Feasibility, reliability and satisfaction of (automated) capillary carcinoembryonic antigen measurements for future home-based blood sampling: the prospective CASA-I study.

AIM: Follow-up for colorectal cancer (CRC) necessitates regular monitoring of carcinoembryonic antigen (CEA) at the hospital. Capillary home-based blood collection, including minimally invasive techniques such as lancet sampling or an automated upper arm device (TAP-II), has the potential to replace a significant portion of hospital-based blood sampling, thereby enhancing self-reliance and quality of life. The objectives of this study were to assess the feasibility, reliability and preference for CEA blood collection. METHODS: Baseline venous and capillary (by lancet and TAP-II) blood samples were collected from 102 participants, including 20 CRC patients with elevated CEA levels, 60 CRC patients undergoing postoperative outpatient monitoring and 20 healthy volunteers. The second group performed capillary blood collections at home on two consecutive follow-up appointments and subsequently sent them to the hospital. Satisfaction was assessed via patient reported outcome measures on pain, burden, ease of use and preference. RESULTS: The Pearson's correlation test of all usable samples resulted in a linear coefficient of 0.998 (95% CI 0.997-0.998) for the TAP-II method and 0.997 (95% CI 0.996-0.998) for the lancet method, both compared to venipuncture. Following the initial blood collection, 86% of the participants (n = 102) favoured the TAP-II, rating it as the least painful and burdensome option. After two home-based blood samples, the preference for the TAP-II method persisted, with 64% of the patients endorsing its use. CONCLUSION: This study demonstrated the feasibility of home-based capillary sampling of CEA. The TAP-II blood collection is the most reliable method and is preferred by patients over venipuncture and lancet sampling.

Long-term oncological outcomes after local excision of T1 rectal cancer.

BACKGROUND: A growing proportion of patients with early rectal cancer is treated by local excision only. The aim of this study was to evaluate long-term oncological outcomes and the impact of local recurrence on overall survival for surgical local excision in pT1 rectal cancer. METHODS: Patients who only underwent local excision for pT1 rectal cancer between 1997 and 2014 in two Dutch tertiary referral hospitals were included in this retrospective cohort study. The primary outcome was the local recurrence rate. Secondary outcomes were distant recurrence, overall survival and the impact of local recurrence on overall survival. RESULTS: A total of 150 patients (mean age 68.5 ± 10.7 years, 57.3% males) were included in the study. Median length of follow-up was 58.9 months (range 6-176 months). Local recurrence occurred in 22.7% (n = 34) of the patients, with a median time to local recurrence of 11.1 months (range 2.3-82.6 months). The vast majority of local recurrences were located in the lumen. Five-year overall survival was 82.0%, and landmark analyses showed that local recurrence significantly impacted overall survival at 6 and 36 months of follow-up (6 months, p = 0.034, 36 months, p = 0.036). CONCLUSIONS: Local recurrence rates after local excision of early rectal cancer can be substantial and may impact overall survival. Therefore, clinical decision-making should be based on patient- and tumour characteristics and should incorporate patient preferences.

Comparing practice and outcome of laparoscopic liver resection between high-volume expert centres and nationwide low-to-medium volume centres.

BACKGROUND: Based on excellent outcomes from high-volume centres, laparoscopic liver resection is increasingly being adopted into nationwide practice which typically includes low-medium volume centres. It is unknown how the use and outcome of laparoscopic liver resection compare between high-volume centres and low-medium volume centres. This study aimed to compare use and outcome of laparoscopic liver resection in three leading European high-volume centres and nationwide practice in the Netherlands. METHOD: An international, retrospective multicentre cohort study including data from three European high-volume centres (Oslo, Southampton and Milan) and all 20 centres in the Netherlands performing laparoscopic liver resection (low-medium volume practice) from January 2011 to December 2016. A high-volume centre is defined as a centre performing >50 laparoscopic liver resections per year. Patients were retrospectively stratified into low, moderate- and high-risk Southampton difficulty score groups. RESULTS: A total of 2425 patients were included (1540 high-volume; 885 low-medium volume). The median annual proportion of laparoscopic liver resection was 42.9 per cent in high-volume centres and 7.2 per cent in low-medium volume centres. Patients in the high-volume centres had a lower conversion rate (7.4 versus 13.1 per cent; P < 0.001) with less intraoperative incidents (9.3 versus 14.6 per cent; P = 0.002) as compared to low-medium volume centres. Whereas postoperative morbidity and mortality rates were similar in the two groups, a lower reintervention rate (5.1 versus 7.2 per cent; P = 0.034) and a shorter postoperative hospital stay (3 versus 5 days; P < 0.001) were observed in the high-volume centres as compared to the low-medium volume centres. In each Southampton difficulty score group, the conversion rate was lower and hospital stay shorter in high-volume centres. The rate of intraoperative incidents did not differ in the low-risk group, whilst in the moderate-risk and high-risk groups this rate was lower in high-volume centres (absolute difference 6.7 and 14.2 per cent; all P < 0.004). CONCLUSION: High-volume expert centres had a sixfold higher use of laparoscopic liver resection, less conversions, and shorter hospital stay, as compared to a nationwide low-medium volume practice. Stratification into Southampton difficulty score risk groups identified some differences but largely outcomes appeared better for high-volume centres in each risk group.

