Laparoscopic-assisted vaginal hysterectomy versus total laparoscopic hysterectomy for the management of endometrial cancer: a randomized clinical trial.

摘要

STUDY OBJECTIVE: To compare laparoscopic-assisted vaginal hysterectomy (LAVH) and total laparoscopic hysterectomy (TLH) for the treatment of endometrial cancer. DESIGN: Randomized, controlled trial. DESIGN CLASSIFICATION: Randomized controlled trial (Canadian Task Force classification I). SETTING: Two gynecologic oncologic units of university hospitals. PATIENTS: Seventy-two women with endometrial cancer randomized to undergo either LAVH or TLH. INTERVENTIONS: Total laparoscopic hysterectomy or laparoscopic-assisted vaginal hysterectomy, bilateral salpingo-oophorectomy, peritoneal washing, and systematic pelvic lymphadenectomy. MEASUREMENTS AND MAIN RESULTS: Parameters of technical feasibility (operating time of hysterectomy phase, estimated blood loss, perioperative complications) were considered as major statistical endpoints. Thirty-seven women were allocated to the LAVH arm, and 35 were allocated to the TLH arm. Mean total operating time was significantly shorter in the TLH than in the LAVH group (184.0 +/- 46.0 vs 213.2 +/- 39.4 minutes, p = .003). The hysterectomy phase was longer in the LAVH than in the TLH group only in overweight (77.9 +/- 9.8 vs 68.1 +/- 9.3 min, p = .005) and obese patients (87.7+/- 13.1 vs. 62.1+/- 9.9 min, p < .0001). The median estimated blood loss during hysterectomy was similar between groups. Intraoperative complications occurred in three (8.1%) patients in the LAVH group and in one patient (2.8%) in the TLH group (p = .61). No difference was found in the postoperative complication rate between women undergoing LAVH and those who had TLH (24.3% vs 17.1%, p = .56). Within a median follow-up period of 10 months (range 3-17 months), 2 patients in the LAVH group developed recurrent disease. No port site metastasis and no vaginal cuff recurrence were detected in either group. CONCLUSION: Both LAVH and TLH can be performed successfully to manage endometrial cancer, with similar surgical outcomes. Obese patients benefit more from TLH than from LAVH in terms of shorter operating time.