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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorAin Shams Maternity Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • laparscopic staging

    Procedure/Surgery

    staging laparotomy

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: laparscopyExperimental treatment 1 intervention
Group B: laparotomyOther 1 intervention

Trial outcomes

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

Locations

This trial has no locations.

Sponsors and contacts

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