About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
laparscopic staging
Procedure/Surgerystaging laparotomy
Treatment groups
Trial outcomes
Primary outcomes
Primary Outcome: perioperative morbidities. intraoperative complications like bladder, ureteric, or intestinal injury
Primary Outcome: perioperative morbidities: . intraoperative complications like bladder, ureteric, or intestinal injury
Secondary outcomes
Secondary outcomes: 1. Amount of blood loss by the allowable blood loss formula
Secondary outcomes: 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).
Other outcomes
postoperative pain by visual analog pain scale
postoperative pain by the visual analog pain scale
oncological outcome like need for post-operative chemo or radiotherapy
oncological outcome like need for post-operative chemo or radiotherapy
Locations
Sponsors and contacts
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