Feasibility Study of Laparoendoscopic Single Site Surgical Staging for Endometrial Cancer

Study Overview
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Brief Summary
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To compare the feasibility, safety, and efficacy between single-port and four-port laparoscopic surgical staging in patients with early stage endometrial cancer.

Official Title
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Prospective Randomized Comparison of Single-port and Four-port Laparoscopic Staging Operation for Endometrial Cancer

Conditions
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Endometrial Cancer

Intervention / Treatment
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* Procedure: single-port laparoscopic surgical staging
* Procedure: Four-port laparoscopic surgical staging


Participation Criteria
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Eligibility Criteria
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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 WBC > 3000 cells/mcl Platelets > 100000/mcl Creatinine < 2.0 mg/dL 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single-port surgery group<br>Single-port laparoscopic surgical staging including total hysterectomy, pelvic lymph node dissection, and/or bilateral salpingooophorectomy, and/or para-aortic lymph node dissection | Procedure: single-port laparoscopic surgical staging<br>* single-port laparoscopic surgical staging indluding total hysterectomy, pelvic lymph node dissection, and/or bilateral salpingooophorectomy, and/or para-aortic lymph node dissection<br>|
| Active Comparator: Four-port surgery group<br>Four-port laparoscopic surgical staging including total hysterectomy, pelvic lymph node dissection, and/or bilateral salpingooophorectomy, and/or para-aortic lymph node dissection | Procedure: Four-port laparoscopic surgical staging<br>* Four-port laparoscopic surgical staging indluding total hysterectomy, pelvic lymph node dissection, and/or bilateral salpingooophorectomy, and/or para-aortic lymph node dissection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operating time | Total operation time and time required for each procedure are calculated and compared. | 1 day (Immediately after operation) | 
| Number of lymph nodes retrieved | The number of right pelvic lymph nodes and left pelvic lymph nodes were obtained and compared. | 1 week after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | The VAS pain score was obtained every 8 hours after surgery and compared. | within 1 week after surgery | 
| Postoperative analgesics requirement | 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. | within 1 week after surgery | 
| transfusion requirement and amount | Investigate and compare blood transfusion volume and frequency during and after surgery. | within 1 week after surgery | 
| postoperative complications | Compare the frequency of fever, urinary retention, anemia, and nausea after surgery. | within 1 month after surgery | 
| recurrence free survival | Compare RFS during the follow-up period. | 34 months after surgery | 
| overall survival | Compare OS during the follow-up period. | 34 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endometrial cancer, laparoscopic surgical staging, single-port, four-port