Peritoneal closure does not reduce the incidence of postoperative lower limb lymphedema after lymphadenectomy for uterine cancers during the first three years after surgery: a single-blinded randomized controlled trial in multiple facilities

Abstract

Objective Lower limb lymphedema (LLL) that occurs after lymphadenectomy for gynecologic malignancies significantly reduces the quality of life of the patients. Although it has long been considered that opening of the retroperitoneum reduces LLL, there have been no randomized studies to date aimed solely to determine whether opening of the retroperitoneum is more favorable than closing for preventing LLL. Methods The subjects were a total of 200 patients with either cervical or endometrial cancer who were enrolled for surgery in 11 institutes. Primary endpoint is the cumulative incidence of LLL during 3 years after surgery, compared between “surgery with no retroperitoneal closure (open)” and “surgery with retroperitoneal closure (closed)”. Secondary endpoint is the frequency of the appearance of lymphocysts. Results No significant difference in the incidence of postoperative LLL between the open and closed groups (24/98 and 25/95, respectively. P = 0.77) was observed. However, a higher risk of lymphocyst formation was detected during the initial postoperative period in the closed group (36/98 and 54/95, respectively. P = 0.005). Conclusion There was no significant difference in the incidence of postoperative LLL between the open and closed groups. However, to prevent the development of lymphocysts, the retroperitoneum should be open rather than closed at the time of surgery for uterine cancers that include retroperitoneal lymph node dissection. Since lymphocyst formation could be a known risk factor of LLL, the favorable outcomes in the incidence of postoperative LLL in the open group might be revealed with longer term investigation.