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NCT03957837
Optical Nerve Sheath Changes During Head Down Laparoscopy
trial testing Optical nerve sheath diameter ultrasound measurement in Intracranial Hypertension in 20 participants. Completed in 30 July 2019.
30 June 2019
Quick facts
| Lead sponsor | ASST Fatebenefratelli Sacco |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 20 |
| Start date | 13 May 2019 |
| Primary completion | 30 June 2019 |
| Estimated completion | 30 July 2019 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Optical nerve sheath diameter ultrasound measurement
Conditions studied
- Intracranial Hypertension — all drugs for Intracranial Hypertension →
- Brain Edema — all drugs for Brain Edema →
- Pneumoperitoneum — all drugs for Pneumoperitoneum →
- Surgery, Laparoscopic — all drugs for Surgery, Laparoscopic →
Sponsor
ASST Fatebenefratelli Sacco — full company profile →
Who can join
Adults 18 to 70, male only, with Intracranial Hypertension or Brain Edema. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Patient undergoing laparoscopic radical prostatectomy in steep trendelenburg position are at risk to develop complication from brain edema. Ultrasound assessment of optical nerve sheath diameter is a simply, non-invasive method to estimate the increase of intracranial pressure. It is unknown how optical nerve sheath diameter changes after prolonged head down position.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03957837
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other ASST Fatebenefratelli Sacco trials
Trials by the same sponsor.
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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 NCT03957837 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by ASST Fatebenefratelli Sacco
- Last refreshed: 5 January 2021
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/NCT03957837.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing