icodextrin and Intestinal-Obstruction

Adhesions are the most common cause of small bowel obstruction (SBO). The costs of hospitalization and surgery for SBO are substantial for the health-care system. The adhesion-limiting potential of icodextrin has been shown in patients undergoing surgery for gynaecological diseases. A randomized, multicentre trial in colorectal cancer surgery started in 2009 with the aim of evaluating whether icodextrin could reduce the long-term risk of surgery for SBO. Because of some concerns about complications (especially anastomotic leakage) after icodextrin use, a preplanned interim analysis of morbidity and mortality was conducted.. Patients with colorectal cancer without metastasis were randomized 1:1 to receive standard surgery, with or without instillation of icodextrin in the abdominal cavity. For the first 300 patients, the 30-day follow-up data were collected from the Swedish ColoRectal Cancer Registry (SCRCR). Pre-, per- and postoperative data, morbidity and mortality were analysed.. Of the 300 randomized patients, 288 had a data file in the SCRCR. Twelve patients did not have cancer and another five did not have a resection, leaving 283 for analysis. The authors were blinded to the randomization groups. Demographic data were similar in both groups. The overall complication rate was 24% in Group 1 and 23% in Group 2 (P = 0.89). Four cases of anastomotic leakage were reported in Group 1 and five were reported in Group 2 (P = 1.0). Mortality, intensive care unit (ICU) stay and re-operations did not differ between the groups.. The pre-planned safety analysis of the first 300 patients enrolled in this randomized trial did not show any differences in adverse effects related to the use of icodextrin. All data were gathered from the SCRCR, giving us a strong message that we can continue to include patients in the trial.

Topics: Abdominal Cavity; Adolescent; Adult; Aged; Aged, 80 and over; Colorectal Neoplasms; Dialysis Solutions; Digestive System Surgical Procedures; Female; Glucans; Glucose; Humans; Icodextrin; Intestinal Obstruction; Intestine, Small; Male; Middle Aged; Patient Safety; Postoperative Complications; Sweden; Tissue Adhesions; Young Adult

Adhesive small bowel obstruction (ASBO) is an important cause of hospital admission, is associated with significant morbidity and mortality, and therefore is a substantial burden for healthcare systems worldwide. Icodextrin 4% solution (Adept, Shire Pharmaceuticals, UK) is a high-molecular-weight a-1,4 glucose polymer approved in Europe for use as intraoperative lavage and postoperative instillation to reduce the occurrence of post-surgery intra-abdominal adhesions. The present clinical study aimed to evaluate the safety and effectiveness of icodextrin 4% in decreasing the incidence, extent, and severity of adhesions in patients after abdominal surgery for ASBO.. The study was a single-center prospective, randomized investigation. The study is designed and conducted in compliance with the principles of Good Clinical Practice regulations. Safety and efficacy of icodextrin 4% in the study group are compared to no anti-adhesion treatment in a parallel control group with blinded evaluation of primary endpoints. Primary endpoints are the evaluation of the therapeutic role of icodextrin 4% in reducing ASBO recurrence incidence and the need of laparotomies for ASBO recurrence, as well as adhesion formation (with evaluation of their incidence, extent, and severity). A sum of 181 patients with ASBO and surgical indication to laparotomy were enrolled and randomized in two groups. Patients were submitted to adhesiolysis with bowel resection if required with or without anastomosis. The first group received traditional treatment (control group), whereas the second group was treated with the addition of icodextrin 4% solution before the abdominal closure.. Ninety-one patients were randomized to have icodextrin 4% solution administered intraperitoneally, and 90 patients were randomized to have the traditional treatment. The two study groups were homogeneous regarding their baseline characteristics. The ASBO recurrence rate was 2.19% (2/91) in the icodextrin groups vs 11.11% (10/90) in the control group after a mean follow-up period of 41.4 months (p < 0.05). No differences were found in the need of laparotomies for ASBO recurrence in the studied groups. The adhesion severity score seems lower in the group treated with the addition of icodextrin (p = n.s.).. The data resulting from this RCT showed that the use of icodextrin 4% solution in ASBO is safe and reduces intra-abdominal adhesion formation and the risk of re-obstruction.

Topics: Aged; Female; Follow-Up Studies; Glucans; Glucose; Humans; Icodextrin; Intestinal Obstruction; Laparotomy; Male; Middle Aged; Peritoneal Diseases; Postoperative Complications; Prospective Studies; Secondary Prevention; Single-Blind Method; Tissue Adhesions; Treatment Outcome

To assess the effectiveness of using sodium hyaluronate-based bioresorbable membrane (Seprafilm(®)) versus 4 % icodextrin solution (Adept(®)) versus no additive intraoperatively and to prevent postoperative small-bowel obstruction in patients undergoing colorectal cancer (CRC) surgery.. The subjects of this retrospective study were 454 patients, who underwent CRC surgery between February 2007 and January 2010. Among the 454 enrolled patients, 114 patients received Seprafilm(®), 180 patients received Adept(®), and 160 patients received no additive, based on the year of their surgery.. The overall incidences of small-bowel obstruction were 8.8, 4.3, and 6.9 %, for the Adept(®), Seprafilm(®), and no additive (control) groups, respectively. The cumulative incidence was significantly higher in the Adept(®) group than in the Seprafilm(®) and control groups (Adept(®) vs. Seprafilm(®), P = 0.043; Adept(®) vs. control group, P = 0.002). No significant difference was found between the Seprafilm group and the control group (P = 0.549). Adept(®) solution and Seprafilm(®) did not alter the liver and renal function, as assessed by blood chemistry.. The use of Adept(®) significantly increased the incidence of small-bowel obstruction in patients undergoing CRC surgery.

Topics: Colectomy; Colorectal Neoplasms; Female; Glucans; Glucose; Humans; Hyaluronic Acid; Icodextrin; Incidence; Intestinal Obstruction; Intestine, Small; Intraoperative Care; Lymph Node Excision; Male; Middle Aged; Postoperative Complications; Retrospective Studies; Risk

Encapsulating peritoneal sclerosis (EPS) is an intestinal obstruction syndrome in which peritoneal deterioration and intraperitoneal inflammation result in intestinal adhesions, which are covered with a fibrin capsule and which cause bowel obstruction. Here, we report the case of a patient with EPS suspected to result from the use of icodextrin peritoneal solution. In this patient, peritoneal permeability to high molecular weight solutes and effluent interleukin-6 (IL-6) levels increased after initiation on-to icodextrin solution. The patient developed symptoms of intestinal obstruction accompanied by intestinal edema 30 months after the start of icodextrin and after a peritoneal dialysis (PD) duration of 78 months. He was then diagnosed as being in a pre-EPS state. The use of icodextrin solution was discontinued, and the symptoms of intestinal obstruction improved after corticosteroid administration. Subsequently, he was managed on a combination of PD using glucose solution low in glucose degradation products and of twice-weekly hemodialysis, but he showed enhanced peritoneal permeability and increases in effluent IL-6. After a PD period of 98 months, severe symptoms of intestinal obstruction developed, and enterolysis was performed. The degeneration of the intestinal wall itself was slight, and the adhesions between the capsule and intestinal surface could be readily removed. In this patient, the degree of peritoneal deterioration and capsule formation differed from that of typical EPS. These findings suggest the promotion of capsule formation by icodextrin solution and the involvement of certain inflammatory reactions.

Topics: Glucans; Glucose; Hemodialysis Solutions; Humans; Icodextrin; Interleukin-6; Intestinal Obstruction; Male; Middle Aged; Peritoneal Dialysis; Peritoneal Fibrosis; Peritoneum; Permeability