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

Not yet recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

30

Phase

  • 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

  • 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

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
Intervention / Treatment
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

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

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

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

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)

April 20, 2026

Primary Completion (Estimated)

October 20, 2026

Study Completion (Estimated)

January 20, 2027

Study Registration Dates

First Submitted

March 17, 2025

First Submitted That Met QC Criteria

April 6, 2026

First Posted (Actual)

April 7, 2026

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID 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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