I. Nesvik

COLOR: A Randomized Clinical Trial Comparing Laparoscopic and Open Resection for Colon Cancer

Background: Laparoscopic surgery has proven to be safe and effective. However, the value of laparoscopic resection for malignancy in terms of cancer outcome can only be assessed by large prospective randomized clinical trials with sufficient follow-up. Methods: COLOR (COlon carcinoma Laparoscopic or Open Resection) is a European multicenter randomized trial which has started in September 1997. In 24 hospitals in Sweden, The Netherlands, Germany, France, Italy and Spain, 1,200 patients will be included. The primary end point of the study is cancer-free survival after 3 years. Results: Within <2 years, more than 540 patients have been randomized for right hemicolectomy (45%), left hemicolectomy (10%) and sigmoidectomy (45%). 33 patients (6%) were excluded after randomization. The accrual rate is approximately 25 patients/month. Current survival rates for the whole study group are: stage I: 95%, stage II: 98%, stage III: 93%, stage IV: 64%. For all patients with stage I disease, the mortality was not cancer related. Conclusions: Although laparoscopic surgery appears of value in colorectal malignancy, results of randomized trials have to be awaited to determine the definitive place of laparoscopy in colorectal cancer. Considering the current accrual rate, the COLOR study will be completed in 2002.

Long-term Follow-up of 1059 Consecutive Primary and Recurrent Inguinal Hernias in a Teaching Hospital

OBJECTIVE To study the early and late outcome of various methods of inguinal hernia repair. DESIGN Retrospective study. SETTING Teaching hospital, Norway. SUBJECTS 1059 repairs of inguinal hernias in men and women by 43 surgeons. INTERVENTIONS Analysis of patients charts, results of questionnaires concerning 712 hernias (67%) and follow-up consultations when needed. MAIN OUTCOME MEASURES Freedom from recurrence and postoperative groin symptoms after repairs of primary and recurrent hernias. RESULTS After a median follow-up of 5.5 years, range 3-8, the recurrence rate was 8% for primary repairs and 29% after recurrent hernias. The incidence of permanent pain or discomfort was unexpectedly high, being 11% after primary repairs and 15% after recurrent hernia repairs. CONCLUSIONS The number of recurrences at long-term follow-up after repairs of primary and recurrent inguinal hernias was unsatisfactory. The extent of postoperative pain was surprising as this was not given enough attention during the learning period. We have introduced a uniform treatment policy with a prospective surveillance programme with the aim of improving results in our teaching programme.

Quality of Life and Pain in Patients with Acute Cholecystitis Results of a Randomized Clinical Trial

Background: Acute cholecystitis carries a higher risk of subsequent gallstone related events than symptomatic, non-complicated disease. However, it is largely unknown to what extent non-operative treatment will affect the patients well-being as no trial has studied the possible consequences on pain and quality of life. Our aim was to study in a randomized trial how observational treatment (watchful waiting) compared to cholecystectomy. Methods: Sixty-four patients with acute cholecystitis were randomized to observation or cholecystectomy. All gallstone related events were registered and patients answered questionnaires on quality of life (PGWB and NHP) and pain (Pain score and VAPS) at randomization and at 6, 12 and 60 months later. Results: Patients were followed-up for a median of 67 months. Ten of 33 patients (30 %, 95 % CI 15 %−46 %) patients randomized to observation and 27 of 31 (87 %, 95 % CI 75 %−99 %) of patients randomized to operation had a cholecystectomy. Twelve of 33 (36 %, 95 % CI 20 %−53 %) patients in the observation group had a gallstone related event compared to 6 of 31 (19 %, 95 % CI 5%−33 %) patients in the operation group, but the difference was not significant. When patients were grouped according to randomization or actual operative outcome (+/− cholecystectomy), we did not find any significant differences in pain or quality of life measurements. Conclusion: Although conservative treatment of AC carried a certain but not significantly increased risk of subsequent gallstone related events, this did not influence the symptomatic outcome as assessed by quality of life and pain measurements. Thus, we argue that conservative (non-operative) treatment and observation of AC is an acceptable option and should at least be considered in elderly and frail patients.

Rapid C-reactive protein (CRP) measurements in the diagnosis of acute appendicitis.

C-reactive protein (CRP) has been measured in plasma of patients with acute appendicitis and in controls without appendicitis to test the accuracy and diagnostic performance of a new rapid test kit for CRP (NycoCard CRP). The values obtained for CRP by the rapid test correlated well (Rs = 0.92) with the reference method for measuring CRP. The sensitivity, specificity and predictive values were calculated at different cut-off values. At values > 10 mg l-1 a sensitivity of 58% and a negative predictive value of 72% were found. Higher values of sensitivity were observed for men than for women, 69% and 44% respectively. Patients with acute appendicitis who had had symptoms for more than 24 h, had elevated CRP values (cut-off > 10 mg l-1) in more than 80% of cases. Our study shows that the rapid CRP test and the reference CRP test gave an almost identical result.

Traumatic and Postoperative Ischemic Liver Necrosis: Causes, Risk Factors and Treatment

Background: To study the cause and outcome of ischemic liver necrosis and suggest treatment of these patients. Methods: Retrospective study of 13 patients with ischemic liver necrosis treated at our departments from 1990 until 1997. Results: Ischemic liver necrosis was caused by general hypoxia (n = 1) or acute arterial occlusion (n = 12) of the celiac and superior mesenteric artery (SMA, n = 3), proper hepatic artery (PHA, n = 1), right hepatic artery (RHA, n = 2), left hepatic artery (LHA, n = 2) and intrahepatic vessels (n = 4). Six of the cases were related to surgical procedures, 5 of these (38%) were unintended arterial injuries after biliary surgery. Ten patients (77%) had risk factors contributing to the development of liver necrosis: septicemia (n = 4), jaundice and septicemia (n = 2), shock and hypoxia (n = 3) and alcoholic cirrhosis (n = 1). Five patients (38%) needed resection of the liver necrosis due to infected necrosis. Three patients (23%) died; two of these had celiac/SMA occlusion. One died due to complete gastrointestinal ischemia and severe lactacidosis, two died of multiorgan failure after bile leakage and septicemia. Conclusion: Ischemic liver necrosis is mainly caused by arterial occlusion due to arteriosclerosis, arterial transection during biliary surgery or blunt liver trauma, and seldom occurs without additional risk factors. 50% of the patients develop infected necrosis and need liver resection. Patients with sterile necrosis may recover without surgical procedures of the liver. The mortality in patients with central (celiac/SMA) and peripheral (CHA, PHA, RHA, LHA, intrahepatic branches) occlusions was 67% (2/3) and 11% (1/9), respectively.

The total number of lymph nodes in resected colon cancer specimens is affected by several factors but the lymph node ratio is independent of these.

The number of lymph nodes retrieved from the specimen may be a surrogate measure of the adequacy of extensive colon cancer surgery, but many variables may influence the total lymph node yield of any specimen. We examined which variables would be influential both for negative and positive node sampling.The combined results from 428 patients from three hospitals A to C treated in 2007–2009 with single colon cancers having R0 segmental resections were analysed. The surgical technique and pathology staining methods were slightly different between the hospitals.The mean number of lymph nodes was 15.8 (range 1–60). Twelve or more lymph nodes were harvested in 78% of the specimens. In the multivariate Poisson regression analysis of all TNM stages, the factors associated with the total lymph node harvest were age, pathology handling, tumour location and size (p < 0.001), whereas for TNM stage III alone the pathology handling (p < 0.001) and a radical operating technique (p = 0.003) were highly significant. The total number of lymph nodes was the only significant factor for the number of positive lymph nodes (Posln) according to the multivariate negative regression analysis (p = 0.02) but the analysis of the lymph node ratio (LNR) detected no statistically significant variable.Several factors, and especially the specimen processing technique, were important for the total number of harvested lymph nodes. The number of Posln varied between segments and increased with the total number of harvested lymph nodes, but for LNR no variable was important. LNR seemed to abolish the combined effect of tumour location and the total lymph node yield in prognosis assessment.

Recurrent Pilonidal Sinus: Etiology and Treatment

A clinical and histologic study of recurrent pilonidal sinus is presented. During a 5-year period 44 patients were treated for recurrent pilonidal sinus. Of these, recurrence had occurred within 1 year in 26 patients (76%). After 26 reoperations with excision and primary suture further recurrence was seen in 23% (6/26), and in 24% (6/25) after reoperations with open treatment. The histologic findings in recurrent sinuses (18 patients) were almost identical to that of primary disease. Recurrent sinuses were situated in the scar in 80% of the cases and caudal in 50% of the cases. A known wound infection had been present in 27% of the patients. Although keratin plugs were observed in 15/18 (83%) of those with a recurrence, the importance of this finding is uncertain. We conclude that recurrent pilonidal sinuses are chronic inflammatory processes usually located at the site of the surgical wound. The cause is uncertain, although there is an indication that wound infection plays a role. Keratin plugs have also been observed in scar tissue. Surgical treatment of recurrent disease has a higher recurrence rate than after that of primary disease.

Oncological outcome in patients treated for rectal carcinoma and followed up for 20 years was associated with local recurrence and a new primary cancer

origin. Particularly impressive was the prospective design (as all published studies of this topic – including ours [4] – have been retrospective). Also remarkable are the size of the study (encompassing over 10 000 patients, exceeding the size of any other study in this subject area) and the very small loss to follow up (8.1%). The timeliness of follow-up investigation of patients in the study – within 30 days of the PET ⁄ CT scan – is praiseworthy. Inadvertent delays (of up to several weeks) are seemingly customary with this patient group. Our experience yielded a similar proportion of incidental colorectal FDG foci, with a comparable division between proximal and distal colonic segments. Interestingly, however, Peng et al. [1] encountered a considerably higher false-positive rate in the right colon than in the left colon. Even allowing for differences in definitions, classifying colorectal lesions as proximal ⁄ distal as opposed to right ⁄ left, the significant difference in the predictive values according to the location of these findings is perplexing. The most significant difference between the two studies is in the populations evaluated. In particular, the study by Peng et al. [1] featured many ‘cancer screening’ patients, over one-third of whom had incidental focal colorectal FDG uptake. This would also account for the younger population of patients investigated for incidental focal colorectal FDG uptake by PET scans (average age 56 years, compared with 64 years in our study). Cancer screening, however, is not an indication for PET ⁄ CT scans in our practice as these have been shown to have limited sensitivity, a low positive predictive value [5] and reduced cost-effectiveness [6]. However, this alone might not be an adequate explanation for the discrepancy between the two series. Why, for example, would FDG-negative adenomas (presumably of smaller size and ⁄ or lower histological grade) exist predominantly in the right ⁄ proximal colon?