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Completed

NCT Number: NCT01526655

Robot Assisted Laparoscopic Hysterectomy vs. Abdominal Hysterectomy in Endometrial Cancer

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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Key information

Conditions

Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Obstetrics and Gynecology, Ryhov Central Hospital, Jönköping, Jönköping County, Sweden

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About this study

If detailed description is requested, please contact sponsor.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Abdominal total hysterectomy

Procedure

Abdominal total hysterectomy through a low transverse abdominal wall incision

Robot assisted laparoscopic hysterectomy

Procedure

Robot assisted laparoscopic total hysterectomy

Primary outcomes

  1. Health Related Quality of Life (HRQoL)

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. 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.

    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.

  3. 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.

    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.

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

    Time frame: 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.

  5. Changes in Biomarkers for Tissue Damage (Cortisol)

    Time frame: 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.

  6. Health Economics (With 300 Robotic Procedures Annually)

    Time frame: 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.

  7. Health Economics (With 500 Robotic Procedures Annually)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Linkoeping

Other

Registry information

Official study title

A Randomized Open Controlled Trial Comparing Robot Assisted Laparoscopic Hysterectomy and Abdominal Hysterectomy for Endometrial Cancer in a Fast Track Program

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Feb 6, 2012
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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