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临床试验/NCT07546825
NCT07546825招募中不适用

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

Assiut University1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2026年6月2日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
48
试验地点
1

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

AM Abdelbary

Principal Investigator

Assiut University

研究点 (1)

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