COLOR II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer.

INTRODUCTION: Laparoscopic resection of rectal cancer has been proven efficacious but morbidity and oncological outcome need to be investigated in a randomized clinical trial. TRIAL DESIGN: Non-inferiority randomized clinical trial. METHODS: The COLOR II trial is an ongoing international randomized clinical trial. Currently 27 hospitals from Europe, South Korea and Canada are including patients. The primary endpoint is loco-regional recurrence rate three years post-operatively. Secondary endpoints cover quality of life, overall and disease free survival, post-operative morbidity and health economy analysis. RESULTS: By July 2008, 27 hospitals from the Netherlands, Belgium, Germany, Sweden, Spain, Denmark, South Korea and Canada had included 739 patients. The intra-operative conversion rate in the laparoscopic group was 17%. Distribution of age, location of the tumor and radiotherapy were equal in both treatment groups. Most tumors are located in the mid-rectum (41%). CONCLUSION: Laparoscopic surgery in the treatment of rectal cancer is feasible. The results and safety of laparoscopic surgery in the treatment of rectal cancer remain unknown, but are subject of interim analysis within the COLOR II trial. Completion of inclusion is expected by the end of 2009. TRIAL REGISTRATION: Clinicaltrials.gov, identifier: NCT00297791 (www.clinicaltrials.gov).

Pain, quality of life and recovery after laparoscopic ventral hernia repair.

BACKGROUND: Laparoscopic ventral hernia repair (LVHR) is a well established procedure in the treatment of ventral hernias. It is our clinical experience that patients suffer intense postoperative pain, but this issue and other recovery parameters have not been studied in detail. METHODS: Thirty-five patients with hernias >3 cm prospectively underwent LVHR using "double-crown" titanium tack mesh fixation. Pre- and postoperative pain was measured on a 0-100-mm visual analogue scale (VAS) and health-related quality of life was measured using the Short Form 36 questionnaire (SF-36). Several other recovery parameters were measured systematically in the 6 months follow-up period. RESULTS: We observed no recurrences or severe complications in the follow-up period (n = 31 at day 30 and n = 28 after 6 months). The median in-hospital stay was 2 days (range 0-5). Patients reported significantly more pain during activity than at rest at all times (p < 0.05). The median VAS-pain score during activity vs. at rest at discharge was 60 and 31, respectively. The median VAS-pain score during activity on the day of operation (day 0) was 78; it returned to baseline values at day 30 (p = 0.148) and, after 6 months, it was below the preoperative score (p = 0.01). The scores for general well-being and fatigue returned to baseline values at days 3 and 30, respectively, and at 6 months, they had both significantly improved compared with preoperative values (p = 0.005). The SF-36 scores were significantly worse in three domains at day 30 (p < 0.005). After 6 months, the bodily pain score had increased significantly compared with preoperative values (p < 0.005) and all eight scales were comparable to the Danish reference population scores. Patients resumed normal daily activities after a median of 14 days (range 1-38). Smokers and patients with hard physical demands at work took a significantly longer amount of time to resume work compared with non-smokers (30 vs. 9 days, p < 0.005) and patients with light work demands (29 vs. 9 days, p < 0.05), respectively. VAS-pain scores were strongly correlated to general well-being (r = -0.8, p < 0.001), patient satisfaction (r = -0.67, p < 0.001) and quality of life (r = -0.63, p < 0.001). We found no significant correlation between the number of tacks used (median 59) and postoperative pain. CONCLUSION: LVHR was associated with considerable postoperative pain and fatigue in the first postoperative month, prolonging the time of convalescence and significantly affecting patients' quality of life up to 6 months postoperatively. Mesh fixation with fibrin glue or other non-invasive/degradable products seems promising for reducing pain and it should be investigated in future randomised trials.