Sentinel lymph node mapping for endometrial cancer: a modern approach to surgical staging.
Nadeem R Abu-Rustum
https://pubmed.ncbi.nlm.nih.gov/24586087/Actively Recruiting
Led by Assiut University · Updated on 2026-06-10
48
Participants Needed
1
Research Sites
26 weeks
Total Duration
Endometrial cancer is a common gynecological cancer, and surgical staging is essential for managing early-stage disease. This trial compares laparoscopic surgery to traditional open surgery laparotomy for surgical staging in low-resource settings. It aims to evaluate early postoperative recovery, focusing on time to ambulation, and to assess various outcomes including operative details, postoperative complications, quality of recovery, hospital stay length, same day discharge rates, and one-year disease-free survival. Participants are randomly assigned to receive either laparoscopic surgical staging or open surgical staging. The surgery involves total hysterectomy, bilateral salpingo-oophorectomy, and possibly pelvic lymphadenectomy based on risk stratification. The study also evaluates discrepancies between preoperative pathology and final histopathology, delays in starting adjuvant therapy, hospital costs, and quality of life using the EQ-5D-5L questionnaire. During the study, participants recovery is closely monitored through measures such as time to independent ambulation, blood loss, lymph node counts, postoperative complications, pain scores, bowel function recovery, and quality of life assessments up to 12 weeks after surgery. Hospital stay duration, readmissions, and analgesic use are recorded, along with the timing of adjuvant treatments. Follow-up includes oncologic outcomes and cost comparisons. The trial is conducted in a low-resource setting to provide data relevant to such environments.
CONDITIONS
Laparotomy vs Laparoscopy in Endometrial Cancer Staging
A
Alaa El-Din Mahmoud Ismail, professor
H
Hisham El-Sayed Abou-Taleb, professor
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Assiut University
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to the day of discharge after surgery
Participants undergo either laparoscopic or open surgical staging involving hysterectomy, removal of ovaries, and possibly pelvic lymphadenectomy.
1 surgery day plus hospital stay up to 7 days
Duration - Up to 12 weeks for quality of life and recovery assessments; oncologic follow-up for 1 year
Participants are monitored for recovery, complications, quality of life, and oncologic outcomes for up to one year after surgery.
Regular visits during the first 12 weeks and oncologic follow-up visits for one year
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor