NCT07546825

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
26mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Jun 2026Oct 2028

First Submitted

Initial submission to the registry

April 9, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 23, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

June 2, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

June 10, 2026

Status Verified

June 1, 2026

Enrollment Period

1.8 years

First QC Date

April 9, 2026

Last Update Submit

June 6, 2026

Conditions

Gynaecological OncologyGynaecological MalignanciesLaparoscopic

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (18)

  • 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)

  • Short-Term Oncologic Outcomes

    follow up for one year

  • Postoperative quality of recovery

    at 12 hours, 24 hours, 48 hours postoperatively , and at time of hospital discharge (up to 5 postoperative days).

  • +13 more secondary outcomes

Study Arms (2)

Laparoscopic surgical staging

OTHER

surgical staging by laparoscopy

Procedure: laparoscopic surgical staging

Open surgical staging (laparotomy)

OTHER

surgical staging by open surgery

Procedure: open surgical staging

Interventions

laparoscopic surgical stagingPROCEDURE

surgical staging by laparoscopy

Laparoscopic surgical staging
open surgical stagingPROCEDURE

surgical staging through open surgery

Open surgical staging (laparotomy)

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University, Assiut,

Asyut, Egypt

RECRUITING

Related Publications (12)

  • Weiss ME, Piacentine LB. Psychometric properties of the Readiness for Hospital Discharge Scale. J Nurs Meas. 2006 Winter;14(3):163-80. doi: 10.1891/jnm-v14i3a002.

    PMID: 17278337BACKGROUND

  • Jaiswal A, Huang KG. "Energy devices in gynecological laparoscopy - Archaic to modern era". Gynecol Minim Invasive Ther. 2017 Oct-Dec;6(4):147-151. doi: 10.1016/j.gmit.2017.08.002. Epub 2017 Sep 1.

    PMID: 30254903BACKGROUND

  • Abu-Rustum NR. Sentinel lymph node mapping for endometrial cancer: a modern approach to surgical staging. J Natl Compr Canc Netw. 2014 Feb;12(2):288-97. doi: 10.6004/jnccn.2014.0026.

    PMID: 24586087BACKGROUND

  • Torok P, Krasznai Z, Molnar S, Lampe R, Jakab A. Preoperative assessment of endometrial cancer. Transl Cancer Res. 2020 Dec;9(12):7746-7758. doi: 10.21037/tcr-20-2068.

    PMID: 35117377BACKGROUND

  • Kong TW, Lee KM, Cheong JY, Kim WY, Chang SJ, Yoo SC, Yoon JH, Chang KH, Ryu HS. Comparison of laparoscopic versus conventional open surgical staging procedure for endometrial cancer. J Gynecol Oncol. 2010 Jun;21(2):106-11. doi: 10.3802/jgo.2010.21.2.106. Epub 2010 Jun 30.

    PMID: 20613901BACKGROUND

  • Bretova P, Ndukwe MI, Laco J, Vosmikova H, Reslova T, Pohankova D, Balcarova K, Haviger J, Havigerova JM, Sirak I. Preoperative risk stratification in endometrial cancer using ESGO/ESTRO/ESP 2021 guidelines: accuracy with and without molecular classification. BMC Cancer. 2025 Aug 11;25(1):1302. doi: 10.1186/s12885-025-14741-5.

    PMID: 40790476BACKGROUND

  • Concin N, Matias-Guiu X, Cibula D, Colombo N, Creutzberg CL, Ledermann J, Mirza MR, Vergote I, Abu-Rustum NR, Bosse T, Chargari C, Espenel S, Fagotti A, Fotopoulou C, Gatius S, Gonzalez-Martin A, Lax S, Levy B, Lorusso D, Macchia G, Marth C, Morice P, Oaknin A, Raspollini MR, Schwameis R, Sehouli J, Sturdza A, Taylor A, Westermann A, Wimberger P, Planchamp F, Nout RA. ESGO-ESTRO-ESP guidelines for the management of patients with endometrial carcinoma: update 2025. Lancet Oncol. 2025 Aug;26(8):e423-e435. doi: 10.1016/S1470-2045(25)00167-6.

    PMID: 40744042BACKGROUND

  • Walker JL, Piedmonte MR, Spirtos NM, Eisenkop SM, Schlaerth JB, Mannel RS, Spiegel G, Barakat R, Pearl ML, Sharma SK. Laparoscopy compared with laparotomy for comprehensive surgical staging of uterine cancer: Gynecologic Oncology Group Study LAP2. J Clin Oncol. 2009 Nov 10;27(32):5331-6. doi: 10.1200/JCO.2009.22.3248. Epub 2009 Oct 5.

    PMID: 19805679BACKGROUND

  • Imai K, Hirooka-Nakama J, Hotta Y, Shigeta H. A Review of Laparoscopic Para-aortic Lymphadenectomy for Early-stage Endometrial Cancer: Extraperitoneal Approach May Have the Advantage over Intraperitoneal Approach. Gynecol Minim Invasive Ther. 2023 Oct 31;13(1):10-18. doi: 10.4103/gmit.gmit_25_23. eCollection 2024 Jan-Mar.

    PMID: 38487605BACKGROUND

  • Galaal K, Donkers H, Bryant A, Lopes AD. Laparoscopy versus laparotomy for the management of early stage endometrial cancer. Cochrane Database Syst Rev. 2018 Oct 31;10(10):CD006655. doi: 10.1002/14651858.CD006655.pub3.

    PMID: 30379327BACKGROUND

  • Concin N, Matias-Guiu X, Vergote I, Cibula D, Mirza MR, Marnitz S, Ledermann J, Bosse T, Chargari C, Fagotti A, Fotopoulou C, Gonzalez Martin A, Lax S, Lorusso D, Marth C, Morice P, Nout RA, O'Donnell D, Querleu D, Raspollini MR, Sehouli J, Sturdza A, Taylor A, Westermann A, Wimberger P, Colombo N, Planchamp F, Creutzberg CL. ESGO/ESTRO/ESP guidelines for the management of patients with endometrial carcinoma. Int J Gynecol Cancer. 2021 Jan;31(1):12-39. doi: 10.1136/ijgc-2020-002230. Epub 2020 Dec 18.

    PMID: 33397713BACKGROUND

  • Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023 Jan;73(1):17-48. doi: 10.3322/caac.21763.

    PMID: 36633525BACKGROUND

Central Study Contacts

Alaa El-Din Mahmoud Ismail, professor

CONTACT

+201001106048alaaismail@aun.edu.eg

Hisham El-Sayed Abou-Taleb, professor

CONTACT

+201003332139

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 9, 2026

First Posted

April 23, 2026

Study Start

June 2, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

October 1, 2028

Last Updated

June 10, 2026

Record last verified: 2026-06

Locations

EG(1)