NCT01679522

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 6, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

November 30, 2022

Status Verified

November 1, 2022

Enrollment Period

8.7 years

First QC Date

September 3, 2012

Last Update Submit

November 28, 2022

Conditions

Endometrial Cancer

Keywords

endometrial cancerlaparoscopic surgical stagingsingle-portfour-port

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Postoperative pain

    within 1 week after surgery

  • Postoperative analgesics requirement

    within 1 week after surgery

  • transfusion requirement and amount

    within 1 week after surgery

  • postoperative complications

    within 1 month after surgery

  • recurrence free survival

    34 months after surgery

  • +1 more secondary outcomes

Study Arms (2)

Single-port surgery group

EXPERIMENTAL

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

Four-port surgery group

ACTIVE COMPARATOR

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

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

Single-port surgery group
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

Four-port surgery group

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seoul, 138-736, South Korea

Location

Related Publications (1)

  • Kang OJ, Nam JH, Park JY. Laparo-endoscopic single-site versus conventional laparoscopic surgery for early-stage endometrial cancer: A randomized controlled non-inferiority trial. Gynecol Oncol. 2023 Jun;173:74-80. doi: 10.1016/j.ygyno.2023.04.005. Epub 2023 Apr 25.

    PMID: 37105060DERIVED

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Joo-Hyun Nam, M.D., Ph.D.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 3, 2012

First Posted

September 6, 2012

Study Start

January 1, 2013

Primary Completion

September 1, 2021

Study Completion

June 1, 2022

Last Updated

November 30, 2022

Record last verified: 2022-11

Locations

KR(1)