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Robot Assisted Laparoscopic Hysterectomy vs. Abdominal Hysterectomy in Endometrial Cancer

Primary Purpose

Endometrial Cancer

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Abdominal total hysterectomy

Robot assisted laparoscopic hysterectomy

About this trial

This is an interventional treatment trial for Endometrial Cancer focused on measuring Endometrial cancer, Robot assisted laparoscopy, Abdominal hysterectomy, Fast track program

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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 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.

Sites / Locations

Department of Obstetrics and Gynecology, Ryhov Central Hospital
Department of Obstetrics and Gynecology, University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Abdominal total hysterectomy

Robot assisted laparoscopic hysterectomy

Arm Description

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

Robot assisted laparoscopic total hysterectomy

Outcomes

Primary Outcome Measures

Quality of life

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

The biomarkers (high sensitive -C reactive protein (hs-CRP), creatin kinase (CK), high-mobility group protein B1 (HMGB1) and aminoacids (glutamin, glutamate, citruline, arginine, ornithine, aspartate and taurine))are measured preoperatively, 2, 24 and 48 hours after surgery, and 1 and 6 weeks postoperatively.

Changes in cytokines and chemokines

The proinflammatory cytokines (interleukine-1 (IL-1), interleukine-6 (IL-6), interleukine 8 (CXCL8), tumour necrosis factor-alpha (TNF-alpha)), the antiinflammatory 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

Blood samples are collected on three occasions: one week preoperatively, one and six weeks postoperatively.

Postoperative symptoms

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

Use of analgesics is registered during hospital stay. After discharge the patient makes notes in a study specific diary of the daily consumption of analgesic until the six weeks visit.

Health economics

Direct and indirect costs for hospital stay and recovery period until six weeks postoperatively. Quality-adjusted life years (QALY) and cost-effectiveness are determined.

Complications

Adverse events (AE) and serious adverse events (SAE) are registered systematically from start of anesthesia to six weeks postoperatively

Full Information

NCT ID

NCT01526655

First Posted

January 28, 2012

Last Updated

December 23, 2018

Sponsor

University Hospital, Linkoeping

1. Study Identification

Unique Protocol Identification Number

NCT01526655

Brief Title

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

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

January 25, 2012 (Actual)

Primary Completion Date

July 27, 2016 (Actual)

Study Completion Date

July 27, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital, Linkoeping

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endometrial Cancer

Keywords

Endometrial cancer, Robot assisted laparoscopy, Abdominal hysterectomy, Fast track program

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Abdominal total hysterectomy

Arm Type

Active Comparator

Arm Description

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

Arm Title

Robot assisted laparoscopic hysterectomy

Arm Type

Active Comparator

Arm Description

Robot assisted laparoscopic total hysterectomy

Intervention Type

Procedure

Intervention Name(s)

Abdominal total hysterectomy

Intervention Description

Abdominal total hysterectomy through a low transverse abdominal wall incision

Intervention Type

Procedure

Intervention Name(s)

Robot assisted laparoscopic hysterectomy

Intervention Description

Robot assisted laparoscopic total hysterectomy

Primary Outcome Measure Information:

Title

Quality of life

Description

Time Frame

Six weeks

Secondary Outcome Measure Information:

Title

Changes in biomarkers for tissue damage

Description

Time Frame

During six weeks

Title

Changes in cytokines and chemokines

Description

Time Frame

During six weeks

Title

Changes in amount and function of T, B and natural killer(NK) lymphocytes

Description

Blood samples are collected on three occasions: one week preoperatively, one and six weeks postoperatively.

Time Frame

During six weeks

Title

Postoperative symptoms

Description

Time Frame

Six weeks

Title

Consumption of analgesic

Description

Use of analgesics is registered during hospital stay. After discharge the patient makes notes in a study specific diary of the daily consumption of analgesic until the six weeks visit.

Time Frame

Six weeks

Title

Health economics

Description

Direct and indirect costs for hospital stay and recovery period until six weeks postoperatively. Quality-adjusted life years (QALY) and cost-effectiveness are determined.

Time Frame

Six weeks

Title

Complications

Description

Adverse events (AE) and serious adverse events (SAE) are registered systematically from start of anesthesia to six weeks postoperatively

Time Frame

Six weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 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.

Overall Study Officials: