of this study was to improve effective rates, provide relief from the pain of the ECF patients under the treatment of percutaneous catheter drainage and ozone therapy.In recent years, ozone therapy has been widely used in clinical treatments and achieved significant disinfection, rot-removal and myogenic effects. It has played an important role in the treatment of infectious diseases, particularly in developing countries. Although in the developed countries (such as USA and Canada), ozone therapy is still not accepted widely. But ozone therapy is getting more and more importance in the medical field due to its unique role, especially in today when nosocomial infections occur frequently for the reason of the widespread use of antibiotics.At present in Europe, ozone therapy is mainly used for lumbar intervertebral disc herniation, osteoarthropathy, trauma, refractory ulcer (such as diabetic foot), the adjuvant therapy for cancer, free redical scavenger, anti-ageing, stroke and viral infection, etc. Its clinical efficacy has been fully affirmed. So, we were tried to combine Digital Subtraction Angiography (DSA)-guided percutaneous catheter drainage with ozone therapy for the treatment of enterocutaneous fistula, aiming to improve the cure rate of intestinal fistula, alleviate the suffering of patients and provide a new method for the clinical treatment of enterocutaneous fistula.ObjectiveThe purpose of the present study was to evaluate the efficacy and safety of ozone therapy for the management of postoperative ECF, preliminary explored ozone therapy experience for ECF and provide a new methods for this group of patients.Materials and Methods1, General information:Subjects included70cases of postoperative enterocutaneous fistula admitted by Nanfang Hospital, Southern Medical University from May2008to October2013. They were divided into group A (35cases) who received conventional surgical treatment and group B (35cases) with ozone therapy. Group A included23male and12female, aging21-77years old with an average of48±2.55years. They were given conventional surgery treatment. And group B included20male and15female, aging27-73years old with an average of46±1.88years. They were given ozone therapy. Diagnosis of enterocutaneous fistula was based on abdominal Computed tomography (CT), gastrointestinal imaging, laboratory tests of fistula effluent and peritoneal drainage and so on. All cases of enterocutaneous fistulas are related to recent or previous surgery.The patients with original diseases included30cases of acute appendicitis,15cases of peptic ulcer perforation (including6cases of gastric perforation and duodenal perforation in9cases),12cases of gynecologic operation (8cases of metrocarcinoma,2cases of ovarian cyst and tubal ligation in2cases),7cases of gastrointestinal malignant tumors,4cases of abdominal trauma,2cases after liver transplantation. And the anatomical position included42cases of intestinal fistula,18cases of colonic fistula,6cases of anastomotic leakage and4cases of duodenal fistula. In the70patients,21 cases with high-flow fistula (>500ml/d) and49cases with low-flow fistula (<500ml/d). The main clinical manifestation in all the patients was described as follows:mostly of the group with different degrees of abdominal pain, fever and the other symptoms of peritonitis, and showing quantity and quality of the change of peritoneal drainage contents and bile and feces liquid was found in the wounds or in thedrainage tube location. Meantime, gender, age, laboratory examination(such as blood routine, liver function, renal function, electrolyte, preoperative eight items, coagulation function, C reactive protein and procalcitonin, fistula exudate and chest X-ray, electrocardiogram and abdominal B ultrasound and so on)before treament, the cause and location of intestinal fistula of all patients were recorded before treatment. All patients underwent routine CT examination to determine the location, number, size of the fistula, the distance between fistula opening and the skin, the situation of drainage and whether there’s secondary abdominal abscess. The two group of patients were comparable in gender composition, age, infection assessment, and nutritional risk screening without significant differences (P>0.05). before treatment.2, Therapeutic method:Once the diagnosis of ECF, strategies for successful resolution of ECF included fasting, gastrointestinal decompression, unobstructed abdominal drainage, in which the drainage catheter is generally placed near the opening of the fistula. The patients also received treatments to maintain organ function and water-electrolyte balance, anti-infection treatments, growth hormone treatment to reduce overflow of intestinal fistula, and nutritional support. At the early stages of enterocutaneous fistula, the patients were given total parenteral nutrition (TPN), with the progression of treatment, the patients gradually shifted to total enteral nutrition (TEN) in accordance with amount of drainage fluid.(1) Group A:patients in group A received conventional surgical treatment as described above to promote fistula healing. At the same time, drainaging of abdominal cavity could be set up smoothly. And patients were treated with physiological saline for all the time. Triple cavity tube were used as the drainage tubes.