STUDY OBJECTIVE: To evaluate the feasibility, safety, and effect on postoperative pain of laparoscopy for the management of adnexal masses by downsizing ancillary trocars from 5- to 3-mm. DESIGN: Randomized, controlled trial (Canadian Task Force classification I). SETTING:Gynecologic department of a university hospital PATIENTS: A total of 102 women with an adnexal mass scheduled for gynecologic laparoscopic procedures were randomized to undergo laparoscopy using either conventional 5-mm ancillary trocars (n=52) or 3-mm instruments (n=50). Preoperative suspicion of malignancy, deep infiltrating endometriosis, and indications for hysterectomy or myomectomy were considered as exclusion criteria. INTERVENTIONS:Laparoscopic procedures for the treatment of benign adnexal masses. MEASUREMENTS AND MAIN RESULTS: Both groups were similar in patient age, body mass index, history of abdominal surgery, and type of procedures. Intraoperative complications occurred in no patient (0%) in the 3-mm group and in two patients (3.8%) in the 5-mm group (p=.49). Conversion from 3- to 5-mm instrumentation was necessary in one procedure. No difference was found in the operative time between the 3-mm and the 5-mm groups (54 min [range 15-175 min] vs 50 min [range 20-150 min], p=.89). The severity of incisional pain was evaluated with a 100-mm visual analog scale at 1, 3, and 24 hours after surgery. Postoperative pain was significantly lower in the 3-mm than in the 5-mm group 1 hour after laparoscopy (20 [range 0-60] vs 32.5 [range 0-80], p=.04). The proportion of women requiring analgesia before discharge, the timing of analgesic requirement, and the total amount of medication in the first 24 hours after surgery were similar in the two groups. CONCLUSION: Three-millimeter ancillary trocars can safely replace traditional-size equipment for the management of adnexal masses without a negative impact on the surgeon's ability to perform gynecologic laparoscopy and are associated with less immediate postoperative pain.
RCT Entities:
STUDY OBJECTIVE: To evaluate the feasibility, safety, and effect on postoperative pain of laparoscopy for the management of adnexal masses by downsizing ancillary trocars from 5- to 3-mm. DESIGN: Randomized, controlled trial (Canadian Task Force classification I). SETTING: Gynecologic department of a university hospital PATIENTS: A total of 102 women with an adnexal mass scheduled for gynecologic laparoscopic procedures were randomized to undergo laparoscopy using either conventional 5-mm ancillary trocars (n=52) or 3-mm instruments (n=50). Preoperative suspicion of malignancy, deep infiltrating endometriosis, and indications for hysterectomy or myomectomy were considered as exclusion criteria. INTERVENTIONS: Laparoscopic procedures for the treatment of benign adnexal masses. MEASUREMENTS AND MAIN RESULTS: Both groups were similar in patient age, body mass index, history of abdominal surgery, and type of procedures. Intraoperative complications occurred in no patient (0%) in the 3-mm group and in two patients (3.8%) in the 5-mm group (p=.49). Conversion from 3- to 5-mm instrumentation was necessary in one procedure. No difference was found in the operative time between the 3-mm and the 5-mm groups (54 min [range 15-175 min] vs 50 min [range 20-150 min], p=.89). The severity of incisional pain was evaluated with a 100-mm visual analog scale at 1, 3, and 24 hours after surgery. Postoperative pain was significantly lower in the 3-mm than in the 5-mm group 1 hour after laparoscopy (20 [range 0-60] vs 32.5 [range 0-80], p=.04). The proportion of women requiring analgesia before discharge, the timing of analgesic requirement, and the total amount of medication in the first 24 hours after surgery were similar in the two groups. CONCLUSION: Three-millimeter ancillary trocars can safely replace traditional-size equipment for the management of adnexal masses without a negative impact on the surgeon's ability to perform gynecologic laparoscopy and are associated with less immediate postoperative pain.