Robot Assisted Laparoscopic Hysterectomy vs. Abdominal Hysterectomy in Endometrial Cancer

Not Applicable

Completed

Conditions: Endometrial Cancer

Interventions: Procedure: Robot assisted laparoscopic hysterectomy
Procedure: Abdominal total hysterectomy

Registration Number: NCT01526655

Lead Sponsor: University Hospital, Linkoeping

Brief Summary: 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.

Detailed Description: If detailed description is requested, please contact sponsor.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 50

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robot assisted laparoscopic hysterectomy	Robot assisted laparoscopic hysterectomy	Robot assisted laparoscopic total hysterectomy
Abdominal total hysterectomy	Abdominal total hysterectomy	Standard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision

Primary Outcome Measures

Name	Time	Method
Health Related Quality of Life (HRQoL)	Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 28, 35, 42	Quality of life measured by means of the EuroQol form (EQ-5D). The EQ-5D form was completed daily during the first eight days after surgery, then once weekly for additional six weeks. The health state index has a possible range from 0 to 1 with a higher score meaning a better quality of life.

Secondary Outcome Measures

Name	Time	Method
Changes in Biomarkers for Tissue Damage (C-reactive Protein (hsCRP))	One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.	The biomarker was measured on seven occasions. Time 1: one week before surgery. Time 2: just before surgery. Time 3: two hours postoperatively. Time 4: 24 hours postoperatively. Time 5: 48 hours postoperatively. Time 6: one week after surgery. Time 7: six weeks after surgery.
Changes in Biomarkers for Tissue Damage (Creatin Kinase (CK))	One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.	The biomarker was measured on seven occasions. Time 1: one week before surgery. Time 2: just before surgery. Time 3: two hours postoperatively. Time 4: 24 hours postoperatively. Time 5: 48 hours postoperatively. Time 6: one week after surgery. Time 7: six weeks after surgery.
Changes in Biomarkers for Tissue Damage (White Blood Cells (WBC))	One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.	The biomarker was measured on seven occasions. Time 1: one week before surgery. Time 2: just before surgery. Time 3: two hours postoperatively. Time 4: 24 hours postoperatively. Time 5: 48 hours postoperatively. Time 6: one week after surgery. Time 7: six weeks after surgery.
Health Economics (With 300 Robotic Procedures Annually)	From the day of surgery until six weeks after surgery.	Total costs (direct and indirect) for hospital stay and recovery period until six weeks postoperatively.
Changes in Biomarkers for Tissue Damage (Interleukin 6 (IL-6))	One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.	The biomarker was measured on seven occasions. Time 1: one week before surgery. Time 2: just before surgery. Time 3: two hours postoperatively. Time 4: 24 hours postoperatively. Time 5: 48 hours postoperatively. Time 6: one week after surgery. Time 7: six weeks after surgery.
Changes in Biomarkers for Tissue Damage (Cortisol)	One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.	The biomarker was measured on seven occasions. Time 1: one week before surgery. Time 2: just before surgery. Time 3: two hours postoperatively. Time 4: 24 hours postoperatively. Time 5: 48 hours postoperatively. Time 6: one week after surgery. Time 7: six weeks after surgery.
Health Economics (With 500 Robotic Procedures Annually)	From the day of surgery until six weeks after surgery.	Total costs (direct and indirect) for hospital stay and recovery period until six weeks postoperatively.

Trial Locations

Locations (2): Department of Obstetrics and Gynecology, Ryhov Central Hospital
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Jönköping, Jönköpings Län, Sweden
Department of Obstetrics and Gynecology, University Hospital
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Linköping, Östergötland, Sweden