Roberta Venturella1, Michele Morelli2, Daniela Lico3, Annalisa Di Cello3, Morena Rocca3, Angela Sacchinelli3, Rita Mocciaro3, Pietro D'Alessandro3, Antonio Maiorana4, Salvatore Gizzo5, Fulvio Zullo2. 1. Department of Obstetrics and Gynecology, "Magna Graecia" University, Catanzaro, Italy. Electronic address: rovefa@libero.it. 2. Department of Obstetrics and Gynecology, "Magna Graecia" University, Catanzaro, Italy; Oncologic Center Tommaso Campanella, Catanzaro, Italy. 3. Department of Obstetrics and Gynecology, "Magna Graecia" University, Catanzaro, Italy. 4. Department of Obstetrics and Gynecology, Civico Hospital, Palermo, Italy. 5. Department of Woman and Child Health, University of Padua, Padua, Italy.
Abstract
OBJECTIVE: To study the effects of the wide excision of soft tissues adjacent to the ovary and fallopian tube on ovarian function and surgical outcomes in women undergoing laparoscopic bilateral prophylactic salpingectomy. DESIGN: Randomized, controlled trial. SETTING: Teaching hospital. PATIENT(S): One hundred eighty-six women undergoing laparoscopic surgery for uterine myoma (n = 143) or tubal surgical sterilization (n = 43). INTERVENTION(S): Patients were randomly divided into two groups. In group A (n = 91), standard salpingectomy was performed. In group B (n = 95), the mesosalpinx was removed within the tubes. Prior to and 3 months after surgery, antimüllerian hormone (AMH), FSH, three-dimensional antral follicle count (AFC), vascular index (VI), flow index (FI), vascular-flow index (VFI), and OvAge were recorded for each patient. MAIN OUTCOME MEASURE(S): Ovarian reserve modification (Δ) before and after surgery was assessed as the primary outcome. Operative time, variation of the hemoglobin level (ΔHb), postoperative hospital stay, postoperative return to normal activity, and complication rate were assessed as secondary outcomes. RESULT(S): No significant difference was observed between groups for ΔAMH, ΔFSH, ΔAFC, ΔVI, ΔFI, ΔVFI, and ΔOvAge. Moreover, the groups were similar for operative time, ΔHb, postoperative hospital stay, postoperative return to normal activity, and complication rate. CONCLUSION(S): Even when the surgical excision includes the removal of the mesosalpinx, salpingectomy does not damage the ovarian reserve. Moreover, wide salpingectomy with excision of the mesosalpinx did not alter blood loss, hospitalization stay, or return to normal activities. CLINICAL TRIAL REGISTRATION NUMBER: NCT02086370.
RCT Entities:
OBJECTIVE: To study the effects of the wide excision of soft tissues adjacent to the ovary and fallopian tube on ovarian function and surgical outcomes in women undergoing laparoscopic bilateral prophylactic salpingectomy. DESIGN: Randomized, controlled trial. SETTING: Teaching hospital. PATIENT(S): One hundred eighty-six women undergoing laparoscopic surgery for uterine myoma (n = 143) or tubal surgical sterilization (n = 43). INTERVENTION(S): Patients were randomly divided into two groups. In group A (n = 91), standard salpingectomy was performed. In group B (n = 95), the mesosalpinx was removed within the tubes. Prior to and 3 months after surgery, antimüllerian hormone (AMH), FSH, three-dimensional antral follicle count (AFC), vascular index (VI), flow index (FI), vascular-flow index (VFI), and OvAge were recorded for each patient. MAIN OUTCOME MEASURE(S): Ovarian reserve modification (Δ) before and after surgery was assessed as the primary outcome. Operative time, variation of the hemoglobin level (ΔHb), postoperative hospital stay, postoperative return to normal activity, and complication rate were assessed as secondary outcomes. RESULT(S): No significant difference was observed between groups for ΔAMH, ΔFSH, ΔAFC, ΔVI, ΔFI, ΔVFI, and ΔOvAge. Moreover, the groups were similar for operative time, ΔHb, postoperative hospital stay, postoperative return to normal activity, and complication rate. CONCLUSION(S): Even when the surgical excision includes the removal of the mesosalpinx, salpingectomy does not damage the ovarian reserve. Moreover, wide salpingectomy with excision of the mesosalpinx did not alter blood loss, hospitalization stay, or return to normal activities. CLINICAL TRIAL REGISTRATION NUMBER: NCT02086370.