A multicentre cohort study of serum and peritoneal biomarkers to predict anastomotic leakage after rectal cancer resection.

AIM: Anastomotic leakage (AL) is one of the most feared complications after rectal resection. This study aimed to assess a combination of biomarkers for early detection of AL after rectal cancer resection. METHOD: This study was an international multicentre prospective cohort study. All patients received a pelvic drain after rectal cancer resection. On the first three postoperative days drain fluid was collected daily and C-reactive protein (CRP) was measured. Matrix metalloproteinase-2 (MMP2), MMP9, glucose, lactate, interleukin 1-beta (IL1ß), IL6, IL10, tumour necrosis factor alpha (TNFα), Escherichia coli, Enterococcus faecalis, lipopolysaccharide-binding protein and amylase were measured in the drain fluid. Prediction models for AL were built for each postoperative day using multivariate penalized logistic regression. Model performance was estimated by the c-index for discrimination. The model with the best performance was visualized with a nomogram and calibration was plotted. RESULTS: A total of 292 patients were analysed; 38 (13.0%) patients suffered from AL, with a median interval to diagnosis of 6.0 (interquartile ratio 4.0-14.8) days. AL occurred less often after partial than after total mesorectal excision (4.9% vs 15.2%, P = 0.035). Of all patients with AL, 26 (68.4%) required reoperation. AL was more often treated by reoperation in patients without a diverting ileostomy (18/20 vs 8/18, P = 0.03). The prediction model for postoperative day 1 included MMP9, TNFα, diverting ileostomy and surgical technique (c-index = 0.71). The prediction model for postoperative day 2 only included CRP (c-index = 0.69). The prediction model for postoperative day 3 included CRP and MMP9 and obtained the best model performance (c-index = 0.78). CONCLUSION: The combination of serum CRP and peritoneal MMP9 may be useful for earlier prediction of AL after rectal cancer resection. In clinical practice, this combination of biomarkers should be interpreted in the clinical context as with any other diagnostic tool.

Structured training pathway and proctoring; multicenter results of the implementation of transanal total mesorectal excision (TaTME) in the Netherlands.

BACKGROUND: Transanal total mesorectal excision (TaTME) is a new complex technique with potential to improve the quality of surgical mesorectal excision for patients with mid and low rectal cancer. The procedure is technically challenging and has shown to be associated with a relative long learning curve which might hamper widespread adoption. Therefore, a national structured training pathway for TaTME has been set up in the Netherlands to allow safe implementation. The aim of this study was to monitor safety and efficacy of the training program with 12 centers. METHODS: Short-term outcomes of the first ten TaTME procedures were evaluated in 12 participating centers in the Netherlands within the national structured training pathway. Consecutive patients operated during and after the proctoring program for rectal carcinoma with curative intent were included. Primary outcome was the incidence of intraoperative complications, secondary outcomes included postoperative complications and pathological outcomes. RESULTS: In October 2018, 12 hospitals completed the training program and from each center the first 10 patients were included for evaluation. Intraoperative complications occurred in 4.9% of the cases. The clinicopathological outcome reported 100% for complete or nearly complete specimen, 100% negative distal resection margin, and the circumferential resection margin was positive in 5.0% of patients. Overall postoperative complication rate was 45.0%, with 19.2% Clavien-Dindo ≥ III and an anastomotic leak rate of 17.3%. CONCLUSIONS: This study shows that the nationwide structured training program for TaTME delivers safe implementation of TaTME in terms of intraoperative and pathology outcomes within the first ten consecutive cases in each center. However, postoperative morbidity is substantial even within a structured training pathway and surgeons should be aware of the learning curve of this new technique.

Adjuvant hepatic arterial infusion pump chemotherapy and resection versus resection alone in patients with low-risk resectable colorectal liver metastases - the multicenter randomized controlled PUMP trial.

BACKGROUND: Recurrences are reported in 70% of all patients after resection of colorectal liver metastases (CRLM), in which half are confined to the liver. Adjuvant hepatic arterial infusion pump (HAIP) chemotherapy aims to reduce the risk of intrahepatic recurrence. A large retrospective propensity score analysis demonstrated that HAIP chemotherapy is particularly effective in patients with low-risk oncological features. The aim of this randomized controlled trial (RCT) --the PUMP trial-- is to investigate the efficacy of adjuvant HAIP chemotherapy in low-risk patients with resectable CRLM. METHODS: This is an open label multicenter RCT. A total of 230 patients with resectable CRLM without extrahepatic disease will be included. Only patients with a clinical risk score (CRS) of 0 to 2 are eligible, meaning: patients are allowed to have no more than two out of five poor prognostic factors (disease-free interval less than 12 months, node-positive colorectal cancer, more than 1 CRLM, largest CRLM more than 5 cm in diameter, serum Carcinoembryonic Antigen above 200 µg/L). Patients randomized to arm A undergo complete resection of CRLM without any adjuvant treatment, which is the standard of care in the Netherlands. Patients in arm B receive an implantable pump at the time of CRLM resection and start adjuvant HAIP chemotherapy 4-12 weeks after surgery, with 6 cycles of floxuridine scheduled. The primary endpoint is progression-free survival (PFS). Secondary endpoints include overall survival, hepatic PFS, safety, quality of life, and cost-effectiveness. Pharmacokinetics of intra-arterial administration of floxuridine will be investigated as well as predictive biomarkers for the efficacy of HAIP chemotherapy. In a side study, the accuracy of CT angiography will be compared to radionuclide scintigraphy to detect extrahepatic perfusion. We hypothesize that adjuvant HAIP chemotherapy leads to improved survival, improved quality of life, and a reduction of costs, compared to resection alone. DISCUSSION: If this PUMP trial demonstrates that adjuvant HAIP chemotherapy improves survival in low-risk patients, this treatment approach may be implemented in the standard of care of patients with resected CRLM since adjuvant systemic chemotherapy alone has not improved survival. TRIAL REGISTRATION: The PUMP trial is registered in the Netherlands Trial Register (NTR), number: 7493 . Date of registration September 23, 2018.

Transanal total mesorectal excision: how are we doing so far?

AIM: This subgroup analysis of a prospective multicentre cohort study aims to compare postoperative morbidity between transanal total mesorectal excision (TaTME) and laparoscopic total mesorectal excision (LaTME). METHOD: The study was designed as a subgroup analysis of a prospective multicentre cohort study. Patients undergoing TaTME or LaTME for rectal cancer were selected. All patients were followed up until the first visit to the outpatient clinic after hospital discharge. Postoperative complications were classified according to the Clavien-Dindo classification and the comprehensive complication index (CCI). Propensity score matching was performed. RESULTS: In total, 220 patients were selected from the overall prospective multicentre cohort study. After propensity score matching, 48 patients from each group were compared. The median tumour height for TaTME was 10.0 cm (6.0-10.8) and for LaTME was 9.5 cm (7.0-12.0) (P = 0.459). The duration of surgery and anaesthesia were both significantly longer for TaTME (221 vs 180 min, P < 0.001, and 264 vs 217 min, P < 0.001). TaTME was not converted to laparotomy whilst surgery in five patients undergoing LaTME was converted to laparotomy (0.0% vs 10.4%, P = 0.056). No statistically significant differences were observed for Clavien-Dindo classification, CCI, readmissions, reoperations and mortality. CONCLUSION: The study showed that TaTME is a safe and feasible approach for rectal cancer resection. This new technique obtained similar postoperative morbidity to LaTME.

Effectiveness of endosponge therapy for the management of presacral abscesses following rectal surgery.

BACKGROUND: Anastomotic leak after rectal surgery is reported in 9% (range 3-28%) of patients. The aim of our study was to evaluate the effectiveness of endosponge therapy for anastomotic. Endpoints were the rate of restored continuity and the functional bowel outcome after anastomotic leakage. METHODS: This was a multicenter retrospective observational cohort study. All patients with symptomatic anastomotic leakage after rectal surgery who had endosponge therapy between January 2012 and August 2017 were included. Functional bowel outcome was measured using the low anterior resection syndrome (LARS) score system. RESULTS: Twenty patients were included. Eighteen patients had low anterior resection (90%) for rectal cancer. A diverting ileostomy was performed at primary surgical intervention in 14 patients (70%). Fourteen patients (70%) were treated with neoadjuvant (chemo-)radiotherapy. The median time between primary surgical intervention and first endosponge placement was 21 (5-537) days. The median number of endosponge changes was 9 (2-28). The success rate of the endosponge treatment was 88% and the restored gastrointestinal continuity rate was 73%. A chronic sinus occurred in three patients (15%). All patients developed LARS, of which 77% reported major LARS. CONCLUSIONS: Endosponge therapy is an effective treatment for the closure of presacral cavities with high success rate and leading to restored gastrointestinal continuity in 73%. However, despite endosponge therapy many patients develop major LARS.

The impact of disease severity, age and surgical approach on the outcome of acute appendicitis in children.

PURPOSE: Although a national guideline has been implemented, the optimal approach for appendectomy in children remains subject of debate in the Netherlands. Opponents of laparoscopy raise their concerns regarding its use in complex appendicitis as it is reported to be associated with an increased incidence of intra-abdominal abscesses. The aim of this study was to evaluate the outcome of surgical approaches in both simple and complex appendicitis in paediatric patients. METHODS: A 10-year retrospective cohort study was performed (2001-2010) in paediatric patients treated for suspected acute appendicitis. Patients were divided into either simple or complex appendicitis and into different age groups. Primary outcome parameters were complication rate (intra-abdominal abscess (IAA), superficial surgical site infection (SSI) and readmission) and hospital stay. RESULTS: In total, 878 patients have been treated (median age 12, range 0-17 years). Two-thirds of the patients younger than 6 years had complex appendicitis, compared to one quarter in the group aged 13-18. In the complex appendicitis group, LA was associated with more IAA and early readmissions. In the simple appendicitis group, the complication rate was comparable between the two approaches. Significantly more IAAs were seen after LA in the youngest age group. CONCLUSION: This study demonstrates the unfavourable outcome of LA in the youngest age group and in patients with complex appendicitis. Therefore, we advise to treat these patients with an open approach.

Treatment of clinical T1 rectal cancer in the Netherlands; a population-based overview of clinical practice.

INTRODUCTION: Local excision is increasingly used as an alternative treatment for radical surgery in patients with early stage clinical T1 (cT1) rectal cancer. This study provides an overview of incidence, staging accuracy and treatment strategies in patients with cT1 rectal cancer in the Netherlands. MATERIALS AND METHODS: Patients with cT1 rectal cancer diagnosed between 2005 and 2018 were included from the Netherlands Cancer Registry. An overview per time period (2005-2009, 2010-2014 and 2015-2018) of the incidence and various treatment strategies used, e.g. local excision (LE) or major resection, with/without neoadjuvant treatment (NAT), were given and trends over time were analysed using the Chi Square for Trend test. In addition, accuracy of tumour staging was described, compared and analysed over time. RESULTS: In total, 3033 patients with cT1 rectal cancer were diagnosed. The incidence of cT1 increased from 540 patients in 2005-2009 to 1643 patients in 2015-2018. There was a significant increased use of LE. In cT1N0/X patients, 9.2% received NAT, 25.5% were treated by total mesorectal excision (TME) and 11.4% received a completion TME (cTME) following prior LE. Overall accuracy in tumour staging (cT1 = pT1) was 77.3%, yet significantly worse in cN1/2 patients, as compared to cN0 patients (44.8% vs 77.9%, respectively, p < 0.001). CONCLUSION: Over time, there was an increase in the incidence of cT1 tumours. Both the use of neoadjuvant therapy and TME surgery in clinically node negative patients decreased significantly. Clinical accuracy in T1 tumour staging improved over time, but remained significantly worse in clinical node positive patients.

