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NCT04358978
A Novel Approach to Posterior Mesh Fixation in Laparoscopic Sacral Colpopexy
NA trial testing laparoscopic sacral colpopexy with posterior mesh no attachment in Pelvic Organ Prolapse in 150 participants. Status unknown.
30 September 2021
Quick facts
| Lead sponsor | Catholic University of the Sacred Heart |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 150 |
| Start date | 23 April 2020 |
| Primary completion | 30 September 2021 |
| Estimated completion | 30 September 2021 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- laparoscopic sacral colpopexy with posterior mesh no attachment
- laparoscopic sacral colpopexy with posterior mesh attachment
Conditions studied
- Pelvic Organ Prolapse — all drugs for Pelvic Organ Prolapse →
Sponsor
Catholic University of the Sacred Heart
Who can join
Under 75, female only, with Pelvic Organ Prolapse. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This randomized controlled study is designed to test the non inferiority of no attachment of posterior mesh compared to fixation of posterior mesh to the vagina in laparoscopic sacral colpopexy in terms of anatomical correction of the prolapse, post-operative and long term morbidity and rate of recurrence.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Posterior mesh fixation versus non-fixation in sacrocolpopexy: A randomized clinical trial.
Di Biasi J, Ruggieri S, Taccaliti C, Ciocca M, et al · · 2025 · cited 1× · PMID 40088520 · DOI 10.1016/j.ejogrb.2025.03.025
Verify or expand the search:
- PubMed search for NCT04358978
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Pelvic Organ Prolapse
Currently open trials in the same condition.
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- NCT07114029 — VNOTES Approach in Mesh Free Sacrocolpopexy: A Functional and Anatomic Evaluation · NA · recruiting
- NCT07082023 — Comparison of V-NOTES and Laparoscopic Mesh-Free Sacrocolpopexy Techniques · NA · recruiting
Other Catholic University of the Sacred Heart trials
Trials by the same sponsor.
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- NCT07516392 — Study of a Polygenic Risk Score to Predict the Risk of Pancreatic Ductal Adenocarcinoma · NA · not yet recruiting
- NCT07140705 — Personalized Virtual Reality for Promoting Well-Being and Psychological Flexibility in General Practitioners · NA · completed
- NCT06992453 — Multi-omics Dissection of Gut Microbiome Engraftment During FMT · NA · not yet recruiting
- NCT06852183 — Restructuring Body Experience in Anorexia Nervosa: Virtual Reality Functionality-Focused Mirror Exposure · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04358978 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Catholic University of the Sacred Heart
- Last refreshed: 24 July 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04358978.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing