Treatment Endometrial CancerNCT07514078
Evaluation of Laparoscopic Staging Versus Staging Laparotomy for Early Stage Endometrial Cancer
A study testing laparscopic staging in people with Treatment Endometrial Cancer, run by Ain Shams Maternity Hospital.
Trial summary
Compared with laparotomy, laparoscopy is associated with faster recovery, better visualization, shorter hospital stays, and less possible adhesion formation. But do the safety, efficacy, and morbidity of laparoscopic staging differ from conventional staging laparotomy in endometrial cancer?Is laparoscopic staging… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Treatment Endometrial Cancer
- What is being tested?
- laparscopic staging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2026to 20 Jan 2027
- 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
Who may be able to join
- Patient histopathological diagnosed early-stage endometrial carcinoma, (stages 1A \&1B) according to FIGO classification.
- •
- -
Who cannot join
- The patient received neoadjuvant chemo or radiotherapy.
- The presence of ovarian tumors, and proven metastasis outside the uterus.
- The presence of any contraindication for general anesthesia like heart failure, myocardial infarction, unstable angina, or COPD, poorly controlled or contraindication of Trendelenburg position for a long duration; marked hip disease preventing the usage of the dorsal lithotomy position.
- Cases with evidenced advanced stage of the neoplasm clinically and radiologically according to the routine pre-operative investigations.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
sara abdelrazik sara hamad, assistant lecture contact
mohamed nader nader, lecture contact
About this study
Compared with laparotomy, laparoscopy is associated with faster recovery, better visualization, shorter hospital stays, and less possible adhesion formation. But do the safety, efficacy, and morbidity of laparoscopic staging differ from conventional staging laparotomy in endometrial cancer?Is laparoscopic staging considered a safe and effective alternative procedure for the surgical treatment of early-stage endometrial carcinoma? This study aims to compare the safety, efficacy, and morbidity between total laparoscopic hysterectomy (TLH) with lymphadenectomy and conventional staging laparotomy for early-stage endometrial cancer.
Read the detailed description
Primary Outcome: perioperative morbidities:
- intraoperative complications like bladder injury, ureteric injury, vascular injury \& bowel injury.
- Early postoperative complications like paralytic ileus, postoperative fever ((defined as a temperature higher than 38 c on two consecutive postoperative days or higher than 39 c on any postoperative day).
Secondary outcomes:
- Amount of blood loss by allowable blood loss formula between conventional staging laparotomy and laparoscopic staging \& need for blood transfusion. (ABL = weight kg * age sex factor (65ml/ kg) *initial HGB(g/dl)-final HGB(g/dl) / initial HGB (g/dl) (Jaramillo, 2019).
- oncological outcomes (one-year survival rate, need for adjuvant chemo or radiotherapy, recurrent rate after one year) indicate radical malignancy elimination.
- Operation time from skin to skin in hours.
- ICU admission.
- Wound infection.
- Hospital stays in days.
- A post-operative pain person rates their pain on a scale of 0 to 10. Zero means "no pain," and 10 means "the worst possible pain. Laparoscopic surgical staging operation is a safe and effective therapeutic procedure for the management of endometrial cancer especially lymphadenectomy with acceptable morbidity and radical treatment to the malignancy compared to the laparotomy.
- Conditions
- Treatment Endometrial Cancer
- Being tested
- laparscopic staging
- Keywords
- laparscopic staging in endometrial cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparscopic stagingProcedure or surgery
Also called staging laparotomy
staging laparotomy
| Study group | Role | What they receive |
|---|---|---|
| laparscopy | Experimental | laparoscopic staging Receives: Procedure: laparscopic staging |
| laparotomy | Other | staging laparotomy Receives: Procedure: laparscopic staging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome: perioperative morbidities. intraoperative complications like bladder, ureteric, or intestinal injury
Primary Outcome: perioperative morbidities: . intraoperative complications like bladder, ureteric, or intestinal injury
Measured: 6 months
Secondary outcomes (1)
Secondary outcomes: 1. Amount of blood loss by the allowable blood loss formula
Secondary outcomes: Amount of blood loss by allowable blood loss formula between conventional staging laparotomy and laparoscopic staging \& need for blood transfusion. (ABL = weight kg * age sex factor (65ml/ kg) *initial HGB(g/dl)-final HGB(g/dl) / initial HGB (g/dl) (Jaramillo, 2019).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start20 Apr 2026 (estimated)
- Primary completion20 Oct 2026 (estimated)
- Study completion20 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara AbdelRazek Ramadan Hamad, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514078
- Sponsor's protocol ID
- lap stag endometrial cancer
- Status last verified
- Apr 2026
- First submitted
- 17 Mar 2025
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Laparoscopic Staging Versus Staging Laparotomy for Early Stage Endometrial Cancer
- ClinicalTrials.gov ID
- NCT07514078
- Acronym / sponsor ID
- lap stag endometrial cancer
- Conditions
- Treatment Endometrial Cancer
- Keywords
- laparscopic staging in endometrial cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 20 Oct 2026 (estimated)
- Study completion
- 20 Jan 2027 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Compared with laparotomy, laparoscopy is associated with faster recovery, better visualization, shorter hospital stays, and less possible adhesion formation. But do the safety, efficacy, and morbidity of laparoscopic staging differ from conventional staging laparotomy in endometrial cancer?Is laparoscopic staging considered a safe and effective alternative procedure for the surgical treatment of early-stage endometrial carcinoma? This study aims to compare the safety, efficacy, and morbidity between total laparoscopic hysterectomy (TLH) with lymphadenectomy and conventional staging laparotomy for early-stage endometrial cancer.
Detailed description
Primary Outcome: perioperative morbidities:
- intraoperative complications like bladder injury, ureteric injury, vascular injury \& bowel injury.
- Early postoperative complications like paralytic ileus, postoperative fever ((defined as a temperature higher than 38 c on two consecutive postoperative days or higher than 39 c on any postoperative day).
Secondary outcomes:
- Amount of blood loss by allowable blood loss formula between conventional staging laparotomy and laparoscopic staging \& need for blood transfusion. (ABL = weight kg * age sex factor (65ml/ kg) *initial HGB(g/dl)-final HGB(g/dl) / initial HGB (g/dl) (Jaramillo, 2019).
- oncological outcomes (one-year survival rate, need for adjuvant chemo or radiotherapy, recurrent rate after one year) indicate radical malignancy elimination.
- Operation time from skin to skin in hours.
- ICU admission.
- Wound infection.
- Hospital stays in days.
- A post-operative pain person rates their pain on a scale of 0 to 10. Zero means "no pain," and 10 means "the worst possible pain. Laparoscopic surgical staging operation is a safe and effective therapeutic procedure for the management of endometrial cancer especially lymphadenectomy with acceptable morbidity and radical treatment to the malignancy compared to the laparotomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparscopy | Experimental | Procedure: laparscopic staginglaparoscopic staging |
| laparotomy | Other | Procedure: laparscopic stagingstaging laparotomy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patient histopathological diagnosed early-stage endometrial carcinoma, (stages 1A \&1B) according to FIGO classification.
- •
- -
Key exclusion criteria (4 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparscopic stagingAlso: staging laparotomystaging laparotomy | Procedure or surgery | laparotomy, laparscopy |
Primary outcome
Primary Outcome: perioperative morbidities. intraoperative complications like bladder, ureteric, or intestinal injury
Time frame: 6 months
Primary Outcome: perioperative morbidities: . intraoperative complications like bladder, ureteric, or intestinal injury
1 secondary outcome
Secondary outcomes: 1. Amount of blood loss by the allowable blood loss formula
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- pubmedLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
sara abdelrazik sara hamad, assistant lecture contact
mohamed nader nader, lecture contact
Questions about this trial
What is this clinical trial studying?
A study testing laparscopic staging in people with Treatment Endometrial Cancer, run by Ain Shams Maternity Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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 sara abdelrazik sara hamad, assistant lecture (+2001092762108 ext. 01092762108, hamadsara358@gmail.con), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome: perioperative morbidities. intraoperative complications like bladder, ureteric, or intestinal injury (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2026.