Study on the effect of 3% sorbitol irrigating solution or 0.9% sodium chloride solution on some test indicators in the transurethral resection of the prostate

g solution 6 sterile water. Goodwin (1951) proposed limiting surgery time to less than an hour. Harrison (1956) demonstrated that water absorption was directly proportional to the time of surgery, the irrigating solution pressure, and the number of opened sinuses. Blood Na + concentration <120 mmol / l appears shock, cerebral edema, headache, vomiting, convulsions, coma. The rate of irrigating solution absorption syndrome is 10%. Henderson DJ (1980) found that up to 23% of patients had hyponatremia <135 mmol/l. In particular, there are cases where 21 to 25 minutes of new coma were cut. Rhymer J C (1985) found that the level of Na + blood decreased from 6-32 mmol/l. The rate of irrigating solution absorption syndrome is 7% and mortality is 1%. Akan H (1997) found that Na +, K + after surgery were significantly reduced (p <0.05) in the sorbitol group. Blood glucose levels increased in both groups. Miyao H (2001) studies with a 3% sorbitol solution found that frequent hyponatremia reduced ALTT. Bishop (2003) introduced a bipolar electric knife technique that enables PROSTATE endoscopy with a 0.9% NaCl irrigating solution. Michielsen DP (2010) found that Na + blood was statistically different between the two groups, p <0.001; 2 patients had irrigating solution absorption syndrome in monopolar group and not bipolar group. The author concludes that bipolar TURP with 0.9% NaCl irrigating solution is safer. Nakahira J (2014) studied TURP with 3% sorbitol irrigating solution in patients over 70 years old and found 23.5% of patients had irrigating solution absorption syndrome. Ishio J (2015) suggested that changes in Na + concentration reduction> 7 mmol / l; > 7% is worth predicting the occurrence of cardiovascular and neurological symptoms. 1.4.2. Study on blood sodium changes and transurethral resection of the prostate (TURP) in the country 1.4.2.1. Several studies of PROSTATE endoscopy in the country Cao Xuan Thanh (2012) assessed the result of transurethral resection of prostate with 3% sorbitol irrigating solution, showed that the operation time of 30-60 minutes accounted for 51.22%; Postoperative bleeding rate was 2.44%. TUR syndrome was 1.22%. Nguyen Cong Binh (2012) studied with 3% sorbitol irrigating solution found that postoperative Na+ level decreased significantly in blood. Bipolar TURP has been applied in Vietnam since 2012. There are few studies evaluating the therapeutic effect of PROSTATE endoscopy with 0.9% NaCl irrigating solution. Tran Van Hinh (2012) found that the blood Na + 7 concentration after surgery was 136.52 ± 4.48 mmol / l change compared with before surgery was 137.48 ± 4.29 mmol / l did not have statistical significance, p> 0.05. Hb level after surgery decreased compared to before surgery with p <0.05. Sinus bleeding does not cause irrigating solution absorption syndrome. The author concludes that bipolar TURP is safer than monopolar. Truong Thanh Tung (2015) suggested that bipolar TURP is a safe, effective and less complicated method. There was no statistically significant change in Na + blood concentration (p> 0.05). 1.4.2.2. Study on changes in blood sodium when TURP carried out in the country Few studies on this issue, Hoang Thi Thu Ha (2007) studied TURP with 3% sorbitol irrigating solution. The rate of irrigating solution absorption syndrome is 7%; with neurological symptoms accounting for 100%; circulation of 42.9%; respiratory 21.4%; Na + blood after surgery significantly decreased by 130.2 mmol / l compared to before surgery 139.4 mmol / l (p <0.05); Hct decreased with statistical significance p <0.05; glucose level increased significantly by 7.5 mmol / l compared with 4.8 mmol / l before surgery; ALTT changes are not statistically significant, p> 0.05. For irrigation solution volume> 20 liters, operative duration is the risk factors for irrigating solution absorption syndrome. Le Thi Cam Thanh (2014) studied with 3% sorbitol irrigating solution found that Na + blood after surgery decreased significantly, p <0.001 (Na + after surgery 137.4 mmol / l compared to before surgery 139.6 mmol / l). Potassium and chlorine change were not statistically significant, p> 0.05. The relationship with decreased Na + blood levels is age and weight of prostate. 