Adhesion prevention with icodextrin
| ISRCTN | ISRCTN76047793 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76047793 |
| Protocol serial number | N/A |
| Sponsor | Päijät-Häme Central Hospital (Finland) |
| Funder | Internally funded by the Päijät-Häme Central Hospital (Finland) |
- Submission date
- 04/01/2008
- Registration date
- 22/02/2008
- Last edited
- 22/02/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jyrki Kössi
Scientific
Scientific
Department of Surgery
Päijät-Häme Central Hospital
Keskussairaalankatu 7
Lahti
15850
Finland
| jyrki.kossi@phsotey.fi |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective, double-blind, multi-centre, randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | The effect of 4% icodextrin solution vs lactated Ringer's solution on adhesiolysis during Hartmann's reversal: A multi-centre randomised controlled trial |
| Study objectives | Laparotomy almost always causes peritoneal adhesions, which further causes morbidity and even mortality. A regimen to prevent peritoneal adhesions is urgently needed. Icodextrin has been shown to prevent adhesion formation, and our study investigated further the efficacy of icodextrin in colorectal operation. Study hypothesis: 4% icodextrin solution decreases adhesion formation and time needed to divide them after hartmann's procedure compared to lactated Ringer's solution. |
| Ethics approval(s) | National approval of the study received on 30 April 2003 from the Ethical Committee of Päijät-Häme Hospital District ETL-code Q36. Further approved by every local ethical committee of participating hospitals. |
| Health condition(s) or problem(s) studied | Laparotomy/ peritoneal adhesions |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Time needed to separate postoperative adhesions, assessed approximately 3 months after hartmann's reversal procedure |
| Key secondary outcome measure(s) |
1. Complications and recovery after Hartmann's reversal procedure. Duration of follow-up: 1 month |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 40 |
| Key inclusion criteria | All patients having rectosigmoid colon obstruction, perforation or diverticulitis (with or without perforation) for which a Hartmann's operation was planned |
| Key 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 |
| Date of first enrolment | 01/10/2003 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- Finland
Study participating centre
Department of Surgery
Lahti
15850
Finland
15850
Finland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
