Efficacy Of Powder-Free Surgical Glove Bag Vs No Glove Bag For Retrieval of The Gallbladder During Laparoscopic Cholecystectomy; A One Year Randomised Controlled Study

Abstract

BACKGROUND: Laparoscopic cholecystectomy (LC) is one of the commonly performed surgical procedures However there has been increasing report of infectious complications due to un-retrieved stones and spillage of bile. Economical sterile surgical gloves or sterile endobag can be used instead of expensive commercial ones to retrieve the gallbladder specimen and also intraabdominal spilt stones safely without complications. But the evidence available on the subject is still conflicting. The present study intended to ascertain the safety, ease of retrieval and septic complications of using powder-free surgical glove bag for retrieval of gallbladder specimens and the spilled gallstones during laparoscopic cholecystectomy. OBJECTIVES: 1. To compare the duration of surgery with the use of powder-free glove bag versus without glove bag for extraction of gallbladder specimen. 2. To determine the ease, efficacy and complications associated with the use of glove bag versus without glove bag for extraction of gall bladder specimen. MATERIALS AND METHODS: This study was a randomized controlled trial, conducted in the Department of general surgery, Dr Prabhaker Kore hospital, KLE, Belgavi. All the patients who are admitted and undergoing laparoscopic cholecystectomy in the study setting were considered as the study population. The data collection for the study was done between 1st January 2017 to 31st January 2018 for one year. Patients with known latex allergy, Patients with deranged coagulopathy, Patients with significant other co-morbidities, in whom ejection fraction is 20% or less, or with COPD and Patients diagnosed with peritonitis were excluded from the study. Computer generated random numbers by SPSS programme were used to assign the type of intervention chosen for the patients that is, group A (use of powder-free glove bag for extraction of gallbladder specimen) and group B (without the use of glove bag for extraction of gallbladder specimen) The intra-op time taken for withdrawal of the specimen in both groups was measured and compared. Initial procedure of the conventional laparoscopic cholecystectomy is done. A powder-free glove bag is introduced into the peritoneal cavity through the umbilical port, with the help of the instruments, the specimen is carefully placed into the glove bag and retrieved through the umbilical port. Time taken for removal of the specimen (minutes), the median values were compared between study groups using the Mann-Whitney U test. (2 groups). The association between group and Gender, history of complaints, comorbidities, associated complications was assessed by cross-tabulation and comparison of percentages. Chi square test was used to test statistical significance. RESULT A total of 60 people were included in the analysis, with 30 participants each in study and control group. No statistically significant differences were observed between the study groups. The majority of 35.59% participants had Cholecystitis, followed by Cholelithiasis, Carcinoma of the gallbladder, gangrenous gallbladder, empyema gallbladder and gallbladder polyp was 20.33%, 6.76%, 5.08%, 5.08% and 3.38% respectively. Majority (86.44%) participants underwent laparoscopic cholecystectomy, followed by laparoscopic subtotal cholecystectomy with ERCP followed by laparoscopic cholecystectomy was 6.67% and 3.38% respectively. Among the control group, the median time taken for removal specimen was 2.05 minutes, it was 4.25 minutes was a study group. The difference in the median time taken for removal specimen between the group was statistically significant (P value <0.001). Among the control, 13 (68.4%) participants had associated complications. Among the study group, 7 (31.8%) participants had associated complications. The difference in the proportion of associated complications between the group was statistically significant (P value 0.019). Among the control, 11 (57.9%) participants had extended incision. Among the study group, 2 (9.1%) participants had an extended incision. The difference in the proportion of extended incision between the group was statistically significant (P value 0.001). Among the control, 5 (26.3%) participants had an infection. Among the study group, 1 (4.5%) participants had infections. The difference in the proportion of infection between the group was statistically significant (P value 0.049). Among the control, 2 (10.5%) participants had intra op bile leak. Among the study group, 4 (18.2%) participants had intra op bile leak. The difference in the proportion of intra op bile leak between the group was statistically not significant (P value 0.489). Among the study group, only 1 (4.5%) participants had bile drained from GB in glove. CONCLUSION: The study has compared the postoperative outcomes between powder-free surgical glove bag and no bag groups, in patients undergoing gallbladder retrieval during laparoscopic cholecystectomy. The post-operative infective complications were significantly lower in the study group, as compared to controls. But the duration and the occurrence of intraoperative bile leak were higher among study group. Hence the choice procedure needs to made with caution, considering all the risks and benefits involved.