Comparing two surgical techniques for salpingectomy
Randomized Study Comparing Endoscopic Transvaginal vNOTES Surgery to Laparoscopy in Terms of Postoperative Pain
This study is testing whether a new less invasive surgery for removing fallopian tubes causes less pain than the traditional method for patients needing this procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Bron) |
| Trial ID | NCT04324034 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of vNOTES transvaginal endoscopic surgery compared to traditional laparoscopy for performing salpingectomies. The study aims to assess postoperative pain levels in patients undergoing these procedures, with the hypothesis that vNOTES will result in less pain due to its minimally invasive nature. It is a prospective randomized trial, meaning participants will be randomly assigned to one of the two surgical techniques. The study focuses on outpatient benign indications for surgery, ensuring a controlled environment for assessing outcomes.
Who should consider this trial
Good fit: Ideal candidates are women scheduled for a bilateral salpingectomy for benign reasons who can provide informed consent.
Not a fit: Patients with conditions that increase the risk of postoperative complications or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to reduced postoperative pain and quicker recovery for patients undergoing salpingectomy.
How similar studies have performed: While laparoscopic techniques are well-established, the vNOTES approach is relatively novel, and this study aims to provide new insights into its effectiveness compared to traditional methods.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * planned surgery procedure : bilateral salpingectomy for outpatient benign indication * patients with free, informed and signed consent Exclusion Criteria: * disorders leading to an unacceptable risk of postoperative complications sought during the interrogation of the patient (disorders of blood coagulation, disorders of the immune system, progressive diseases ....) * pregnancy or wish for subsequent pregnancy * lactating women * intervention in the context of pelvic cancer * history of uni- or bilateral salpingectomy * contraindication to laparoscopy * history of rectal surgery * endometriosis * pelvic inflammatory disease * genital infection * not eligible for outpatient care * associated surgical procedure planned during the intervention (hysterectomy, sub-urethral strip, prolapse cure ...) * participation in another interventional research related to the gynecological sphere * inability to understand the information given * a person not affiliated to a social security scheme, or deprived of liberty, or under guardianship.
Where this trial is running
Bron
- Hospices Civils de Lyon — Bron, France (Recruiting)
Study contacts
- Study coordinator: Gery LAMBLIN, Pr
- Email: gery.lamblin@chu-lyon.fr
- Phone: (0)4 72 35 58 71
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.