Endometrial Cancer
Conditions
Keywords
endometrial cancer, laparoscopic surgical staging, single-port, four-port
Brief summary
To compare the feasibility, safety, and efficacy between single-port and four-port laparoscopic surgical staging in patients with early stage endometrial cancer.
Interventions
PROCEDUREsingle-port laparoscopic surgical staging
single-port laparoscopic surgical staging indluding total hysterectomy, pelvic lymph node dissection, and/or bilateral salpingooophorectomy, and/or para-aortic lymph node dissection
PROCEDUREFour-port laparoscopic surgical staging
Four-port laparoscopic surgical staging indluding total hysterectomy, pelvic lymph node dissection, and/or bilateral salpingooophorectomy, and/or para-aortic lymph node dissection
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Previously untreated, histologically confirmed endometrial cancer * Presumed FIGO stage 1 * Endometrioid adenocarcinoma * patient who is planned to undergo surgical staging * adequate oran function 1. WBC \> 3000 cells/mcl 2. Platelets \> 100000/mcl 3. Creatinine \< 2.0 mg/dL 4. Bilirubin \< 1.5 \* normal and SGOT or SGPT \< 3 \* normal * American Society of Anesthesiologists Physical Status I-II * Eastern Cooperative Oncology Group performance status 0-2 * Patients who have signed an approved Informed Consent
Exclusion criteria
* Uncontrolled medical disease * Active infectious disease requiring antibiotics * Previous pelvic radiation therapy * Pregnant and lactating woman * Patient who requires additional surgical procedures which are not necessary for surgical staging of endometrial cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| operating time | 1 day (Immediately after operation) | Total operation time and time required for each procedure are calculated and compared. |
| Number of lymph nodes retrieved | 1 week after surgery | The number of right pelvic lymph nodes and left pelvic lymph nodes were obtained and compared. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| transfusion requirement and amount | within 1 week after surgery | Investigate and compare blood transfusion volume and frequency during and after surgery. |
| postoperative complications | within 1 month after surgery | Compare the frequency of fever, urinary retention, anemia, and nausea after surgery. |
| Postoperative pain | within 1 week after surgery | The VAS pain score was obtained every 8 hours after surgery and compared. |
| overall survival | 34 months after surgery | Compare OS during the follow-up period. |
| recurrence free survival | 34 months after surgery | Compare RFS during the follow-up period. |
| Postoperative analgesics requirement | within 1 week after surgery | If the VAS pain score is 3 or more or the patient desires, additional pain medication is administered. The frequency of the pain medication administered in this way is investigated and compared. |
Countries
South Korea
Outcome results
None listed