Clinical trial · Interventional
Laparotomy vs Laparoscopy in Endometrial Cancer Staging
Perioperative Outcomes of Surgical Staging in Patients With Early-stage Endometrial Carcinoma: Comparison Between Laparoscopy and Laparotomy in a Low-resource Setting
- 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 cancer is one of the most common gynecological malignancies worldwide. Surgical staging is the cornerstone of management and traditionally performed via laparotomy. However, minimally invasive surgery, particularly laparoscopy, has emerged as an effective alternative with potential benefits in reducing postoperative morbidity. This study aims to compare the outcomes of laparoscopic versus open (laparotomy) surgical staging in patients with endometrial cancer in low-resource settings. Primary aim: To compare early postoperative recovery after surgical staging for early-stage endometrial cancer between laparoscopic and open approaches, assessed primarily by time to ambulation. • Secondary aim: To compare intraoperative outcomes (operative time, blood loss, lymph node yield), postoperative morbidity (Clavien-Dindo classification), quality of recovery (QoR-15), length of hospital stay, same day discharge(SDD), discrepancy between preoperative curettage pathology and final histopathology, delay in initiation of adjuvant therapy, one-year disease-free survival, direct hospital costs between both approaches, and quality of life using EQ-5D-5L questionnaire. Given the limited resources and variations in surgical expertise in low-resource settings, this study seeks to evaluate the feasibility, safety, and effectiveness of laparoscopy compared to laparotomy. The findings may help guide clinical decision-making and optimize surgical approaches in similar healthcare environments.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynaecological Malignancies | — | UNRESOLVED | — |
| Gynaecological Oncology | — | UNRESOLVED | — |
| Laparoscopic | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laparoscopic surgical staging | Procedure | — | UNRESOLVED |
| open surgical staging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Laparoscopic surgical staging
- description
- surgical staging by laparoscopy
- interventionNames
- Procedure: laparoscopic surgical staging
- type
- OTHER
- label
- Open surgical staging (laparotomy)
- description
- surgical staging by open surgery
- interventionNames
- Procedure: open surgical staging
Primary outcomes (1)
- measure
- Early postoperative recovery assessed by time to ambulation (hours).
- timeFrame
- From the end of surgery until the patient achieves independent ambulation or ambulation with minimal assistance, assessed during the first 24 postoperative hours.
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
1. Inclusion criteria: * Histologically confirmed endometrial carcinoma, diagnosed by endometrial biopsy or dilatation and curettage. * patient candidate for pelvic lymphadenectomy according to risk stratification in endometrial cancer according to ESGO/ESTRO/ESP, 2021 (6). * Planned surgical staging including: total hysterectomy, bilateral salpingo-oophorectomy ± pelvic lymphadenectomy. * good performance status : ECOG 0, 1, 2 * patients who provide informed written consent to participate in the study. 2. Exclusion criteria: * severe cardiopulmonary diseases (e.g unstable angina, severe COPD). * Absolute contraindication to laparoscopy. * stage Ⅲ and Ⅳ endometrial cancer. * patients who received previous pelvic radiotherapy. * patients who underwent prior lymphadenectomy.
References
Publications (12)
- BACKGROUNDWeiss ME, Piacentine LB. Psychometric properties of the Readiness for Hospital Discharge Scale. J Nurs Meas. 2006 Winter;14(3):163-80. doi: 10.1891/jnm-v14i3a002. PMID 17278337
- BACKGROUNDJaiswal A, Huang KG. "Energy devices in gynecological laparoscopy - Archaic to modern era". Gynecol Minim Invasive Ther. 2017 Oct-Dec;6(4):147-151. doi: 10.1016/j.gmit.2017.08.002. Epub 2017 Sep 1. PMID 30254903
- BACKGROUNDAbu-Rustum NR. Sentinel lymph node mapping for endometrial cancer: a modern approach to surgical staging. J Natl Compr Canc Netw. 2014 Feb;12(2):288-97. doi: 10.6004/jnccn.2014.0026. PMID 24586087
- BACKGROUNDTorok P, Krasznai Z, Molnar S, Lampe R, Jakab A. Preoperative assessment of endometrial cancer. Transl Cancer Res. 2020 Dec;9(12):7746-7758. doi: 10.21037/tcr-20-2068. PMID 35117377
- BACKGROUNDKong TW, Lee KM, Cheong JY, Kim WY, Chang SJ, Yoo SC, Yoon JH, Chang KH, Ryu HS. Comparison of laparoscopic versus conventional open surgical staging procedure for endometrial cancer. J Gynecol Oncol. 2010 Jun;21(2):106-11. doi: 10.3802/jgo.2010.21.2.106. Epub 2010 Jun 30. PMID 20613901
- BACKGROUNDBretova P, Ndukwe MI, Laco J, Vosmikova H, Reslova T, Pohankova D, Balcarova K, Haviger J, Havigerova JM, Sirak I. Preoperative risk stratification in endometrial cancer using ESGO/ESTRO/ESP 2021 guidelines: accuracy with and without molecular classification. BMC Cancer. 2025 Aug 11;25(1):1302. doi: 10.1186/s12885-025-14741-5. PMID 40790476
- BACKGROUNDConcin N, Matias-Guiu X, Cibula D, Colombo N, Creutzberg CL, Ledermann J, Mirza MR, Vergote I, Abu-Rustum NR, Bosse T, Chargari C, Espenel S, Fagotti A, Fotopoulou C, Gatius S, Gonzalez-Martin A, Lax S, Levy B, Lorusso D, Macchia G, Marth C, Morice P, Oaknin A, Raspollini MR, Schwameis R, Sehouli J, Sturdza A, Taylor A, Westermann A, Wimberger P, Planchamp F, Nout RA. ESGO-ESTRO-ESP guidelines for the management of patients with endometrial carcinoma: update 2025. Lancet Oncol. 2025 Aug;26(8):e423-e435. doi: 10.1016/S1470-2045(25)00167-6.