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Completed

NCT Number: NCT01679522

Feasibility Study of Laparoendoscopic Single Site Surgical Staging for Endometrial Cancer

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

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Key information

Conditions

Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Seoul, 138-736, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

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

Treatment and study plan

single-port laparoscopic surgical staging

Procedure

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

Procedure

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

Primary outcomes

  1. operating time

    Time frame: 1 day (Immediately after operation)

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

  2. Number of lymph nodes retrieved

    Time frame: 1 week after surgery

    The number of right pelvic lymph nodes and left pelvic lymph nodes were obtained and compared.

Secondary outcomes

  1. Postoperative pain

    Time frame: within 1 week after surgery

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

  2. Postoperative analgesics requirement

    Time frame: 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.

  3. transfusion requirement and amount

    Time frame: within 1 week after surgery

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

  4. postoperative complications

    Time frame: within 1 month after surgery

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

  5. recurrence free survival

    Time frame: 34 months after surgery

    Compare RFS during the follow-up period.

  6. overall survival

    Time frame: 34 months after surgery

    Compare OS during the follow-up period.

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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

Acronym: LESS-E

Important dates

Study start
2013
Primary completion
2021
Study completion
2022
First posted
Sep 6, 2012
Registry last updated
Nov 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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