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NCT Number: NCT07514078

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

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

• Inclusion Criteria:

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

-

Exclusion criteria

  • Exclusion Criteria:
  • 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.

Treatment and study plan

laparscopic staging

Procedure

staging laparotomy

Other names: staging laparotomy

Primary outcomes

  1. 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

Secondary outcomes

  1. 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).

Other outcomes

  1. postoperative pain by visual analog pain scale

    Time frame: 6 months

    postoperative pain by the visual analog pain scale

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

    Time frame: 6 months

    oncological outcome like need for post-operative chemo or radiotherapy

Study contacts

Contact information is provided by the study sponsor or research team.

mohamed nader nader, lecture

CONTACT

+2001002745161 ext. 01002745161

sara abdelrazik sara hamad, assistant lecture

CONTACT

[email protected]

+2001092762108 ext. 01092762108

Sponsors and collaborators

Lead sponsor

Ain Shams Maternity Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.