Assiut University, Assiut,
Asyut, Egypt
Location status: Recruiting
Location contact
Abdulrahman Muhammad Rageh, lecturer
CONTACT
Alaa El-Din Mahmoud Ismail, professor
CONTACT
NCT Number: NCT07546825
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.
Interested in participating?
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Interventional
Not applicable
Asyut, Egypt
Location status: Recruiting
Abdulrahman Muhammad Rageh, lecturer
CONTACT
Alaa El-Din Mahmoud Ismail, professor
CONTACT
Endometrial cancer is the most common gynecologic malignancy in developed countries, with increasing incidence related to obesity, aging, and metabolic disorders. Most patients present with early-stage disease confined to the uterus, making surgical staging the cornerstone of treatment. Standard management includes total hysterectomy, bilateral salpingo-oophorectomy, and pelvic lymph node assessment when indicated for accurate staging and risk stratification . Minimally invasive surgery (MIS), particularly laparoscopy, has increasingly replaced laparotomy in the surgical staging of endometrial cancer because of its perioperative advantages. Previous studies demonstrated that laparoscopic surgery is associated with reduced blood loss, fewer postoperative complications, shorter hospital stay, and faster return to normal activity while maintaining comparable oncologic outcomes to open surgery. Recently, greater emphasis has been placed on patient-centered outcomes and enhanced recovery after surgery (ERAS) pathways. Early postoperative recovery is considered an important indicator of surgical quality and functional rehabilitation. Time to ambulation is a simple and clinically relevant marker of recovery, as delayed mobilization is associated with prolonged hospitalization and increased postoperative morbidity. Faster recovery may also facilitate earlier initiation of adjuvant therapy when indicated. Additionally, discrepancies between preoperative curettage pathology and final histopathology may alter risk stratification and postoperative management. Despite strong evidence supporting laparoscopy, most data originate from high-resource settings with advanced ERAS systems. Evidence from low-resource settings remains limited, particularly regarding functional recovery metrics, cost-effectiveness, and real-world delays in adjuvant therapy. Furthermore, few randomized trials have incorporated patient-reported recovery outcomes alongside oncologic endpoints.Therefore, this study aims to compare laparoscopic and open surgical staging for early-stage endometrial cancer regarding early postoperative recovery, perioperative outcomes, postoperative morbidity, delay in initiation of adjuvant therapy, and concordance between preoperative and final histopathological findings.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
surgical staging by laparoscopy
surgical staging through open surgery
Time frame: From the end of surgery until the patient achieves independent ambulation or ambulation with minimal assistance, assessed during the first 24 postoperative hours.
Time frame: From the day of surgery through hospital discharge, assessed up to 7 days postoperatively.
Time frame: Day 0 (day of surgery)
Time frame: At final histopathological examination (within 2 weeks postoperatively)
Comparison of the total number of pelvic lymph nodes retrieved between laparoscopic and open surgical staging.
Time frame: follow up for one year
One-year disease-free survival (DFS), defined as the time from surgery to first documented recurrence (local, regional, or distant) or death from any cause.
Time frame: at 12 hours, 24 hours, 48 hours postoperatively , and at time of hospital discharge (up to 5 postoperative days).
Postoperative quality of recovery assessed by the Quality Of Recovery -15 questionnaire (QoR-15 questionnaire) 0-150 130-150: Excellent recovery 122-129: Good recovery 90-121: Moderate recovery <90: Poor recovery / significant postoperative impairment
Time frame: During surgery (intraoperative period)
Time frame: During surgery
Time frame: Within 30 days after surgery
Comparison of the incidence and severity of postoperative complications between laparoscopic and open surgical staging. Complications will be graded according to the Clavien-Dindo classification, where Grade I represents minor deviation from normal postoperative course and Grade V represents death.
Time frame: baseline (preoperative), 6 weeks, and 12 weeks postoperatively.
Time frame: From surgery until hospital discharge, assessed up to 30 days postoperatively.
Hospital-based costs will include operating room time cost, surgical instruments and energy devices, hospital stay cost, and costs related to the management of postoperative complications occurring within 30 days after surgery.
Time frame: From preoperative endometrial sampling through final postoperative histopathological assessment, up to 30 days after surgery.
Comparison of histological type, tumor grade, and disease characteristics between preoperative endometrial sampling pathology and the final postoperative histopathological diagnosis.
Time frame: guring surgery
Rate and causes of conversion from laparoscopy to open surgery in the laparoscopic arm.
Time frame: Defined as the interval between date of surgery and initiation of adjuvant chemotherapy and/or radiotherapy. Delayed initiation will be considered when adjuvant treatment is started more than 6 weeks after surgery.
Time frame: within 6 weeks postoperative
Time frame: "From arrival at the recovery room until hospital discharge (up to 72 hours postoperatively)"
Time frame: From the end of surgery until first passage of flatus and stool, assessed up to 7 days postoperatively.
Time frame: From the end of surgery until first tolerated oral intake, assessed up to 72 hours postoperatively.
Time frame: Time Frame: 6, 12, 24, and 48 hours postoperatively, and at hospital discharge (up to 7 days postoperatively).
Contact information is provided by the study sponsor or research team.
Alaa El-Din Mahmoud Ismail, professor
CONTACT
Hisham El-Sayed Abou-Taleb, professor
CONTACT
Assiut University
Other
Perioperative Outcomes of Surgical Staging in Patients With Early-stage Endometrial Carcinoma: Comparison Between Laparoscopy and Laparotomy in a Low-resource Setting
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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