Long-term oncological outcomes of endoscopic full-thickness resection after previous incomplete resection of low-risk T1 CRC (LOCAL-study): study protocol of a national prospective cohort study

Background: T1 colorectal cancer (CRC) without histological high-risk factors for lymph node metastasis (LNM) can potentially be cured by endoscopic resection, which is associated with significantly lower morbidity, mortality and costs compared to radical surgery. An important prerequisite for endoscopic resection as definite treatment is the histological confirmation of tumour-free resection margins. Incomplete resection with involved (R1) or indeterminate (Rx) margins is considered a strong risk factor for residual disease and local recurrence. Therefore, international guidelines recommend additional surgery in case of R1/Rx resection, even in absence of high-risk factors for LNM. Endoscopic full-thickness resection (eFTR) is a relatively new technique that allows transmural resection of colorectal lesions. Local scar excision after prior R1/Rx resection of low-risk T1 CRC could offer an attractive minimal invasive strategy to achieve confirmation about radicality of the previous resection or a second attempt for radical resection of residual luminal cancer. However, oncologic safety has not been established and long-term data are lacking. Besides, surveillance varies widely and requires standardization. Methods/design: In this nationwide, multicenter, prospective cohort study we aim to assess feasibility and oncological safety of completion eFTR following incomplete resection of low-risk T1 CRC. The primary endpoint is to assess the 2 and 5 year luminal local tumor recurrence rate. Secondary study endpoints are to assess feasibility, percentage of curative eFTR-resections, presence of scar tissue and/or complete scar excision at histopathology, safety of eFTR compared to surgery, 2 and 5 year nodal and/or distant tumor recurrence rate and 5-year disease-specific and overall-survival rate. Discussion: Since the implementation of CRC screening programs, the diagnostic rate of T1 CRC is steadily increasing. A significant proportion is not recognized as cancer before endoscopic resection and is therefore resected through conventional techniques primarily reserved for benign polyps. As such, precise histological assessment is often hampered due to cauterization and fragmentation and frequently leads to treatment dilemmas. This first prospective trial will potentially demonstrate the effectiveness and oncological safety of completion eFTR for patients who have undergone a previous incomplete T1 CRC resection. Hereby, substantial surgical overtreatment may be avoided, leading to treatment optimization and organ preservation.Cellular mechanisms in basic and clinical gastroenterology and hepatolog

Optimizing strategies in gastrointestinal surgery

Een kijkoperatie gecombineerd met 'fast track' zorg is de optimale behandeling voor patiënten met darmkanker ten aanzien van het herstel van de patiënt tot 1 maand na de operatie. Dit is de belangrijkste conclusie uit het proefschrift van Malaika Vlug. Binnen de darmchirurgie zijn belangrijke ontwikkelingen geweest. Zo is in 1991 de eerste laparoscopische (=kijkoperatie) darmoperatie uitgevoerd en halverwege de jaren negentig is het ‘fast track’ protocol ontwikkeld met als doel het herstel van de patiënt na de operatie te versnellen. In het fast track programma speelt de patiënt een actieve rol in zijn/haar eigen herstel. Bij ongeveer een kwart van de patiënten met colitis ulcerosa (=chronische ontstekingsziekte aan de dikke darm) en familiare adenomateuze polyposis (=erfelijke vorm van darmkanker/FAP) wordt uiteindelijk de hele dikke darm verwijderd en een ‘pouch’ aangelegd. Een pouch is een als endeldarm functionerend anaal reservoir van de dunne darm dat direct op de anus wordt gehecht. Malaika Vlug heeft de gevolgen van deze chirurgische ingreep kritisch beoordeeld. Dit onderzoek leverde drie belangrijke resultaten op. Allereerst bleek de kans op het ontstaan van kwaadaardige cellen in de 'pouch' laag, daarom is het onduidelijk of de 'pouch' routinematig moet worden onderzocht. Ten tweede wordt het seksuele disfunctioneren, wat vaak optreedt na deze operatie, waarschijnlijk veroorzaakt door schade aan de zenuwen in het kleine bekken. Ten derde moeten patiënten worden gewezen worden op het risico van een vaginale bevalling op het op lange termijn goed blijven functioneren van de pouch

Which fast track elements predict early recovery after colon cancer surgery?

AIM: It is questioned whether all separate fast track elements are essential for enhanced postoperative recovery. We aimed to determine which baseline characteristics and which fast track elements are independent predictors of faster postoperative recovery in patients undergoing resection for colon cancer. METHOD: Data from the LAFA trial database were used. In this trial, fast track care was compared with standard perioperative care in 400 patients undergoing laparoscopic or open surgery for colonic cancer. During admission 19 fast track elements per patient were prospectively evaluated and scored whether or not they were successfully applied. To identify predictive factors six baseline characteristics and those fast track items that were successfully achieved were entered in a univariate and multivariate linear regression analysis with total postoperative hospital stay (THS) as the primary outcome. RESULTS: In 400 patients, two baseline characteristics and two fast track elements were found to be significant independent predictors of THS: female sex [B = 0.85; 95% CI 0.75-0.96; reduction of 15% (CI 14-25%) in THS], laparoscopic resection [B = 0.85; 95% CI 0.75-0.96; reduction of 15% (CI 14-25%) in THS], 'normal diet at postoperative days 1, 2 and 3' [B = 0.70; 95% CI 0.61-0.81; reduction of 30% (CI 19-39%) in THS] and 'enforced mobilization at postoperative days 1, 2 and 3' [B = 0.68; 95% CI 0.59-0.80; reduction of 32% (CI 20-41%) in THS]. CONCLUSION: Evaluating only those fast track elements that were successfully achieved, enforced advancement of oral intake, early mobilization, laparoscopic surgery and female sex were independent determinants of early recovery

Small bowel obstruction, incisional hernia and survival after laparoscopic and open colonic resection (LAFA study)

Short-term advantages to laparoscopic surgery are well described. This study compared medium- to long-term outcomes of a randomized clinical trial comparing laparoscopic and open colonic resection for cancer. The case notes of patients included in the LAFA study (perioperative strategy in colonic surgery; LAparoscopy and/or FAst track multimodal management versus standard care) were reviewed 2-5 years after randomization for incisional hernia, adhesional small bowel obstruction (SBO), overall survival, cancer recurrence and quality of life (QoL). The laparoscopic and open groups were compared irrespective of fast-track or standard perioperative care. Data on incisional hernias, SBO, survival and recurrence were available for 399 of 400 patients: 208 laparoscopic and 191 open resections. These outcomes were corrected for duration of follow-up. Median follow-up was 3·4 (i.q.r. 2·6-4·4) years. Multivariable regression analysis showed that open resection was a risk factor for incisional hernia (odds ratio (OR) 2·44, 95 per cent confidence interval (c.i.) 1·12 to 5·26; P = 0·022) and SBO (OR 3·70, 1·07 to 12·50; P = 0·039). There were no differences in overall survival (hazard ratio 1·10, 95 per cent c.i. 0·67 to 1·80; P = 0·730) or in cumulative incidence of recurrence (P = 0·514) between the laparoscopic and open groups. There were no measured differences in QoL in 281 respondents (P > 0·350 for all scales). Laparoscopic colonic surgery led to fewer incisional hernia and adhesional SBO events. NTR222 (http://www.trialregister.nl

Laparoscopy in Combination with Fast Track Multimodal Management is the Best Perioperative Strategy in Patients Undergoing Colonic Surgery A Randomized Clinical Trial (LAFA-study)

To investigate which perioperative treatment, ie, laparoscopic or open surgery combined with fast track (FT) or standard care, is the optimal approach for patients undergoing segmental resection for colon cancer. Important developments in elective colorectal surgery are the introduction of laparoscopy and implementation of FT care, both focusing on faster recovery. In a 9-center trial, patients eligible for segmental colectomy were randomized to laparoscopic or open colectomy, and to FT or standard care, resulting in 4 treatment groups. Primary outcome was total postoperative hospital stay (THS). Secondary outcomes were postoperative hospital stay (PHS), morbidity, reoperation rate, readmission rate, in-hospital mortality, quality of life at 2 and 4 weeks, patient satisfaction and in-hospital costs. Four hundred patients were required to find a minimum difference of 1 day in hospital stay. Median THS in the laparoscopic/FT group was 5 (interquar-tile range: 4-8) days; open/FT 7 (5-11) days; laparoscopic/standard 6 (4.5-9.5) days, and open/standard 7 (6-13) days (P < 0.001). Median PHS in the laparoscopic/FT group was 5 (4-7) days; open/FT 6 (4.5-10) days; laparoscopic/standard 6 (4-8.5) days and open/standard 7 (6-10.5) days (P < 0.001). Secondary outcomes did not differ significantly among the groups. Regression analysis showed that laparoscopy was the only independent predictive factor to reduce hospital stay and morbidity. Optimal perioperative treatment for patients requiring segmental colectomy for colon cancer is laparoscopic resection embedded in a FT program. If open surgery is applied, it is preferentially done in FT care. This study was registered under NTR222 (www.trialregister.nl

Reporting Guidelines, Review of Methodological Standards, and Challenges Toward Harmonization in Bone Marrow Adiposity Research. Report of the Methodologies Working Group of the International Bone Marrow Adiposity Society

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