Gynaecological Malignancies, Gynaecological Oncology, Laparoscopic
Conditions
Brief 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.
Detailed description
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.
Interventions
PROCEDURElaparoscopic surgical staging
surgical staging by laparoscopy
PROCEDUREopen surgical staging
surgical staging through open surgery
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
1. Inclusion criteria: * 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. 2.
Exclusion criteria
* severe cardiopulmonary diseases (e.g unstable angina, severe COPD). * Absolute contraindication to laparoscopy. * stage Ⅲ and Ⅳ endometrial cancer. * patients who received previous pelvic radiotherapy. * patients who underwent prior lymphadenectomy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Early postoperative recovery assessed by time to ambulation (hours). | From the end of surgery until the patient achieves independent ambulation or ambulation with minimal assistance, assessed during the first 24 postoperative hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of hospital stay duration between laparoscopic and open surgical staging | From the day of surgery through hospital discharge, assessed up to 7 days postoperatively. | — |
| comparsion between same day discgarge between laparoscopic and open surgical staging | Day 0 (day of surgery) | — |
| Pelvic lymph node yield (number of nodes) | At final histopathological examination (within 2 weeks postoperatively) | Comparison of the total number of pelvic lymph nodes retrieved between laparoscopic and open surgical staging. |
| Short-Term Oncologic Outcomes | 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. |
| Postoperative quality of recovery | 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 |
| Comparison of estimated blood loss during surgery between laparoscopic and open surgical staging. | During surgery (intraoperative period) | — |
| Comparison of intraoperative complications between laparoscopic and open surgical staging. | During surgery | — |
| Postoperative complications (Clavien-Dindo classification, Grades I-V) | 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. |
| comparsion of health-related quality of life assessed using the EQ-5D-5L questionnaire between open and laparoscopic surgical staging | baseline (preoperative), 6 weeks, and 12 weeks postoperatively. | — |
| hospital-based cost comparison between both surgical approaches | 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. |
| Discrepancy between preoperative curettage pathology and final histopathology | 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. |
| Conversion Rate | guring surgery | Rate and causes of conversion from laparoscopy to open surgery in the laparoscopic arm. |
| Delay in initiation of adjuvant therapy | 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. | — |
| Readmission within 6 weeks after surgery. | within 6 weeks postoperative | — |
| Total postoperative analgesic consumption during hospital stay. | "From arrival at the recovery room until hospital discharge (up to 72 hours postoperatively)" | — |
| Time to bowel function recovery | From the end of surgery until first passage of flatus and stool, assessed up to 7 days postoperatively. | — |
| Time to oral intake | From the end of surgery until first tolerated oral intake, assessed up to 72 hours postoperatively. | — |
| Postoperative pain score using Visual Analogue Scale (VAS) | Time Frame: 6, 12, 24, and 48 hours postoperatively, and at hospital discharge (up to 7 days postoperatively). | — |
Countries
Egypt
Contacts
CONTACTAlaa El-Din Mahmoud Ismail, professor
CONTACTHisham El-Sayed Abou-Taleb, professor
Outcome results
None listed