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Prospective controlled randomised trial on Prevention Of Postoperative abdominal Adhesions by icodextrin 4% solution after laparotomic operation for small bowel obstruction caused by adherences

Prospective controlled randomised trial on Prevention Of Postoperative abdominal Adhesions by icodextrin 4% solution after laparotomic operation for small bowel obstruction caused by adherences

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN22061989
Enrollment
180
Registered
2007-07-05
Start date
2007-01-01
Completion date
Unknown
Last updated
2021-11-08

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

Conditions

Prevention of postoperative abdominal adhesions Surgery Abdominal adhesions

Interventions

The study will be performed in the Department of Transplant, General and Emergency Surgery of St Orsola-Malpighi University Hospital (Bologna, Italy)
a large teaching institution, with the participation of all surgeons who accept to be involved, together with the Emergency Surgery Department of Maggiore Hospital (Bologna, Italy). These two institut

Sponsors

Baxter Biosurgery (Italy)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult patients (over 18 years) 2. Submitted to laparotomic surgical procedures for ASIO 3. Clinical and radiological evidence of adhesive small intestine obstruction 4. American Society of Anesthesiologists (ASA) grade one to three patients 5. Informed consent

Exclusion criteria

Exclusion criteria: 1. Intra-abdominal cancer 2. Peritoneal contamination 3. Inflammatory Bowel Disease (IBD) 4. Positive history of radiotherapy 5. Patients with an intra-operative findings of different pathology will be excluded from the study

Design outcomes

Primary

MeasureTime frame
To evaluate the therapeutic role of icodextrin 4% to reduce ASIO incidence.

Secondary

MeasureTime frame
To reduce adherences rate (in case of reoperation for ASIO).

Countries

Italy

Outcome results

None listed

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