Feasibility Study of Laparoendoscopic Single Site Surgical Staging for Endometrial Cancer

Endometrial Cancer Clinical Trial

— LESS-E  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01679522
• Other study ID #: LESS-E
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: June 2022

Study information

• Verified date: November 2022
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: June 2022
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Procedure:
• single-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
• Four-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

Locations

Country	Name	City	State
Korea, Republic of	Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	operating time	Total operation time and time required for each procedure are calculated and compared.	1 day (Immediately after operation)
Primary	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	Postoperative pain	The VAS pain score was obtained every 8 hours after surgery and compared.	within 1 week after surgery
Secondary	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
Secondary	transfusion requirement and amount	Investigate and compare blood transfusion volume and frequency during and after surgery.	within 1 week after surgery
Secondary	postoperative complications	Compare the frequency of fever, urinary retention, anemia, and nausea after surgery.	within 1 month after surgery
Secondary	recurrence free survival	Compare RFS during the follow-up period.	34 months after surgery
Secondary	overall survival	Compare OS during the follow-up period.	34 months after surgery