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Adhesion prevention with icodextrin

The effect of 4% icodextrin solution vs lactated Ringer's solution on adhesiolysis during Hartmann's reversal: A multi-centre randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN76047793
Enrollment
40
Registered
2008-02-22
Start date
2003-10-01
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

Laparotomy/ peritoneal adhesions Digestive System Laparotomy/ peritoneal adhesions

Interventions

The study group receives at the end of Hartmann's procedure 1000 ml of 4 % icodextrin instilled into the abdomen. The control group receives same amount of lactated Ringer's solution.

Sponsors

Päijät-Häme Central Hospital (Finland)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients having rectosigmoid colon obstruction, perforation or diverticulitis (with or without perforation) for which a Hartmann's operation was planned

Exclusion criteria

Exclusion criteria: 1. Refusal to consent 2. Pregnancy 3. Peritoneal carcinoma 4. Postoperative radiotherapy before restorative surgery 5. Reoperation violating study protocol 6. Severe concomitant disease or other reason that would probably interfere with the restorative surgery

Design outcomes

Primary

MeasureTime frame
1. Time needed to separate postoperative adhesions, assessed approximately 3 months after hartmann's reversal procedure 2. Total operative time

Secondary

MeasureTime frame
1. Complications and recovery after Hartmann's reversal procedure. Duration of follow-up: 1 month 2. Safety of icodextrin. Duration of follow-up: 1 month

Countries

Finland

Outcome results

None listed

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