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The study aims at investigating if icodextrin 4% instilled in abdominal cavity during surgery can reduce the risk of surgery and hospitalisation for small bowel obstruction in patients with colorectal cancer. Follow-up data is collected from the Swedish national colorectal cancer registry.Patients are followed for 5 years postoperatively.The study is a randomized Swedish multicenter study and planned to include 1,800 patients. A safety control is planned after 300 included patients.
Icodextrin 7.5% is used in peritoneal dialysis. In animal models and in gynecological surgery a 4% solution of Icodextrin has been tested as a possible agent of reducing adhesions by acting as a barrier between peritoneal surfaces. Some data support a reduction af adhesions (van den Tool et al., Brown et al.). However, is not known whether icodextrin reduces the need for surgery or hospitalisation for small bowel obstruction.This study aims to study these parameters as well as complications and survival.
Patients with colorectal cancer and scheduled for surgery with curative intent will be (after patients acceptance) randomized to have icodextrin 4% instilled in the abdominal cavity or not. Patients allocated to icodextrin arm will have 100 ml of icodextrin 4% instilled every 30 minutes during surgery and at end of operation further 1000 ml instilled in the abdominal cavity. Postoperative care is performed according to each hospital praxis.
Follow-up data will be collected from the Swedish National Colorectal cancer registry. Data 30 days postoperatively will be analysed for early small bowel obstruction and other early complications. The study ends 5 years postoperatively with analysis of surgery and hospitalization for small bowel obstruction as well as survival and longterm complications.
A safety analysis is planned after the first 300 randomized patients with respect to early (30 days) complications. These data will analysed blindly by external reviewers.
Randomization (1:1) will be performed at the Regional Cancer Centrum in the Uppsala-Örebro region. The study aims to randomise 1800 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery and Icodextrin | Experimental | Icodextrin 4% instilled every 30 minutes during surgery and 1000 ml instilled before closure of abdomen |
|
| Surgery | Active Comparator | No instillations during surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery | Procedure |
| ||
| Icodextrin |
| Measure | Description | Time Frame |
|---|---|---|
| Surgery for small bowel obstruction | The proportion of patients that have undergone surgery for small bowel obstruction will be compared between the groups. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalisation for small bowel obstruction | 5 years | |
| Overall and cancer survival | 5 years | |
| Postoperative complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Urban Karlbom, PhD | University Hospital, Uppsala | Principal Investigator |
| Lars Påhlman, Professor | University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eskilstuna Hospital | Eskilstuna | Sweden | ||||
| Falun Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15746791 | Background | van den Tol P, ten Raa S, van Grevenstein H, Marquet R, van Eijck C, Jeekel H. Icodextrin reduces postoperative adhesion formation in rats without affecting peritoneal metastasis. Surgery. 2005 Mar;137(3):348-54. doi: 10.1016/j.surg.2004.06.001. | |
| 17383643 | Background | Brown CB, Luciano AA, Martin D, Peers E, Scrimgeour A, diZerega GS; Adept Adhesion Reduction Study Group. Adept (icodextrin 4% solution) reduces adhesions after laparoscopic surgery for adhesiolysis: a double-blind, randomized, controlled study. Fertil Steril. 2007 Nov;88(5):1413-26. doi: 10.1016/j.fertnstert.2006.12.084. Epub 2007 Mar 26. |
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| ID | Term |
|---|---|
| D000267 | Tissue Adhesions |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D000077607 | Icodextrin |
| ID | Term |
|---|---|
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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| Drug |
|
Safety control of first 300 randomised patients |
| 30 days |
| Postoperative complications | For all randomised patients | 30 days |
| Falun |
| Sweden |
| Gävle Hospital | Gävle | Sweden |
| Jönköping Hospital | Jönköping | Sweden |
| Karlstad Hospital | Karlstad | Sweden |
| Lidköping Hospital | Lidköping | Sweden |
| Luleå Hospital | Luleå | Sweden |
| Mora Hospital | Mora | Sweden |
| Norrrköping Hospital | Norrköping | Sweden |
| Nyköping Hospital | Nyköping | Sweden |
| Torsby Hospital | Torsby | Sweden |
| University Hospital | Uppsala | Sweden |
| Västerås Hospital | Västerås | Sweden |
| 26934850 | Derived | Sakari T, Sjodahl R, Pahlman L, Karlbom U. Role of icodextrin in the prevention of small bowel obstruction. Safety randomized patients control of the first 300 in the ADEPT trial. Colorectal Dis. 2016 Mar;18(3):295-300. doi: 10.1111/codi.13095. |
| D007414 |
| Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |