Effect of simethicone on reducing operative difficulty associated with bowel interference during minilaparotomy for modified Pomeroy salpingectomy: A randomized controlled trial^,

Abstract

© 2019 Elsevier Inc. Objective: To examine the effect of simethicone on reducing operative difficulty associated with bowel interference during minilaparotomy for postpartum modified Pomeroy partial salpingectomy. Study design: We enrolled 20–45-year-old women planning the procedure from March 2018 to February 2019. We randomized participants to chew simethicone 160 mg with water 50 mL 2–8 h before surgery or no treatment. The participants were not blinded; however, surgeons, care providers, and outcome assessors were blinded to the study allocation. We measured surgeon-rated operative difficulty using a 10-cm visual analog scale that represented the difficulty perceived to be resulting from bowel interference. Secondary outcomes included operative time and intraoperative and postoperative complications. Results: We enrolled 60 women in each group; baseline characteristics and procedural profiles were comparable. Women in the intervention group used simethicone a median of 157 min (interquartile range 127–192) before the procedure. Surgeons rated the procedure difficulty score as 4.8 in the simethicone group and 4.5 in the control group (p = 0.57). Operative time in the two groups were 26 and 24 min, respectively (p = 0.14). We found no difference in intraoperative adverse events including blood loss and mesosalpinx tear, postoperative morbidities, hospital stay, and patient-rated satisfaction scores. Conclusion: Preprocedural simethicone has no demonstrable benefit in reducing operative difficulty caused by bowel interference during minilaparotomy for postpartum tubal sterilization. Implications: Preprocedural simethicone as given in this study did not result in reduced bowel interference and improved procedure difficulty. Further research examining simethicone in this setting would not be worthwhile as clinically meaningful benefit is unlikely.