A pilot study to assess near infrared laparoscopy with indocyanine green (ICG) for intraoperative sentinel lymph node mapping in early colon cancer.

BACKGROUND: Previous attempts at sentinel lymph node (SLN) mapping in colon cancer have been compromised by ineffective tracers and the inclusion of advanced disease. This study evaluated the feasibility of fluorescence detection of SLNs with indocyanine green (ICG) for lymphatic mapping in T1/T2 clinically staged colonic malignancy. METHODS: Consecutive patients with clinical T1/T2 stage colon cancer underwent endoscopic peritumoral submucosal injection of indocyanine green (ICG) for fluorescence detection of SLN using a near-infrared (NIR) camera. All patients underwent laparoscopic complete mesocolic excision surgery. Detection rate and sensitivity of the NIR-ICG technique were the study endpoints. RESULTS: Thirty patients mean age = 68 years [range = 38-80], mean BMI = 26.2 (IQR = 24.7-28.6) were studied. Mesocolic sentinel nodes (median = 3/patient) were detected by fluorescence within the standard resection field in 27/30 patients. Overall, ten patients had lymph node metastases, with one of these patients having a failed SLN procedure. Of the 27 patients with completed SLN mapping, nine patients had histologically positive lymph nodes containing malignancy. 3/9 had positive SLNs with 6 false negatives. In five of these false negative patients, tumours were larger than 35 mm with four also being T3/T4. CONCLUSION: ICG mapping with NIR fluorescence allowed mesenteric detection of SLNs in clinical T1/T2 stage colonic cancer. CLINICALTRIALS.GOV: ID: NCT01662752.

Systematic review of surgical innovation reporting in laparoendoscopic colonic polyp resection.

BACKGROUND: The IDEAL framework (Idea, Development, Exploration, Assessment, Long-term study) proposes a staged assessment of surgical innovation, but whether it can be used in practice is uncertain. This study aimed to review the reporting of a surgical innovation according to the IDEAL framework. METHODS: Systematic literature searches identified articles reporting laparoendoscopic excision for benign colonic polyps. Using the IDEAL stage recommendations, data were collected on: patient selection, surgeon and unit expertise, description of the intervention and modifications, outcome reporting, and research governance. Studies were categorized by IDEAL stages: 0/1, simple technical preclinical/clinical reports; 2a, technique modifications with rationale and safety data; 2b, expanded patient selection and reporting of both innovation and standard care outcomes; 3, formal randomized controlled trials; and 4, long-term audit and registry studies. Each stage has specific requirements for reporting of surgeon expertise, governance details and outcome reporting. RESULTS: Of 615 abstracts screened, 16 papers reporting outcomes of 550 patients were included. Only two studies could be put into IDEAL categories. One animal study was classified as stage 0 and one clinical study as stage 2a through prospective ethical approval, protocol registration and data collection. Studies could not be classified according to IDEAL for insufficient reporting details of patient selection, relevant surgeon expertise, and how and why the technique was modified or adapted. CONCLUSION: The reporting of innovation in the context of laparoendoscopic colonic polyp excision would benefit from standardized methods.

A prospective case controlled study of the short-term outcome following hemicolectomy for benign compared with malignant colonic polyps.

AIM: The number of patients diagnosed with advanced colonic polyps has increased due to screening. The outcome of hemicolectomy for benign lesions is poorly documented. We present a case-matched study comparing the results of hemicolectomy for benign and malignant polyps performed in two institutions. METHODS: Data for consecutive patients undergoing surgery for benign colonic polyps (BCPs) were prospectively collected in two hospitals. Each patient was matched for age, sex, ASA grade, site and type of resection (laparoscopic, open and converted) with two controls who underwent surgery for colon cancer (CC). The length of stay (LOS) and 30-day outcome were analysed adjusting for potential confounders. Multilevel linear and logistic regression analyses were performed. RESULTS: Forty-six patients having hemicolectomy for BCP were matched with 81 patients with CC. The median size of BCP was 4 cm [interquartile range (IQR) 2.5-5.4 cm]. Patients with a BCP had a marginally longer LOS [median 5.5 (IQR 4-8) days and 5 (IQR 3-7) days (P = 0.04)]. Twenty-one (46%) of 46 patients with BCP had a postoperative complication compared with 25 (31%) of 81 CC patients (P = 0.12, OR = 2.11, 95% CI 0.82-5.41). Four (9%) of 46 patients with BCP underwent re-operation and a further three (7%) were readmitted compared with one (1%) and two (2%) of 81 patients with CC (P = 0.07 and 0.28). There was no mortality in either group. CONCLUSION: Complications following hemicolectomy for BCP or CC are not significantly different. The results of the study provide further impetus to develop local full thickness colonic excision for benign colonic lesions as an alternative to major surgery.

Full-thickness laparoendoscopic colonic excision in an experimental model.

