The EORTC QLQ-CR29 quality of life questionnaire for colorectal cancer: validation of the Dutch version.

PURPOSE: To validate the Dutch version of the EORTC QLQ-CR29 quality of life questionnaire for colorectal cancer. METHODS: We translated and pilot-tested the original questionnaire in the Netherlands, following EORTC guidelines. We assessed factor structure, reliability and construct validity in different samples of patients from four hospitals. RESULTS: Of 296 patients, 236 (80 %) returned the questionnaire, and 27 out of 48 patients returned the retest questionnaire. In addition to the original three scales, we found a reliable bowel functioning scale (α = 0.80), reducing the number of individual items by five. Two of the other scales had sufficient to good reliability (urinary frequency, α = 0.71, original α = 0.75, body image α = 0.80, original α = 0.84), the third, blood and mucus in stool, only moderate (α = 0.56, original α = 0.69). Item functioning was sufficient to excellent for all but two items (urinary incontinence and dysuria). Construct validity was similar to that in earlier studies. CONCLUSION: We found a very satisfactory scale for bowel problems, in patients both with and without stoma. The body image and urinary incontinence scales were reliable, and construct validity was sufficient. We suggest the questionnaire to be adapted to decrease the number of individual items, improve the scales, and therefore increase reliability of the entire questionnaire.

The DULK (Dutch leakage) and modified DULK score compared: actively seek the leak.

AIM: A standardized postoperative score, the DULK (Dutch leakage) score, has been demonstrated to be a useful clinical tool in the diagnosis of anastomotic leakage. It is complicated, however, and a simplification (the modified DULK score) based on fewer parameters derived from multiple logistic regression analyses has been developed. These include clinical condition, abdominal pain not localized at the wound, C-reactive protein level and respiratory rate. The accuracy of each was compared. METHOD: Data of all patients from five Dutch centres operated on between 16 October 2007 and 1 November 2009 with an anastomosis in the colon or rectum were entered into a prospectively maintained database. RESULTS: In total, 782 patients were included of whom 81 (10.4%) had a clinically relevant anastomotic leakage. The DULK score gave an overall sensitivity of 97% for anastomotic leakage, overall specificity of 53%, a positive predictive value (PPV) of 16% and a negative predictive value (NPV) of 99%. The modified DULK score used clinical condition, abdominal pain not localized at the wound, C-reactive protein level and respiratory rate. With at least one parameter present, overall sensitivity was 97%, overall specificity 57%, PPV 17% and NPV 99.5%. With at least two points PPV was 41% and with three points 57%. CONCLUSION: Both the original and modified DULK scores are useful for the early diagnosis of clinically relevant anastomotic leakage. The modified DULK score offers the benefit of fewer parameters and so can easily be used in a clinical environment to estimate the likelihood of anastomotic leakage. However, the early diagnosis of anastomotic leakage remains difficult.

Unexpected rectal cancer after TEM: outcome of completion surgery compared with primary TME.

BACKGROUND: Transanal endoscopic microsurgery (TEM) has gained wide-spread acceptance as a safe and useful technique for the resection of rectal adenomas and selected T1 malignant lesions. If the lesion appears >T1 rectal cancer after resection with TEM, a completion TME resection is recommended. The aim of this study was to investigate the results of TME surgery after TEM for rectal cancer. METHODS: In four tertiary referral hospitals for TEM, all patients with completion TME surgery after initial TEM were selected. All eligible patients who were treated with 5 × 5 Gy radiotherapy followed by TME surgery from the Dutch TME trial were selected as reference group. A multivariate logistic regression model was used to calculate odds ratio's (OR) for colostomies and for colo- and ileostomies combined. Local recurrence and survival rates were compared in hazard ratio's (HR) using the multivariate Cox proportional hazard model. RESULTS: Fifty-nine patients were included in the TEM-COMPLETION group and 881 patients from the TME trial. In the TEM-COMPLETION group, 50.8% of the patients had a colostomy compared to 45.9% in the TME trial, OR 2.51 (p < 0.006). There is no significant difference when ileo- and colostomies are analyzed together. In the TEM-COMPLETION group, 10.2% developed a local recurrence compared to 5.2% in the TME trial, HR 6.8 (p < 0.0001). CONCLUSIONS: Completion TME surgery after TEM for unexpected rectal adenocarcinoma results in more colostomies and higher local recurrence rates compared to one stage TME surgery preceded with preoperative 5 × 5 Gy radiotherapy. Pre-operative investigations must be optimized to distinguish malignant and benign lesions and prevent avoidable local recurrence and colostomies.

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).

Impact of transanal endoscopic microsurgery on functional outcome and quality of life.

INTRODUCTION: Transanal endoscopic microsurgery (TEM) is a minimal invasive technique for local excision of rectal tumours. The procedure is performed via a rectoscope with a diametre of 4 cm. The aim of this prospective study was to assess both functional outcome and quality of life after TEM. PATIENTS AND METHODS: Between 2004 and 2006, 47 patients were studied prior to and at least 6 months after TEM. Demographics, operative details and post-operative complications were recorded. Functional outcome was determined using the Faecal Incontinence Severity Index (FISI). Quality of life was measured using the EuroQol EQ-5D questionnaire and the Faecal Incontinence Quality of Life (FIQL) score. RESULTS: Six months after surgery, median FISI score was found to be decreased (p<0.01), depicting an improvement in faecal continence. This improvement was most significant in tumours within 7 cm from the dentate line (p=0.01). From the patients' perspective, post-operative quality of life was found to be higher (p<0.02). A significant improvement was observed in two of the four FIQLS domains (embarrassment, p=0.03; lifestyle, p=0.05). The domains of lifestyle, coping and behaviour and embarrassment were correlated with the FISI (all p<0.05). CONCLUSION: This study indicates TEM has no deteriorating effect on faecal continence. Moreover, once the tumour has been excised using TEM, quality of life is improved.

Spontaneous rupture of a utero-ovarian vein during pregnancy.

Atraumatic rupture of a utero-ovarian vein during pregnancy is a potentially lethal complication that is likely to be misdiagnosed because of its rarity. We report the case of a 31-year-old woman at 25 weeks' gestation who had an acute abdomen and shock.

Universal primary colonic repair in the firearm era.

All patients with colonic trauma treated at King Edward VIII Hospital, Durban, from August 1993 to May 1994 underwent primary repair of the colonic wound. They were evaluated prospectively to assess the mode of injury and outcome variables. Colonic injuries were sustained by 102 patients. These were inflicted by gunshots (62), stabs (22), shotguns (14), and blunt trauma (4). The transverse colon was injured most frequently (53). All shotgun injuries were multiple. Average time from admission to theatre was similar for shocked and non-shocked patients. Eighty-seven patients had simple closure (18 deaths) and 15 required resection and anastomosis (eight deaths). Ten patients died in the first 48 h, and 16 died subsequently owing to multiple-organ systems dysfunction. The mortality rates were stabs 9% (2), gunshots 27% (17), shotguns 50% (7), and 0% for blunt trauma. Septic morbidity was seen in 16 but was not related to breakdown of the colonic repair. Implementation of strategies to reduce preoperative time delays and use damage control principles for the management of massive trauma should be evaluated as methods of reducing mortality.

Superior vena caval thrombosis complicating central venous catheterisation and total parenteral nutrition.

Although venous thrombosis is a common sequela of central venous catheterisation, the vast majority of patients remain asymptomatic. Possible aetiological factors include catheter material, catheter-related sepsis, endothelial trauma, osmotic injury, and hypercoagulable states. Of these, only the first and last have been proven to increase the incidence. Thrombosis of the great veins of the thorax is a rare but life-threatening complication and the diagnosis is suggested by swelling of the head, upper limbs, and torso. Mediastinal widening on plain chest radiography may precede these signs. Confirmation of thrombosis is best achieved using contrast venography or contrast-enhanced CT scan. Acute symptomatic thrombosis is probably best treated by thrombolytic agents, but anticoagulation remains the commonest therapeutic approach.

Patterns of injury and white cell response in critically ill trauma patients who present with leucopenia.

The outcome of critically ill trauma patients who presented to the intensive care unit with leucopenia (total peripheral white cell count < 4 x 10(9)/1) was studied prospectively with respect to the total white cell and neutrophil response. A total of 105 patients, of whom 30 were leucopenic, were admitted to the ICU during a 4-month period. The prevalence of leucopenia was significantly higher in patients with gunshot wounds (P < 0.05) and hollow visceral intra-abdominal injury (P < 0.001). Eight (27%) of the leucopenic patients died. No significant difference was found in initial mean total white cell or neutrophil count, or in the differential percentages, between survivors and non-survivors. The total peripheral white cell count increased significantly in survivors compared with non-survivors (P < 0.001), and significant differences were found in absolute neutrophil counts and differential percentages by days 5 and 10 (counts P = 0.01, P < 0.02; differentials P < 0.01, P < 0.01). These results suggest that granulocyte colony-stimulating factor may have a role in the treatment of trauma patients with persistent neutropenia following intra-abdominal hollow visceral injury.

Distal splenocaval shunt as an alternative to distal splenorenal shunt in a patient with a retro-aortic left renal vein.

A 19-year-old patient with schistosomiasis and portal hypertension presented with bleeding oesophageal varices. A selective distal splenorenal shunt was planned. At surgery a retro-aortic left renal vein prevented a classical splenorenal anastomosis, and a distal splenocaval anastomosis was performed which is clinically patent at 18 months.

Prediction of the risk of death by APACHE II scoring in critically ill trauma patients without head injury.

The ability of the Acute Physiology And Chronic Health Evaluation (APACHE) II scoring system to predict outcome in 199 critically ill patients with trauma but without head injury was assessed prospectively over an 8-month period. Some 178 patients (89.4 per cent) underwent operation and 50 (25.1 per cent) died, 44 after operation and six without undergoing surgery. The mean(s.d.) APACHE II score was 8.0(5.2) for survivors and 14.5(5.5) for non-survivors (P < 0.001). In patients who underwent surgery the mean(s.d.) scores were 7.7(4.6) and 13.4(5.5) (P < 0.001) and for those managed without operation 11.1(7.2) and 14.7(6.3) (P = 0.31) in survivors and non-survivors respectively. The predicted risk of death and observed mortality rate were 5.1 and 25.1 per cent respectively for the entire group, 5 and 25 per cent for patients undergoing surgery, and 7 and 29 per cent for those not operated on. Although the APACHE II system correctly identified all survivors (specificity 100 per cent), it failed to predict death in any patient (sensitivity 0 per cent). The results suggest that this objective prognostic scoring system is not applicable to the patient with trauma who does not have concurrent head injury.