8 CHAPTER 2 SUBJECTS AND METHODS 2.1. Research subjects: 2.1.1 Criteria for selecting patients 2.1.2. Criteria to exclude patients from the study: The following cases will be excluded from the research team: - Classify ASA before surgery as IV and V. - CCTS GTTS; Unregulated electrolyte disorders; Diabetes is not controlled; Progressive myocardial ischemia, myocardial infarction <6 months; Hypertension is unstable, stroke <6 months, sensory difficulties. - Renal insufficiency with blood creatinine level> 120 μmol / l, PSA before surgery ≥ 10 ng / ml. 2.1.3. Exclusion criteria - The result of postoperative pathological surgery is prostatic carcinoma, change surgery or change the type of irrigating solution in surgery. 2.2. Research method 2.2.1. Study design: Descriptive, prospective, and longitudinal studies with comparisons. Patients with benign prostatic hyperplasia (BPH) were indicated for TURP surgery under spinal anesthesia at Hospital 103 and Hospital 19.8 from March 2012 to January 2014. 2.2.2. Sampling method 2.2.2.1. Formula to calculate sample size Apply the formula for calculating the sample size of clinical trials comparing the ratio between the two groups:   2 11 2 221112/ 21 )qp( )qpqp(Z)q.p2(Z nn     In which: (p1, p2 based on the research results of Nakahira J and Akman T) n1: sample size of the control group; n2: sample size of the studying group p1: 76.5% of patients without transurethral resection (TUR) syndrome and hyponatremia with 3% sorbitol irrigating solution. 9 In this study, we estimated the success rate in group 1 is 75% leading to p1=0,75 p2: 99% of the patients had no significant change in blood sodium concentration with 0.9% NaCl irrigating solution. In this study, we estimated the 95% success rate in group 2 to have p2 = 0.95. p= (p1+ p2)/2; q1= 1-p1 ; q2=1-p2; q=1-p Ζ1- α/2: reliability coefficient at 95% probability level (= 1.96); Ζ1- β = 0,84 (sample force = 80%) Instead we calculate n1=n2=48; rounded to n = 50. 2.2.2.2. How to divide the research groups 2.2.3. Research materials 2.2.4. How to conduct research. 2.2.4.1. Preparing patients for research. 2.2.4.2. Spinal anesthesia method for TURP: • Preparing patients and facilities before spinal anesthesia: + Prepare the patient + Prepare instruments + Preparing medicine and means for resuscitation • Implementation of spinal anesthesia technique: + Posture of the patient: + Technical implementation steps • Methods of monitoring, managing complications and collecting data related to spinal anesthesia 2.2.4.3 Transurethral resection of prostate (TURP) surgery Surgical techniques were similar in the two groups, group 1 irrigating solution 3% sorbitol contained in 5 liter can, group 2 using 0.9% sodium chloride irrigating solution contained in 5 liter can (Appendix 2). 2.3. Research content and evaluation criteria. 2.3.1. General characteristics of the two research groups 2.3.2. The common research indicators of the two groups relate to the time of irrigation during surgery 10 Surgery duration, preoperative prostate gland weight, removed prostate gland weight, surgical accident, rate of irrigating solution absorption syndrome, volume of irrigating solution used, volume of irrigating solution recovered, volume of blood lost, volumetric irrigating solution uptake Hematology index Hb, Hct, tPSA, ALTT, Na + concentration; K +; Ca ++; Cl-, blood glucose level. 2.3.3. Evaluation of changes in some major electrolytes and serum ALTT Study the changes in the concentration of major electrolytes, ALTT at different times and compare the two research groups - Testing of the concentration of electrolytes in plasma mainly includes: Na +; K +; Ca ++; Cl- and serum ALTT - Time of evaluation of blood sample: + t0: test right before surgery + t1: 15 minutes from the beginning of surgery according to the authors Hurlbert, Henderson, Ladevic + t2: 30 minutes after the surgery starts + t3: 45 minutes from the start of surgery + t4: 60 minutes from the start of surgery + t5: 75 minutes after the start of surgery + t6: immediately after surgery. + t7: 5 hours after surgery according to Collins, Norris, Hahn, Michielsen. 2.3.4. Evaluate the glycemic index, Hb at the time before surgery, right after surgery, 5 hours after surgery and compare between the two groups - Taking samples to test hemoglobin concentration index, blood sugar immediately before surgery, immediately after surgery and the fifth hour after surgery according to Do Trung Phan, Hb irrigating solution recovered according to Akan, Do Trung Phan - The blood volume lost according to the formula: Blood volume lost (ml) = {volume of irrigating solution recovered (ml) × 11 concentration Hb irrigating solution recovered (g / l)}: blood Hb concentration before surgery (g / l) According to the author Akan, Hahn. - Compare indicators between the two research groups 2.3.5. Study on some clinical characteristics in patients with changing test parameters and related factors 2.3.5.1. Several clinical characteristics in patients with variable test parameters + Clinical characteristics of patients with irrigating solution absorption syndrome. + Symptoms of early warning of the appearance of irrigating solution absorption syndrome. + Clinical symptoms in patients when the index: - Concentration 130 <Na + blood <135 mmol/l - Na + blood concentration of 125 ≤Na + ≤ 130 mmol/l - Na + blood concentration <125 mmol / l + Incidence of absorption syndrome irrigating solution and comparison between the two groups. + The osmotic pressure variation. 2.3.5.2. Assess the relationship of changes in electrolytes, serum ALTT with factors + Surgical time, prostate weight before surgery, removed prostate weight, right sinus ablation, prostate capsule perforation during surgery, volume of irrigating solution during surgery, absorbed irrigating solution + Compare related factors between the two research groups. 2.3.5.3. Study on some risk factors causing hyponatremia <135 mmol/l and occurrence of irrigating solution absorption syndrome in groups + Age above and below 70 years old (Nakahira), history of smoking, drinking, diabetes, hypertension (Narayanan), weight PROSTATE before surgery ≥ 60g (Porter M), weight of cutting gland (Hoang Thi) Thu Ha), surgery time (Nguyen Cong Binh, Porter M), seizure complications, perforation of the capsule (Chen Q). 12 + Absorbing solution volume ≥ 1000ml and ≥ 500ml (Hoang Thi Thu Ha). + Irrigating solution volume: ≥ 20 liters and ≥ 30 liters (Hoang Thi Thu Ha). + Compare related factors between the two research groups. 2.4. Several standards apply in research 2.4.1. Patient condition according to ASA: American Association of General Anesthesia 2.4.2. Prostate weight before surgery: 2.4.3. Specimens and tests: 2.4.4. Diagnostic criteria and grading of absorption syndrome irrigating solution. • Diagnosis of irrigating solution absorption syndrome (Collins, Ishio, Michielsen, Porter M): + Neurological symptoms: nausea, vomiting, headache, irritation, confusion, restlessness, convulsions, coma; or respiratory, circulatory symptoms: chest pain, shortness of breath, increased BP followed by hypotension, bradycardia, arrhythmia, respiratory failure, cardiogenic shock or acute pulmonary edema + Subclinical symptoms: blood sodium concentration: when there are ≥2 clinical symptoms, get emergency test samples; if Na + <125 mmol / l is a diagnostic confirmation (Miyao H, Porter M, Ishio J, Collins J W). • Diagnosis of typical irrigating solution absorption syndrome with> 2 clinical symptoms of cardiovascular, neurological and Na + <125 mmol/l (Collins, Ishio, Michielsen, Porter M). Irritant solution absorption syndrome is atypical when ≤ 2 clinical symptoms and 125 mmol/l ≤ Na + ≤ 130 mmol/l (Ishio, Michielsen, Porter M). • Classify the degree of irrigating solution absorption syndrome 2.4.5. Complications during surgery: rate of blood transfusion, perforation of the capsule, vascular sinuses 2.5. Data processing methods 13 The results are processed by the method of medical statistics by software program Stata 12.0. The statistical threshold was chosen with 95% confidence and the p value <0.05 was considered to be statistically significant. 2.6. Ethics in research Irrigating solution 3% sorbitol has been used for a long time, solution 0.9% NaCl is intravenous fluid and is accepted for use in many parts of the world in transurethral resection PROSTATE. The patient has the right to voluntarily participate and refuse or stop participating in research at any time without discrimination. 2.7. Research design diagram CHAPTER 3 RESEARCH RESULTS 3.1. General characteristics of the two groups of patients studied 3.1.1. General characteristics of patients in two groups The results presented in Table 3.1, 3.2, 3.3, 3.4 show that the common characteristics of the two groups of patients studied were not statistically significant (p> 0.05). 3.1.2. Research indicators before, during and after surgery were shared by the two groups. 3.1.2.1. The general research indicators in surgery related to irrigation time The only Table 3.5 with V absorbing solution absorbed was different between the two groups with statistical significance (p <0.05). 3.1.2.2. The index of circulatory, respiratory before, during and after surgery of the two groups 3.2. The average concentration of electrolytes mainly at the study time of the two groups 3.2.1. Average Na + blood concentration according to study time 3.2.1.1. The average Na + blood concentration at the time of the study 14 Table 3.9. Comparison of mean blood sodium concentration at study points between the two groups Time Blood Na+ level (mmol/l) (  SD) p Group 1 (3% sorbitol) Group 2 (0.9% NaCl) n Blood Na+ n Blood Na+ t0 50 137.18±3.10 50 138.06±2.53 >0.05 t1 50 136.82±2.28 50 137.84±2.88 >0.05 t2 33 135.76±4.01 34 138.44±3.01 <0.05 t3 15 134.27±5.71 15 138.53±1.19 <0.05 t4 8 131.63±6.70 10 138.00±1.76 <0.05 t5 3 131.67±6.51 1 136 <0.05 t6 50 135.58±3.79 50 137.54±2.71 <0.05 t7 50 136.52±3.69 50 137.70±2.27 >0.05 p0-6 0.05 The level of blood sodium reduction before and after surgery in group 1 was statistically different (p <0.05); In group 2, the changes were not statistically significant (p> 0.05). Comparisons between the two groups at different times were statistically significant (p <0.05). 3.2.1.2. Several factors are involved in changes in the blood Na + concentration. Group 1 Group 2 r=0.41 p0.05 Figure 3.4. Correlation between level of hyponatremia (mmol/l) of each group by time of surgery (minutes) X -5 0 5 10 15 20 40 60 80 tgmo namaxmin Fitted values -5 0 5 10 20 40 60 80 100 tgmo namaxmin Fitted values Na reduction Na reduction Surgical duration Surgical duration 15 Analysis of correlation between hyponatremia by surgery time showed that blood sodium decreased more strongly in group 1, proportional to the surgery time and had a moderate correlation (p <0.01). But in group 2, blood sodium concentration was not related to surgery time (p> 0.05) (Figure 3.4). 3.2.2. The average K + blood concentration at the time of the study 3.2.3. The average blood Ca ++ concentration at the time of the study 3.2.4. The average Cl- blood concentration at the time of the study Table 3.17. Compare the average Cl- blood levels before, during and after surgery in the two groups Time Blood Cl- level (mmol/l) (  SD) p Group 1 (3% sorbitol) Group 2 (0.9% NaCl) n Blood Cl- level n Blood Cl- level t0 50 107.24±2.70 50 106.4±2.81 >0.05 t1 50 107.04±3.26 50 106.9±3.22 >0.05 t2 33 106.42±3.05 34 109±3.16 <0.05 t3 15 106.6±2.06 15 111.67±2.02 <0.05 t4 8 106±2.20 10 113.7±2.95 <0.05 t5 3 105.5±0.71 1 109 <0.05 t6 50 106.88±2.70 50 112.78±3.24 <0.05 t7 50 107.78±3.13 50 109.88±3.22 >0.05 Pbefore- after(to-t6) >0.05 <0.001 The mean concentration of blood chlorine ions before, during and after surgery was significantly different in group 2 (p <0.001); the comparison between the two groups also differed significantly (p <0.05). However, the concentration of Cl- changes was not statistically significant in group 1 (p> 0.05). 3.3. Average osmotic pressure at study points 3.4. Hb and average blood sugar at the time of the study X 16 3.5. Clinical manifestations of irrigating solution absorption syndrome and associated factors 3.5.1. The common clinical symptoms of the two groups were associated with irrigating solution absorption syndrome Table 3.22. Grouping by the blood Na + level (mmol/l) related to clinical symptoms Na+(mmol/l) Symptoms < 130 (n=5)(%) 130 - < 135 (n=10)(%)  135 (n=85)(%) Total (n=100) p Headache 2 (40) 1 (10) 5 (5.88) 8 <0.05 Nausea, vomiting 4 (80) 5 (50) 11 (12.94) 20 <0.001 Chest pain 0 2 (20) 2 (2.35) 4 -- Irritation 2 (40) 0 5 (5.88) 7 >0.05 Abdominal pain 1 (20) 0 4 (4.71) 5 >0.05 Tremor 1 (20) 4 (40) 22 (25.88) 27 >0.05 Blood Na + level <130 mmol/l is related highly to clinical symptoms of nausea, vomiting 80%, restlessness 40%, headache 40%. While Na + level ≥135 mmol/l, the headache rate is 5.88%; nausea, vomiting 12.94%; irritation 5.88%. 3.5.2. Results of diagnosis of irrigating solution absorption syndrome 3.5.3. Several factors are associated with the risk of an irrigating solution absorption syndrome and a decrease in blood Na + levels 17 Table 3.26. A number of factors related to the reduction of Na + <135 mmol/l in each study group Related factors Blood Na + level < 135 mmol/l RR 95%CI p ≥70 age group Group 1 (n=50) 0.98 0.34-2.79 >0.05 Group 2 (n=50) 0.28 0.03-2.54 >0.05 Smoking Group 1 (n=50) 1.55 0.42-5.67 >0.05 Group 2 (n=50) 3.27 0.42- >0.05 Alcohol drinking Group 1 (n=50) 0.91 0.24-3.49 >0.05 Group 2 (n=50) 3.18 0.5 20.46 >0.05 Diabetes Group 1 (n=50) 1.25 0.30-5.39 >0.05 Group 2 (n=50) 0.62 0-4.86 >0.05 Hypertension Group 1 (n=50) 1.45 0.34-6.37 >0.05 Group 2 (n=50) 5.57 0.83-37.75 >0.05 Capsular perforation, vascular sinus cutting Group 1 (n=50) 14.25 1.73 - <0.05 Group 2 (n=50) 0 0- -- Operative duration ≥ 60 minutes Group 1 (n=50) 10 2.03- 49.2 <0.01 Group 2 (n=50) 3.18 0.5-20.46 >0.05 Pre-operative gland weight ≥60g Group 1 (n=50) 4.1 1.15-14.51 <0.05 Group 2 (n=50) 4.67 0.60- >0.05 Removed weight ≥40g Group 1 (n=50) 10.8 1.34- <0.05 Group 2 (n=50) 7.3 80.45 >0.05 V irrigating absorption solution ≥500 ml Group 1 (n=50) 2.53 0.62-10.11 >0.05 Group 2 (n=50) 2.83 0.45-18.05 >0.05 V irrigating absorption solution ≥1000 ml Group 1 (n=50) 15.42 2.7-85.71 <0.01 Group 2 (n=50) 0 0-26.63 -- V irrigating solution used ≥20 litre Group 1 (n=50) 2.26 0.60-8.49 >0.05 Group 2 (n=50) 3.27 0.42- >0.05 V irrigating solution used ≥30 litre Group 1 (n=50) 10 2.03- 49.2 <0.01 Group 2 (n=50) 3.18 0.49- 20.46 >0.05 18 Factors of capsular perforation, vascular sinus cutting, gland weight ≥ 60g, removed weight ≥40g, the volume of irrigating solution absorbed ≥1000ml, the volume of irrigating solution used ≥30 liters are the risk-related factors of hyponatremia below normal level only in group 1 (3% sorbitol irrigating solution); (p<0.05) and not found in group 2 (0.9% sodium chloride irrigating solution); (p>0.05). CHAPTER 4 DISCUSSION 4.2.2. Changes of some major electrolytes in the blood 4.2.2.1. Compare the changes of blood Na + level between the two study groups Research results in group 1 with 3% sorbitol irrigating solution, the blood Na + level at the time of the study and immediately after surgery decreased significantly compared to before surgery, p <0.05 (Table 3.9). This result is similar to Akan H (1996) with