Jin-Sung Yuk1, Hyun Young Ji1, Kye Hyun Kim2, Jung Hun Lee3. 1. The Department of Obstetrics and Gynecology, MizMedi Hospital, Eulji University School of Medicine, Seoul, Republic of Korea. 2. The Department of Obstetrics and Gynecology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. 3. The Department of Obstetrics and Gynecology, MizMedi Hospital, Eulji University School of Medicine, Seoul, Republic of Korea. Electronic address: leemjjm@gmail.com.
Abstract
OBJECTIVE: To evaluate whether single-port laparoscopically assisted-transumbilical ultraminilaparotomic myomectomy (SPLA-TUM) has a shorter operating time than single port laparoscopic myomectomy (SP-LM), without negatively affecting postoperative pain and cosmesis. STUDY DESIGN: We performed a randomized controlled trial at a University teaching hospital. A total of 92 premenopausal women with symptomatic, superficial intramural or subserosal fibroids were randomized to receive either SPLA-TUM or SP-LM. The primary outcome measured was the operating time. The secondary outcome measures included postoperative pain, as measured by a visual analog scale (VAS) at 2, 6, 12, 24, and 48h after the operation, and cosmetic outcomes, as measured by the Vancouver scar scale (VSS) and patient satisfaction with the scars, using a VAS at 3 postoperative months. RESULTS: There were no differences in the patient demographics or in the clinical characteristics of the resected fibroids between the two groups. The operation results showed no differences in the hemoglobin changes, return of bowel activity, hospital stay, and complication rate between the groups. The mean operating time in the SPLA-TUM group was shorter than that in the SP-LM group (87.0±32.7min compared with 102.3±32.9min, P=0.026). The patients in each group demonstrated no differences in their postoperative pain levels, VSS scores, and satisfaction with the scars, but the SPLA-TUM group had a longer umbilical wound compared with the SP-LM group. Two (4.3%) patients in the SPLA-TUM group received SP-LM. One (2.2%) patient in the SP-LM group and two (4.3%) patients in the SPLA-TUM group were converted to two or three port laparoscopic myomectomy. CONCLUSIONS:SPLA-TUM has a shorter operating time than SP-LM due to convenient suturing and knotting; the two procedures have comparable postoperative pain levels and cosmetic outcomes. However, further study is needed to evaluate the long-term outcomes of SPLA-TUM.
RCT Entities:
OBJECTIVE: To evaluate whether single-port laparoscopically assisted-transumbilical ultraminilaparotomic myomectomy (SPLA-TUM) has a shorter operating time than single port laparoscopic myomectomy (SP-LM), without negatively affecting postoperative pain and cosmesis. STUDY DESIGN: We performed a randomized controlled trial at a University teaching hospital. A total of 92 premenopausal women with symptomatic, superficial intramural or subserosal fibroids were randomized to receive either SPLA-TUM or SP-LM. The primary outcome measured was the operating time. The secondary outcome measures included postoperative pain, as measured by a visual analog scale (VAS) at 2, 6, 12, 24, and 48h after the operation, and cosmetic outcomes, as measured by the Vancouver scar scale (VSS) and patient satisfaction with the scars, using a VAS at 3 postoperative months. RESULTS: There were no differences in the patient demographics or in the clinical characteristics of the resected fibroids between the two groups. The operation results showed no differences in the hemoglobin changes, return of bowel activity, hospital stay, and complication rate between the groups. The mean operating time in the SPLA-TUM group was shorter than that in the SP-LM group (87.0±32.7min compared with 102.3±32.9min, P=0.026). The patients in each group demonstrated no differences in their postoperative pain levels, VSS scores, and satisfaction with the scars, but the SPLA-TUM group had a longer umbilical wound compared with the SP-LM group. Two (4.3%) patients in the SPLA-TUM group received SP-LM. One (2.2%) patient in the SP-LM group and two (4.3%) patients in the SPLA-TUM group were converted to two or three port laparoscopic myomectomy. CONCLUSIONS:SPLA-TUM has a shorter operating time than SP-LM due to convenient suturing and knotting; the two procedures have comparable postoperative pain levels and cosmetic outcomes. However, further study is needed to evaluate the long-term outcomes of SPLA-TUM.