Clinical trial · Interventional
Complications of Laparoscopic Hysterectomy and Sentinel Lymph Node Biopsy for Endometrial Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Endometrial adenocarcinoma is believed to be a more treatable malignancy. Poor prognosis is associated with age, grade and depth of myometrial invasion, lymph node status, tumor size, invasion of lymphovascular space and involvement of the lower uterine segment. Sentinel lymph node (SLN) mapping can be considered as an al¬ternative to standard lymphadenectomy in the patients with apparently uterine-confined disease and to assess whether they have metastatic pelvic lymph nodes. Randomized trials, a Cochrane Database Systematic Review, and population-based surgical studies support minimally invasive techniques due to a lower rate of surgical site infection, ve¬nous thromboembolism, reduced hospitalisation, and lower cost of care. This is a one arm clinical trial pilot study that focuses on the intraoperative and early postoperative complications of laparoscopic hysterectomy in patients with endometrial carcinoma and assess the feasibility and the diagnostic reliability of sentinel lymph node biopsy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Laparoscopic Hysterectomy and Sentinel Lymph Node Biopsy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic Hysterectomy and Sentinel Lymph Node Biopsy for Endometrial Carcinoma | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- One arm clinical trial
- description
- Convenience sampling method in which the first twenty cases of endometrial carcinoma patients who will undergo laparoscopic hysterectomy will be included. All cases will undergo laparoscopic hysterectomy. Sentinel lymph node biopsy will be detected, dissected and isolated. Then standard lymphadenectomy will be done
- interventionNames
- Procedure: Laparoscopic Hysterectomy and Sentinel Lymph Node Biopsy for Endometrial Carcinoma
Primary outcomes (1)
- measure
- Complications of laparoscopic hysterectomy in patients with endometrial carcinoma
- timeFrame
- one week
- description
- To assess the intraoperative and early postoperative complications of laparoscopic hysterectomy in patients with endometrial carcinoma
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who have endometrial carcinoma and undergoing laparoscopic hysterectomy * Estimated uterine upper margin is not beyond the midpoint between the umbilicus and the symphysis pubis. * No preexisting cardiopulmonary dysfunction or poor control of systemic diseases. * Bimanual pelvic examination confirmed good mobility of an enlarged uterus. * Fractional curettage revealed no tumor extension in the endocervical canal. * Preoperative metastatic work up revealed no extra-uterine disease either regional or systemic. Exclusion Criteria: * Patient refusal. * Estimated uterine upper margin is beyond the midpoint between the umbilicus and the symphysis pubis. * Cardiopulmonary dysfunction or poor control of systemic diseases. * Bimanual pelvic examination confirmed fixed enlarged uterus. * Fractional curettage revealed tumor extension in the endocervical canal. * Preoperative metastatic work up revealed extra-uterine disease either regional or systemic.
References
Publications (9)
- BACKGROUNDBarlin JN, Khoury-Collado F, Kim CH, Leitao MM Jr, Chi DS, Sonoda Y, Alektiar K, DeLair DF, Barakat RR, Abu-Rustum NR. The importance of applying a sentinel lymph node mapping algorithm in endometrial cancer staging: beyond removal of blue nodes. Gynecol Oncol. 2012 Jun;125(3):531-5. doi: 10.1016/j.ygyno.2012.02.021. Epub 2012 Feb 22. PMID 22366409
- BACKGROUNDBenedetti Panici P, Basile S, Salerno MG, Di Donato V, Marchetti C, Perniola G, Palagiano A, Perutelli A, Maneschi F, Lissoni AA, Signorelli M, Scambia G, Tateo S, Mangili G, Katsaros D, Campagnutta E, Donadello N, Greggi S, Melpignano M, Raspagliesi F, Cormio G, Grassi R, Franchi M, Giannarelli D, Fossati R, Torri V, Croce C, Mangioni C. Secondary analyses from a randomized clinical trial: age as the key prognostic factor in endometrial carcinoma. Am J Obstet Gynecol. 2014 Apr;210(4):363.e1-363.e10. doi: 10.1016/j.ajog.2013.12.025. Epub 2013 Dec 19. PMID 24361787
- BACKGROUNDFader AN, Weise RM, Sinno AK, Tanner EJ 3rd, Borah BJ, Moriarty JP, Bristow RE, Makary MA, Pronovost PJ, Hutfless S, Dowdy SC. Utilization of Minimally Invasive Surgery in Endometrial Cancer Care: A Quality and Cost Disparity. Obstet Gynecol. 2016 Jan;127(1):91-100. doi: 10.1097/AOG.0000000000001180. PMID 26646127
- BACKGROUNDHolloway RW, Abu-Rustum NR, Backes FJ, Boggess JF, Gotlieb WH, Jeffrey Lowery W, Rossi EC, Tanner EJ, Wolsky RJ. Sentinel lymph node mapping and staging in endometrial cancer: A Society of Gynecologic Oncology literature review with consensus recommendations. Gynecol Oncol. 2017 Aug;146(2):405-415. doi: 10.1016/j.ygyno.2017.05.027. Epub 2017 May 28. PMID 28566221
- BACKGROUNDJanda M, Gebski V, Davies LC, Forder P, Brand A, Hogg R, Jobling TW, Land R, Manolitsas T, Nascimento M, Neesham D, Nicklin JL, Oehler MK, Otton G, Perrin L, Salfinger S, Hammond I, Leung Y, Sykes P, Ngan H, Garrett A, Laney M, Ng TY, Tam K, Chan K, Wrede CD, Pather S, Simcock B, Farrell R, Robertson G, Walker G, Armfield NR, Graves N, McCartney AJ, Obermair A. Effect of Total Laparoscopic Hysterectomy vs Total Abdominal Hysterectomy on Disease-Free Survival Among Women With Stage I Endometrial Cancer: A Randomized Clinical Trial. JAMA. 2017 Mar 28;317(12):1224-1233. doi: 10.1001/jama.2017.2068.