Synthesis and summary of patient-reported outcome measures to inform the development of a core outcome set in colorectal cancer surgery.

AIM: Patient-reported outcome (PRO) measures (PROMs) are standard measures in the assessment of colorectal cancer (CRC) treatment, but the range and complexity of available PROMs may be hindering the synthesis of evidence. This systematic review aimed to: (i) summarize PROMs in studies of CRC surgery and (ii) categorize PRO content to inform the future development of an agreed minimum 'core' outcome set to be measured in all trials. METHOD: All PROMs were identified from a systematic review of prospective CRC surgical studies. The type and frequency of PROMs in each study were summarized, and the number of items documented. All items were extracted and independently categorized by content by two researchers into 'health domains', and discrepancies were discussed with a patient and expert. Domain popularity and the distribution of items were summarized. RESULTS: Fifty-eight different PROMs were identified from the 104 included studies. There were 23 generic, four cancer-specific, 11 disease-specific and 16 symptom-specific questionnaires, and three ad hoc measures. The most frequently used PROM was the EORTC QLQ-C30 (50 studies), and most PROMs (n = 40, 69%) were used in only one study. Detailed examination of the 50 available measures identified 917 items, which were categorized into 51 domains. The domains comprising the most items were 'anxiety' (n = 85, 9.2%), 'fatigue' (n = 67, 7.3%) and 'physical function' (n = 63, 6.9%). No domains were included in all PROMs. CONCLUSION: There is major heterogeneity of PRO measurement and a wide variation in content assessed in the PROMs available for CRC. A core outcome set will improve PRO outcome measurement and reporting in CRC trials.

A systematic review of outcome reporting in colorectal cancer surgery.

AIM: Evaluation of surgery for colorectal cancer (CRC) is necessary to inform clinical decision-making and healthcare policy. The standards of outcome reporting after CRC surgery have not previously been considered. METHOD: Systematic literature searches identified randomized and nonrandomized prospective studies reporting clinical outcomes of CRC surgery. Outcomes were listed verbatim, categorized into broad groups (outcome domains) and examined for a definition (an appropriate textual explanation or a supporting citation). Outcome reporting was considered inconsistent if results of the outcome specified in the methods were not reported. Outcome reporting was compared between randomized and nonrandomized studies. RESULTS: Of 5644 abstracts, 194 articles (34 randomized and 160 nonrandomized studies) were included reporting 766 different clinical outcomes, categorized into seven domains. A mean of 14 ± 8 individual outcomes were reported per study. 'Anastomotic leak', 'overall survival' and 'wound infection' were the three most frequently reported outcomes in 72, 60 and 44 (37.1%, 30.9% and 22.7%) studies, respectively, and no single outcome was reported in every publication. Outcome definitions were significantly more often provided in randomized studies than in nonrandomized studies (19.0% vs 14.9%, P = 0.015). One-hundred and twenty-seven (65.5%) papers reported results of all outcomes specified in the methods (randomized studies, n = 21, 61.5%; nonrandomized studies, n = 106, 66.2%; P = 0.617). CONCLUSION: Outcome reporting in CRC surgery lacks consistency and method. Improved standards of outcome measurement are recommended to permit data synthesis and transparent cross-study comparisons.

Colorectal stenting in malignant large bowel obstruction: the learning curve.

Aim. Self-expanding metal stents (SEMSs) are increasingly used for the palliation of metastatic colorectal cancer and as a bridge to surgery for obstructing tumours. This case series analyses the learning curve and changes in practice of colorectal stenting over a three year period. Methods. A study of 40 patients who underwent placement of SEMS for the management of colorectal cancer. Patients spanned the learning curve of a single surgeon endoscopist. Results. Technical success rates increased from 82% initially, using an average of 1.7 stents per procedure, to a 94% success rate where all patients were stented using a single stent. There has been a change in practice from elective palliative stenting toward emergency preoperative stenting. Conclusion. There is a steep learning curve for the use of SEMS in the management of malignant colorectal bowel obstruction. We suggest that at least 20 cases are required for an operator to be considered experienced.

Clinical and psychometric validation of the EORTC QLQ-CR29 questionnaire module to assess health-related quality of life in patients with colorectal cancer.

This international study aimed to test the measurement properties of the updated European Organisation for Research and Treatment of Cancer (EORTC) questionnaire module for colorectal cancer, the QLQ-CR29. The QLQ-CR29 was administered with the QLQ-C30, core questionnaire, to 351 patients from seven countries. Questionnaire scaling and reliability were established and clinical and psychometric validity examined. Patient acceptability and understanding were assessed with a debriefing questionnaire. Multi-trait scaling analyses and face validity refined the module to four scales assessing urinary frequency, faecal seepage, stool consistency and body image and single items assessing other common problems following treatment for colorectal cancer. Scales distinguished between clinically distinct groups of patients and did not correlate with QLQ-C30 scales, demonstrating construct validity. The QLQ-CR29 scores were reproducible over time in stable health. The EORTC QLQ-CR29 demonstrates sufficient validity and reliability to support its use to supplement the EORTC QLQ-C30 to assess patient-reported outcomes during treatment for colorectal cancer in clinical trials and other settings.

Haematoma of the sigmoid colon secondary to Ehlers Danlos Syndrome presenting as a colonic tumour.

Ehlers Danlos Syndrome (EDS) is a collective term for a number of connective tissue disorders. Vascular rupture and dissection are well-documented sequelae as is gastrointestinal perforation. We present a rare presentation where dissection of the bowel wall presented as a suspected sigmoid colon tumour.

Laparoscopic appendicectomy: a training model for laparoscopic right hemicolectomy?

OBJECTIVE: To analyse the outcome of laparoscopic appendicectomy and right hemicolectomy and see if the surgical approach to the former can be applied to the latter. METHOD: A prospective electronic laparoscopic database identified 330 appendicectomies and 78 right hemicolectomies (using this approach) between 1996 and 2005. RESULTS: Three hundred and thirty patients (188 males: median age 38 years, range 17-74 years) underwent laparoscopic appendicectomy; 270 (82%) were performed by trainees (higher surgical trainee 71%, basic surgical trainee 12%). The median operative time for trainees was 35 min (14-75 min) with a conversion rate 2%. There were no intra-operative complications. The postoperative complication rate excluding minor wound infection (5.5%) was 1.5%. There were no deaths. The median hospital stay was 2 days (1-15 days). The 30-day readmission rate was 1%. Seventy-eight patients (23-93 years) underwent laparoscopic right hemicolectomy during 2004/5; trainees performed parts thereof in the majority or all of the surgery in 25 cases. The median operation time was 55 min: trainees 115 (65-145 min). There was one conversion. The median hospital stay was 4 days (2-23 days) falling to 3 for the last 20 operations (1-8 days). There were two readmissions for wound sepsis and small bowel obstruction and three deaths (3.8%): anastomotic leak (one), C difficile infection leading to renal failure (one) and duodenal perforation (one). CONCLUSION: Laparoscopic appendicectomy is a safe, predictable, easily learnt operation and an ideal model for learning the skills and principles required for more advanced laparoscopic colorectal interventions and in particular, right hemicolectomy.

A colorectal cancer patient focus group develops an information package.

INTRODUCTION: In order to deliver high quality care and empower cancer patients in decision-making, good quality information and communication are essential. We describe the development of an information booklet. PATIENTS AND METHODS: A total of 22 colorectal cancer patients (12 male; median age, 72 years, range, 40-86 years) met on 3 occasions. Patients were asked to define their information needs and score them (1-4) according to importance. The information document was written. The second meeting involved feedback on the booklet. The modified booklet was reviewed/approved by the group before submission for local ethics committee approval prior to its distribution to other patients. RESULTS: All participants felt the project a good idea. Essential information included the surgeon's individual morbidity, mortality, survival, recurrence data and details of adjuvant therapies (score = 4). Also important were type of surgery, complications and postoperative recovery (score = 3). Simple anatomical drawings were also considered important. CONCLUSIONS: The booklet is now used to personalise information for all our patients and serves, in part, as a record of the key issues discussed during the consultation. The booklet has been evaluated in a randomised trial.

The role of colonoscopic endoanal ultrasound scanning (EUS) in selecting patients suitable for resection by transanal endoscopic microsurgery (TEM).

OBJECTIVE: This study was performed to assess the accuracy of colonoscopic endoanal ultrasound scanning (EUS) in the selection of patients with rectal neoplasia suitable for local excision by transanal endoscopic microsurgery (TEM). Our policy is to offer TEM to patients with premalignant (T0) lesions or with T1 tumours that have early disease. PATIENTS AND METHODS: Data were collected prospectively on all patients undergoing EUS for the assessment of rectal neoplasia at our institution over a six-year period. A colonoscopic EUS probe was used to determine whether the tumour breached the muscularis propria (the interface between T1 and T2 disease). Subsequently patients underwent surgical resection, including TEM for those with T0/1 disease. The preoperative stage predicted by EUS (uT stage) was compared to the postoperative histopathological stage of the resected specimens (pT stage). RESULTS: One hundred and fifty-six EUS examinations were evaluated. Sixty-two patients went on to have TEM whilst the remaining 94 had another form of surgery. Of the 62 patients undergoing TEM, 3 were overstaged on EUS. No patients were understaged, giving an accuracy of 95%. Of the 94 patients undergoing an alternative procedure, 5 were overstaged on EUS as having T2 tumours when in fact their histology was T1. Accuracy of EUS at predicting more advanced disease fell to 89%, giving an overall accuracy of 92%. CONCLUSIONS: EUS is accurate at predicting T0/1 vs T2 disease in our institution, and we believe that it is a useful modality in assessing patient suitability for local excision.

Laparoscopic inguinal hernia repair: a NICE operation.

Published evidence comparing laparoscopic and open herniorraphy is controversial. NICE recommends that open techniques are used for first time repairs and that TEP be considered for bilateral/recurrent repairs undertaken in specialist units. We report a consecutive series of 224 patients undergoing 268 TEP repairs between 1996 and 2001. Operating time, complications, return to normal activity/full time employment and recurrence were examined. The median operating time was 30 minutes. There was one conversion. Ninety four percent of patients drove on the third post-operative day. The median time to normal activity was 4 days (1-10 days). The median time to return to professional employment in 82 patients was 3 days (range 2-9 days). Four patients (1.7%) had self-limiting minor groin pain. There were 3 recurrences (1.4%) and none since altering the surgical technique to use a larger anchored mesh. We have demonstrated TEP to be an easily learnt, safe, effective technique with low morbidity, and with sufficient experience, takes no longer than an open repair. It can be performed at little increased cost and restores selected patients to an early return to full-time employment. We believe that the choice between open and laparoscopic repair is a subjective decision for patient and surgeon

Knowledge of cancer symptoms among patients attending one-stop breast and rectal bleeding clinics.

AIM AND METHOD: The aim of this questionnaire study was to identify knowledge of breast and colorectal cancer symptoms among 100 patients attending one-stop breast clinics and rectal bleeding clinics and to determine the source of the information. RESULTS: Seventy-five breast clinic (mean age 46 years, all female) and 78 colorectal clinic patients (mean age 59 years, 51% male) responded. Knowledge of breast was significantly greater than bowel cancer in both groups (P<0.0001, McNemar's chi(2)). There was no difference in knowledge of symptoms of breast cancer or bowel cancer between patients attending either clinic. There was a positive association between cancer knowledge, family history and female gender but no association with age. Knowledge of Bowel Cancer Awareness Week was positively associated with colorectal cancer knowledge. CONCLUSION: Knowledge of colorectal cancer is much less than breast cancer in clinic attenders. Seventy-five per cent of women attending breast clinic could name a breast cancer symptom whereas only 37% of patients attending colorectal clinic could name a bowel cancer symptom. These findings have implications when considering patients' anxiety, expectations of a cancer diagnosis and breaking bad news.

The impact of bowel cancer awareness week.

