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1 Title: “Appendicular stump disinfection- Povidone-Iodine vs ElectrocauteryWhich one is the best option? Authors: 1. Qamar Ashfaq Ahmad. FCPS, MRCS (Eng). Assistant Professor Surgery, Services 2. 3. 4. 5. 6. 7. Institute of Medical Sciences / Services Hospital Lahore.Res. add: 44-View R Block, Model Town Ext. Lahore, Pakistan. E mail: [email protected] Mb: 03334234484 Res: 00924235440042 Contribution: Substantial contributions to the design of the work, the acquisition, analysis, interpretation of data & drafting, Final approval of the version and am accountable for all aspects of the work. Muhammad Zeeshan Sarwar. FCPS. Assistant professor Surgery, East Surgical Unit, King Edward Medical University/ Mayo Hospital Lahore. E mail: [email protected] Ph: 03228420433 Contribution: He helped in design of the work, data collection, analysis, interpretation of data & drafting, Final approval of the version and is accountable for all aspects of the work. Mah Jabeen Muneera. MBBS, M Phil. Assistant Professor Anatomy, King Edward Medical University, Lahore. E mail: [email protected] Ph: 03028494514 Contribution: She helped in trial conception, analysis, interpretation of results, drafting and final approval of the version of study. She reviewed literature, revised article and feels accountable as well. Danish Ali. Post Graduate trainee, Surgical Unit 4, Services Institute of Medical Sciences / Services Hospital Lahore. Email: [email protected] Ph: 03348119554 Contrbution: He helped in design of the work, data collection and analysis and is accountable for all aspects of the work. Waqas Latif. Msc (Stat). Biostatistics Data Analyst, University of health sciences, new campus road Lahore. E mail: [email protected] Ph: 03334461126 Contribution: Helped in conception, design, statistical analysis and drafting. He agrees to be accountable for statistical aspects the work. Dr. Asad Aizaz Chatha. FCPS, FRCS. Assistant Professor, Department of Maxillofacial Surgery, King Edward Medical University/Mayo Hospital, Lahor. Email: [email protected] Ph: 03334205802 Contribution: He helped in design of the work and analysis and is accountable for all aspects of the work. Dr. Khadija Waheed. FCPS. Assistant Professor, Department of Gynaecology and Obstetrics Unit IV, Lady Aitchison Hospital, Lahore. Email: [email protected] Ph: 0333 4274228 Contribution: He helped in design of the work, data collection and analysis and is accountable for all aspects of the work. 2 ABSTRACT Objective: To evaluate effectiveness of Povidone-iodine (10%) swab versus electrocautery to treat appendicular stump. Subjects and Method: A randomized controlled trial was conducted in Services Institute of Medical Sciences, Lahore, with a sample size of 40 patients. Random allocation was done into two groups Group A (Electrocautery) & B (Povidone-Iodine). After cutting appendix, a culture swab was taken from appendix stump. Now, Povidone-Iodine in Group B or electrocautery in Group A was applied to appendicular stump. Second culture swab was taken from stump after five minutes. No growth obtained from second culture swab will be considered as ‘effective therapy’. Secondary outcome variable measured were wound infection and hospital stay. Results: Out of 40 patients, 27 (67%) were males and 13 (33%) were females. Mean age of the patients were 25.55 ± 9.99 years. Electrocautery was ‘effective therapy’ in 20/20 (100%) while Povidone-Iodine was effective in 12/20 (60%) cases. (p < 0.05). Wound infection was found in 3/20 (15%) cases in electrocautery group while in 4/20 (20%) cases in povidoneiodine group. Relationship between effectiveness of the therapy and wound infection couldn’t reach to the statistically significance level. (p = 0.06) Conclusion: Electrocautery is better option in disinfecting appendix stump as compared to Povidone-Iodine swab. Key words: Appendix, Povidone-Iodine, Electrocoagulation, Disinfection. 3 INTRODUCTION: Appendectomy is the most commonly performed operation in the surgical emergency. The lifetime risk of developing acute appendicitis is 8.6% for males and 6.7% for female.[1] Emergency appendectomy is the standard treatment with approximately 400,000 appendectomies being done annually in Pakistan.[2] Appendectomy is a clean contaminated surgery. The stump of appendix is lined by the highly contaminated flora of the colon.[3] So the stump should be treated in a way to keep the spillage of septic material to the minimum level.[4] Appendicular stump had been dealt in many different ways in order to avoid septic complications. In the past, appendicular stump invagination was attempted with no definite advantage.[5] Later on, carbolic acid and phenol were used for cauterization of appendicular mucousa with variable results.[6] Currently, electrocautery using monopolar or bipolar Cautery is being widely used and is becoming the gold standard technique to deal with the contaminated colonic mucousa on appendicular stump.[7] As electrocautery can do the lateral damage to the cecum, application of Povidone-Iodine to disinfect the appendicular stump came in vogue.[8] The usual practice is surgeon’s own preference. There is scarce data available to address this issue. This prompted us to evaluate effectiveness of Povidone-Iodine as compared to electrocautery for disinfecting appendix stump. 4 MATERIAL AND METHODS: This was a randomized controlled trial conducted in surgical unit III, Services Institute of Medical Sciences, Lahore, Pakistan from March 2014-sep.2015. A pilot study was conducted to check the effectiveness of Povidone-Iodine application after appendectomy. The results showed electrocautery to be 100% effective in comparison to Povidone-Iodine (60%) in disinfecting appendicular stump. A sample size of 40 (20 in each group) was calculated by keeping (alpha) level of significance 5%, power (1-beta) 90% and, a decrease in the primary outcome measure from 100% in the control group (Electrocautery) to 60% in the experimental group (Povidone-Iodine). All patients who presented in surgical emergency with pain right iliac fossa were evaluated by the consultant surgeon. Clinically diagnosed acute appendicitis who underwent open appendectomy were included in the study. Patients with age less than 8 years and more than 65 years, complicated acute appendicitis and those taking antibiotics for 3 to 4 days were excluded from the study. Patients in which 1st sample from appendicular stump didn’t reveal any bacterial growth were also excluded from the study. A written informed consent was obtained. All the researchers obliged themselves to practice in accordance to Helsinki declaration 1964 and its later amendments. Patients were randomly divided into group A or B by computer generated number. All patients received prophylactic antibiotics (inj. Ciprofloxacin 500mg) at the time of skin incision. After cutting appendix, a culture swab was taken from appendicular stump. Appendicular stump was treated by electrocautery in Group A and Povidone-Iodine in Group B. Second culture swab from treated stump was taken after 5 minutes. The samples were sent to pathology laboratory. Microbiologist was unaware of the treatment group. The patients were followed up till one month postoperatively. 5 The primary outcome measure was ‘no growth obtained’ after application of either of the treatment, considering it as ‘effective therapy’. Secondary outcome measures were wound infection and hospital stay. The data was analyzed using SPSS (version 20). Percentages were given for qualitative and mean ± SD (standard deviation) for quantitative variables. Student’s t-test was applied to observe mean differences in age and hospital stay between groups. Pearson Chi-square test was applied to compare the percentage of effectiveness and wound infection between groups. A pvalue of <0.05 was considered statistically significant. Operational definitions: Cauterization of appendix stump: Monopolar electro cauterization of mucosa until nothing projects beyond cut surface but a little carbonized tissue. Application of Povidone-iodine swab: Povidone-iodine (10% w/v) impregnated swab on the exposed mucosa so that exudates is absorbed and mucosal surface gets the tinge of PyodineIodine. Effectiveness of treatment: No bacterial growth obtained from stump after application of either electrocautery or Povidone-Iodine. Wound infection: Pus or purulent fluid discharge from the wound with pain, inflammation of skin edges within 30 days of operation. 6 RESULTS: Out of 63 patients, 40 patients were included in the study. Rest of 23 patients were excluded due to negative culture report of specimen taken before the application of any intervention. (Fig 1) The mean age of the patients were 25.55 ± 9.99 years. Out of 40 patients, 27 (67 %) were males and 13 (33 %) were females. In group A, 15 (75.0%) were males and 5 (25.0%) were females with mean age of 26.60 ± 10.02 years. In group B, 12 (60.0%) were males and 8 (40.0%) were females with mean age of 24.50 ± 10.11 years. No statistically significant difference was found in age (p =0.51) and gender (p = 0.31) distribution among both groups (Table 1). Intervention was found ‘effective’ in 20 (100%) patients in group A while in group B, intervention was effective in only 12 (60%) patients. (Table 2) Statistically significant difference was found between two groups (p < 0.05). Wound infection was found among 3 (15%) cases in group A while among 4 (20%) cases in group B. (p = 0.67). (Table 2) All patients were managed conservatively with antibiotics. Relationship between effectiveness of the therapy and wound infection couldn’t reach to the statistically significance level. (p = 0.06) (Table 3) The mean hospital stay in group B (1.60 ± 0.68 days) was generally higher as compared to group A (1.25 ± 0.44 days) but this difference was not statistically significant (p = 0.06). (Table 2) 7 DISCUSSION: This study showed that wound infection rate is significantly lower if the appendicular stump is treated with electrocautery as compared to the cases where appendicular stump was treated with povidone-Iodine. In electrocautery, heat exerts its bactericidal action by ablating the mucousa. This results in better outcome as documented in literature.[9, 10] Our study also supports this option. Extreme care must be exercised to avoid accidental bowel injury, particularly using monopolar current. This can lead to subsequent necrosis, sloughing and ceacal fistula formation.[11] This could be possible reason why search for more appropriate method to disinfect appendicular stump continued, resulting in use of povidone-Iodine. In the present study no iatrogenic injury to bowel occurred with electrocautery. Povidone-Iodine is a widely used antiseptic solution with broad spectrum bactericidal activity. Its use on intact skin is well established but its use as irrigation fluid in bacterial peritonitis for prevention of surgical site infection is still matter of debate.[12] Many authors recommend Povidone-Iodine to treat the appendicular stump, despite the absence of well-established guidelines for its use.[8, 13] Our study also showed results of Povidone-Iodine application inferior to that of electrocautery (60% vs 100%). One of the possible reasons could be that we waited for only 5 minutes for its bactericidal action. Literature says that Povidone-Iodine may need a contact time of 15 minutes for its bactericidal effect.[14] Intra-operative culture during appendectomy had been a routine practice but with poor yield. Literature reports wide variation in positive culture, ranging from 18-95%.[4] We also had 37% (23/63) rate of negative culture report even after 48 hrs. This could be attributed to sampling error, perioperative antibiotic prophylaxis or culture technique employed. The routine of intra-operative culture during appendectomy is now becoming controversial. This is partly due to the fact that pathogens encountered in acute appendicitis are well 8 characterized and are easily dealt with broad spectrum antibiotics against aerobic and anaerobic organism.[4] Also, organism isolated during appendectomy can be different from organism isolated from wound infection of the same case. So a negative or a positive culture report cannot predict wound infection or influence its treatment.[15] Same happened in our series. Out of 28 cases which were ‘effectively treated’ as shown by negative culture reports, three cases developed wound infection. Though, this percentage is little higher in ‘not effectively treated’ group where 4/12 cases develop wound infection. (Table 3) Wound infection rate after uncomplicated appendectomy is 10-20%.[16] Our study showed wound infection rate of 17%, which is comparable. Wound infection rate between the two groups was not statistically significant (p = 0.67). This study has its own limitations. Its small sample size study due to limited resources. Organisms cultured from appendicular stump and wound infection were not discussed. A third group may have been added showing effect of ‘no treatment to appendicular stump’. Duration of application of Povidone-Iodine may have been increased to 15 minutes. 9 CONCLUSION: The fluid on appendix stump is potentially contaminated. Electrocautery is best in disinfecting appendix stump whereas Pyodine swab application is only partially effective. 10 ACKNOWLEDGEMENT: We are thankful to Dr Muhammad Kamran Saeed, specialist surgeon, Kingdom of Saudi Arabia for help in conception of study. 11 REFERENCES: 1. Ohle, R., et al., The Alvarado score for predicting acute appendicitis: a systematic review. BMC medicine, 2011. 9(1): p. 139. 2. Rafiq, M.S., et al., Receiver operator characteristic curve analysis of the lintula score for reduction of negative appendectomies in adults. Journal of the College of Physicians and Surgeons--Pakistan: JCPSP, 2015. 25(2): p. 100-103. 3. Harbin, R.M., The Stump of the Appendix, an Agent of Infection. Annals of surgery, 1934. 99(4): p. 633. 4. Gladman, M.A., et al., Intra-operative culture in appendicitis: traditional practice challenged. Annals of the Royal College of Surgeons of England, 2004. 86(3): p. 196. 5. Suvera, M.S., et al., Open appendicectomy stump: invaginate or not to invaginate? International Journal, 2013. 1(3): p. 248. 6. Rosenberg, I., The effect of diathermy to the appendix stump in the control of wound sepsis. Journal of the Royal College of Surgeons of Edinburgh, 1974. 19(6): p. 381383. 7. Jason F Hall, R.H., General Surgery Principles and International Practice. 2nd ed. 2009, London, UK: Springer-Verlag London Limited. 2011. 8. Kochar, S., Common Surgical Emergencies. 2000, Delhi, India: JAYPEE Brothers Medical Publisher Limited. 330. 9. Lin, E., Anatomic basis of tumor surgery. 2nd ed. 2010, Germany London,New York.: Springer-Verlag Berlin Heidelberg. 850. 10. Palanevileu, C., Art of Laparoscopic Surgery Text Book and Atlas. 2nd ed. Vol. 2. 2007, India: Jaypee Brothers Medical Publishers Ltd. 1262. 11. Palanivelu, C., Palanivelu's Text Book of Surgical Laparoscopy. 1st ed. 2002, India: Gem Digestive Diseases Foundation. 558. 12 12. Drosou, A., A. Falabella, and R.S. Kirsner, Antiseptics on wounds: an area of controversy. Wounds, 2003. 15(5): p. 149-166. 13. Mark Erian, G.M., State of the Art Atlas and Textbook of Laparoscopic Suturing. 1st ed. 2006, India: Jaypee Brothers Medical Publishers Ltd. 231. 14. Bapat, R., A. Supe, and M. Sathe, Management of small bowel perforation with intraand post-operative lavages with povidone iodine.(A prospective study). Journal of postgraduate medicine, 1983. 29(1): p. 29. 15. Jaffers, G.J. and T.W. Pollock, Intraoperative culturing during surgery for acute appendicitis. Archives of Surgery, 1981. 116(7): p. 866-868. 16. Bickel, A., et al., Perioperative hyperoxygenation and wound site infection following surgery for acute appendicitis: A randomized, prospective, controlled trial. Archives of Surgery, 2011. 146(4): p. 464-470. 13 CONFLICT OF INTEREST & FUNDING INFORMATION: For the study no grant/funding from any source was involved. We declare that there was no conflict of interest involved. 14 Figure 1: CONSORT diagram. Assessed for Eligibility (n=63) Excluded (n=23) Randomized (n=40) Electrocautery application (n=20) Povidone-Iodine application (n=20) Received allocated intervention (n=20) Did not receive allocated intervention (n= Zero ) Received allocated intervention (n=20) Did not receive allocated intervention (n= Zero ) Lost to follow-up (n= Zero ) Analysed (n=20) Lost to follow-up (n= Zero ) Analysed (n=20) 15 Table 1: Demographic data of the participants Variables Age (years) Group A (Electrocautery) Group A (Povidone-Iodine) n=20 n=20 26.60 ± 10.02 24.50 ± 10.11 p- Value 0.51 Gender Male 12 15 Female 08 05 0.31 ASA Grade Grade I 17 18 Grade II 3 2 0.63 16 Table 2: Outcome Variables Variables Group A (Electrocautery) Group A (Povidone-Iodine) n=20 n=20 p- Value Effective Therapy Yes 20 8 No 0 12 17 16 03 04 1.60 ± 0.68 1.25 ± 0.44 < 0.05 Wound Infection Yes No Hospital Stay (days) 0.67 0.06 17 Table 3: Relationship of ‘Effective Therapy’, ‘Wound Infection’ and ‘Treatment Groups’. Treatment Groups Povidone- Results Total not effective effective NO 8 8 16 YES 4 0 4 12 8 20 NO 0 17 17 YES 0 3 3 0 20 20 NO 8 25 33 YES 4 3 7 12 28 40 p value WOUNDINFECTION Iodine Total WOUNDINFECTION Electrocautery Total WOUNDINFECTION Total Total 0.06