[Study of early postoperative lactitol versus paraffin following anal surgery in 110 adult patients].
The aim of this open and randomised clinical trial was to compare, in terms of efficacy, lactitol with petroleum jelly, regarding the time before recovery of intestinal transit in patients having undergone anal surgery. Efficacy, comfort and tolerability were assessed on day 4 and 7, the convenience of treatments at the end of the period. The main criterion for efficacy was the time taken to obtain the first stool after surgery. Lactitol appears to be more effective than petroleum in terms of recovery of intestinal transit: the first postoperative stool was obtained 13 hours earlier with lactitol. This difference is statistically significant whatever the comparison: survival analysis (p = 0.0018) or t test on means (p = 0.0014). The secondary criteria for efficacy are consistent with this first result: the mean number of stools per day was significantly higher with lactitol (p = 0.046), the daily dose could be-reduced for more patients under lactitol on day 4 (p = 0.004) and, also on day 4, the general efficacy assessment was significantly in favour of lactitol (p = 0.033). The separate analysis of the items included in the comfort score shows that stools are more often "normal or soft" in the petroleum group and that pain on defecation is frequently less severe in the lactitol group. This led to a significantly higher comfort score in the petroleum group from D1 to D4 but not from D1 to D7. Tolerance was rated "good" by 97% of patients on day 7, and no statistically significant difference was observed for any of the tolerability criteria. Lactitol therefore appears to be an interesting choice, with a high benefit/risk ratio, in the treatment of the transitory constipation frequently observed immediately after anal surgery.
Copé
R
R
Service de Colo-Proctologie, Hôpital Gouin, Clichy.
Debou
J M
JM
Cohen
S
S
Callens
A
A
D000328:Adult; D000368:Aged; D001004:Anus Diseases / Q000601:surgery*; D002400:Cathartics / Q000627:therapeutic use*; D000075202:Contraindications; D004334:Drug Administration Schedule; D004361:Drug Tolerance; D004643:Emollients / Q000627:therapeutic use*; D005772:Gastrointestinal Transit / Q000187:drug effects*; D006801:Humans; D008875:Middle Aged; D010577:Petrolatum / Q000627:therapeutic use*; D011184:Postoperative Period; D013402:Sugar Alcohols / Q000627:therapeutic use*
D002400:Cathartics; D004643:Emollients; D013402:Sugar Alcohols; D010577:Petrolatum; C014635:lactitol