Laparotomy vs Laparoscopy in Endometrial Cancer Staging

Official title

Perioperative Outcomes of Surgical Staging in Patients With Early-stage Endometrial Carcinoma: Comparison Between Laparoscopy and Laparotomy in a Low-resource Setting

Overview

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.

Detailed description

Endometrial cancer is the most common gynecologic malignancy in developed countries, with increasing incidence related to obesity, aging, and metabolic disorders. Most patients present with early-stage disease confined to the uterus, making surgical staging the cornerstone of treatment. Standard management includes total hysterectomy, bilateral salpingo-oophorectomy, and pelvic lymph node assessment when indicated for accurate staging and risk stratification . Minimally invasive surgery (MIS), particularly laparoscopy, has increasingly replaced laparotomy in the surgical staging of endometrial cancer because of its perioperative advantages. Previous studies demonstrated that laparoscopic surgery is associated with reduced blood loss, fewer postoperative complications, shorter hospital stay, and faster return to normal activity while maintaining comparable oncologic outcomes to open surgery. Recently, greater emphasis has been placed on patient-centered outcomes and enhanced recovery after surgery (ERAS) pathways. Early postoperative recovery is considered an important indicator of surgical quality and functional rehabilitation. Time to ambulation is a simple and clinically relevant marker of recovery, as delayed mobilization is associated with prolonged hospitalization and increased postoperative morbidity. Faster recovery may also facilitate earlier initiation of adjuvant therapy when indicated. Additionally, discrepancies between preoperative curettage pathology and final histopathology may alter risk stratification and postoperative management. Despite strong evidence supporting laparoscopy, most data originate from high-resource settings with advanced ERAS systems. Evidence from low-resource settings remains limited, particularly regarding functional recovery metrics, cost-effectiveness, and real-world delays in adjuvant therapy. Furthermore, few randomized trials have incorporated patient-reported recovery outcomes alongside oncologic endpoints.Therefore, this study aims to compare laparoscopic and open surgical staging for early-stage endometrial cancer regarding early postoperative recovery, perioperative outcomes, postoperative morbidity, delay in initiation of adjuvant therapy, and concordance between preoperative and final histopathological findings.

Interventions

• Procedure laparoscopic surgical staging
  surgical staging by laparoscopy
• Procedure open surgical staging
  surgical staging through open surgery

Primary outcome measures

• Early postoperative recovery assessed by time to ambulation (hours). [Time frame: From the end of surgery until the patient achieves independent ambulation or ambulation with minimal assistance, assessed during the first 24 postoperative hours.]

Secondary outcome measures (12)

• Comparison of hospital stay duration between laparoscopic and open surgical staging [Time frame: From the day of surgery through hospital discharge, assessed up to 7 days postoperatively.]
• comparsion between same day discgarge between laparoscopic and open surgical staging [Time frame: Day 0 (day of surgery)]
• Pelvic lymph node yield (number of nodes) [Time frame: At final histopathological examination (within 2 weeks postoperatively)]
• Short-Term Oncologic Outcomes [Time frame: follow up for one year]
• Postoperative quality of recovery [Time frame: at 12 hours, 24 hours, 48 hours postoperatively , and at time of hospital discharge (up to 5 postoperative days).]
• Comparison of estimated blood loss during surgery between laparoscopic and open surgical staging. [Time frame: During surgery (intraoperative period)]
• Comparison of intraoperative complications between laparoscopic and open surgical staging. [Time frame: During surgery]
• Postoperative complications (Clavien-Dindo classification, Grades I-V) [Time frame: Within 30 days after surgery]
• comparsion of health-related quality of life assessed using the EQ-5D-5L questionnaire between open and laparoscopic surgical staging [Time frame: baseline (preoperative), 6 weeks, and 12 weeks postoperatively.]
• hospital-based cost comparison between both surgical approaches [Time frame: From surgery until hospital discharge, assessed up to 30 days postoperatively.]
• Discrepancy between preoperative curettage pathology and final histopathology [Time frame: From preoperative endometrial sampling through final postoperative histopathological assessment, up to 30 days after surgery.]
• Conversion Rate [Time frame: guring surgery]

Eligibility criteria

• 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.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Assiut University, Assiut, — Asyut

Publications

• Weiss 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
• Jaiswal 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
• Abu-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
• Torok 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
• Kong 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
• Bretova 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
• Concin 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 PMID 40744042
• Walker JL, Piedmonte MR, Spirtos NM, Eisenkop SM, Schlaerth JB, Mannel RS, Spiegel G, Barakat R, Pearl ML, Sharma SK. Laparoscopy compared with laparotomy for comprehensive surgical staging of uterine cancer: Gynecologic Oncology Group Study LAP2. J Clin Oncol. 2009 Nov 10;27(32):5331-6. doi: 10.1200/JCO.2009.22.3248. Epub 2009 Oct 5. PMID 19805679

Identifiers

NCT: NCT07546825 · EC-STAGE-LL-2026

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