Low grade endometrial cancer
Conditions
Interventions
Sponsors
none
Eligibility
Inclusion criteria
Inclusion criteria: - 18 years and older - Written and orally given informed consent - Patients with a histologically confirmed low grade endometrial carcinoma with no signs of progressive or metastatic disease - Patients with atypical hyperplasia - Clinical assessment of feasibility to perform laparoscopic or vNOTES hysterectomy with BSO
Exclusion criteria
Exclusion criteria: Patients with high grade endometrial cancer Patients with advanced stage low grade endometrial cancer Patients unfit for surgery Significant language barrier Contraindication for laparoscopic or vNOTES hysterectomy such as: • History of rectal surgery • History of pelvic radiation • History of pelvic inflammatory disease, especially prior tubo-ovarian or pouch of Douglas abscess • 2 or more caesarean sections in history
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| percentage of patients treated in day-care setting | — |
Secondary
| Measure | Time frame |
|---|---|
| Major complications, severity scored by Clavien-Dindo classification o injuries to bowel, bladder, ureter, vessels, nerves o thrombo-embolic events o haematoma requiring surgical intervention o haemorrhage requiring transfusion or surgical intervention o wound dehiscence requiring surgical intervention o wound infections including vaginal vault abscesses requiring surgical intervention or admission Minor complications o urinary tract infections in the first 2 weeks postoperative for which antibiotics are started o surgical site infections; excluding vaginal vault abscesses that do not require surgical intervention but are treated expectantly or with antibiotics. Treatment related outcomes o conversion rate (number of vNOTES cases that were converted to TLH) o operating time (measured from the start of the inscision until end of surgery) o time in operation room (measured from the entry and departure of the patients in the OR) o successful resection of adnexa o total amount of CO2 used during procedure. (measured in litres CO2) o blood loss (measured in millilitres) o hospital stay (measured in hours) o usage of analgesics (usage and amount of paracetamol, NSAIDs or opioids) o resumption of daily activity (scored by return to daily activity questionnaire) o hospital readmission within 6 weeks after surgery o post-operative pain the first 48 hours after surgery (measured on a numeric rating scale) Quality of life up to 12 weeks o QoR-40 questionnaire (day 1,2 and 7) o Recovery-Index 10 (week 1,4,6, 12) | — |
Contacts
Public ContactAlbert Tjalsma
Albert Schweitzer Ziekenhuis
Outcome results
None listed