AzTrials
AzTrials

Gynaecological OncologyNCT07546825

Laparotomy vs Laparoscopy in Endometrial Cancer Staging

A study testing laparoscopic surgical staging and open surgical staging in people with Gynaecological Oncology and Gynaecological Malignancies, run by Assiut University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Any age, women only
What is being tested?
laparoscopic surgical staging and open surgical staging
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteEgypt
Study dates
2 Jun 2026to 1 Oct 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult
  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.
  1. 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Alaa El-Din Mahmoud Ismail, professor contact

+201001106048

alaaismail@aun.edu.eg

Hisham El-Sayed Abou-Taleb, professor contact

+201003332139

Egypt1 site, 1 recruiting
  • Assiut University, Assiut,

    Asyut

    Alaa El-Din Mahmoud Ismail, professor, +201001106048, alaaismail@aun.edu.eg

    Abdulrahman Muhammad Rageh, lecturer, +201005056259, Abdulrahmanrageh@med.aun.edu.eg

    Recruiting

Other trials in Egypt

About this study

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

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.

Read more
  • 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.

Read the 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.

Being tested
laparoscopic surgical staging, open surgical staging

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • laparoscopic surgical stagingProcedure or surgery

    surgical staging by laparoscopy

  • open surgical stagingProcedure or surgery

    surgical staging through open surgery

Study groups in NCT07546825
Study groupRoleWhat they receive
Laparoscopic surgical stagingOthersurgical staging by laparoscopy
Receives: Procedure: laparoscopic surgical staging
Open surgical staging (laparotomy)Othersurgical staging by open surgery
Receives: Procedure: open surgical staging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Early postoperative recovery assessed by time to ambulation (hours).

    Measured: 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)
  1. Comparison of hospital stay duration between laparoscopic and open surgical staging

    Measured: From the day of surgery through hospital discharge, assessed up to 7 days postoperatively.

  2. comparsion between same day discgarge between laparoscopic and open surgical staging

    Measured: Day 0 (day of surgery)

  3. Pelvic lymph node yield (number of nodes)

    Comparison of the total number of pelvic lymph nodes retrieved between laparoscopic and open surgical staging.

    Measured: At final histopathological examination (within 2 weeks postoperatively)

  4. Short-Term Oncologic Outcomes

    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.

    Measured: follow up for one year

  5. Postoperative quality of recovery

    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

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

  6. Comparison of estimated blood loss during surgery between laparoscopic and open surgical staging.

    Measured: During surgery (intraoperative period)

  7. Comparison of intraoperative complications between laparoscopic and open surgical staging.

    Measured: During surgery

  8. Postoperative complications (Clavien-Dindo classification, Grades I-V)

    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.

    Measured: Within 30 days after surgery

  9. comparsion of health-related quality of life assessed using the EQ-5D-5L questionnaire between open and laparoscopic surgical staging

    Measured: baseline (preoperative), 6 weeks, and 12 weeks postoperatively.

  10. hospital-based cost comparison between both surgical approaches

    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.

    Measured: From surgery until hospital discharge, assessed up to 30 days postoperatively.

  11. Discrepancy between preoperative curettage pathology and final histopathology

    Comparison of histological type, tumor grade, and disease characteristics between preoperative endometrial sampling pathology and the final postoperative histopathological diagnosis.

    Measured: From preoperative endometrial sampling through final postoperative histopathological assessment, up to 30 days after surgery.

  12. Conversion Rate

    Rate and causes of conversion from laparoscopy to open surgery in the laparoscopic arm.

    Measured: guring surgery

  13. Delay in initiation of adjuvant therapy

    Measured: 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.

  14. Readmission within 6 weeks after surgery.

    Measured: within 6 weeks postoperative

  15. Total postoperative analgesic consumption during hospital stay.

    Measured: "From arrival at the recovery room until hospital discharge (up to 72 hours postoperatively)"

  16. Time to bowel function recovery

    Measured: From the end of surgery until first passage of flatus and stool, assessed up to 7 days postoperatively.

  17. Time to oral intake

    Measured: From the end of surgery until first tolerated oral intake, assessed up to 72 hours postoperatively.

  18. Postoperative pain score using Visual Analogue Scale (VAS)

    Measured: Time Frame: 6, 12, 24, and 48 hours postoperatively, and at hospital discharge (up to 7 days postoperatively).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2026
  2. Study start2 Jun 2026
  3. Primary completion1 Apr 2028 (estimated)
  4. Study completion1 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07546825
Sponsor's protocol ID
EC-STAGE-LL-2026
Status last verified
Jun 2026
First submitted
9 Apr 2026
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 17278337
  • 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.

    PubMed 30254903
  • 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.

    PubMed 24586087
  • 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.

    PubMed 35117377
  • 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.

    PubMed 20613901
  • 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.

    PubMed 40790476
  • 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.

    PubMed 40744042
  • 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.

    PubMed 19805679
  • 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.

    PubMed 38487605
  • 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.

    PubMed 30379327
  • 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.

    PubMed 33397713
  • 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.

    PubMed 36633525

Questions about this trial

What is this clinical trial studying?

A study testing laparoscopic surgical staging and open surgical staging in people with Gynaecological Oncology and Gynaecological Malignancies, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alaa El-Din Mahmoud Ismail, professor (+201001106048, alaaismail@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Early postoperative recovery assessed by time to ambulation (hours). (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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07546825, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in