Discussion
prostate enlargement/carcinoma, urinary urgency, peri-anal itching, pain, anal itching, anal pain, urinary urgency and bowel urgency
RECTAL CARCINOMA, INTESTINAL OBSTRUCTION, CARRION, COMPLICATION, HAEMORRHOIDS
This study was designed to ascertain the efficacy of the shea lubricant in achieving the same level of anal pain reduction as obtained with 2% lidocaine gel during the digital rectal examination. We found that the shea lubricant was just as effective as the 2% lidocaine gel in this non-inferiority trial and thus a good substitute for the control. Even more, the shea lubricant was rated as having a better level of lubricity (p = 0.002) and ease of use by the clinicians involved in the trial (p = 0.001). Secondary outcomes such as the level of perianal discomfort (p = 0.446), anal itching (p = 0.728), bowel urgency (p = 0.077), urinary urgency (p = 0.841) and anal pain (0.762) during the procedure were similar. The non-inferiority (NI) of the shea lubricant to the lidocaine gel for the mean difference in anal pain as set at the trial commencement was firmly established (Δ -0.01 95% CI − 0.595 to 0.579 ΔThe baseline demographic characteristics (shea lubricant and 2% lidocaine gel) were fairly similar with no statistical difference in the age (p = 0.710) and marital status (p = 0.601) of participants except for employment status (p = 0.04). The main indications for DRE were prostate enlargement/carcinoma (87%), suspicion of rectal haemorrhoids (4.6%), intestinal obstruction (3.9%) and rectal carcinoma (0.7%). This is attributable to the fact that the study was carried out mainly within a surgical setting; these dynamics could have been different had it been carried out in another medical field. Marcias et al.To the best of our knowledge, this is the first study comparing the efficacy of 2% lidocaine gel to a vegetable oil-based lubricant for digital rectal examination. The mean pain scores evaluated using the Visual Analogue Scale were similar. This finding is consistent with results obtained by Carrion et al.The experiences of patients with regards to peri-anal discomfort, peri-anal itching, urinary urgency and bowel urgency were similar for the two groups before, during and 30 min after the procedure.. In a similar study on patients’ perceptions of pain and discomfort during DRE, Romero et al.At the outset, the non-inferiority limit for anal pain perception was set at a mean between-group difference of − 0.72 based on a previous studyThe findings from this study is important as it confirms the extent to which the shea lubricant can be a good non-inferior substitute to the control. Coupled with the fact that it can be produced at a competitive cost, it is advantageous to advocate for the regular use of the shea lubricant, especially in low-resource settings as it has similar pain reduction and complication rates as lidocaine gel. Mcfarlene et al.Although our findings are significant and generalizable, there were some constraints. Due to differences in the consistency of the lubricants, the trial doctors were not blinded even though attempts were made to mitigate its effect. Larger cohorts are required to further test the efficacy and long-term effects of the shea lubricant, especially in procedures such as urethral catheterization and endoscopy.