NCT07514078

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Ain Shams Maternity Hospital · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Treatment Endometrial Cancer

Interventions

Type	Name	Description
PROCEDURE	laparscopic staging	staging laparotomy

Timeline

• Start date: 2026-04-20
• Primary completion: 2026-10-20
• Completion: 2027-01-20
• First posted: 2026-04-07
• Last updated: 2026-04-07