Evaluation of Laparoscopic Staging Versus Staging Laparotomy for Early Stage Endometrial Cancer

Обзор

Compared with laparotomy, laparoscopy is associated with faster recovery, better visualization, shorter hospital stays, and less possible adhesion formation. But do the safety, efficacy, and morbidity of laparoscopic staging differ from conventional staging laparotomy in endometrial cancer?Is laparoscopic staging considered a safe and effective alternative procedure for the surgical treatment of early-stage endometrial carcinoma? This study aims to compare the safety, efficacy, and morbidity between total laparoscopic hysterectomy (TLH) with lymphadenectomy and conventional staging laparotomy for early-stage endometrial cancer.

Подробное описание

Primary Outcome: perioperative morbidities:

1. intraoperative complications like bladder injury, ureteric injury, vascular injury \& bowel injury. 2. Early postoperative complications like paralytic ileus, postoperative fever ((defined as a temperature higher than 38 c on two consecutive postoperative days or higher than 39 c on any postoperative day).

Secondary outcomes:

1. Amount of blood loss by allowable blood loss formula between conventional staging laparotomy and laparoscopic staging \& need for blood transfusion. (ABL = weight kg \* age sex factor (65ml/ kg) \*initial HGB(g/dl)-final HGB(g/dl) / initial HGB (g/dl) (Jaramillo, 2019). 2. oncological outcomes (one-year survival rate, need for adjuvant chemo or radiotherapy, recurrent rate after one year) indicate radical malignancy elimination. 3. Operation time from skin to skin in hours. 4. ICU admission. 5. Wound infection. 6. Hospital stays in days. 7. A post-operative pain person rates their pain on a scale of 0 to 10. Zero means "no pain," and 10 means "the worst possible pain. Laparoscopic surgical staging operation is a safe and effective therapeutic procedure for the management of endometrial cancer especially lymphadenectomy with acceptable morbidity and radical treatment to the malignancy compared to the laparotomy.

Вмешательства

• Процедура laparscopic staging
  staging laparotomy

Первичные конечные точки

• Primary Outcome: perioperative morbidities. intraoperative complications like bladder, ureteric, or intestinal injury [Срок оценки: 6 months]

Вторичные конечные точки (1)

• Secondary outcomes: 1. Amount of blood loss by the allowable blood loss formula [Срок оценки: 6 months]

Критерии участия

Inclusion Criteria:• Inclusion Criteria:

I. Patient histopathological diagnosed early-stage endometrial carcinoma, (stages 1A \&1B) according to FIGO classification.

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Критерии исключения

• Exclusion Criteria:

• The patient received neoadjuvant chemo or radiotherapy.
• The presence of ovarian tumors, and proven metastasis outside the uterus.
• The presence of any contraindication for general anesthesia like heart failure, myocardial infarction, unstable angina, or COPD, poorly controlled or contraindication of Trendelenburg position for a long duration; marked hip disease preventing the usage of the dorsal lithotomy position.
• Cases with evidenced advanced stage of the neoplasm clinically and radiologically according to the routine pre-operative investigations.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07514078 · lap stag endometrial cancer

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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