Robot Assisted Laparoscopic Hysterectomy vs. Abdominal Hysterectomy in Endometrial Cancer

University Hospital, Linkoeping

Status

Completed

Conditions

Endometrial Cancer

Treatments

Procedure: Abdominal total hysterectomy

Procedure: Robot assisted laparoscopic hysterectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT01526655

ROBOTHYST

Details and patient eligibility

About

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.

Full description

If detailed description is requested, please contact sponsor.

Enrollment

50 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.