Robot Assisted Laparoscopic Hysterectomy vs. Abdominal Hysterectomy in Endometrial Cancer

University Hospital, Linkoeping50 enrolled

Overview

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.

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Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Endometrial Cancer

Interventions

Abdominal total hysterectomyPROCEDURE

Abdominal total hysterectomy through a low transverse abdominal wall incision

Robot assisted laparoscopic hysterectomyPROCEDURE

Robot assisted laparoscopic total hysterectomy

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Department of Obstetrics and Gynecology, Ryhov Central Hospital

Jönköping, Jönköping County, Sweden

Department of Obstetrics and Gynecology, University Hospital

Linköping, Östergötland County, Sweden

Outcomes

Primary Outcomes

Health Related Quality of Life (HRQoL)

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.

Time frame: Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 28, 35, 42

Secondary Outcomes

Changes in Biomarkers for Tissue Damage (C-reactive Protein (hsCRP))

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.

Time frame: One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.

Changes in Biomarkers for Tissue Damage (White Blood Cells (WBC))

Time frame: One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.

Changes in Biomarkers for Tissue Damage (Interleukin 6 (IL-6))

Time frame: One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.

Changes in Biomarkers for Tissue Damage (Creatin Kinase (CK))

Data from ClinicalTrials.gov

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