Clinical trial NCT01526655: Robot Assisted Laparoscopic Hysterectomy vs. Abdominal Hysterectomy in Endometrial Cancer
Official title: A Randomized Open Controlled Trial Comparing Robot Assisted Laparoscopic Hysterectomy and Abdominal Hysterectomy for Endometrial Cancer in a Fast Track Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Cancer
Keywords: Endometrial cancer
Robot assisted laparoscopy
Abdominal hysterectomy
Fast track program
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2012-02-06
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Health Related Quality of Life (HRQoL)
timeFrame: Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 28, 35, 42
Secondary outcomes:
measure: Changes in Biomarkers for Tissue Damage (C-reactive Protein (hsCRP))
timeFrame: One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.
measure: Changes in Biomarkers for Tissue Damage (White Blood Cells (WBC))
timeFrame: One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.
measure: Changes in Biomarkers for Tissue Damage (Interleukin 6 (IL-6))
timeFrame: One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.
measure: Changes in Biomarkers for Tissue Damage (Creatin Kinase (CK))
timeFrame: One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.
measure: Changes in Biomarkers for Tissue Damage (Cortisol)
timeFrame: One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.
measure: Health Economics (With 300 Robotic Procedures Annually)
timeFrame: From the day of surgery until six weeks after surgery.
measure: Health Economics (With 500 Robotic Procedures Annually)
timeFrame: From the day of surgery until six weeks after surgery.
Other outcomes:
Locations:
city: Jönköping
country: Sweden
facility: Department of Obstetrics and Gynecology, Ryhov Central Hospital
state: Jönköpings Län
city: Linköping
country: Sweden
facility: Department of Obstetrics and Gynecology, University Hospital
state: Östergötland
Study officials:
affiliation: Department of Obstetrics and Gynecology, University Hospital, 58185 Linköping, Sweden
name: Preben Kjölhede, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Obstetrics and Gynecology, University Hospital, 58185 Linköping, Sweden
name: Evelyn Lundin, MD
role: STUDY_DIRECTOR
affiliation: Department of Obstetrics and Gynecology, University Hospital, 58185 Linköping, Sweden
name: Ninnie Borendal Wodlin, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Anesthesiology, University Hospital, 58185 Linköping, Sweden
name: Lena Nilsson, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Clinical Immunology, University Hospital, 58185 Linköping, Sweden
name: Jan Ernerudh, MD, PhD
role: STUDY_CHAIR
affiliation: Centre for Medical Technology Assessment, University Hospital, 58185 Linköping, Sweden
name: Per Carlsson, PhD
role: STUDY_CHAIR
References: