NCT01526655

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 25, 2012

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 6, 2012

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2016

Completed
7.7 years until next milestone

Results Posted

Study results publicly available

April 18, 2024

Completed
Last Updated

April 18, 2024

Status Verified

August 1, 2023

Enrollment Period

4.5 years

First QC Date

January 28, 2012

Results QC Date

January 13, 2022

Last Update Submit

April 11, 2024

Conditions

Endometrial Cancer

Keywords

Endometrial cancerRobot assisted laparoscopyAbdominal hysterectomyFast track program

Outcome Measures

Primary Outcomes (1)

  • 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.

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

Secondary Outcomes (7)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • +2 more secondary outcomes

Study Arms (2)

Abdominal total hysterectomy

ACTIVE COMPARATOR

Standard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision

Procedure: Abdominal total hysterectomy

Robot assisted laparoscopic hysterectomy

ACTIVE COMPARATOR

Robot assisted laparoscopic total hysterectomy

Procedure: Robot assisted laparoscopic hysterectomy

Interventions

Abdominal total hysterectomyPROCEDURE

Abdominal total hysterectomy through a low transverse abdominal wall incision

Abdominal total hysterectomy
Robot assisted laparoscopic hysterectomyPROCEDURE

Robot assisted laparoscopic total hysterectomy

Robot assisted laparoscopic hysterectomy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Obstetrics and Gynecology, Ryhov Central Hospital

Jönköping, Jönköping County, 551 85, Sweden

Location

Department of Obstetrics and Gynecology, University Hospital

Linköping, Östergötland County, 58185, Sweden

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Limitations and Caveats

Nothing to declare.

Results Point of Contact

Title
Professor Dr. Preben Kjölhede
Organization
Department of Obstetrics and Gynaecology, and Department of Clinical and Experimental Medicine, Linköpings universitet (LIU), Sweden
preben.kjolhede@liu.se
+4638231188

Study Officials

  • Preben Kjölhede, MD, PhD

    Department of Obstetrics and Gynecology, University Hospital, 58185 Linköping, Sweden

    STUDY CHAIR

  • Evelyn Lundin, MD

    Department of Obstetrics and Gynecology, University Hospital, 58185 Linköping, Sweden

    STUDY DIRECTOR

  • 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

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 28, 2012

First Posted

February 6, 2012

Study Start

January 25, 2012

Primary Completion

July 27, 2016

Study Completion

July 27, 2016

Last Updated

April 18, 2024

Results First Posted

April 18, 2024

Record last verified: 2023-08

Locations

SE(2)