VALUE study

Rationale: The treatment of clinical stage 1 low-grade endometrial cancer consists of hysterectomy and bilateral salpingo-oophorectomy (BSO). Nowadays total laparoscopic hysterectomy (TLH) with BSO is the principal mode of surgery in these cases, resulting in shorter hospital stay, less pain and earlier recovery after surgery when compared to laparotomy. Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) is a new surgical endoscopic technique that can be applied to perform a hysterectomy. Recent research has demonstrated that vNOTES hysterectomy leads to a shorter hospital stay, lower self-reported VAS pain scores and less postoperative use of analgesics compared to laparoscopic hysterectomy.

Objective: To evaluate the duration of admission, feasibility, patient satisfaction and complication rate of vNOTES hysterectomy with BSO and compare it with laparoscopic hysterectomy and BSO in case of clinical stage 1 low grade endometrial cancer.

Study design: Multicentre randomized controlled trial

Study population: Women aged over 18 years old with a clinical stage 1 low-grade (grade 1 or 2) endometrioid adenocarcinoma of the endometrium or atypical hyperplasia of the endometrium who are planned for hysterectomy and bilateral salpingo-oophorectomy.

Intervention: Patients are randomized between hysterectomy and bilateral salpingo-oophorectomy with vNOTES or conventional laparoscopy.

Main study parameters/endpoints: The primary outcome is percentage of women discharged on the same day as the hysterectomy (day 0). Secondary outcomes are removal of uterus via allocated technique, major complications, minor complications, operating time, conversion rate, blood loss, hospital stay, usage of analgesics, pain scores, costs and quality of life (QoL). We calculated a sample size of 147 women assuming a 30% same day discharge difference with an alpha of 0.05 and a power of 90%. We plan to perform a follow up study of this trial to proof oncological safety of the procedure.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Standard of care in women diagnosed with clinical stage 1 low-grade endometrial cancer is to perform a chest X-ray. If there are no signs of metastatic disease and no advanced stage patients are planned for hysterectomy and BSO. Patients with the indication of laparoscopic hysterectomy with BSO for endometrial cancer or atypical hyperplasia and no contraindications for vNOTES hysterectomy are asked if they want to participate in this study. At this moment, TLH with BSO is the standard surgical technique in these patients. All included women will be randomized between vNOTES or laparoscopic hysterectomy with BSO in a 2:1 ratio. Standard postoperative contact by phone or out patient department visits at 2 and 6 weeks will be planned and patients will be asked to complete QoL questionnaires after 1 and 2 days, 1,4,6 and 12 weeks. Studies have shown that vNOTES hysterectomy is associated with a shorter hospital stay, less pain, less usage of analgesics, no scars and a quicker resumption to daily activity and no higher risk of complications when compared to laparoscopic hysterectomy. Permission will be asked to consult the national pathology database (PALGA) and the database of the Dutch Integrated Cancer Centre (IKNL) up to 5 years postoperative to ensure oncological follow up. Besides this follow-up we plan to perform a follow up study of all patients with low-grade endometrial cancer treated by vNOTES hysterectomy and BSO to ensure oncologic safety.
It is expected that patients treated with vNOTES will have a shorter hospital stay without increased risk of major complications and have a less pain, less usage of analgesics and a quicker resumption to daily activity.

vNOTES hysterectomy will lead to shorter duration of admission

12 weeks follow up

vNOTES hysterectomy