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Evaluation of bio-clinician plus of perisurgery administration of Metilprednisolone MP in high doses in short term in laparotomy and laparoscopic colic surgeryfor neoplastic patology. Prospective, controlled double blind, randomized study. - ND

Evaluation of bio-clinician plus of perisurgery administration of Metilprednisolone MP in high doses in short term in laparotomy and laparoscopic colic surgeryfor neoplastic patology. Prospective, controlled double blind, randomized study. - ND

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-005692-15-IT
Enrollment
104
Registered
2006-02-17
Start date
2006-02-16
Completion date
Unknown
Last updated
2021-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients undergoing to laproscopic and laparotomic colic surgery MedDRA version: 6.1 Level: PT Classification code 10023693

Interventions

Trade Name: SOLU-MEDROL IM IV1FL1ML40MG Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: Methylprednisolone CAS Number: 2921-57-5 Concentration unit: mg milligram

Sponsors

OSPEDALE S. RAFFAELE
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -patients to be submitted to colic surgery with laparotony LPT or laparoscopy LPS otherwise healthy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: patients planned hospitalization in intensive unit care, patients with alteration in connective tissue, patients in chronic therapy with corticosteroids or patients with ongoing infective diseases.

Design outcomes

Primary

MeasureTime frame
Main Objective: better imuunoinflammatory response, less postoperative pain , better respiratory function,,less medic-surgical complications and less time of hospedalizationi in the group MP laparoscopy LPS versus teh other 3 groups;Secondary Objective: better imuunoinflammatory response, less postoperative pain , better respiratory function,,less medic-surgical complications and less time of hospedalizationi in the group MP laparoscopy LPS versus teh other 3 groups;Primary end point(s): better imuunoinflammatory response, less postoperative pain , better respiratory function,,less medic-surgical complications and less time of hospedalizationi in the group MP laparoscopy LPS versus teh other 3 groups—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026