Robotassisted Laparoscopic Hysterectomy vs. Abdominal Hysterectomy in Endometrial Cancer - Full Text View

Purpose

The purpose of the trial is to determine whether robotassisted 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.

Condition	Intervention
Endometrial Cancer	Procedure: Abdominal total hysterectomy Procedure: Robotassisted laparoscopic hysterectomy

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized Open Controlled Trial Comparing Robotassisted Laparoscopic Hysterectomy and Abdominal Hysterectomy for Endometrial Cancer in a Fast Track Program

Resource links provided by NLM:

MedlinePlus related topics: Benign Tumors Cancer Hysterectomy

U.S. FDA Resources

Further study details as provided by University Hospital, Linkoeping:

Primary Outcome Measures:

Quality of life [ Time Frame: Six weeks ] [ Designated as safety issue: No ]
Quality of life measured by means of the Euroqol form EQ-5D and the Short form 36 (SF-36). The EQ-5D form is filled in on one occasion one week preoperatively, then daily in a week from the evening after surgery, then once weekly for additional five weeks. The SF-36 is filled in one week preoperatively and six weeks postoperatively.

Secondary Outcome Measures:

Changes in biomarkers for tissue damage [ Time Frame: During six weeks ] [ Designated as safety issue: No ]
The biomarkers (high sensitive -C reactive protein (hs-CRP), creatin kinas (CK), high-mobility group protein B1 (HMGB1) and aminoacids (glutamin, glutamat, citrullin, arginin, ornitin, aspartat and taurin))are measured preoperatively, 2, 24 and 48 hours after surgery, and 1 and 6 weeks postoperatively.
Changes in cytokines and chemokines [ Time Frame: During six weeks ] [ Designated as safety issue: No ]
The proinflammatory cytokines (interleukine-1 (IL-1), interleukine-6 (IL-6), CXCL8, tumour necrosis factor-alpha (TNF-alpha)), the antiinflammatoric cytokine (interleukine-10 (IL-10)) and the Th-1 mediated inflammatory chemokine (CXCL10) are measured preoperatively, 2, 24 and 48 hours after surgery, and 1 and 6 weeks postoperatively.
Changes in amount and function of T, B and natural killer(NK) lymphocytes [ Time Frame: During six weeks ] [ Designated as safety issue: No ]
Blodsamples are collected on three occasions: one week preoperatively, one and six weeks postoperatively.
Postoperative symptoms [ Time Frame: Six weeks ] [ Designated as safety issue: No ]
Symptoms are self-reported in the Swedish Postoperative Symptom Questionnaire. The questionnaire are filled in on one occasion one week preoperatively, then once daily for a week from day of surgery; thereafter once weekly for additional five weeks.
Consumption of analgesic [ Time Frame: Six weeks ] [ Designated as safety issue: No ]
Use of analgesics is registrered during hospital stay. After discharge the patient makes notes in a study specific diary of the daily consumption of analgesic untill the six weeks visit.
Health economics [ Time Frame: Six weeks ] [ Designated as safety issue: No ]
Direct and indirect costs for hospital stay and recovery period untill six weeks postoperatively. Quality-adjusted life years (QALY) and cost-effectiveness are determined.
Complications [ Time Frame: Six weeks ] [ Designated as safety issue: No ]
Adverse events (AE) and serious adverse events (SAE) are registered systematically from start of anesthesia to six weeks postoperatively

Estimated Enrollment:	50
Study Start Date:	January 2012
Estimated Study Completion Date:	March 2015
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Abdominal total hysterectomy Standard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision	Procedure: Abdominal total hysterectomy Abdominal total hysterectomy through a low transverse abdominal wall incision
Active Comparator: Robotassisted laparoscopic hysterectomy Robotassisted laparoscopic total hysterectomy	Procedure: Robotassisted laparoscopic hysterectomy Robotassisted laparoscopic total hysterectomy

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Over 18 years of age.
Scheduled to total hysterectomy + bilateral salpingooophorectomy (BSAE) and peritoneal lavage because of endometrial carcinoma, FIGO stage 1, grade 1 and 2, with diploid DNA profile (i.e. low risk profile).
WHO 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01526655

Contacts

Contact: Preben Kjölhede, MD, PhD	+46101030000 ext 3187	Preben.Kjolhede@lio.se
Contact: Evelyn Lundin, MD	+46101030000	Evelyn.Lundin@lio.se

Locations

Sweden
Department of Obstetrics and Gynecology, Ryhov Central Hospital	Not yet recruiting
Jönköping, Jönköpings län, Sweden, 551 85
Contact: Laila Falknäs, MD +4636321000 Laila.Falknas@lj.se
Contact: Johan Skoglund, MD +4636321000 Johan.Skoglund@lj.se
Principal Investigator: Laila Falknäs, MD
Sub-Investigator: Johan Skoglund, MD
Department of Obstetrics and Gynecology, University Hospital	Recruiting
Linköping, Östergötland, Sweden, 58185
Contact: Preben Kjölhede, MD, PhD +46101030000 ext 3187 Preben.Kjolhede@lio.se
Contact: Evelyn Lundin, MD +46101030000 Evelyn.Lundin@lio.se
Principal Investigator: Preben Kjölhede, MD, PhD
Sub-Investigator: Evelyn Lundin, MD
Sub-Investigator: Shefqet Halili, MD
Sub-Investigator: Peter Lukas, MD
Sub-Investigator: Gulnara Kassymova, MD
Sub-Investigator: Ninnie Borendal Wodlin, MD, PhD

Sponsors and Collaborators

University Hospital, Linkoeping

Investigators

Study Chair:	Preben Kjölhede, MD, PhD	Department of Obstetrics and Gynecology, University Hospital, 58185 Linköping, Sweden
Study Director:	Evelyn Lundin, MD	Department of Obstetrics and Gynecology, University Hospital, 58185 Linköping, Sweden
Study Chair:	Ninnie Borendal Wodlin, MD, PhD	Department of Obstetrics and Gynecology, University Hospital, 58185 Linköping, Sweden
Study Chair:	Lena Nilsson, MD, PhD	Department of Anesthesiology, University Hospital, 58185 Linköping, Sweden
Study Chair:	Jan Ernerudh, MD, PhD	Department of Clinical Immunology, University Hospital, 58185 Linköping, Sweden
Study Chair:	Per Carlsson, PhD	Centre for Medical Technology Assessment, University Hospital, 58185 Linköping, Sweden
Study Chair:	Göran Berg, MD, PhD	Department of Obstetrics and Gynecology, University Hospital, 58185 Linköping, Sweden
Study Director:	Måns Muhrbeck, MD	Department of Obstetrics and Gynecology, University Hospital, 58185 Linköping, Sweden

More Information

No publications provided

Responsible Party:	Preben Kjolhede, Professor, University Hospital, Linkoeping
ClinicalTrials.gov Identifier:	NCT01526655 History of Changes
Other Study ID Numbers:	ROBOTHYST
Study First Received:	January 28, 2012
Last Updated:	February 1, 2012
Health Authority:	Sweden: Regional Ethical Review Board

Keywords provided by University Hospital, Linkoeping:

Endometrial cancer
Robotassisted laparoscopy
Abdominal hysterectomy
Fast track program

Additional relevant MeSH terms:

Endometrial Neoplasms
Sarcoma, Endometrial Stromal
Adenoma
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms

Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Sarcoma
Neoplasms, Connective and Soft Tissue
Endometrial Stromal Tumors
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 22, 2013