BACKGROUND: Patients requiring surgery for complex colonic polyps traditionally undergo colectomy, with significant risks. Typically in excess of 10-30 cm of colon is removed at laparoscopic or open surgery lasting over 60 min. This study details the preclinical development of a rapid, minimally invasive, limited full-thickness colonic resection. METHODS: Both survival and non-survival procedures were performed in anaesthetized 70-kg pigs. A simulated colonic polyp was created by endoscopic ink injection with a clearance margin delineated by circumferential placement of mucosal argon plasma coagulation marks. Full-thickness eversion of the bowel was achieved using endoscopically placed anchors and the polyp was excised using a laparoscopic stapler. In survival procedures, pigs were killed under anaesthetic 8 days after surgery. All pigs underwent post-mortem examination. RESULTS: Five procedures were performed (5 pigs). The median (range) procedure duration was 26 (20-31) min, with a specimen diameter of 5.1 (4.5-6.3) cm. The postoperative recovery of survival animals (4 pigs) was uneventful. At post-mortem evaluation the resection sites were well healed with no evidence of stenosis, intra-abdominal infection or inadvertent organ damage. Histological assessment of anastomoses showed mucosal repair and restoration of submucosal continuity. CONCLUSION: Full-thickness localized colonic excision with this technique provides a large specimen with adequate healing in a porcine model.

Individualization of surgical management for early-stage colonic cancer.

A significant number of patients each year undergo radical segmental colectomy for node-negative colonic cancer in the UK. They are likely to represent 50% of our colonic cancer population in the future due to the implementation of the National Bowel Cancer Screening Programme. Short-term morbidity rates of up to 40% are associated with the current surgical treatment and need serious consideration. In this article, we discuss a combination of two techniques that will allow minimally invasive treatment in an increasing number of patients with early colonic cancer.

Reporting clinical outcomes of breast reconstruction: a systematic review.

BACKGROUND: Breast reconstruction after mastectomy for cancer requires accurate evaluation to inform evidence-based participatory decision making, but the standards of outcome reporting after breast reconstruction have not previously been considered. METHODS: We used extensive searches to identify articles reporting surgical outcomes of breast reconstruction. We extracted data using published criteria for complication reporting modified to reflect reconstructive practice. Study designs included randomized controlled trials, cohort studies, and case series. The Cochrane Risk of Bias tool was used to critically appraise all study designs. Other criteria used to assess the studies were selection and funding bias, statistical power calculations, and institutional review board approval. Wilcoxon signed rank tests were used to compare the breadth and frequency of study outcomes, and χ² tests were used to compare the number of studies in each group reporting each of the published criteria. All statistical tests were two-sided. RESULTS: Surgical complications following breast reconstruction in 42,146 women were evaluated in 134 studies. These included 11 (8.2%) randomized trials, 74 (55.2%) cohort studies, and 49 (36.6%) case series. Fifty-three percent of studies demonstrated a disparity between methods and results in the numbers of complications reported. Complications were defined by 87 (64.9%) studies and graded by 78 (58.2%). Details such as the duration of follow-up and risk factors for adverse outcomes were omitted from 47 (35.1%) and 58 (43.3%) studies, respectively. Overall, the studies defined fewer than 20% of the complications they reported, and the definitions were largely inconsistent. CONCLUSIONS: The results of this systematic review suggest that outcome reporting in breast reconstruction is inconsistent and lacks methodological rigor. The development of a standardized core outcome set is recommended to improve outcome reporting in breast reconstruction.

Optimising methods for communicating survival data to patients undergoing cancer surgery.

BACKGROUND: Patients undergoing cancer surgery require outcome data to inform decisions, but communication of numerical risk is difficult. This study assessed patient understanding of survival data presented in different formats. METHODS: Semi-structured interviews in which patients interpreted four presentation formats of survival data (three graphical and one narrative) were audio-recorded. The interviewer and a blinded observer (listening to the audio-recordings) scored patients' understanding of each format. Logistic regression examined associations between understanding and clinical and socio-demographic details. RESULTS: Seventy participants with colorectal cancer were interviewed and 67 [95.7%, 95% confidence intervals (CIs) 90.9-100%] correctly interpreted a simplified Kaplan-Meier survival curve. A high proportion accurately understood data presented as a bar chart or pictograph (94.3%, 95% CIs 88.7-99.9% and 92.9%, 95% CIs 86.7-99.0% respectively). Standard narrative alone was least well understood (n = 53, 75.7%, 95% CIs 65.4-86.0%). Multivariable analyses demonstrated that older and female patients had poorer overall understanding (OR 0.93 per year, 95% CIs 0.87-0.98, p = 0.01 and OR 0.24, 95% CIs 0.07-0.86, p = 0.03). CONCLUSION: Patient understanding of survival data was higher when presented with graphs compared to narrative alone. Further work examining understanding in the clinical context and before surgery is recommended before this can be used routinely.