OBJECTIVES: To assess knowledge of Bowel Cancer Awareness Week (BCAW) amongst patients attending their general practice surgery and to identify whether BCAW could increase knowledge of colorectal cancer symptoms. METHOD: Questionnaire study with ethics committee approval. Patients attending non-emergency clinics in a single general practice during the week following BCAW were given a questionnaire. Respondents were asked for knowledge of colorectal cancer symptoms, sources of this information and awareness of BCAW compared to similar knowledge of breast cancer. RESULTS: Seventy-seven patients responded (96% response rate, median age 42, 40% male). Eighty-five percent could name a breast cancer symptom compared to only 44% who could name a colorectal cancer symptom (McNemar's chi2, P < 0.0001). Respondents identified more sources of information for breast than colorectal cancer. Only 21% had heard of BCAW and none could name any symbol for bowel cancer awareness whereas 69% were aware of Breast Cancer Awareness Month and 28% could name its symbol (McNemar's chi2, P < 0.0001). Multivariate analysis demonstrated that patients who were aware of BCAW were 4.6 times more likely to have knowledge of colorectal cancer symptoms (95% CI 1.25-17.1). CONCLUSIONS: Despite their similar incidence, knowledge of colorectal cancer is much less than breast cancer. In part this may be due to the greater publicity given to breast cancer. BCAW can increase knowledge of colorectal cancer symptoms but currently, too few people are aware of it.

Fat necrosis of the female breast--Hadfield re-visited.

Examination of pathology records from three hospitals over an 8-year period identified 42 cases of primary fat necrosis of the female breast. The mean age of the women was 56 (range 24-85) and the lump was most commonly in the upper, inner quadrant of the breast having been present for a mean of 11 weeks (range 1-56). Twenty-one percent of patients gave a history of trauma which had occurred a mean of 69 weeks (range 3-208) previously. The mammograms gave an appearance of malignancy in 12 of the 22 cases where they were performed. Cytology was suspicious in five cases. Thirty-seven patients subsequently underwent wide local excision to confirm the diagnosis. The histology was re-examined by a pathologist and a subgroup of patients were identified who had fat necrosis associated with periductal mastitis. Two patients who had a core biopsy diagnosis of fat necrosis were found to have malignancy on wide local excision. Here we review the changes in presentation since the original description of the condition, and highlight that although this series reflects difficult cases, fat necrosis remains a condition which can still be difficult to diagnose.

Is routine histological reporting of doughnuts justified after anterior resection for colorectal cancer?

OBJECTIVE: 'Doughnuts' of colonic tissue which remain on a circular stapler after firing are routinely examined histologically. However, Royal College of Pathologists' guidelines state that this is not necessary. The aim of this study was to examine current practice among pathologists in one region in the UK and to determine the incidence of clinically significant pathology within colonic doughnuts. METHODS: Current practice in all pathology Departments within the South-west Region was examined and 100 doughnuts from anterior resection specimens were reviewed for the presence of abnormal pathology. RESULTS: Practice varied between hospitals with only 15% following guidelines for examination of doughnuts and 38% following guidelines for reporting of resection margins. Review of pathology specimens demonstrated no incidence of colonic adenocarcinoma in a doughnut. Benign pathology was present in 9% and dysplasia in 3% but in no case was patient management altered as a result of the pathology report. CONCLUSION: Application of recommended guidelines is inconsistent. We have demonstrated a low incidence of clinically significant pathology in doughnuts and more economical guidelines could therefore be safely applied without detriment to patient care.

Monoclonal antibody treatment of colorectal cancer.

BACKGROUND: The recent development of adjuvant monoclonal antibody immunotherapy for patients suffering from colorectal cancer has led to a re-evaluation of the role of these molecules in the treatment of solid tumours. In particular, interest has been directed at identifying appropriate candidates for therapy, evaluating treatment schedules and developing new molecules of therapeutic potential. METHODS: This is a review of published data on patients undergoing antibody therapy. In addition, current theories of the mechanism of action of antitumour monoclonal antibodies are presented, along with potential future therapeutic approaches. RESULTS AND CONCLUSION: Monoclonal antibody-based adjuvant therapy of colorectal cancer appears to be effective; international multicentre trials continue. The development of new molecules, such as chimaeric antibodies, offers the potential of increased tumour targeting with reduced toxicity. Such molecules may be used alone or in combination with agents such as chemotherapy or cytokines.

Interleukin 1 and tumour necrosis factor alpha may be responsible for the lytic mechanism during anti-tumour antibody-dependent cell-mediated cytotoxicity.

