N/A
N=50
Robot Assisted Laparoscopic Hysterectomy vs. Abdominal Hysterectomy in Endometrial Cancer
Endometrial Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01526655 ↗Enrolled (actual)
50
Serious AEs
4.1%
Results posted
Apr 2024
Primary outcome: Primary: Health Related Quality of Life (HRQoL) — 0.34; 0.30; 0.66; 0.48 scores on a scale — p=0.011
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Abdominal total hysterectomy (Procedure); Robot assisted laparoscopic hysterectomy (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University Hospital, Linkoeping
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Health Related Quality of Life (HRQoL) |
0.34; 0.30; 0.66; 0.48; 0.74; 0.56 | 0.011 sig |
| SECONDARY Changes in Biomarkers for Tissue Damage (C-reactive Protein (hsCRP)) |
2.5; 6.0; 2.7; 4.7; 2.3; 3.5 | 0.03 sig |
| SECONDARY Changes in Biomarkers for Tissue Damage (White Blood Cells (WBC)) |
6.7; 7.7; 6.2; 6.6; 6.8; 11.4 | <0.01 sig |
| SECONDARY Changes in Biomarkers for Tissue Damage (Interleukin 6 (IL-6)) |
15.0; 10.9; 15.7; 9.6; 21.0; 47.6 | 0.03 sig |
| SECONDARY Changes in Biomarkers for Tissue Damage (Creatin Kinase (CK)) |
1.8; 1.6; 1.9; 1.6; 1.5; 2.5 | 0.03 sig |
| SECONDARY Changes in Biomarkers for Tissue Damage (Cortisol) |
273.4; 266.0; 489.0; 510.1; 301.0; 533.2 | 0.06 |
| SECONDARY Health Economics (With 300 Robotic Procedures Annually) |
65,728; 46,776; 12,451; 18,318; 78,179; 65,094 | 0.06 |
| SECONDARY Health Economics (With 500 Robotic Procedures Annually) |
61,862; 46,769; 12,451; 18,318; 74,313; 65,087 | 0.04 sig |
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.
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 (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.
Data sourced from ClinicalTrials.gov (NCT01526655). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.