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Предстои набиране Не е приложимо NCT07546825

Laparotomy vs Laparoscopy in Endometrial Cancer Staging

Не е приложима фаза (напр. обсервационно)
Заболявания: Gynaecological Oncology Gynaecological Malignancies Laparoscopic

Спонсор: Assiut University

Налично на: БГ
Обобщение
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. The primary outcome will be comparison of operative time between laparoscopic and open pelvic lymphadenectomy. Secondary outcomes include intraoperative complications, intraoperative blood loss, hospital stay, recovery parameters, and oncological outcomes. 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.
Описание
Endometrial Cancer is the most common gynecologic malignancy in developed countries, and its incidence continues to rise worldwide. The majority of patients present with early-stage disease due to symptoms such as abnormal uterine bleeding, which facilitates early diagnosis and treatment. Surgical management remains the cornerstone of therapy and typically includes total hysterectomy with bilateral salpingo-oophorectomy with or without lymph node assessment depending on the patient's risk factors and disease stage. Pelvic lymphadenectomy plays an important role in accurate staging, prognostic stratification, and guiding decisions regarding adjuvant therapy. Traditionally, surgical staging was performed through open laparotomy, which provides adequate exposure for lymph node dissection. However, open surgery is associated with significant perioperative morbidity, including increased blood loss, postoperative pain, longer hospital stay, and higher rates of wound complications . Minimally invasive surgery has increasingly been adopted in gynecologic oncology as an alternative to open surgery. Laparoscopic approaches offer several advantages, including improved visualization of anatomical structures, reduced intraoperative blood loss, faster recovery, and shorter hospitalization. Several studies have evaluated the feasibility and safety of laparoscopic surgical staging in endometrial cancer. In addition to the conventional transperitoneal approach, laparoscopic extraperitoneal lymphadenectomy has emerged as an alternative technique that avoids peritoneal entry and may offer advantages in selected patients, particularly those with obesity or extensive intra-abdominal adhesions. However, extraperitoneal lymphadenectomy is technically demanding, requires advanced spatial orientation . The oncologic safety of minimally invasive surgical staging has been demonstrated in the randomized LAP2 Trial, which showed comparable recurrence and survival outcomes between laparoscopic and open surgical staging while providing improved perioperative outcomes for laparoscopy. Recent advances in molecular pathology have introduced a molecular classification system for endometrial cancer based on genomic analysis described by The Cancer Genome Atlas (TCGA). This classification divides tumors into four main molecular subgroups: POLE ultramutated, microsatellite instability or mismatch repair deficient (MMRd), copy-number low (p53 wild-type), and copy-number high (p53 abnormal). Molecular classification provides significant prognostic information and has been incorporated into modern risk-stratification systems to guide adjuvant therapy and surgical decision-making in endometrial cancer. Therefore, this study hypothesizes that laparoscopic pelvic lymphadenectomy provides superior perioperative outcomes while maintaining comparable oncologic safety compared with open pelvic lymphadenectomy in patients with endometrial cancer in low-resource settings.
Кой може да участва
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 (7). * Planned surgical staging including: total hysterectomy, bilateral salpingo-oophorectomy and pelvic lymphadenectomy. * good performance status : ECOG 0, 1, 2 * patients who provide informed written consent to participate in the study. b. 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.
Интервенции
laparoscopic pelvic lymphadenectomy
PROCEDURE
open pelvic lymphadenectomy
PROCEDURE
Места на провеждане 1
Egypt (1)
Assiut University, Assiut,
Asyut
Alaa El-Din Mahmoud Ismail, professor
Технически детайли
Статус
Предстои набиране
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Само жени
Здрави доброволци
Не
Начална дата
01.05.2026
Крайна дата
01.10.2028
Регистрационен номер
NCT07546825
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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