RESUMEN
BACKGROUND: Recent studies have shown that a disrupted microbiome is associated with endometriosis. Despite endometriosis affecting 1 in 10 reproductive-aged women, there is a lack of innovative and nonhormonal long-term effective treatments. Studies have reported an approximately 20% to 37.5% persistence of pain after fertility-sparing endometriosis surgery. Metronidazole has been shown to decrease inflammatory markers and the size of endometriosis lesions in animal studies. OBJECTIVE: To determine if modulating the microbiome with oral metronidazole for 14 days after fertility-sparing endometriosis surgery decreases pain persistence postoperatively. STUDY DESIGN: This was a randomized, multicenter, placebo-controlled, double-blind trial. Individuals 18 to 50 years old were prospectively randomized to placebo vs oral metronidazole for 14 days immediately after endometriosis fertility-sparing excision surgery. The primary outcome was binary, subjective pain persistence at 6 weeks postoperatively. Secondary outcomes included quality of life, sexual function, and endometriosis-associated pain scores according to the Endometriosis Health Profile-5, Female Sexual Function Index, and a visual analog scale. RESULTS: One hundred fifty-two participants were approached from October 2020 to October 2023 to enroll in the study. Sixty-four participants were excluded either because they did not meet inclusion or exclusion criteria or because they declined to participate. Eighty-eight participants were randomized in a 1:1 ratio to receive either the oral placebo or metronidazole after endometriosis excision surgery; 18.2% of participants were lost to follow-up or discontinued treatment and this was not significantly different between the 2 arms, yielding a final cohort of 72 participants. Baseline demographics of the 2 study groups were similar. There was no statistically significant improvement in the primary outcome of binary subjective pain persistence between the metronidazole group compared to placebo (84% vs 88%, P=.74) at 6 weeks postoperatively. Further, no significant differences between treatments were detected in the secondary outcomes. CONCLUSION: A postoperative 14-day regimen of oral metronidazole immediately after fertility-sparing endometriosis surgery was not associated with any significant differences between treatment groups in the persistence of endometriosis-related pain symptoms compared to placebo at 6 weeks.
RESUMEN
BACKGROUND: Video seems advantageous over traditional text as an educational tool in conceptually-based procedures such as laparoscopy. However, this has never been tested directly. OBJECTIVE: The purpose of this study was to compare the use of text versus video as an educational tool for laparoscopic training, through a randomized controlled trial. STUDY DESIGN: Prospective, randomized, controlled clinical trial (Canadian Task Force classification I). METHODS: Eighty (n = 80) medical students, who had no experience with tying a laparoscopic intracorporeal knot, were randomly taught to do so by either reading a text with accompanying pictures (n = 40) or watching a short video with audio of comparable content (n = 40). The participants were allowed to review the material for as long as they needed to achieve understanding of the procedure. They were then asked to tie a laparoscopic square knot in a box trainer, with a limit time of 15 minutes. Time to review the educational material(s), time to tie the knot(s), numbers of attempts at the task (n), and numbers of those who expressed understanding of the task (n) were recorded. RESULTS: The number of participants who were able to complete the knot (n = 14 text v. n = 18 video, p = 0.49) and the average time needed for completion (479 s text v.494 s video, p = 0.38) were not statistically different in the two groups. However, time to review the material (407 s text v. 258 s video, p < 0.001), number of attempts at the task (15 text v. 5 video had n>2 attempts, p = 0.01), and number of those who expressed understanding when they could not complete the task (35% text v. 59% video, p = 0.047) were statistically different. CONCLUSIONS: This is the first randomized trial evaluating video alone as an educational tool in laparoscopic training. It demonstrates that video is superior to text in achieving superior conceptual understanding, without improving operative times. Understanding through video instruction cannot make up for a lack of technical ability in novice surgeons.