ClinicalTrials.gg
Not yet recruitingNCT07514078Updated Apr 7, 2026

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

An interventional study of laparscopic staging in Treatment Endometrial Cancer, sponsored by Ain Shams Maternity Hospital. Not yet recruiting. Open to female participants. Per ClinicalTrials.gov, last updated 2026-04-07.

Sponsored by Ain Shams Maternity Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Sex
Female
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Study 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 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:

  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.
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Conditions studied

  • Treatment Endometrial Cancer

Keywords

  • laparscopic staging in endometrial cancer
03

In context

Endometrial Neoplasms

1,425 studies on the registry are indexed under Endometrial Neoplasms; 473 are open to participants now.

This study's planned enrollment of 30 is below the median of 71 across 1,026 interventional studies indexed under Endometrial Neoplasms.

Browse Endometrial Neoplasms studies →

Lead sponsor

Ain Shams Maternity Hospital is the lead sponsor of 139 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

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 chemo or radiotherapy.
    2. The presence of ovarian tumors, and proven outside the uterus.
    3. The presence of any for general anesthesia like heart failure, myocardial infarction, unstable angina, or , 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    laparscopy

    laparoscopic staging

    Procedure: laparscopic staging

  • Other
    laparotomy

    staging laparotomy

    Procedure: laparscopic staging

Interventions

  • Procedurelaparscopic staging

    staging laparotomy

    Also known as: staging laparotomy

06

What researchers measure

Primary outcomes

  1. Primary Outcome: perioperative morbidities. intraoperative complications like bladder, ureteric, or intestinal injury

    Primary Outcome: perioperative morbidities: . intraoperative complications like bladder, ureteric, or intestinal injury

    Time frame: 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).

    Time frame: 6 months

Other outcomes

  1. postoperative pain by visual analog pain scale

    postoperative pain by the visual analog pain scale

    Time frame: 6 months

  2. oncological outcome like need for post-operative chemo or radiotherapy

    oncological outcome like need for post-operative chemo or radiotherapy

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Related links

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Apr 2026; primary completion for Oct 2026, 6 months later.

Of 195 non-industry interventional studies with no phase under Endometrial Neoplasms, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 76. This study's planned 6 months is below that.

Counting every sponsor, half of 201 studies reached it within 43 months; a quarter within 19 and three quarters within 76.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 17, 2025
First posted
Apr 7, 2026
StartEst.
Apr 20, 2026
Primary completionEst.
Oct 20, 2026
CompletionEst.
Jan 20, 2027
Last update
Apr 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07514078
Responsible party
Sara AbdelRazek Ramadan Hamad (ASSIT LECTURE, Ain Shams Maternity Hospital) — Principal investigator
First posted
Apr 7, 2026
Start date
Apr 20, 2026 (estimated)
Primary completion
Oct 20, 2026 (estimated)
Completion
Jan 20, 2027 (estimated)
Last update
Apr 7, 2026

Study contacts

sara abdelrazik sara hamad, assistant lecture
Contact
hamadsara358@gmail.con
+2001092762108 ext. 01092762108
mohamed nader nader, lecture
Contact
+2001002745161 ext. 01002745161

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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