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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | The VAS pain score was obtained every 8 hours after surgery and compared. | within 1 week after surgery |
| 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. |
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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
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:
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| Name | Affiliation | Role |
|---|---|---|
| Joo-Hyun Nam, M.D., Ph.D. | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center | Seoul | 138-736 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37105060 | Derived | 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. |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| 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 |
|
| within 1 week after surgery |
| transfusion requirement and amount | Investigate and compare blood transfusion volume and frequency during and after surgery. | within 1 week after surgery |
| postoperative complications | Compare the frequency of fever, urinary retention, anemia, and nausea after surgery. | within 1 month after surgery |
| recurrence free survival | Compare RFS during the follow-up period. | 34 months after surgery |
| overall survival | Compare OS during the follow-up period. | 34 months after surgery |
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |