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A Randomized Open Controlled Trial Comparing Robot Assisted Laparoscopic Hysterectomy and Abdominal Hysterectomy for Endometrial Cancer in a Fast Track Program


N/A
18 Years
N/A
Open (Enrolling)
Female
Endometrial Cancer

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Trial Information

A Randomized Open Controlled Trial Comparing Robot Assisted Laparoscopic Hysterectomy and Abdominal Hysterectomy for Endometrial Cancer in a Fast Track Program


If detailed description is requested, please contact sponsor.


Inclusion Criteria:



- Over 18 years of age.

- Scheduled to total hysterectomy + bilateral salpingooophorectomy (BSAE) and
peritoneal lavage because of endometrial carcinoma, International federation of
gynecology and obstetrics (FIGO) stage 1, grade 1 and 2, with diploid DNA profile
(i.e. low risk profile).

- WHO performance status ≤ 2.

- Proficiency in Swedish

- Accept to participate in the study and has signed written informed consent document.

- The operation should be considered possible to be perform laparoscopically and by
laparotomy through a low transverse abdominal wall incision.

Exclusion Criteria:

- The operation is anticipated to comprise more than the hysterectomy + BSAE.

- A midline incision is planned for the laparotomy.

- Contraindications towards spinal anesthesia with intrathecally applied morphine.

- Physically disabled women who cannot be expected to be mobilized in accordance to the
fast track program in a way similar to what is expected from not-physically disabled
women.

- Mentally disabled women who cannot fill in the questionnaires or understand the
consequences of participating in a trial.

- Severe psychiatric disease or on medication for psychiatric disease so that the
physician consider participation in the trial inappropriate.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Quality of life

Outcome Description:

Quality of life measured by means of the Euroqol form (EQ-5D) and the Short form 36 (SF-36). The EQ-5D form is filled in on one occasion one week preoperatively, then daily in a week from the evening after surgery, then once weekly for additional five weeks. The SF-36 is filled in one week preoperatively and six weeks postoperatively.

Outcome Time Frame:

Six weeks

Safety Issue:

No

Principal Investigator

Preben Kjölhede, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Department of Obstetrics and Gynecology, University Hospital, 58185 Linköping, Sweden

Authority:

Sweden: Regional Ethical Review Board

Study ID:

ROBOTHYST

NCT ID:

NCT01526655

Start Date:

January 2012

Completion Date:

March 2015

Related Keywords:

  • Endometrial Cancer
  • Endometrial cancer
  • Robot assisted laparoscopy
  • Abdominal hysterectomy
  • Fast track program
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma

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