Endoscopy Clinical Trials

Clinical trials related to Endoscopy Procedure

Perioperative Outcomes of Surgical Staging in Patients With Early-stage Endometrial Carcinoma: Comparison Between Laparoscopy and Laparotomy in a Low-resource Setting

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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. Primary aim: To compare early postoperative recovery after surgical staging for early-stage endometrial cancer between laparoscopic and open approaches, assessed primarily by time to ambulation. • Secondary aim: To compare intraoperative outcomes (operative time, blood loss, lymph node yield), postoperative morbidity (Clavien-Dindo classification), quality of recovery (QoR-15), length of hospital stay, same day discharge(SDD), discrepancy between preoperative curettage pathology and final histopathology, delay in initiation of adjuvant therapy, one-year disease-free survival, direct hospital costs between both approaches, and quality of life using EQ-5D-5L questionnaire. 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.

Eligibility
Participation Requirements
Sex: Female
Healthy Volunteers: f
View:

⁃ 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 (6).

• Planned surgical staging including: total hysterectomy, bilateral salpingo-oophorectomy ± pelvic lymphadenectomy.

• good performance status : ECOG 0, 1, 2

• patients who provide informed written consent to participate in the study.

Locations
Other Locations
Egypt
Assiut University, Assiut,
RECRUITING
Asyut
Contact Information
Primary
Alaa El-Din Mahmoud Ismail, professor
alaaismail@aun.edu.eg
+201001106048
Backup
Hisham El-Sayed Abou-Taleb, professor
+201003332139
Time Frame
Start Date: 2026-06-02
Estimated Completion Date: 2028-10-01
Participants
Target number of participants: 48
Treatments
Other: Laparoscopic surgical staging
surgical staging by laparoscopy
Other: Open surgical staging (laparotomy)
surgical staging by open surgery
Related Therapeutic Areas
Sponsors
Leads: Assiut University

This content was sourced from clinicaltrials.gov