a 3.5 mmol/l reduction in postoperative Na + and consistent with the announcement of Miyao H (2001). Georgiadou T I (2007) and Nakahira (2014) also found that decreased Na + blood concentration correlated linearly with process time with p <0.001. Authors such as Hoang Thi Thu Ha (2007), Le Thi Cam Thanh (2014) also concluded that the blood Na + level after surgery was 137.4 ± 5.3 mmol / l decreased compared to before surgery was 139.6 ± 3.5 mmol/l (p<0.001). With 09% NaCl irrigating solution, the blood Na + level after surgery compared with before surgery changed without statistical significance, p>0.05. Comparisons between the two groups were statistically different (Table 3.9). This result is consistent with the announcement of Michielsen D P (2007), Mamoulakis (2012). The blood Na + level after surgery decreased by 0.8 mmol/l in the 0.9% NaCl group compared with the reduction of 2.5 mmol/l in the monopolar group with statistical significance, p=0.003. 4.2.2.2. The change in blood potassium concentration 19 The concentration of blood potassium in group 1 and group 2 changes were not statistically significant compared to before surgery (p> 0.05) (Table 3.15). This result is consistent with the announcement of Michielsen (2007), Michielsen (2010), the blood potassium concentration after surgery was 4.0 ± 0.4 changes compared to before surgery was 4.2 ± 0.4 had no statistical significance and also suitable with Park JT (2011), Akman (2013). In the country, Le Thi Cam Thanh (2014) concluded that postoperative blood K + level of 3.9 ± 0.5 mmol/l change was not statistically significant compared with 4.0 ± 0.4 mmol/l before surgery. Michielsen (2007) and Michielsen (2010) also concluded that the average blood potassium concentration after surgery was not statistically significant (p=0.317; p=0.803) when comparing monopolar TURP and bipolar TURP with 0.9% NaCl irrigating solution. 4.2.2.3. The change in blood calcium level The average blood calcium ion concentration right after surgery in both groups had no significant changes compared to before surgery, p> 0.05. The comparison of calcium ion concentrations between the two groups also differed significantly (Table 3.16). This research result is similar to Dawkins DP (1999), Nguyen Cong Binh (2012). 4.2.2.4. Changes in blood chlorine level The results of the study showed that the Cl- level in group 1 was not significantly changed. However, in group 2, Cl- ion concentration tends to increase after surgery and the change is statistically significant, p <0.05 (Table 3.17). This result is consistent with published by Michielsen (2007), Michielsen (2010), Akman (2013) and Hermanns (2015) (Cl- increased from 108 to 111mmo / l; p = 0.001). 4.2.3. Changes in serum osmotic pressure Postoperative ALTT compared with before surgery in both groups had no significant changes. The comparison of ALTT between the two groups was also not significant (Table 3.18). This result is consistent with the announcement of Akan (1996), Singhania (2010) 20 and Park JT (2011) with sorbitol irrigating solution and compared with 0.9% NaCl irrigating solution. 4.2.4. Changes in blood hemoglobin level between the two groups The mean blood hemoglobin (Hb) level immediately after surgery compared to before surgery decreased significantly in both groups and comparing Hb index between the two different groups was not statistically significant (Table 3.19). This result is consistent with the publication of Akan H (1996), Akan H (1997) and Tran Van Hinh (2012), Truong Thanh Tung (2015) and similar studies of Henry SS (2007), Akman (2013) , Masolutionuri (2016) when comparing the mean Hb change between the 2 groups. 4.2.5. The variation of blood glucose level between the two groups The mean blood glucose level after surgery in group 1 increased significantly compared with before surgery, p<0.05; in group 2, there are no statistically significant changes, p>0.05. The comparison of blood glucose