Laparoscopic-monitored colonoscopic polypectomy: a multimodality method to avoid segmental colon resection.

AIM: In some patients with adenoma, snare polypectomy may be technically impossible owing to angulation of the colon or after previous surgery. This may result in a segmental colonic resection, if malignant invasion is thought to be likely. Laparoscopic mobilization of the colon to enable a simultaneous colonoscopy can avoid this difficulty. METHOD: A feasibility study was performed in 11 patients for whom endoscopic removal was technically impossible due to fibrosis after previous surgery or to anatomical difficulty. In 10, adenoma (histologically benign) had been diagnosed during diagnostic colonoscopy and in the remaining patient the indication was rectal bleeding. RESULTS: It was possible to perform a full colonoscopy after laparoscopic mobilization in all cases. In nine of the 10 patients with adenoma 11 tubulovillous adenomas were removed endoscopically, and in one the tumour was too large for endoscopic resection even after full mobilization. A laparoscopic segmental resection was performed in this case. In the patient with rectal bleeding, colonoscopy revealed an angiodysplasia of the caecum, also treated by resection. Apart from the two patients having resection, all patients were discharged within 24 h of the procedure. During endoscopic follow up (4-27 months) there were no recurrences. CONCLUSIONS: Combined laparoscopy and endoscopy enabled removal of adenomas otherwise inaccessible for endoscopic techniques. Thus, segmental colon resections can be avoided in most of these patients.

Recurrences after transanal excision or transanal endoscopic microsurgery of T1 rectal cancer.

Local excision for T1 rectal cancer is increasingly applied, in a strive to avoid the morbidity associated with radical surgery, despite limited evidence. One of the issues is the high rate of local recurrence following local excision (LE). In this article we focus on this item and review the literature articles concerning local excision and transanal endoscopic microsurgery (TEM), recurrence, and salvage surgery. Local recurrence rates after LE or TEM are unacceptably high. As outcome of this subgroup is limited, future studies should focus on proper tumor selection and adjuvant treatment strategies following salvage surgery.

The effect of neoadjuvant short-course radiotherapy and delayed surgery versus chemoradiation on postoperative outcomes in locally advanced rectal cancer patients - A propensity score matched nationwide audit-based study.

OBJECTIVE: To investigate differences in postoperative outcomes between short-course radiotherapy and delayed surgery (SCRT-delay) and chemoradiation (CRT) in patients with locally advanced rectal cancer (LARC). BACKGROUND: Previous trials suggest that SCRT-delay could serve as an adequate neoadjuvant treatment for LARC. Therefore, in frail LARC patients SCRT-delay is recommended as an alternative to CRT. However, data on postoperative outcomes after SCRT-delay in comparison to CRT is scarce. METHODS: This was an observational study with data from the Dutch ColoRectal Audit (DCRA). LARC patients who underwent surgery (2014-2017) after an interval of ≥6 weeks were included. Missing values were replaced by multiple imputation. Propensity score matching (PSM), using age, Charlson Comorbidity Index, cT-stage and surgical procedure, was applied to create comparable groups. Differences in postoperative outcomes were analyzed using Chi-square test for categorical variables, independent sample t-test for continuous variables and Mann-Whitney U test for non-parametric data. RESULTS: 2926 patients were included. In total, 288 patients received SCRT-delay and 2638 patients underwent CRT. Patients in the SCRT-delay group were older and had more comorbidities. Also, ICU-admissions and permanent colostomies were more common, as well as pulmonic, cardiologic, infectious and neurologic complications. After PSM, both groups comprised 246 patients with equivalent age, comorbidities and tumor stage. There were no differences in postoperative complications. CONCLUSION: Postoperative complications were not increased in LARC patients undergoing SCRT-delay as neoadjuvant treatment. Regarding treatment-related complications, SCRT-delay is a safe alternative neoadjuvant treatment option for frail LARC patients.

A left paraduodenal hernia causing acute bowel obstruction: a case report.

We present the case of a 54-year old woman who presented twice at our emergency department with progressive abdominal pain. Over the last few years, multiple short periods of abdominal pain had occurred: the pain always resolved spontaneously after a few hours. She had no past medical history. CT scan revealed a sac-like mass of small bowel loops to the left of the ligament of Treitz, consistent with the diagnosis of a left paraduodenal hernia. On laparotomy, a left paraduodenal hernia with incarceration of small bowel loops was found; the herniated loops were reduced and the hernia orifice closed. The anatomy, treatment and importance of considering this uncommon diagnosis when examining a patient with acute small bowel obstruction are discussed.

