Clinical trial · Interventional
Surgical Success After Laparoscopic vs Abdominal Hysterectomy
Randomized Trial of Laparoscopic Versus Abdominal Hysterectomy for Benign Indications and Impact on Surgical Success
NCT01793584CI-TRIAL-00030057completedN/AClinicalTrials.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 proposed pilot study is to investigate the effectiveness, cost, safety, and long-term impact on quality of life of laparoscopic hysterectomy (LH) in relation to abdominal hysterectomy (AH) for the treatment of benign gynecologic disease in women through a randomized surgical trial.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenomyosis | — | UNRESOLVED | — |
| Endometriosis | — | UNRESOLVED | — |
| Leiomyoma | Leiomyoma | ONTOLOGY_EXACT | 0.98 |
| Menorrhagia | — | UNRESOLVED | — |
| Metrorrhagia | — | UNRESOLVED | — |
| Pelvic Inflammatory Disease | — | UNRESOLVED | — |
| Pelvic Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abdominal hysterectomy | Procedure | — | UNRESOLVED |
| Laparoscopic hysterectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Laparoscopic hysterectomy
- description
- Total laparoscopic hysterectomy, laparoscopic assisted vaginal hysterectomy
- interventionNames
- Procedure: Laparoscopic hysterectomy
- type
- ACTIVE_COMPARATOR
- label
- Abdominal hysterectomy
- description
- Total Abdominal Hysterectomy
- interventionNames
- Procedure: Abdominal hysterectomy
Primary outcomes (1)
- measure
- Quality of life
- timeFrame
- 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Women undergoing hysterectomy for benign indications within 8 weeks of enrollment * Women \>18 years of age * Non-emergent surgery * Non-pregnant Exclusion Criteria: * Candidate for vaginal hysterectomy * Uterine size \>14 weeks by clinical exam OR \>300 mL by ultrasound measurement * History of cancer of reproductive tract * Requires concomitant pelvic organ prolapse (POP) surgery * Requires surgery for urinary incontinence * Has acute angle glaucoma * Has severe cardiac/respiratory disease * Desires supracervical hysterectomy
References
Publications (0)
Data not yet available
No reference posted for this study.