icodextrin and Colorectal-Neoplasms

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

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

This pilot study utilised the sustained intraperitoneal (i.p.) dwell properties of an iso-osmotic solution of 4% icodextrin to investigate the tolerability, toxicity and feasibility of home-based i.p. 5FU adjuvant chemotherapy following resective surgery for colorectal cancer.. Twenty eligible patients (Dukes' stage B and C with potentially curative resection) underwent perioperative Tenckhoff catheter placement. Ten (6 male, 4 female, aged 46-85; mean 67.5 years) received 5FU chemotherapy. After initial flushing and gradual increase in volumes of 4% icodextrin alone, patients received home-based i.p. 5FU (150-300 mg/m(2)/day given as equal doses at 12-hourly intervals) for 14 days, with a 14-day recovery period, for a maximum of 6 courses. Two incurable patients, treated on compassionate grounds, provided further safety data.. Nine of the 10 patients became proficient in self-treatment with 5FU and two completed 6 courses. Frequent abdominal pain was the main dose-limiting toxicity of 5FU, causing withdrawal of three patients after a high (300 mg/m(2)/day) first course and one following a third course at lower doses. I.p. 5FU concentrations (mean>30000 ngml(-1)) were 1000 fold higher than systemic venous levels. Bacterial peritonitis led to two withdrawals but was not a frequent event (microbiologically confirmed incidence of 1 per 27 catheter-months).. Home-based i.p. adjuvant chemotherapy is a feasible treatment option in patients with surgically resected colorectal carcinoma.

Topics: Adenocarcinoma; Aged; Aged, 80 and over; Antimetabolites, Antineoplastic; Chemotherapy, Adjuvant; Colorectal Neoplasms; Dialysis Solutions; Female; Fluorouracil; Glucans; Glucose; Home Care Services; Humans; Icodextrin; Infusions, Parenteral; Male; Middle Aged; Pilot Projects; Treatment Outcome