290 ORIGINAL ARTICLE Conversion of laparoscopic to open cholecystectomy, is gender a predictor? Farzana Memon, Roger Christopher Gill, Sumera Baloch, Mehmood A. Khan, Amber Bawa, M. Saeed Quraishy, Noman Shehzad Civil Hospital Karachi F Memon S Baloch MS Quraishy Aga Khan University Hospital, Karachi RC Gill A Bawa N Shehzad Rangers Hospital, Karachi MA Khan Correspondence: Dr. Farzana Memon FCPS Associate Professor of Surgery, Surgical Unit IV, Civil Hospital Karachi [email protected] Abstract: Background: It had generally been thought that male gender is associated with difficult cholecystectomies. Laparoscopic Cholecystectomy has been considered as a standard of care for treating patients with gall stone disease. However increased difficulties are encountered when males undergo surgery with increased conversion rates to open procedures. Objective: The objective of our study was to analyze gender as predictor of conversion of laparoscopic to open cholecystectomy and to also find out other factors predicting conversion of laparoscopic to open cholecystectomy. Material and methods: We conducted Retrospective Cohort Study at Surgical Unit IV Civil Hospital Karachi. Record of all the patients who had undergone Laparoscopic Cholecystectomy from Jan 2013 to Dec 2013 were retrieved and reviewed. Patients were divided into two sub groups based upon their gender. Exposed group included male patients with gall stones disease and control group included female patients with gall stone disease. Results: A total of 123 Laparoscopic Cholecystectomies were performed in the above mentioned period. 24%(30) of the participants were males while seventy six percent of the participants (93) were females. Mean age of the participants was 40 +/- 11.8 years. Mean age of males was 45 +/- 14.5 years while that of females was 38.6 +/- 10.5 years, p value 0.028. 12 (9.8%) patients required conversion of the laparoscopic to open procedure. The risk of conversation of laparoscopic cholecystectomy to open procedure in male patients was 4.34 times those of female patients which when adjusted for covariates including age and cholecystitis reduced to 2.95 and did not achieve statistical significance. For male patients, adjusted relative risk for operating surgeon to encounter difficulty during operation turned out to be 1.86 times than those for female patients but this did not achieve statistical significance. Conclusion: Male gender does exhibit increased difficulty and conversion to open procedures while performing laparoscopic cholecystectomy however in our study they did not achieve statistical significance. Whether gender is an important risk factor to encounter difficulties and increased conversions to open procedures still needs to be studied in prospective setting. Keywords: Male gender, Conversion of laparoscopic to open cholecystectomy, Open procedures, Cholelithiasis Introduction: Since its advent in late 20th century, laparoscopic cholecystectomy is now the gold standard for treatment of symptomatic gall stones disease1,2. Laparoscopic approach to cholecystectomy has several advantages over open procedure including less surgical trauma, less post operative pain, small scar, early discharge from hospital, early return to work and less chances of wound infection. Common bile duct (CBD) injury is the most dreaded complication of cholecystectomy. Rate of CBD injury in the earlier periods of laparoscopic cholecystectomy was higher as compared to open procedure. With experience Pak J Surg 2014; 30(4):290-295 Conversion of laparoscopic to open cholecystectomy, is gender a predictor? gained in this area, now CBD injury risk is rare and is the same for laparoscopic cholecystectomy as for open cholecystectomy3-5. Despite advancement in experience and technology, laparoscopic approach to cholecystectomy may not be possible in every patient. In these situations conversion of laparoscopic procedure to open procedure is required. Most common reasons requiring conversion are bleeding not controlled via laparoscopic approach, dense adhesions hindering dissection to the extent that either safety is risked or progression of procedure is poor or unintentional injury to surrounding structures like liver and major bile ducts would take place which may require conversion to open procedure. Various factors have been proposed by investigators around the globe, related to difficulty in dissection and conversion to open procedure. These include age, gender, obesity, comorbid conditions, gall bladder wall thickness and inflammatory response6-10. These are the factors based on which the difficulty encountered during laparoscopic procedure may be predicted. Male gender has been seen as an independent risk factors for difficulty in laparoscopic cholecystectomy in some of the these studies resulting in higher conversions2,6,11,12. There is also impression of male cholecystectomy being more difficult than female patients but there are no reports to date from our population to have in depth analysis of this perception. The objective of our study was to analyze gender as predictor of conversion of laparoscopic to open cholecystectomy and also to find out other factors predicting conversion of laparoscopic to open cholecystectomy. Material and methods: We conducted Retrospective Cohort Study. Record of all the patients who had undergone laparoscopic cholecystectomy from Jan 2013 to Dec 2013 were retrieved and reviewed. Patients were divided into two sub groups based upon their gender. Exposed group included male patients with gall stones disease and control group included female patients with gall stone disease. Pak J Surg 2014; 30(4): 290-295 291 Main outcome measure was conversion from laparoscopic to open procedure. Information was collected from operative notes. Secondary outcome measures were duration of operation and surgeon’s subjective assessment of difficulty of operation. Time of operation was categorized into two categories as < 90 minutes and > 90 minutes. Surgeon was labeled to have encountered difficulty in operation if any one or more of the following were encountered during operation: difficulty in dissection at triangle of callots, significant bleeding during operation, and injury to surrounding structures. Information was collected regarding age of the patients, history of cholecystitis at the time of presentation and history of choledocholithiasis at the time of presentation. This study was conducted at General Surgery Department of Civil Hospital Karachi. Civil Hospital Karachi is a public sector tertiary care center. Adult patients diagnosed with gall stones disease requiring elective laparoscopic cholecystectomy were included in the study. Patients of age 16 years and above were included in the study. Diagnosis of gall stones disease included biliary colic, acute cholecystitis, chronic cholecystitis, Choledocholithiasis after CBD stones removal through ERCP, gall stones pancreatitis requiring cholecystectomy. Diagnosis was confirmed using Ultrasound of liver and gall bladder and laboratory investigations including complete blood count and liver function tests. Exclusion criteria were Patients diagnosed with Gall bladder malignancy; complicated gall stones disease like gangrenous cholecystitis, gall bladder perforation; previous open abdominal surgeries; missing data and operative procedure other than laparoscopic cholecystectomy. All procedures were performed under general anaesthesia by standard four port technique. Pneumoperitoneum was established by open 292 F Memon, RC Gill, S Baloch et. al Hassan’s technique. All procedure were done by either consultant general surgeon or residents under supervision of consultant general surgeons. At our institutions, in case of cholecystitis, laparoscopic cholecystectomy is done in the same admission if presentation is within one week of cholecystitis and in case presentation is more than seven days after cholecystitis, then cholecystectomy is planned after six weeks of cholecystitis. Approval from Institutional Review Board was sought prior to starting the study. All the data was collected in coded form with no identifiable information collected. Data was collected on pre-formed questionnaire having information regarding outcome of interest and predictor variables. Data was recorded in coded form. Hard copies were submitted to research office of the Civil Hospital and were kept under lock and key. Data was entered in SPSS version 19. All the electronic form of data was password protected. Hard copies of the questionnaire are in the custody of Department of Research of Civil Hospital Karachi and will be shredded three years after the publication of study. Categorical variables have been reported in percentages and quantitative variables reported in means +/- Standard Deviations. Univariable logistic regression was done to analyze impact of main predictor variable and other predictor variables upon outcome of conversion to open cholecystectomy. Multivariate logistic regression was run to analyze impact of predictor variables on various difficulties encountered during surgery. P value of less 0.05 was considered as significant. To be included in multivariate logistic regression analysis, p value of less than 0.2 was considered significant. Adjusted relative risks with 95% confidence intervals were reported. Analysis was run to check for confounding and plausible interactions. Results: A total of 123 Laparoscopic Cholecystectomies were performed in the above mentioned period. Twenty four percent (30) of the participants were males while seventy six percent of the participants (93) were females. Mean age of the participants was 40 +/- 11.8 years. Mean age of males was 45 +/- 14.5 years while that of females was 38.6 +/- 10.5 years, p value 0.028. Table 1 gives comparison of different variables between two groups. In our study, 12 (9.8%) patients required conversion of the laparoscopic to open procedure. Relative risk of conversion from Laparoscopic to open procedure is given in table 2. All the predictor variables given in table 2 were considered for multivariable analysis. Relative risks of conversion from laparoscopic to open procedure when adjusted for co-variates including age and cholecystitis at the time of presentation are given in table 2. Potential interactions were checked between all predictor variables, none of them turned out to be significant and affecting the model. So analysis showed that risk of conversation of laparoscopic cholecystectomy to open procedure in male patients is 4.34 time those of female patients when not adjusting for co-variates. Adjustment of co-variates including age and cholecystitis at the time of admission reduced this value from 4.34 to 2.95 and adjusted value did not achieve statistical significance. Adjusted relative risk of males for length of surgical procedure was not statistically significant and different from females. For male patients, adjusted relative risk for operating surgeon to encounter difficulty during operation turned out to be 1.86 times than those for female patients. Distribution and values are given in table 4. Discussion: Laparoscopic cholecystectomy is gold standard treatment of uncomplicated symptomatic gall stones2,13-22. Despite advancement in medical technology and experience, there remain cases in which difficulties are encountered during operation which may lead to conversions to open procedure. Prediction of difficulty before operaPak J Surg 2014; 30(4): 290-295 293 Conversion of laparoscopic to open cholecystectomy, is gender a predictor? Table 1: Comparison of Various Characteristic Between Two Groups significance could not be achieved. This could be due to insufficient power at the given sample size. Variable Males (n1 = 30) Females (n2 = 93) P Value Age (Years) 45.1 38.6 0.028 Cholecystitis At Initial Presentation 4 8 0.48 CBD Stones Present at time of presentation 11 28 0.50 Table 2: Univariable Analysis reporting Un-adjusted Relative Risks of Predictor Variables Variable Relative Risk (95% CI of Relative Risk) P Value Gender (Male) 4.34 (9.38 – 13.67) 0.012 Age (> 40 Years) 4.53 (1.23 – 16.73) 0.023 Cholecystitis At Presentation 4.62 (1.39 – 15.36) 0.012 CBD Stones Present at time of presentation 6.46 (1.75 - 23.87) 0.005 Table 3: Multivariable Analysis reporting Adjusted relative risks of Predictor Variables Variable Adjusted Relative Risk (95% CI of Relative Risk) P Value Gender (Male) 2.95 (.92– 9.41) 0.068 Age (> 40 Years) 4.73 (1.22– 18.34) 0.025 Cholecystitis at Presentation 5.97 (1.74– 20.50) 0.005 Table 4: Adjusted Relative Risk with 95% Confidence Interval for Duration of Operation and Difficulty Encountered During Operation Outcome Measure Male (n = 30) Duration of Operation 9 (30%) > 90 min Female (n = 93) Adjusted Relative Risk for Males (95% Confidence Interval) 12 (13%) 1.64 (0.66-4.08) Difficulty Encountered 20 (67%) 27 (29%) 1.86 (1.01-3.43) During operation P Value 0.29 0.045 tion helps prepare operating surgeon for logistics as well as proper counseling of patient and family23. Active or past inflammation of gall bladder is known to increase the level of difficulty in dissection and operative time4,29,38,39,42. Impact of gender has been evaluated in different studies with varying results. Male gender is seen to be associated with more difficult Cholecystectomies2,6,11,19,23,24,27-42. Our results at level of Univariate analysis show a significant increase in risk of conversion from laparoscopic to open cholecystectomy in male patients. Age of the patient, history of cholecystitis and choledocholithiasis at the time of presentation were also significantly associated with increased risk of conversion from laparoscopic to open procedure. When adjusted for history of cholecystitis and age of patients, still risk was greater for male patient but statistical Pak J Surg 2014; 30(4): 290-295 Differences in humoral and inflammatory responses to body insult have been proposed as the underlying causes of the observed differences in surgical findings29,35,38,39. There is more collagen and hydroxyl proline deposition seen in the inflammatory response exhibited by males and the decreased active estrogens within the male blood may partly contribute to the excessive inflammatory response generated35. Estrogen the female hormone is known to lessen the inflammatory response and prevent it from over exhibition. Studies support the idea that estrogens may decrease the macrophage accumulation at the site of inflammation and resultant fibrosis may contribute to the more vigorous inflammatory response seen in males35,44. Others speculate that the difference in pain thresholds in both genders and anthropometric differences in body fat distribution and shielding of gall bladder by the liver from anterior abdominal wall may lead to inaccuracy in physical examination findings misleading the surgeon in estimating the severity and diagnosis in males29. There is evidence that preoperative history, physical examination and laboratory studies less reliably predict disease severity in men29,45. The natural history of gall stone disease is extensive inflammation and scarring leading to distorted gall bladder anatomy including porta hepatis which leads to difficulties in performing laparoscopic cholecystectomy in safe manner and this is more aggressively presented in males45,46. Our findings that level of difficulty encountered during laparoscopic cholecystectomy in male patients is significantly greater than female patients is also consistent with finding reported in literature. Our study reports risk of male gender from our region which can help treating surgeons in counseling the patients. It can also serve as a benchmark study upon which further prospective studies can be planned. It highlights the importance of future considerations into the genetic and molecular basis of this difference in gender specific disease process. 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