(2) Group B:patients of this group received ozone therapy. Ozone were produced by an ozone generator from medical oxygen with a final concentration of40ug/ml. Ozone water was obtained by ozone gas via into sterile double distilled water through antioxidant pipe bubbled for at least5minutes. The patients were laid in supine position on a DS A examination bed, after prepping and draping, the dilator was slowly pushed into the sinus under the guidance of guiding wire, contrast agent was injected while pushing to understand the length of fistulous tract, dead space, the size and the communication with the intestinal etc. Then the dilator was pulled out, and an8.5F five-hole external biliary drainage catheter (Ultrathane biliary drainage catheter, COOK, USA) was put in the fistula tract until the large dead space or bowel guided by the guiding wire. Both the sinus and intestine were visible in the following angiography. After transferring the patient back to ward, ozone water can be continuously infused through the drainage catheter. Angiographic re-examination can be performed periodically during the course, and position of the drainage catheter can be adjusted at any time according to change in size of abscess cavity. When drainage amount was significantly reduced and fistula opening shrunk, ozone gas can be infused through drainage catheter to keep the fistula opening clean and dry. The patients were deprived of water and food for3-5days when necessary to reduce intestinal fluid secretion and to promote fistula healing. Digestive tract angiography or CT examination were performed at2weeks after surgery to evaluate the efficacy.Ozone fumigation treatment was performed in case of skin erosion. And the extubation pointer was depend on the existence of dead space and overflow of fistula liquid. 3, Postoperative treatment, evaluation and follow-up:All patients were given conventional anti-infection, nutritional support and maintain organ function etc. Restoration of bowel continuity, overflowing juice and healing wound were evaluated. The follow-up including the telephone follow-up and patient came back to hospital for review. All patients were followed up at1,3,6and12month after the treatment. And the contents of follow-up included the examination of blood routine, liver and renal function, electrolyte, preoperative eight items, coagulation function, CRP and procalcitonin, fistula exudate and chest x-ray, electrocardiogram, abdominal B ultrasound and CT, etc. The surgical infection score in2group before and after treatment (3days,1week,2weeks,1months) was recorded and compared with repeated measures ANOVA. The adverse reaction would be counted but not the effect for the patients who failed to complete the treatment due to the side reaction. Re-surgery or ozone treatment could also be done for the patients with recurrence of symptoms.4,Statistical analysis:data were analyzed using SPSS13.0statistical software. Measurement data were presented as x±S and analyzed using t test; count data were analyzed using x2test. The surgical infection score in2group before and after treatment (3days,1week,2weeks,1months) was recorded and compared with repeated measures ANOVA P<0.05was considered to indicate a statistically significant difference.ResultsAll the patients were followed for a mean of6months (range3to12months). The mean (+SD) hospital stay was40.7+4.70days in group A, as compared with27.3±1.87days (P=0.049) in group B indicating the hospital stay in group B was shorter than that in group A(t=2.672, P=0.009). And the mean (±SD) hospitalization expense was56±6.6thousand yuan in the group A and25±1.1thousand yuan in the group B. There was a significantly lower hospitalization expense in patients treated in group B. In the conservative group of35cases,30cases (85.71%) cured,4cases were automatic discharged and1died for the reason of septic shock and acute generalized peritonitis. In the second group of35cases,28cases (80.00%) cured,5cases were also automatic discharged,2case was transferred to the surgeon for an operation after three months of therapy. And there was no death in group B. Comparison of the two groups of cure rate and mortality showed no statistically significant differences (P>0.05).8of the35cases in group A had suffered from surgery-related complications,4from incision,2from intra-abdominal hemorrhage, one from severe pneumonia and one from septic shock,respectively.There were no complications in group B except for two patients suffering from stomachache, but relieved soon after treatment. It was thought to be gastrointestinal cramps caused by ozone water. There was great significant in the incidence of complications between the two groups (x2=4.200,P=0.040). And no difference of surgical infection score between the two groups was found, but obviously lower before and after treatment when using repeated measures ANOVA. The surgical infection score decreased by an average of19.9in group A and23.5in group B, indicating a better anti-infective effect in group B.ConclusionOzone therapy for postoperative enterocutaneous fistula is effective and safe, which can obviously reduce hospitalization time, cost and complications and can even avoid a second surgery and significantly alleviate pain of the patient in some cases. Although compared with conventional surgical treatment, this method showed no significant increase in cure rate, it does have its unique advantages such as minimal invasiveness, high safety, simple operation, short hospitalization time, low cost and less complications. In addition, this method also provides an alternative for patients unwilling to undergo surgery, and shows bright prospects.