Antibodies are thought to bring about tumour cell lysis by antibody-dependent cell-mediated cytotoxicity (ADCC), but the exact mechanism is not well elucidated. Monocytes are known to be important mediators of anti-tumour ADCC and are also known to secrete the cytokines tumour necrosis factor alpha (TNF-alpha) and interleukin 1 beta (IL-1 beta), both of which have been shown to bring about tumour cell lysis. We examined the release of these cytokines during ADCC and attempted to elucidate which components of the ADCC reaction were necessary for cytokine production. We measured TNF-alpha and IL-1 beta in supernatants collected from a standard ADCC assay using each of the anti-colorectal antibodies m17-1A, c17-1A and cSF25. We found that there was significant TNF-alpha and IL-1 beta release during ADCC mediated by each of these three antibodies and that the magnitude of cytokine release seemed to reflect the degree of tumour cell lysis produced by each antibody. Furthermore, we found that effector cells, target cells and a specific anti-tumour antibody were necessary for this to occur. The presence of only some of the components of the reaction or of an irrelevant antibody produced little or no TNF-alpha or IL-1 beta. We conclude that TNF-alpha and IL-1 beta are released when an effector and tumour target cell are united by a specific tumour antibody and that these cytokines may be important in bringing about tumour cell lysis during the ADCC reaction.

m17-1A-, c17-1A- and cSF25-mediated antibody-dependent cell-mediated cytotoxicity in patients with advanced cancer.

The anti-tumour antibody-dependent cell-mediated cytotoxicity (ADCC) capacity of the conventional antibody m17-1A was compared with its chimerised analogue c17-1A and a newer chimeric antibody, cSF25, specific for colonic adenocarcinoma. The results (AUC units +/- s.e.m., control versus cancer) show that mononuclear cells from patients with adenocarcinoma mediate ADCC as efficiently as those from controls for m17-1A (143 +/- 14 vs 153 +/- 14), c17-1A (174 +/- 16 vs 189 +/- 14) cSF25 (215 +/- 18 vs 237 +/- 13) and effectors and targets alone (57 +/- 9 vs 51 +/- 8). Both chimeric antibodies mediated ADCC more effectively than m17-1A with cSF25 consistently producing the highest lysis. Furthermore, more efficient ADCC was found to correspond with monocyte activation examined flow cytometrically. The results (mean channel fluorescence) show that HLA-DR expression is increased with c17-1A (1436 +/- 200) and cSF25 (2252 +/- 298) above that observed when effectors and targets were incubated alone (1157 +/- 168) or with m17-1A (1286 +/- 170). Similarly, interleukin 2 receptor (IL-2R) expression (percentage of positive cells) was augmented in the presence of m17-1A (15 +/- 3), c17-1A (14 +/- 3) and cSF25 (25 +/- 3) when compared with no antibody (9 +/- 2). We discuss the possibility that the superior ADCC activity of chimeric antibodies, especially cSF25, may be due to increased monocyte activation.

Comparison between peripherally implanted ports and externally sited catheters for long-term venous access.

In a comparative study, we examined the use of a peripherally implantable venous access system which does not require either central venous cannulation or radiological screening. We compared the complication rate in 85 patients receiving this system with that in 112 similar patients receiving Hickman lines. In addition, we examined the safety and cost implications of using a ward setting instead of full operating facilities for port insertion. There was a 10.7% incidence of early and 37.6% incidence of late complications in the group receiving Hickman lines compared with only 2.4% early complications and 10.6% late complications in those receiving peripherally implantable ports. There was no difference in complication rates between those patients who had the ports inserted in a ward side room compared with those who had their procedure performed in the operating theatre. We have demonstrated the ease and reliability of port insertion in the absence of screening radiology and we therefore suggest the peripheral port as a safe, cost-effective alternative to existing venous access systems.

Long-term circulatory access via a peripheral implantable port.

The use of a novel indwelling central venous catheter system is described which combines the safety of peripheral venous catheter placement with a novel electromagnetic locator device for guidance of the catheter tip into the correct position. This locator system obviates the need for radiological screening or chest radiography for checking catheter placement. Fifty-one patients were studied prospectively and all were successfully cannulated. An infection rate of 0.29 per 1000 catheter-days was seen with a mean system life of 220 (range 15-510) days. The new port has a lower infection rate than other commonly used systems and eliminates complications such as pneumothorax and puncture of major arteries.