Clinical trial · Interventional
Robot Assisted Laparoscopic Hysterectomy vs. Abdominal Hysterectomy in Endometrial Cancer
A Randomized Open Controlled Trial Comparing Robot Assisted Laparoscopic Hysterectomy and Abdominal Hysterectomy for Endometrial Cancer in a Fast Track Program
NCT01526655CI-TRIAL-00076230completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abdominal total hysterectomy | Procedure | — | UNRESOLVED |
| Robot assisted laparoscopic hysterectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Abdominal total hysterectomy
- description
- Standard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision
- interventionNames
- Procedure: Abdominal total hysterectomy
- type
- ACTIVE_COMPARATOR
- label
- Robot assisted laparoscopic hysterectomy
- description
- Robot assisted laparoscopic total hysterectomy
- interventionNames
- Procedure: Robot assisted laparoscopic hysterectomy
Primary outcomes (1)
- measure
- Health Related Quality of Life (HRQoL)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.