Robot Assisted Laparoscopic Hysterectomy vs. Abdominal Hysterectomy in Endometrial Cancer

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

The purpose of the trial is to determine whether robot assisted laparoscopic hysterectomy compared with abdominal hysterectomy in a fast track program gives a faster recovery postoperatively, causes less tissue damage and less effects on the immunological system, and is health economically cost-effective.

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 (World Health Organisation) 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.