The efficacy of postoperative hydrotubation: a randomized prospective multicenter clinical trial.
Term pregnancies following surgery on patients with distal tubal obstruction have been disappointingly few. There has been continuing interest in whether postoperative hydrotubation increases the rate of pregnancy following salpingoneostomy and fimbrioplasty. This hypothesis was tested in a prospective, randomized, multicenter clinical trial. Patients with no infertility factors other than distal fimbrial disease were randomly assigned to either a control group (no hydrotubation, n = 86) or one of two treatment groups (hydrotubation with lactated Ringer's solution, n = 60, or lactated Ringer's solution containing hydrocortisone, n = 60). The statistical evaluation of differences among treatment groups was based on the Cox Proportional Hazards Model, which allows for covariable adjustment and for the inclusion of all patients regardless of the length of follow-up. A significant difference in the live birth rate could not be demonstrated among the groups studied (P = 0.36). The probability of a successful live birth among women treated by hydrotubation with hydrocortisone was about one-half that of the other groups (P = 0.12). Patients with moderate and severe disease had a substantially lower probability of pregnancy than those with mild disease (P = 0.013 and P = 0.0016, respectively). The probability of pregnancy increased somewhat as the number of previous pregnancies increased (P = 0.12). In this clinical trial, a beneficial effect following postoperative hydrotubation could not be demonstrated.
D000328:Adult; D002986:Clinical Trials as Topic; D003131:Combined Modality Therapy; D005184:Fallopian Tube Diseases / Q000601:surgery / Q000628:therapy*; D005260:Female; D006801:Humans; D006854:Hydrocortisone / Q000008:administration & dosage; D007247:Infertility, Female / Q000601:surgery / Q000628:therapy*; D007552:Isotonic Solutions / Q000008:administration & dosage; D011184:Postoperative Period; D011247:Pregnancy; D011897:Random Allocation; D000077325:Ringer's Lactate; D012306:Risk
D007552:Isotonic Solutions; D000077325:Ringer's Lactate; D006854:Hydrocortisone