OBJECTIVE:The aim of this study was to evaluate oncological outcome for patients with and without anastomotic leakage after colon or rectal cancer surgery.
SUMMARY OF BACKGROUND DATA:The role of ...anastomotic leakage in oncological outcome after colorectal cancer surgery is still topic of debate and impact on follow-up and consideration for further treatment remains unclear.
METHODS:Patients included in the international, multicenter, non-inferior, open label, randomized, controlled trials COLOR and COLOR II, comparing laparoscopic surgery for curable colon (COLOR) and rectal (COLOR II) cancer with open surgery, were analyzed. Patients operated by abdominoperineal excision were excluded. Both univariate and multivariate analyses were performed to investigate the impact of leakage on overall survival, disease-free survival, local and distant recurrences, adjusted for possible confounders. Primary endpoints in the COLOR and COLOR II trial were disease-free survival and local recurrence at 3-year follow-up, respectively, and secondary endpoints included anastomotic leakage rate.
RESULTS:For colon cancer, anastomotic leakage was not associated with increased percentage of local recurrence or decreased disease-free-survival. For rectal cancer, an increase of local recurrences (13.3% vs 4.6%; hazard ratio 2.96; 95% confidence interval 1.38–6.34; P = 0.005) and a decrease of disease-free survival (53.6% vs 70.9%; hazard ratio 1.67; 95% confidence interval 1.16–2.41; P = 0.006) at 5-year follow-up were found in patients with anastomotic leakage.
CONCLUSION:Short-term morbidity, mortality, and long-term oncological outcomes are negatively influenced by the occurrence of anastomotic leakage after rectal cancer surgery. For colon cancer, no significant effect was observed; however, due to low power, no conclusions on the influence of anastomotic leakage on outcomes after colon surgery could be reached. Clinical awareness of increased risk of local recurrence after anastomotic leakage throughout the follow-up is mandatory.Trial RegistrationRegistered with ClinicalTrials.gov, number NCT00387842 and NCT00297791.
Background
Transanal total mesorectal excision (TaTME) is a safe alternative to laparoscopic TME for mid and low rectal cancer. TaTME allows improved visualization of the surgical planes and margins, ...and may potentially improve oncological outcomes. However, functional results after total mesorectal excision (TME) are variable and there are currently only a few published studies that include functional data related to the outcomes of TaTME.
Methods
Fifty-four consecutive patients were included in this study: one group included 27 patients who underwent laparoscopic low anterior and the other included 27 patients who underwent TaTME. All patients were asked to complete five questionnaires related to quality of life (QOL) and function EQ-5D-3L, EORTC-QLQ C30, EORTC-QLQ C29, Low Anterior Resection Syndrome score (LARS), and International Prostate Symptom Score IPSS. All TaTME patients were operated on at The Gelderse Vallei Hospital by a single surgeon and had a follow-up of at least 6.6 months.
Results
The EORTC-QLQ C30 and EQ-5D-3L questionnaires showed comparable outcomes in terms of QOL between the two groups. Almost all items evaluated by the EORTC-QLQ C29, including sexual outcomes, were similar between the two groups. One item concerning fecal incontinence, however, was scored worse for TaTME. There were no significant differences between the groups in terms of LARS symptoms or urinary function.
Conclusions
Patients undergoing laparoscopic or transanal TME showed comparable functional and QOL outcomes. Although the TaTME technique is still evolving, this study indicates that this technique is a safe alternative to laparoscopic surgery in terms of functional outcomes for mid and low rectal cancers.
Transanal total mesorectal excision (TaTME) has been developed to improve quality of TME for patients with mid and low rectal cancer. However, despite enthusiastic uptake and teaching facilities, ...concern exists for safe introduction. TaTME is a complex procedure and potentially a learning curve will hamper clinical outcome. With this systematic review, we aim to provide data regarding morbidity and safety of TaTME. A systematic literature search was performed in MEDLINE (PubMed), EMBASE (Ovid) and Cochrane Library. Case reports, cohort series and comparative series on TaTME for rectal cancer were included. To evaluate a potential effect of case volume, low-volume centres (
n
≤ 30 total volume) were compared with high-volume centres (
n
> 30 total volume). Thirty-three studies were identified (three case reports, 25 case series, five comparative studies), including 794 patients. Conversion was performed in 3.0% of the procedures. The complication rate was 40.3, and 11.5% were major complications. The quality of the mesorectum was “complete” in 87.6%, and the circumferential resection margin (CRM) was involved in 4.7%. In low- versus high-volume centres, the conversion rate was 4.3 versus 2.7%, and major complication rates were 12.2 versus 10.5%, respectively. TME quality was “complete” in 80.5 versus 89.7%, and CRM involvement was 4.8 and 4.5% in low- versus high-volume centres, respectively. TaTME for mid and low rectal cancer is a promising technique; however, it is associated with considerable morbidity. Safe implementation of the TaTME should include proctoring and quality assurance preferably within a trial setting.
Background
Transanal total mesorectal excision (TaTME) has rapidly become an important component of the treatment of rectal cancer surgery. Cohort studies have shown feasibility concerning procedure, ...specimen quality and morbidity. However, concerns exist about quality of life and ano(neo)rectal function. The aim of this study was to prospectively evaluate quality of life in patients following TaTME for rectal cancer with anastomosis.
Methods
Consecutive patients who underwent restorative TaTME surgery for rectal adenocarcinoma in an academic teaching center with tertiary referral function were evaluated. Validated questionnaires were prospectively collected. Quality of life was assessed by the EuroQol 5D (EQ-5D), European Organization for Research and Treatment of Cancer’s QLQ-C30 and QLQ-CR29 and low anterior resection syndrome (LARS) scale. Outcomes of the questionnaires at 1 and 6 months were compared with preoperative (baseline) values.
Results
Thirty patients after restorative TaTME for rectal cancer were included. Deterioration for all domains was mainly observed at 1 month after surgery compared to baseline, but most outcomes had returned to baseline at 6 months. Social function and anal pain remained significantly worse at 6 months. Major LARS (score >30) was 33% at 6 months after ileostomy closure. No end colostomies were required.
Conclusions
TaTME is associated with acceptable quality of life and functional outcome at 6 months after surgery comparable to published results after conventional laparoscopic low anterior resection.
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.
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.
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.
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.
NCT02371304 , registration date: February 2015.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
To investigate trajectories of cognitive decline in patients with different types of dementia compared to controls in a longitudinal study.
In 199 patients with Alzheimer's disease (AD), 10 with ...vascular dementia (VaD), 26 with dementia with Lewy bodies (DLB), 20 with behavioural variant frontotemporal dementia (bvFTD), 15 with language variant frontotemporal dementia (lvFTD) and 112 controls we assessed five cognitive domains: memory, language, attention, executive and visuospatial functioning, and global cognition (Mini-Mental State Examination, MMSE). All subjects had at least two neuropsychological assessments (median 2, range 2-7). Neuropsychological data were standardized into z scores using baseline performance of controls as reference. Linear mixed models (LMMs) were used to estimate baseline cognitive functioning and cognitive decline over time for each group, adjusted for age, gender and education.
At baseline, patients with dementia performed worse than controls in all cognitive domains (p < 0.05) except visuospatial functioning, which was only impaired in patients with AD and DLB (p < 0.001). During follow-up, patients with AD declined in all cognitive domains (p < 0.001). DLB showed decline in every cognitive domain except language and global cognition. bvFTD showed rapid decline in memory, language, attention and executive functioning (all p < 0.01) whereas visuospatial functioning remained fairly stable. lvFTD declined mostly in attention and executive functioning (p < 0.01). VaD showed decline in attention and executive functioning.
We show cognitive trajectories of different types of dementia. These estimations of natural disease course have important value for the design of clinical trials as neuropsychological measures are increasingly being used as outcome measures.
Background
Transanal total mesorectal excision (TaTME) provides an excellent view of the resection margins for rectal cancer from below, but is challenging due to few anatomical landmarks. During ...implementation of this technique, patient safety and optimal outcomes need to be ensured. The aim of this study was to evaluate the learning curve of TaTME in patients with rectal cancer in order to optimize future training programs.
Methods
All consecutive patients after TaTME for rectal cancer between February 2012 and January 2017 were included in a single-center database. Influence of surgical experience on major postoperative complications, leakage rate and operating time was evaluated using cumulative sum charts and the splitting model. Correction for potential case-mix differences was performed.
Results
Over a period of 60 months, a total of 138 patients were included in this study. Adjusted for case-mix, improvement in postoperative outcomes was clearly seen after the first 40 patients, showing a decrease in major postoperative complications from 47.5 to 17.5% and leakage rate from 27.5 to 5%. Mean operating time (42 min) and conversion rate (from 10% to zero) was lower after transition to a two-team approach, but neither endpoint decreased with experience. Readmission and reoperation rates were not influenced by surgical experience.
Conclusions
The learning curve of TaTME affected major (surgical) postoperative complications for the first 40 patients. A two-team approach decreased operative time and conversion rate. When implementing this new technique, a thorough teaching and supervisory program is recommended to shorten the learning curve and improve the clinical outcomes of the first patients.
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.