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Clinical Trials/NCT02320565
NCT02320565CompletedNot Applicable

Prospective Randomized Trial on 2D Versus 3D Laparoscopic Total Laparoscopic Hysterectomy With Pelvic Lymphadenectomy for the Treatment of Endometrial Cancer FIGO Stage IB-II

Catholic University of the Sacred Heart2 sites in 1 country36 target enrollmentStarted: October 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
36
Locations
2
Primary Endpoint
Operative time for laparoscopic total hysterectomy with pelvic lymphadenectomy

Study Overview

Brief Summary

This prospective randomized pilot study is aimed to verify if the operative time of a total laparoscopical hysterectomy (TLH) with pelvic lymphadenectomy for endometrial cancer FIGO stage IB-II could be reduced using 3D laparoscopy versus standard laparoscopy

Detailed Description

The standard treatment for early-stage endometrial cancer is surgery. Surgical procedures include washing for cytology, total extrafascial hysterectomy and bilateral salpinges-oophorectomy. Although the therapeutic value of routine pelvic and para-aortic lymphadenectomy is debated, staging information is a critical determinant of adjuvant therapy for most gynecologic oncologists.

Type-1 endometrial cancer spread is limited to the pelvic nodes in most cases. If there are positive lymph nodes, those around the obturator nerve and around the external and common iliac vessels are more likely to be involved than those in the presacral area. Isolated involvement of the para-aortic nodes is rare. Complete excision of the nodes located around the iliac vessels and above the obturator nerve allows identification of 90% of node-positive patients.

The decision on whether to undertake lymphadenectomy should not be based on palpation of the nodal area, because less than 10% of patients with nodal metastases have grossly enlarged nodes.

Patients with endometrioid cancer, grade 1-2 with deep myometrial invasion and any grade 3 endometrioid endometrial cancer have at least a 5% risk of having positive pelvic lymph nodes. In our current treatment protocol, these patients undergo complete pelvic lymphadenectomy. Laparotomy may be indicated in endometrial cancer patients presenting with grossly positive pelvic nodes, grossly positive adnexal metastasis, or serosal infiltration.

Although the complication rate of a simple hysterectomy with bilateral salpinges-oophorectomy is not very high, over 70% new cases of endometrial cancer are diagnosed in post-menopausal women, commonly associated with medical co-morbidities, such as diabetes, hypertension and obesity. Abdominal surgery therefore exposes them to an increased risk of complications. Vaginal hysterectomy has been suggested as an attractive alternative to abdominal surgery for these patients, but this approach does not allow exploration of the abdominal cavity, peritoneal washing, and lymph-node dissection. Laparoscopic-assisted vaginal hysterectomy or total laparoscopic hysterectomy overcome the previous limitations.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
Double (Care Provider, Investigator)

Eligibility Criteria

Ages
— to 75 Years (Child, Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Age ≤ 75 years
  • Patient's informed consent
  • American Society of Anesthesiologists: < class III or IV
  • No actual pregnancies or P.I.D.
  • No previous major abdominal surgical procedures
  • Endometrial cancer FIGO stages IB-II
  • Endometrioid histotype
  • No previous radiotherapy on pelvic fields
  • No uterine size larger than conform 10 weeks gestation

Outcomes

Primary Outcomes

Operative time for laparoscopic total hysterectomy with pelvic lymphadenectomy

Time Frame: intraoperative

Operative time will be calculated from the entrance in the abdominal cavity to the closure of the skin trocar accesses

Secondary Outcomes

  • number of participants with intra or post operative complications(two years)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Prof. Giovanni Scambia

Director, Dip per la Tutela della Salute della Donna e della Vita Nascente, del Bambino e dell'Adolescente

Catholic University of the Sacred Heart

Study Sites (2)

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