Evaluation of Laparoscopic Staging Versus Staging Laparotomy for Early Stage Endometrial Cancer

April 6, 2026 updated by: Sara AbdelRazek Ramadan Hamad, Ain Shams Maternity Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Primary Outcome: perioperative morbidities:

  1. intraoperative complications like bladder injury, ureteric injury, vascular injury & bowel injury.
  2. 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:

  1. 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).
  2. oncological outcomes (one-year survival rate, need for adjuvant chemo or radiotherapy, recurrent rate after one year) indicate radical malignancy elimination.
  3. Operation time from skin to skin in hours.
  4. ICU admission.
  5. Wound infection.
  6. Hospital stays in days.
  7. 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: sara abdelrazik sara hamad, assistant lecture
  • Phone Number: 01092762108 +2001092762108
  • Email: hamadsara358@gmail.con

Study Contact Backup

  • Name: mohamed nader nader, lecture
  • Phone Number: 01002745161 +2001002745161

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:• Inclusion Criteria:

I. Patient histopathological diagnosed early-stage endometrial carcinoma, (stages 1A &1B) according to FIGO classification.

•

-

Exclusion Criteria:

  • Exclusion Criteria:

    1. The patient received neoadjuvant chemo or radiotherapy.
    2. The presence of ovarian tumors, and proven metastasis outside the uterus.
    3. 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.
    4. Cases with evidenced advanced stage of the neoplasm clinically and radiologically according to the routine pre-operative investigations.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: laparscopy
laparoscopic staging
Procedure: laparscopic staging
staging laparotomy
Other Names:
  • staging laparotomy
Other: laparotomy
staging laparotomy
Procedure: laparscopic staging
staging laparotomy
Other Names:
  • staging laparotomy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Secondary outcomes: 1. Amount of blood loss by the allowable blood loss formula
Time Frame: 6 months
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).
6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
postoperative pain by visual analog pain scale
Time Frame: 6 months
postoperative pain by the visual analog pain scale
6 months
oncological outcome like need for post-operative chemo or radiotherapy
Time Frame: 6 months
oncological outcome like need for post-operative chemo or radiotherapy
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ain Shams Maternity Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 20, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 20, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 7, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • lap stag endometrial cancer

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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