Laparoscopic vs. open incisional hernia repair: a randomized clinical trial.

IMPORTANCE: Incisional hernia is the most frequent surgical complication after laparotomy. Up to 30% of all patients undergoing laparotomy develop an incisional hernia. OBJECTIVE: To compare laparoscopic vs open ventral incisional hernia repair with regard to postoperative pain and nausea, operative results, perioperative and postoperative complications, hospital admission, and recurrence rate. DESIGN: Multicenter randomized controlled trial between May 1999 and December 2006 with a mean follow-up period of 35 months. SETTING: All patients were operated on in a clinical setting at 1 of the 2 participating university medical centers or at the other 8 teaching hospitals. PARTICIPANTS: Two hundred six patients from 10 hospitals were randomized equally to laparoscopic or open mesh repair. Patients with an incisional hernia larger than 3 cm and smaller than 15 cm, either primary or recurrent, were included. Patients were excluded if they had an open abdomen treatment in their medical histories. INTERVENTION: Laparoscopic or open ventral incisional hernia repair. MAIN OUTCOME MEASURES: The primary outcome of the trial was postoperative pain. Secondary outcomes were use of analgesics, perioperative and postoperative complications, operative time, postoperative nausea, length of hospital stay, recurrence, morbidity, and mortality. RESULTS: Median blood loss during the operation was significantly less (10 mL vs 50 mL; P = .05) as well as the number of patients receiving a wound drain (3% vs. 45%; P < .001) in the laparoscopic group. Operative time for the laparoscopic group was longer (100 minutes vs. 76 minutes; P = .001). Perioperative complications were significantly higher after laparoscopy (9% vs. 2%). Visual analog scale scores for pain and nausea, completed before surgery and 3 days and 1 and 4 weeks postoperatively, showed no significant differences between the 2 groups. At a mean follow-up period of 35 months, a recurrence rate of 14% was reported in the open group and 18%, in the laparoscopic group (P = .30). The size of the defect was found to be an independent predictor for recurrence (P < .001). CONCLUSIONS AND RELEVANCE: During the operation, there was less blood loss and less need for a wound drain in the laparoscopic group. However, operative time was longer during laparoscopy. Perioperative complications were significantly higher in the laparoscopic group. Visual analog scores for pain and nausea did not differ between groups. The incidence of a recurrence was similar in both groups. The size of the defect was found to be an independent factor for recurrence of an incisional hernia.

Bowel obstruction after laparoscopic and open colon resection for cancer: results of 5 years of follow-up in a randomized trial.

BACKGROUND: Postoperative bowel obstruction caused by intra-abdominal adhesions occurs after all types of abdominal surgery. It has been suggested that the laparoscopic technique should reduce the risk for adhesion formation and thus for postoperative bowel obstruction. This study was designed to compare the incidence of bowel obstruction in a randomized trial where laparoscopic and open resection for colon cancer was compared. METHODS: A retrospective analysis was performed, collecting data of episodes of bowel obstruction with or without surgery. Only episodes treated in the hospital where the index surgery took place were included. Data for 786 patients were collected for the 5-year period after cancer surgery. RESULTS: Baseline characteristics for the evaluated laparoscopic (n = 383) and open (n = 403) groups were comparable. The cumulative obstruction percentages at 5 years for the open and laparoscopic groups were 6.5 and 5.1% respectively and did not significantly differ from each other. Tumor stage seemed to influence the risk for bowel obstruction: 2.8% in stage I, 6.6% in stage II, and 7% in stage III, but the differences were not significant. CONCLUSIONS: This analysis does not support the hypothesis that laparoscopy leads to fewer episodes of bowel obstruction compared with open surgery.

Level of arterial ligation in total mesorectal excision (TME): an anatomical study.

INTRODUCTION: High-tie ligation is a common practice in rectal cancer surgery. However, it compromises perfusion of the proximal limb of the anastomosis. This anatomical study was designed to assess the value of low-tie ligation in order to obtain a tension-free anastomosis. MATERIALS AND METHODS: Consecutive high- and low-tie resections were performed on 15 formalin-fixed specimens, with or without splenic flexure mobilization. If the proximal colon limb could reach the superior aspect of the symphysis pubis with more than 3 cm, the limb would be long enough for a tension-free colorectal anastomosis. RESULTS: In 80% of cases, it was not necessary to perform high-tie ligation as sufficient length was gained with low-tie ligation. The descending branch of the left colic artery was the limiting factor in the other 20% of cases. Resecting half the sigmoid resulted in four times as many tension-free anastomoses after low-tie resection. CONCLUSION: In the majority of cases, it was not necessary to perform high-tie ligation in order to create a tension-free anastomosis. Low-tie ligation was applicable in 80% of cases and might prevent anastomotic leakage due to insufficient blood supply of the proximal colon limb.

Survival after laparoscopic surgery versus open surgery for colon cancer: long-term outcome of a randomised clinical trial.

BACKGROUND: Laparoscopic surgery for colon cancer has been proven safe, but debate continues over whether the available long-term survival data justify implementation of laparoscopic techniques in surgery for colon cancer. The aim of the COlon cancer Laparoscopic or Open Resection (COLOR) trial was to compare 3-year disease-free survival and overall survival after laparoscopic and open resection of solitary colon cancer. METHODS: Between March 7, 1997, and March 6, 2003, patients recruited from 29 European hospitals with a solitary cancer of the right or left colon and a body-mass index up to 30 kg/m(2) were randomly assigned to either laparoscopic or open surgery as curative treatment in this non-inferiority randomised trial. Disease-free survival at 3 years after surgery was the primary outcome, with a prespecified non-inferiority boundary at 7% difference between groups. Secondary outcomes were short-term morbidity and mortality, number of positive resection margins, local recurrence, port-site or wound-site recurrence, and blood loss during surgery. Neither patients nor health-care providers were blinded to patient groupings. Analysis was by intention-to-treat. This trial is registered with ClinicalTrials.gov, number NCT00387842. FINDINGS: During the recruitment period, 1248 patients were randomly assigned to either open surgery (n=621) or laparoscopic surgery (n=627). 172 were excluded after randomisation, mainly because of the presence of distant metastases or benign disease, leaving 1076 patients eligible for analysis (542 assigned open surgery and 534 assigned laparoscopic surgery). Median follow-up was 53 months (range 0.03-60). Positive resection margins, number of lymph nodes removed, and morbidity and mortality were similar in both groups. The combined 3-year disease-free survival for all stages was 74.2% (95% CI 70.4-78.0) in the laparoscopic group and 76.2% (72.6-79.8) in the open-surgery group (p=0.70 by log-rank test); the difference in disease-free survival after 3 years was 2.0% (95% CI -3.2 to 7.2). The hazard ratio (HR) for disease-free survival (open vs laparoscopic surgery) was 0.92 (95% CI 0.74-1.15). The combined 3-year overall survival for all stages was 81.8% (78.4-85.1) in the laparoscopic group and 84.2% (81.1-87.3) in the open-surgery group (p=0.45 by log-rank test); the difference in overall survival after 3 years was 2.4% (95% CI -2.1 to 7.0; HR 0.95 [0.74-1.22]). INTERPRETATION: Our trial could not rule out a difference in disease-free survival at 3 years in favour of open colectomy because the upper limit of the 95% CI for the difference just exceeded the predetermined non-inferiority boundary of 7%. However, the difference in disease-free survival between groups was small and, we believe, clinically acceptable, justifying the implementation of laparoscopic surgery into daily practice. Further studies should address whether laparoscopic surgery is superior to open surgery in this setting.

Level of arterial ligation in rectal cancer surgery: low tie preferred over high tie. A review.

Consensus does not exist on the level of arterial ligation in rectal cancer surgery. From oncologic considerations, many surgeons apply high tie arterial ligation (level of inferior mesenteric artery). Other strategies include ligation at the level of the superior rectal artery, just caudally to the origin of the left colic artery (low tie), and ligation at a level without any intraoperative definition of the inferior mesenteric or superior rectal arteries. Publications concerning the level of ligation in rectal cancer surgery were systematically reviewed. Twenty-three articles that evaluated oncologic outcome (n = 14), anastomotic circulation (n = 5), autonomous innervation (n = 5), and tension on the anastomosis/anastomotic leakage (n = 2) matched our selection criteria and were systematically reviewed. There is insufficient evidence to support high tie as the technique of choice. Furthermore, high tie has been proven to decrease perfusion and innervation of the proximal limb. It is concluded that neither the high tie strategy nor the low tie strategy is evidence based and that low tie is anatomically less invasive with respect to circulation and autonomous innervation of the proximal limb of anastomosis. As a consequence, in rectal cancer surgery low tie should be the preferred method.