Feasibility Study of Laparoendoscopic Single Site Surgical Staging for Endometrial Cancer

Not Applicable

Completed

• Conditions: Endometrial Cancer
• Interventions: Procedure: Four-port laparoscopic surgical staging; Procedure: single-port laparoscopic surgical staging

• Registration Number: NCT01679522
• Lead Sponsor: Asan Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-03
• Study First Submitted QC: 2012-09-05
• Study First Posted: 2012-09-06
• Study Start: 2013-01
• Primary Completion: 2021-09
• Study Completion: 2022-06
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-28
• Last Update Posted: 2022-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 107

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Four-port surgery group	Four-port laparoscopic surgical staging	Four-port laparoscopic surgical staging including total hysterectomy, pelvic lymph node dissection, and/or bilateral salpingooophorectomy, and/or para-aortic lymph node dissection
Single-port surgery group	single-port laparoscopic surgical staging	Single-port laparoscopic surgical staging including total hysterectomy, pelvic lymph node dissection, and/or bilateral salpingooophorectomy, and/or para-aortic lymph node dissection

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of