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Study to evaluate the efficacy, safety and tolerability of pumactant 240mg in the prevention of the formation of peritoneal adhesions following abdominal surgery

A randomised, partially double-blind, controlled, parallel group study to evaluate the efficacy, safety and tolerability of pumactant 240mg in the prevention of the formation of peritoneal adhesions following abdominal surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN99599132
Enrollment
140
Registered
2011-03-31
Start date
2001-04-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Post operative intraperitoneal adhesions Surgery Post operative intraperitoneal adhesions

Interventions

On completion of the first surgical procedure for each subject, the peritoneum was cleansed and irrigated with saline. A single dose of pumactant powder 240 mg (comprising of 3 puffer devices administ

Sponsors

Research and Innovation Service, University of Dundee (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Male and female subjects ( > 18 years old) were recruited into the study if it was thought that at the primary surgical procedure, they required the formation of a temporary stoma 2. Patients undergoing emergency treatment of obstructed /perforated carcinoma of the bowel or colonic diverticulitis by Hartmanns procedure 3. Patients undergoing elective low anterior bowel resection for the treatment of rectal carcinoma requiring formation of a temporary ileostomy

Exclusion criteria

Exclusion criteria: 1. Patients unable to comply with the study requirements, had cognitive impairments, had a history of drug and / or alcohol abuse 2. Patients receiving steroid medication 3. Patients had metastatic disease 4. Patients had American Society of Anesthesiologists (ASA) fitness grade of IV or above 5. Pregnant or lactating females

Design outcomes

Primary

MeasureTime frame
The evaluation of the efficacy of pumactant 240 mg in reducing the formation of peritoneal adhesions following abdominal surgery

Secondary

MeasureTime frame
Evaluate the safety and tolerability of pumactant 240 mg used in the peritoneal cavity following abdominal surgery

Countries

United Kingdom

Outcome results

None listed

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