Long-term stoma-related reinterventions after anterior resection for rectal cancer with or without anastomosis: population data from the Dutch snapshot study.

BACKGROUND: The aim of this study was to analyze the stoma-related reinterventions, complications and readmissions after an anterior resection for rectal cancer, based on a cross-sectional nationwide cohort study with 3-year follow-up. METHODS: Rectal cancer patients who underwent a resection with either a functional anastomosis, a defunctioned anastomosis, or Hartmann's procedure (HP) with an end colostomy in 2011 in 71 Dutch hospitals were included. The primary outcome was number of stoma-related reinterventions. RESULTS: Of the 2095 patients with rectal cancer, 1400 patients received an anterior resection and were included in this study; 257 received an initially functional anastomosis, 741 a defunctioned anastomosis, and 402 patients a HP. Of the 1400 included patients, 62% were males, 38% were females and the mean age was 67 years (SD 11.1). Following a primary functional anastomosis, 48 (19%) patients received a secondary stoma. Stoma-related complications occurred in six (2%) patients, requiring reintervention in one (0.4%) case. In the defunctioned anastomosis group, stoma-related complications were present in 92 (12%) patients, and required reintervention in 23 (3%) patients, in 10 (1%) of these more than 1 year after initial resection. Stoma-related complications occurred in 92 (23%) patients after a HP, and required reintervention in 39 (10%) patients in 17 (4%) of cases more than 1 year after initial resection. The permanent stoma rate was 11% and 20%, in the functional anastomosis and the defuctioned anastomosis group, respectively. The end colostomy in the HP group was reversed in 4% of cases. CONCLUSIONS: Construction of a stoma after resection for rectal cancer with preservation of the sphincter is accompanied with long-term stoma-related morbidity. Stoma complications are more frequent after a HP. Even after 1 year, a significant number of reinterventions are required.

Propensity score-matched analysis of oncological outcome between stent as bridge to surgery and emergency resection in patients with malignant left-sided colonic obstruction.

BACKGROUND: Although self-expandable metal stent (SEMS) placement as bridge to surgery (BTS) in patients with left-sided obstructing colonic cancer has shown promising short-term results, it is used infrequently owing to uncertainty about its oncological safety. This population study compared long-term oncological outcomes between emergency resection and SEMS placement as BTS. METHODS: Through a national collaborative research project, long-term outcome data were collected for all patients who underwent resection for left-sided obstructing colonic cancer between 2009 and 2016 in 75 Dutch hospitals. Patients were identified from the Dutch Colorectal Audit database. SEMS as BTS was compared with emergency resection in the curative setting after 1 : 2 propensity score matching. RESULTS: Some 222 patients who had a stent placed were matched to 444 who underwent emergency resection. The overall SEMS-related perforation rate was 7·7 per cent (17 of 222). Three-year locoregional recurrence rates after SEMS insertion and emergency resection were 11·4 and 13·6 per cent (P = 0·457), disease-free survival rates were 58·8 and 52·6 per cent (P = 0·175), and overall survival rates were 74·0 and 68·3 per cent (P = 0·231), respectively. SEMS placement resulted in significantly fewer permanent stomas (23·9 versus 45·3 per cent; P < 0·001), especially in elderly patients (29·0 versus 57·9 per cent; P < 0·001). For patients in the SEMS group with or without perforation, 3-year locoregional recurrence rates were 18 and 11·0 per cent (P = 0·432), disease-free survival rates were 49 and 59·6 per cent (P = 0·717), and overall survival rates 61 and 75·1 per cent (P = 0·529), respectively. CONCLUSION: Overall, SEMS as BTS seems an oncologically safe alternative to emergency resection with fewer permanent stomas. Nevertheless, the risk of SEMS-related perforation, as well as permanent stoma, might influence shared decision-making for individual patients.

Redo coloanal anastomosis for anastomotic leakage after low anterior resection for rectal cancer: an analysis of 59 cases.

AIM: The construction of a new coloanal anastomosis (CAA) following anastomotic leakage after low anterior resection (LAR) is challenging. The available literature on this topic is scarce. The aim of this two-centre study was to determine the clinical success and morbidity after redo CAA. METHOD: This retrospective cohort study included all patients with anastomotic leakage after LAR for rectal cancer who underwent a redo CAA between 2010 and 2014 in two tertiary referral centres. Short- and long-term morbidity were analysed, including both anastomotic leakage and permanent stoma rates on completion of follow-up. RESULTS: A total of 59 patients were included, of whom 45 (76%) were men, with a mean age of 59 years (SD ± 9.4). The median interval between index and redo surgery was 14 months [interquartile range (IQR) 8-27]. The median duration of follow-up was 27 months (IQR 17-36). The most frequent complication was anastomotic leakage of the redo CAA occurring in 24 patients (41%), resulting in a median of three reinterventions (IQR 2-4) per patient. At the end of follow-up, bowel continuity was restored in 39/59 (66%) patients. Fourteen (24%) patients received a definitive colostomy and six (10%) still had a diverting ileostomy. In a multivariable model, leakage of the redo CAA was the only risk factor for permanent stoma (OR 0.022; 95% CI 0.004-0.122). CONCLUSION: Redo CAA is a viable option in selected patients with persisting leakage after LAR for rectal cancer who want their bowel continuity restored. However, patients should be fully informed about the relatively high morbidity and reintervention rates.

Vacuum-assisted early transanal closure of leaking low colorectal anastomoses: the CLEAN study.

INTRODUCTION: Non-healing of anastomotic leakage can be observed in up to 50% after total mesorectal excision for rectal cancer. This study investigates the efficacy of early transanal closure of anastomotic leakage after pre-treatment with the Endosponge® therapy. METHODS: In this prospective, multicentre, feasibility study, transanal suturing of the anastomotic defect was performed after vacuum-assisted cleaning of the presacral cavity. Primary outcome was the proportion of patients with a healed anastomosis at 6 months after transanal closure. Secondary, healing at last follow-up, continuity, direct medical costs, functionality and quality of life were analysed. RESULTS: Between July 2013 and July 2015, 30 rectal cancer patients with a leaking low colorectal anastomosis were included, of whom 22 underwent neoadjuvant radiotherapy. Median follow-up was 14 (7-29) months. At 6 months, the anastomosis had healed in 16 (53%) patients. At last follow-up, anastomotic integrity was found in 21 (70%) and continuity was restored in 20 (67%) patients. Non-healing at 12 months was observed in 10/29 (34%) patients overall, and in 3/14 (21%) when therapy started within three weeks following the index operation. Major LARS was reported in 12/15 (80%) patients. The direct medical costs were €8933 (95% CI 7268-10,707) per patient. CONCLUSION: Vacuum-assisted early transanal closure of a leaking anastomosis after total mesorectal excision with 73% preoperative radiotherapy showed that acceptable anastomotic healing rates and stoma reversal rates can be achieved. Early diagnosis and start of treatment seems crucial.

Organ preservation in rectal cancer: a synopsis of current guidelines.

BACKGROUND: The high morbidity associated with radical resection for rectal cancer is an incentive for surgeons to adopt strategies aimed at organ preservation, particularly for early disease. There are a number of different approaches to achieve this. In this study we have collated current national and international guidelines to produce a synopsis to support this changing practice. METHODS: The databases PubMed, Embase, Trip database, national guideline clearinghouse, BMJ Best practice were interrogated. Guidelines published before 2010 were excluded. The AGREE-II tool was used for quality assessment. RESULTS: 24 guidelines were drawn from 2278 potential publications. A consensus exists for local excision for "low risk" T1 rectal cancer but there is no agreement how to stratify the risk of treatment failure. There is a low level of agreement for rectal preservation for more advanced disease but when mentioned is recommended for unfit patients or in th context of a clinical trial. Guidelines are inconsistent with respect to surveillance in node negative disease and after, complete response to chemoradiotherapy CONCLUSION: According to current guidelines and consensus statements organ preservation for rectal cancer beyond low risk T1, is still considered experimental and only indicated in patients unsuitable for radical surgery.. Follow up strategies and cN0 staging deserve attention and highlight the need for high quality clinical trials. This article is protected by copyright. All rights reserved.

Meta-analysis of oncological outcomes after local excision of pT1-2 rectal cancer requiring adjuvant (chemo)radiotherapy or completion surgery.

BACKGROUND: Completion total mesorectal excision (TME) is advised for high-risk early (pT1/pT2) rectal cancer following transanal removal. The main objective of this meta-analysis was to determine oncological outcomes of adjuvant (chemo)radiotherapy as a rectum-preserving alternative to completion TME. METHODS: A literature search using PubMed, Embase and the Cochrane Library was performed in February 2015. Studies had to include at least ten patients with pT1/pT2 adenocarcinomas that were removed transanally and followed by either adjuvant chemoradiotherapy or completion surgery. A weighted average of the logit proportions was determined for the pooled analyses of subgroups according to treatment modality and pT category. RESULTS: In total, 14 studies comprising 405 patients treated with adjuvant (chemo)radiotherapy and seven studies comprising 130 patients treated with completion TME were included. Owing to heterogeneity it was not possible to compare the two strategies directly. However, the weighted average local recurrence rate for locally excised pT1/pT2 rectal cancer treated with adjuvant (chemo)radiotherapy was 14 (95 per cent c.i. 11 to 18) per cent, and 7 (4 to 14) per cent following completion TME. The weighted averages for distance recurrence were 9 (6 to 14) and 9 (5 to 16) per cent respectively. Weighted averages for local recurrence rate after adjuvant chemo(radiotherapy) and completion TME for pT1 were 10 (4 to 21) and 6 (3 to 15) per cent respectively. Corresponding averages for pT2 were 15 (11 to 21) and 10 (4 to 22) per cent respectively. CONCLUSION: A higher recurrence rate after transanal excision and adjuvant (chemo)radiotherapy must be balanced against the morbidity and mortality associated with mesorectal excision. A reasonable approach is close follow-up and salvage mesorectal surgery as needed.

A multi-centred randomised trial of radical surgery versus adjuvant chemoradiotherapy after local excision for early rectal cancer.

BACKGROUND: Rectal cancer surgery is accompanied with high morbidity and poor long term functional outcome. Screening programs have shown a shift towards more early staged cancers. Patients with early rectal cancer can potentially benefit significantly from rectal preserving therapy. For the earliest stage cancers, local excision is sufficient when the risk of lymph node disease and subsequent recurrence is below 5 %. However, the majority of early cancers are associated with an intermediate risk of lymph node involvement (5-20 %) suggesting that local excision alone is not sufficient, while completion radical surgery, which is currently standard of care, could be a substantial overtreatment for this group of patients. METHODS/STUDY DESIGN: In this multicentre randomised trial, patients with an intermediate risk T1-2 rectal cancer, that has been locally excised using an endoluminal technique, will be randomized between adjuvant chemo-radiotherapylimited to the mesorectum and standard completion total mesorectal excision (TME). To strictly monitor the risk of locoregional recurrence in the experimental arm and enable early salvage surgery, there will be additional follow up with frequent MRI and endoscopy. The primary outcome of the study is three-year local recurrence rate. Secondary outcomes are morbidity, disease free and overall survival, stoma rate, functional outcomes, health related quality of life and costs. The design is a non inferiority study with a total sample size of 302 patients. DISCUSSION: The results of the TESAR trial will potentially demonstrate that adjuvant chemoradiotherapy is an oncological safe treatment option in patients who are confronted with the difficult clinical dilemma of a radically removed intermediate risk early rectal cancer by polypectomy or transanal surgery that is conventionally treated with subsequent radical surgery. Preserving the rectum using adjuvant radiotherapy is expected to significantly improve morbidity, function and quality of life if compared to completion TME surgery. TRIAL REGISTRATION: NCT02371304 , registration date: February 2015.

Feasibility of the TAMIS technique for redo pelvic surgery.

AIM: The aim of this study was to report on the feasibility of transanal minimally invasive surgery (TAMIS) as a novel approach to redo colorectal or ileoanal anastomoses. METHODS: From October 2014, a prospective institutional database was created for all consecutive patients who underwent redo surgery by TAMIS for presacral sinus or anastomotic stenosis after low anterior resection or pouch-related problems following restorative proctocolectomy. Intra-operative feasibility, 30-day postoperative outcomes, intestinal continuity and complications after 6-month follow-up were evaluated. RESULTS: Of 17 included patients, 14 underwent anastomotic reconstruction and three completion proctectomy. The median operation time was 265 min (range 201-413). A successful rendezvous with simultaneous transabdominal access was achieved in 15 patients, and the procedure was completed by TAMIS alone in two. Five patients were readmitted within 30 days (29 %). Two (14 %) patients developed an anastomotic leakage within 30 days and 4 (24 %) developed a pelvic abscess requiring reintervention. One patient developed an urethra stenosis and was managed with a suprapubic catheter. Median follow-up was 9 (6-15) months. Within 6-month follow-up, the redo-TAMIS 1 patient developed a delayed anastomotic leak and 1 patient had a recurrent presacral abscess after stoma closure. Intestinal continuity was reached in 71 % of the patients at 6-month follow-up. CONCLUSION: TAMIS is a valuable approach in redo pelvic surgery, but is still associated with high complication rates related to the complexity of the underlying problem.

Iron therapy for the treatment of preoperative anaemia in patients with colorectal carcinoma: a systematic review.

AIM: Preoperative anaemia is associated with increased morbidity and mortality. The aim of this systematic review is to evaluate the efficacy of preoperative iron supplementation in the treatment of anaemia, and its effect on the postoperative recovery of patients undergoing surgery for colorectal carcinoma. METHOD: This systematic review was performed using MEDLINE, EMBASE and the Cochrane library to assess current evidence on the role of iron supplementation in the treatment of preoperative anaemia. Our main outcomes were absolute increase in haemoglobin, blood transfusion rate and postoperative morbidity. Main inclusion criteria were: preoperative iron supplementation, presence of colorectal carcinoma and elective surgery. The Downs-Black questionnaire was used for quality assessment of the included studies. RESULTS: Of the 605 studies analysed, seven, three randomized controlled trials and four cohort studies, were included. Despite iron supplementation, the three randomized controlled trials showed a decrease in haemoglobin level. This was contrary to the four cohort studies which all showed a significant increase. All studies showed a decreased blood transfusion rate following iron supplementation. None of the included studies assessed postoperative morbidity. Due to heterogeneity in study design, duration of treatment, dosages and variation in iron substrates, we were unable to perform a meta-analysis. CONCLUSION: In anaemic patients who require surgery for colorectal carcinoma, current evidence is of inadequate quality to draw a definitive conclusion on the efficacy of the various measures to treat preoperative anaemia.

Multicentre randomized controlled trial comparing ferric(III)carboxymaltose infusion with oral iron supplementation in the treatment of preoperative anaemia in colorectal cancer patients.

BACKGROUND: At least a third of patients with a colorectal carcinoma who are candidate for surgery, are anaemic preoperatively. Preoperative anaemia is associated with increased morbidity and mortality. In general practice, little attention is paid to these anaemic patients. Some will have oral iron prescribed others not. The waiting period prior to elective colorectal surgery could be used to optimize a patients' physiological status. The aim of this study is to determine the efficacy of preoperative intravenous iron supplementation in comparison with the standard preoperative oral supplementation in anaemic patients with colorectal cancer. METHODS/DESIGN: In this multicentre randomized controlled trial, patients with an M0-staged colorectal carcinoma who are scheduled for curative resection and with a proven iron deficiency anaemia are eligible for inclusion. Main exclusion criteria are palliative surgery, metastatic disease, neoadjuvant chemoradiotherapy (5 × 5 Gy = no exclusion) and the use of Recombinant Human Erythropoietin within three months before inclusion or a blood transfusion within a month before inclusion. Primary endpoint is the percentage of patients that achieve normalisation of the haemoglobin level between the start of the treatment and the day of admission for surgery. This study is a superiority trial, hypothesizing a greater proportion of patients achieving the primary endpoint in favour of iron infusion compared to oral supplementation. A total of 198 patients will be randomized to either ferric(III)carboxymaltose infusion in the intervention arm or ferrofumarate in the control arm. This study will be performed in ten centres nationwide and one centre in Ireland. DISCUSSION: This is the first randomized controlled trial to determine the efficacy of preoperative iron supplementation in exclusively anaemic patients with a colorectal carcinoma. Our trial hypotheses a more profound haemoglobin increase with intravenous iron which may contribute to a superior optimisation of the patient's condition and possibly a decrease in postoperative morbidity. TRIAL REGISTRATION: ClincalTrials.gov: NCT02243735 .

Evolution of clinical nature, treatment and survival of locally recurrent rectal cancer: Comparative analysis of two national cross-sectional cohorts.

BACKGROUND: In the Netherlands, use of neoadjuvant radiotherapy for rectal cancer declined after guideline revision in 2014. This decline is thought to affect the clinical nature and treatability of locally recurrent rectal cancer (LRRC). Therefore, this study compared two national cross-sectional cohorts before and after the guideline revision with the aim to determine the changes in treatment and survival of LRRC patients over time. METHODS: Patients who underwent resection of primary rectal cancer in 2011 (n = 2094) and 2016 (n = 2855) from two nationwide cohorts with a 4-year follow up were included. Main outcomes included time to LRRC, synchronous metastases at time of LRRC diagnosis, intention of treatment and 2-year overall survival after LRRC. RESULTS: Use of neoadjuvant (chemo)radiotherapy for the primary tumour decreased from 88.5% to 60.0% from 2011 to 2016. The 3-year LRRC rate was not significantly different with 5.1% in 2011 (n = 114, median time to LRRC 16 months) and 6.3% in 2016 (n = 202, median time to LRRC 16 months). Synchronous metastasis rate did not significantly differ (27.2% vs 33.7%, p = 0.257). Treatment intent of the LRRC shifted towards more curative treatment (30.4% vs. 47.0%, p = 0.009). In the curatively treated group, two-year overall survival after LRRC diagnoses increased from 47.5% to 78.7% (p = 0.013). CONCLUSION: Primary rectal cancer patients in 2016 were treated less often with neoadjuvant (chemo)radiotherapy, while LRRC rates remained similar. Those who developed LRRC were more often candidate for curative intent treatment compared to the 2011 cohort, and survival after curative intent treatment also improved substantially.

[Wearing surgical masks in the operation theatre: yes or no?] / Wel of geen mondmaskers dragen op de OK?

OBJECTIVE: In the Netherlands, the surgical mask is part of the standard surgical attire even for the non-sterile personnel in the operation theatre. Solid evidence on the effect on postoperative infection rates is missing. Due to a national scarcity in surgical masks during the first wave of the COVID-19 crisis the usage of these masks was decreased. In our tertiary referral centre for Surgical Oncology, this led to the decision that, for a period of ten weeks, the surgical masks were only being used by the sterile surgical team and not by non-sterile operation theatre personnel. This retrospective study evaluates the influence of this intervention in terms of postoperative wound infection rates. DESIGN: Retrospective cohort study. METHOD: Consecutive patients undergoing surgery during the first COVID-19 wave (2-3-2020 until 11-05-2020) were compared with patients undergoing surgery in the same period a year earlier. Patients undergoing surgery for soft-tissue malignancies were included. Intra-abdominal surgery was excluded. Primary outcome measurement was wound infection rate within 30 days following surgery. Secondary, a cost reduction analysis was made. RESULTS: In the COVID-19 wave, a total of 219 patients underwent surgery for soft-tissue malignancies, compared to 241 a year earlier. The incidence of postoperative wound infection was 58/460 (12.6%) for the total cohort. There was no difference in infection rate between the COVID-19 period and the same period in 2019; 25/219 (11,4%; 95% CI: 7,8-16,4)) vs. 33/241 (13,7%; 95% CI: 9,8-18,6), p = 0,46) respectively. During the COVID-19 wave, a total of 6.400 of surgical masks were used by the personnel in the operation theatre complex, compared to a total of 11.000 in the same period in 2019. This resulted in a reduction of 42% in usage of surgical masks. CONCLUSION: Based on this mono-centric, explorative retrospective cohort study, it seems that omitting the surgical mask for the non-sterile operation theatre personnel does not influence the postoperative wound infection rate. Despite the fact that our sample size is small, the impressive reduction in usage of 42% demands further research initiatives on a larger scale.

Impact of an institutional change from routine to highly selective diversion of a low anastomosis after TME for rectal cancer.

INTRODUCTION: The need for routine diverting ileostomy following restorative total mesorectal excision (TME) is increasingly debated as the benefits might not outweigh the disadvantages. This study evaluated an institutional shift from routine (RD) to highly selective diversion (HSD) after TME surgery for rectal cancer. MATERIALS AND METHODS: Patients having TME with primary anastomosis and HSD for low or mid rectal cancer between December 2014 and March 2017 were compared with a historical control group with RD in the preceding period since January 2011. HSD was introduced in conjunction with uptake of transanal TME. RESULTS: In the RD group, 45/50 patients (90%) had a primary diverting stoma, and 3/40 patients (8%) in the HSD group. Anastomotic leakage occurred in 10 (20%) and three (8%) cases after a median follow-up of 36 and 19 months after RD and HSD, respectively. There was no postoperative mortality. An unintentional stoma beyond 1 year postoperative was present in six and two patients, respectively. One-year stoma-related readmission and reoperation rate (including reversal) after RD were 84% and 86%, respectively. Corresponding percentages were significantly lower after HSD (17% and 17%; P < 0.001). Total hospital stay within one year was median 11 days (IQR 8-19) versus 5 days (IQR 4-11), respectively (P < 0.001). CONCLUSION: This single institutional comparative cohort study shows that highly selective defunctioning of a low anastomosis in rectal cancer patients did not adversely affect incidence or consequences of anastomotic leakage with a substantial decrease in 1-year readmission and reintervention rate, leading to an overall significantly reduced hospital stay.