Robot Assisted Laparoscopic Hysterectomy vs. Abdominal Hysterectomy in Endometrial Cancer

Endometrial Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01526655
• Other study ID #: ROBOTHYST
• Status: Completed
• Phase: N/A
• Start date: January 25, 2012
• Est. completion date: July 27, 2016

Study information

• Verified date: August 2023
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

If detailed description is requested, please contact sponsor.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 27, 2016
• Est. primary completion date: July 27, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Procedure:
• Abdominal total hysterectomy
Abdominal total hysterectomy through a low transverse abdominal wall incision
• Robot assisted laparoscopic hysterectomy
Robot assisted laparoscopic total hysterectomy

Locations

Country	Name	City	State
Sweden	Department of Obstetrics and Gynecology, Ryhov Central Hospital	Jönköping	Jönköpings Län
Sweden	Department of Obstetrics and Gynecology, University Hospital	Linköping	Östergötland

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.
Secondary	Changes in Biomarkers for Tissue Damage (White Blood Cells (WBC))	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.	One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.
Secondary	Changes in Biomarkers for Tissue Damage (Interleukin 6 (IL-6))	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.	One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.
Secondary	Changes in Biomarkers for Tissue Damage (Creatin Kinase (CK))	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.	One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.
Secondary	Changes in Biomarkers for Tissue Damage (Cortisol)	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.	One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.
Secondary	Health Economics (With 300 Robotic Procedures Annually)	Total costs (direct and indirect) for hospital stay and recovery period until six weeks postoperatively.	From the day of surgery until six weeks after surgery.
Secondary	Health Economics (With 500 Robotic Procedures Annually)	Total costs (direct and indirect) for hospital stay and recovery period until six weeks postoperatively.	From the day of surgery until six weeks after surgery.