Feasibility Study of Laparoendoscopic Single Site Surgical Staging for Endometrial Cancer (LESS-E)

Asan Medical Center

Status: Completed

Conditions: Endometrial Cancer

Treatments: Procedure: Four-port laparoscopic surgical staging; Procedure: single-port laparoscopic surgical staging

Study type: Interventional

Funder types: Other

Identifiers

NCT01679522

LESS-E

Details and patient eligibility

About

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

Enrollment: 107 patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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107 participants in 2 patient groups

Single-port surgery group

Experimental group

Description:

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

Treatment:

Procedure: single-port laparoscopic surgical staging

Four-port surgery group

Active Comparator group

Description:

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

Treatment:

Procedure: Four-port laparoscopic surgical staging