br The aim of this study was
The aim of this study was to pilot the use of an objective measure-ment technique to prospectively describe the incidence of lower-extremity lymphedema among women after minimally invasive staging surgery for endometrial cancer. We hypothesized that a substantial pro-portion of patients experience this morbidity. Secondary objectives in-cluded observation of changes in lower extremity function and quality of life in this patient population. Additional exploratory analysis of this prospective cohort was also performed to examine outcomes in the SLNB and LND subjects separately.
2. Materials and methods
2.1. Selection of patients
A longitudinal, prospective pilot study of women undergoing staging surgery for presumed early stage endometrial cancer was conducted by enrolling patients from September 2013 to September 2015. Inclusion criteria were: (a) older than 18 years; (b) endometrial cancer of any his-tologic type; (c) suitable candidate for surgery; (d) scheduled to un-dergo laparoscopic or robotic-assisted (RA) laparoscopic hysterectomy; and (e) no severe physical or mental comorbidity. Pa-tients were excluded if they had known metastatic disease. Given trends during the enrollment years toward minimally invasive surgery for the management of endometrial cancer, the investigation was confined to planned laparoscopies to create a more homogenous surgical cohort. Patient demographic, clinical, surgical and pathological data were col-lected using a standardized abstraction form.
2.2. Study procedures
Institutional Review Board approval for the study was obtained. Consent was obtained at the preoperative visit. During the enrollment visit, baseline demographic data, baseline leg volume measurements, lower extremity function and quality of life surveys were completed. Each subject then underwent endometrial cancer staging surgery, either with conventional or robotic-assisted laparoscopy. Conversion to lapa-rotomy was not considered an exclusion criterion. Removal of Doxorubicin nodes and technique of lymph node dissection (SLNB or LND) were left to physician discretion based on clinical criteria. Post-staging assess-ments, including leg volume measurement and lower extremity func-tion and quality of life surveys, were administered at three separate measurement periods: 4–6 weeks, 6–9 months and 12–18 months postoperatively.
2.3.1. Lymphedema measurements
The Comparative Circumferential Volume (CCV) measurement method was used to evaluate leg volume preoperatively and at 4–6 weeks, 6–9 months and 12–18 months postoperatively . This method consists of measuring the circumference of each lower extrem-ity from the level of the ankle to two centimeters below the gluteal fold at four-centimeter intervals (Fig. 1). A certified lymphedema specialist trained a single clinical research coordinator in accurate assessment using the CCV. The research coordinator then performed all measure-ments to ensure consistency. These measurements were used to com-pute total limb volume. Presence of lymphedema was defined as an increase in volume of at least 10% from preoperative measurements; this minimum is based on previously established, clinically meaningful thresholds for postoperative LEL . Results were dichotomized into absent (0 to b10% excess of limb volume) or present (10% or greater limb volume change).
2.3.2. Lymphedema related-morbidity
The Lower Extremity Functional Scale (LEFS) was used to evaluate lymphedema-related morbidity after staging surgery . The LEFS is a validated survey that consists of twenty questions that assess the ef-fect of a lower limb condition on a person's ability to perform everyday tasks (Fig. 2). The cumulative score can range from 0 to 80, with a higher score indicating better lower extremity function. Median score in a healthy population is 77. A minimal clinically important difference for the broad category of lower extremity injury has been defined as a 9-point decrease . The LEFS questionnaire was administered before surgery and at 4–6 weeks, 6–9 months and 12–18 months postoperatively.