Feasibility Study of Laparoendoscopic Single Site Surgical Staging for Endometrial Cancer

Asan Medical Center107 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

107

Conditions

Endometrial Cancer

Interventions

single-port laparoscopic surgical stagingPROCEDURE

single-port laparoscopic surgical staging indluding total hysterectomy, pelvic lymph node dissection, and/or bilateral salpingooophorectomy, and/or para-aortic lymph node dissection

Four-port laparoscopic surgical stagingPROCEDURE

Four-port laparoscopic surgical staging indluding total hysterectomy, pelvic lymph node dissection, and/or bilateral salpingooophorectomy, and/or para-aortic lymph node dissection

Eligibility

Sex: FEMALEMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

operating time

Total operation time and time required for each procedure are calculated and compared.

Time frame: 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.

Time frame: 1 week after surgery

Secondary Outcomes

Postoperative pain

The VAS pain score was obtained every 8 hours after surgery and compared.

Time frame: 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.

Time frame: within 1 week after surgery

transfusion requirement and amount

Investigate and compare blood transfusion volume and frequency during and after surgery.

Time frame: within 1 week after surgery

postoperative complications

Compare the frequency of fever, urinary retention, anemia, and nausea after surgery.

Time frame: within 1 month after surgery

recurrence free survival

Compare RFS during the follow-up period.

Time frame: 34 months after surgery

overall survival

Data from ClinicalTrials.gov

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