Transanal endoscopic microsurgery for rectal cancer.

If curation is intended for rectal cancer, total mesorectal excision with autonomic nerve preservation (TME) is the gold standard. Transanal resection is tempting because of low mortality and morbidity rates. However, inferior tumour control, provoked by the limitations of the technique, resulted in its cautious application and use mainly for palliation. Transanal endoscopic microsurgery (TEM) is a minimal invasive technique for the local resection of rectal tumours. It is a one-port system, introduced transanally. An optical system with a 3D-view, 6-fold magnification and resolution as the human eye, together with the creation of a stabile pneumorectum, and specially designed instruments allow full-thickness excision under excellent view and a proper histological examination. The technique can also be applied for larger and more proximal tumours. Mortality, morbidity as well as incomplete excision rates are minimal. Local recurrence and survival rates seem comparable to TME in early rectal cancer. TEM is the method of choice when local resection of rectal cancer is indicated. Results justify a re-evaluation of the indications for the local excision of rectal cancer with a curative intent.

[Transanal endoscopic microsurgery: a good choice for local resection of rectal tumors]. / Transanale endoscopische microchirurgie: een goede mogelijkheid voor de lokale verwijdering van rectumtumoren.

OBJECTIVE: To investigate the feasibility of transanal endoscopic microsurgery (TEM), a minimal access technique for the local resection of rectal tumours. DESIGN: Prospective. SETTING: IJsselland Hospital, Capelle a/d IJssel, the Netherlands. PATIENTS AND METHOD: TEM was performed in all patients between January 1996 and December 1997 with a rectal adenoma that could not be removed endoscopically, or with a rectal carcinoma and poor general condition which allowed no transabdominal surgery. TEM involves air insufflation and endosurgical resection of the tumour under direct vision. RESULTS: In all 11 tumours within approximately 4 cm from the linea anorectalis conversion was necessary due to technical problems and 1 tumour could not be visualized because of a stenosis. In all 23 other tumours TEM was performed. Mean distance from the linea anorectalis was 6.9 cm (4-12), with a mean surface of the base of the tumour of 7.7 cm2 (1-30). Mean operating time was 76 minutes (10-180). In one tumour the defect could not be completely closed, and conversion was necessary. Postoperatively one suture dehiscence and one urinary tract infection occurred. None of the patients had functional disorders. Every specimen contained all bowel layers, and in all but one, the margins were free of tumour. In 13 tumours an adenoma was diagnosed and in 10, a carcinoma. In 2 patients with carcinoma additional resection was performed. Mean follow-up was 9 months (1-23), and concerned 21 tumours. No recurrence has been observed. CONCLUSION: TEM is a good method for the local resection of rectal tumours, when located more than 4 cm from the linea anorectalis. Radical resection, containing all bowel layers, is possible, and has, as it appears, a low recurrence rate.

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.

Transanal endoscopic microsurgery versus total mesorectal excision of T1 rectal adenocarcinomas with curative intention.

PURPOSE: After total mesorectal excision (TME) for rectal cancer, pathology is standardized with margin status as a predictor for recurrence. This has yet to be implemented after transanal endoscopic microsurgery (TEM) and was investigated prospectively for T1 rectal adenocarcinomas. PATIENTS AND METHODS: Eighty patients after TEM were compared to 75 patients after TME. The study protocol included standardized pathology. TEM patients were eligible when excision margins were negative. RESULTS: TEM was safer than TME as reflected by operating time, blood loss, hospital stay, morbidity, re-operation rate and stoma formation (all P<0.001). Mortality after TEM was 0% and after TME 4%. At 5 years after TEM and TME, both overall survival (TEM 75% versus TME 77%, P=0.9) and cancer-specific survival (TEM 90% versus TME 87%, P=0.5) were comparable. Local recurrence rate after TEM was 24% and after TME 0% (HR 79.266, 95% CI, 1.208 to 5202, P<0.0001). CONCLUSION: For T1 rectal adenocarcinomas TEM is much saver than TME and survival is comparable. After TEM local recurrence rate is substantial, despite negative excision margins.