Operative hysteroscopy in the operating room versus the outpatient clinic
Comparison of Operative Hysteroscopy Performed in the Operating Room Versus Outpatient Settings : A Prospective Observational Study
Centre Hospitalier Intercommunal Creteil · NCT07146659
This will test whether operative hysteroscopy done in an outpatient clinic works as well as when it's done in the operating room for women treated for fibroids, polyps, or retained products of conception.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Centre Hospitalier Intercommunal Creteil (other) |
| Locations | 1 site (Créteil) |
| Trial ID | NCT07146659 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-center observational comparison of operative hysteroscopies performed in the operating room under general or regional anesthesia versus those performed in an outpatient setting without such anesthesia at CHI Créteil. About 400 women will be enrolled over two years (July 2025–May 2027) and followed to determine procedural success. The primary outcome is the success rate of the procedure, with secondary outcomes including postoperative pain, patient satisfaction, complications, and time to return to work. Data will be collected from routine clinical care and follow-up appointments to compare real-world effectiveness and recovery.
Who should consider this trial
Good fit: Women aged 18 or older undergoing operative hysteroscopy for intrauterine pathology (submucosal fibroids, endometrial polyps, or retained products of conception) who can give informed non-opposition and speak French.
Not a fit: Patients with contraindications to hysteroscopy, those who are pregnant, or those who require complex procedures needing general or regional anesthesia or inpatient care are unlikely to benefit from outpatient management compared here.
Why it matters
Potential benefit: If successful, more patients could safely have operative hysteroscopies as outpatient procedures, reducing anesthesia use, recovery time, and resource costs.
How similar studies have performed: Previous studies have generally shown outpatient operative hysteroscopy to be feasible, safe, and similarly effective to operating-room procedures, although some reported higher immediate pain during outpatient procedures and others reported cost advantages.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women aged ≥ 18 years -⁃ Undergoing operative hysteroscopy for intrauterine pathology * Able to provid e informed non-opposition * French-speaking Exclusion Criteria: * Patients with contraindications to hysteroscopy * Pregnancy * Inability to complete follow-up
Where this trial is running
Créteil
- CHI Créteil - Gynécologie et obstétrique — Créteil, France (RECRUITING)
Study contacts
- Study coordinator: Yann SALHI, MD
- Email: yann.salhi@chicreteil.fr
- Phone: 0157022000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Fibroid Uterus, Polyp Uterus, Retained Products of Conception, Hysteroscopy, Operative hysteroscopy, Outpatient ambulatory, Patient satisfaction, Outpatient hysteroscopy