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1.
Colorectal Dis ; 2024 Sep 24.
Article in English | MEDLINE | ID: mdl-39317953

ABSTRACT

AIM: The rate of surgical recurrence following ileorectal anastomosis (IRA) in patients with Crohn's disease (CD) remains poorly understood. Most studies were conducted before the advent of biologics. Our aim was to assess the fate of IRA in patients with CD during the biologics era and identify risk factors for endoscopic, clinical, and surgical recurrence. METHODS: This retrospective multicentre cohort study included patients with CD who underwent IRA between 2006 and 2022. The association of patient characteristics and postoperative measures with each type of postoperative recurrence and need for a definitive stoma was investigated using the chi-square test or Fisher's exact test. RESULTS: During a median follow-up period of 60 months, the rates of endoscopic, clinical, and surgical postoperative recurrence were 70%, 59%, and 35%, respectively. The rate of perianal lesions was higher in patients who underwent a definitive stoma (70% vs. 35%, p = 0.007) and with endoscopic (50% vs. 25%, p = 0.038), clinical (54% vs. 24%, p = 0.006), and surgical (63% vs. 34%, p = 0.015) recurrence. The incidence of residual microscopic disease at the rectal margin was higher in patients with endoscopic recurrence (p = 0.047). Biologics were identified as protective factors against the need for a definitive stoma (p = 0.044). CONCLUSION: IRA is a good treatment option for extensive colitis in patients with CD. However, its consideration should be weighed in the presence of perianal lesions, which have been shown to be a risk factor for delayed proctectomy.

2.
Surgery ; 2024 Jul 04.
Article in English | MEDLINE | ID: mdl-38969550

ABSTRACT

BACKGROUND: In patients with multifocal intestinal Crohn disease requiring surgery for complication or uncontrolled disease, resection of all the lesions may lead to diarrhea and malnutrition. METHODS: This is a single-center retrospective review of all patients undergoing targeted surgery for multifocal Crohn disease with at least one residual Crohn disease location left behind. The primary endpoint was the rate of insufficient control of residual Crohn disease lesions requiring redo-surgery targeting these lesions. The rate of clinical remission defined by Harvey-Bradshaw index <4 was studied over time. RESULTS: From January 2012 to August 2022, among 320 patients undergoing surgery for intestinal Crohn disease, 30 met all criteria. Before surgery, patients had received a mean of 3 medical treatment lines; 83% (n = 25) had a clinically active Crohn disease (Harvey-Bradshaw index ≥4). Surgery consisted in ileocolonic (n = 14;47%), small bowel (n = 5;17%) or colonic resection (n = 12;40%) and strictureplasty (n = 4;13%). Operative mortality was nil. Overall postoperative and severe morbidity rates were 15 of 30 (50%) and 3 of 30. Residual lesions were in the small bowel (n = 15;50%), the colon (n = 16;53%), and/or the rectum (n = 16;53%). Twenty-five patients (83%) had postoperative medical therapy. Median follow-up was 65. Six patients (20%) required reoperation for insufficient control of residual lesions at index surgery after a mean of 98 ± 8 months. The clinical remission rate increased from 17% before surgery to 59% at 6-12 months and 71% at 24 months. CONCLUSION: In patients with multifocal Crohn disease, surgery targeted to severe and complicated lesions combined with postoperative medical treatment is a safe and effective strategy.

3.
J Visc Surg ; 161(3): 182-193, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38897710

ABSTRACT

Treatment of ulcerative colitis (UC) has been revolutionized by the arrival of biotherapies and technical progress in interventional endoscopy and surgery. (Sub)total emergency colectomy is required in the event of complicated severe acute colitis: colectasis, perforation, hemorrhage, organ failure. Corticosteroid therapy is the reference treatment for uncomplicated severe acute colitis, while infliximab and ciclosporin are 2nd-line treatments. At each step, before and after each line of treatment failure, surgery should be considered as an option. In cases refractory to medical treatment, the choice between surgery and change in medication must weigh the chronic symptoms associated with the disease against the risks of postoperative complications and functional sequelae inherent to surgery. Detection of dysplastic lesions necessitates chromoendoscopic imaging with multiple biopsies and anatomopathological verification. Endoscopic treatment of these lesions remains reserved for selected patients. These different indications call for multidisciplinary medical-surgical discussion. Total coloproctectomy with ileo-anal anastomosis (TCP-IAA) is the standard surgery, and it holds out hope for healing. Modalities depend on patient characteristics, previous emergency colectomy, and presence of dysplasia. It may be carried out in one, in two modified, or in three phases. The main complications are anastomotic fistula, short-term pouch-related fistula, ileo-anal pouch syndrome, pouchitis and long-term digestive and sexual disorders. For selected cases, an alternative can consist in total colectomy with ileo-rectal anastomosis or permanent terminal ileostomy. The objective of this update is to clarify the indications, modalities, and results of surgical treatment of ulcerative colitis in accordance with the most recent data in the literature.


Subject(s)
Colitis, Ulcerative , Colitis, Ulcerative/surgery , Humans , Proctocolectomy, Restorative/methods , Treatment Outcome , Colectomy/methods , Postoperative Complications/etiology
5.
Clin Epigenetics ; 16(1): 28, 2024 02 14.
Article in English | MEDLINE | ID: mdl-38355645

ABSTRACT

BACKGROUND: E-cadherin, a major actor of cell adhesion in the intestinal barrier, is encoded by the CDH1 gene associated with susceptibility to Crohn Disease (CD) and colorectal cancer. Since epigenetic mechanisms are suspected to contribute to the multifactorial pathogenesis of CD, we studied CpG methylation at the CDH1 locus. The methylation of the CpG island (CGI) and of the 1st enhancer, two critical regulatory positions, was quantified in surgical specimens of inflamed ileal mucosa and in peripheral blood mononuclear cells (PBMC) of 21 CD patients. Sixteen patients operated on for a non-inflammatory bowel disease, although not normal controls, provided a macroscopically normal ileal mucosa and PBMC for comparison. RESULTS: In ileal mucosa, 19/21 (90%) CD patients vs 8/16 control patients (50%) (p < 0.01) had a methylated CDH1 promoter CGI. In PBMC, CD patients with methylated CGI were 11/21 (52%) vs 7/16 controls (44%), respectively. Methylation in the 1st enhancer of CDH1 was also higher in the CD group for each of the studied CpGs and for their average value (45 ± 17% in CD patients vs 36 ± 17% in controls; p < 0.001). Again, methylation was comparable in PBMC. Methylation of CGI and 1st enhancer were not correlated in mucosa or PBMC. CONCLUSIONS: Methylation of several CpGs at the CDH1 locus was increased in the inflamed ileal mucosa, not in the PBMC, of CD patients, suggesting the association of CDH1 methylation with ileal inflammation. Longitudinal studies will explore if this increased methylation is a risk marker for colorectal cancer.


Subject(s)
Colorectal Neoplasms , Crohn Disease , Humans , DNA Methylation , Leukocytes, Mononuclear/metabolism , Crohn Disease/genetics , CpG Islands , Cadherins/genetics , Colorectal Neoplasms/genetics , Antigens, CD/genetics , Antigens, CD/metabolism
7.
J Crohns Colitis ; 2023 Oct 18.
Article in English | MEDLINE | ID: mdl-37850342

ABSTRACT

BACKGROUND AND AIMS: Postoperative recurrence is a major concern in Crohn's disease. The Kono-S anastomosis has been described to reduce the rate of recurrence. However, the level of evidence for its effectiveness remains low. The KoCoRICCO study aimed to compare outcomes between Kono-S anastomosis and conventional anastomosis in two nationwide prospective cohorts. METHODS: Adult patients with Crohn's disease who underwent ileocolonic resection with Kono-S anastomosis were prospectively included in seven referral centers between 2020 and 2022. Patients with conventional side-to-side anastomosis were enrolled from a previously published cohort. A propensity score analysis was performed to compare recurrence at first endoscopy in a matched 1:2 ratio population. RESULTS: A total of 433 patients with ileocolonic anastomosis were enrolled, of whom 155 had a Kono-S anastomosis. Before matching, both groups were unbalanced for preoperative, intraoperative, and postoperative characteristics. After matching patients with available endoscopic follow-up, endoscopic recurrence ≥i2 was found in 47.5% of the Kono-S group and 44.3% of the conventional side-to-side group (p=0.6745). CONCLUSIONS: The KoCoRICCO study suggests that Kono-S anastomosis does not reduce the risk of endoscopic recurrence in Crohn's disease compared to conventional side-to-side anastomosis. Further research with a longer follow-up is necessary to determine whether there is a potential benefit on surgical recurrence.

9.
Colorectal Dis ; 25(1): 128-143, 2023 01.
Article in English | MEDLINE | ID: mdl-36128685

ABSTRACT

AIM: A stoma exposes patients to several complications which could impair their quality of life (QoL). In the last decade, the market for stoma therapy in France has evolved, with a significant increase in the activities of home health providers, meeting a need for patient follow-up and companionship. International studies have demonstrated the impact of the stoma therapist (ST) follow-up on the improvement of an ostomy patient's QoL. However, the impact of home stoma nurse management has not been analysed. In this context we would like to assess the added value on health-related QoL from the enhanced follow-up of ostomy patients by STs. METHODS: This is a randomized, controlled, open, national and multicentre trial (12 centres) which includes patients with an ostomy who benefit from either standard follow-up or from an enhanced and personalized follow-up with, in particular, regular consultations with an ST after discharge. The primary end-point is the 3-month QoL score obtained from the Stoma-QoL questionnaire. The secondary end-points are satisfaction of the care, comparison of QoL scores (Stoma-QoL and EuroQuol EQ-5D) and the economic gains by calculating the consumption of resources between the two arms. There will be a modified intention-to-treat analysis with 6-month follow-up in both study arms. DISCUSSION: The StomaCare trial will be the first randomized controlled study in France to evaluate the impact on QoL of an enhanced follow-up at home of ostomy patients by an ST.


Subject(s)
Nursing Services , Ostomy , Humans , Quality of Life , Follow-Up Studies , Surveys and Questionnaires , Delivery of Health Care
10.
J Surg Oncol ; 126(2): 330-338, 2022 Aug.
Article in English | MEDLINE | ID: mdl-35397122

ABSTRACT

BACKGROUND: outcome of patients who develop resectable metachronous colorectal liver metastases (CLM) after adjuvant oxaliplatin-based chemotherapy for Stage III colorectal cancer (CRC) is not well defined and the value of preoperative chemotherapy is controversial. METHODS: From 2006 to 2013, all patients undergoing liver resection for Class I metachronous CLM after adjuvant oxaliplatin-based chemotherapy for CRC, across 32 French academic centers, were included. RESULTS: Sixty-two patients with an average of 2 ± 1 CLM were included. Thirty-two (52%) patients received preoperative chemotherapy. There was no significant difference in the characteristics of CLM between patients with or without preoperative chemotherapy. After a median follow-up of 29 months, 3-year overall and disease-free survival rates were 79.8% and 34.6%, respectively. The median disease-free survival was not different in patients with or without preoperative chemotherapy (17 vs. 35 months respectively, p = 0.112). In multivariate analysis, only CEA level > 200 ng/ml was associated with the risk of recurrence (p = 0.027; OR = 4.7, 95% CI = 1.2-18.7). CONCLUSION: Liver resection provides a good outcome in patients with limited metachronous CLM after adjuvant oxaliplatin-based chemotherapy for CRC. The interest of preoperative chemotherapy is not obvious and should be tested in a prospective controlled study.


Subject(s)
Colorectal Neoplasms , Liver Neoplasms , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Chemotherapy, Adjuvant , Colorectal Neoplasms/pathology , Hepatectomy , Humans , Liver Neoplasms/drug therapy , Liver Neoplasms/surgery , Oxaliplatin/therapeutic use , Prospective Studies , Treatment Outcome
11.
Rev Prat ; 72(1): 50-54, 2022 Jan.
Article in French | MEDLINE | ID: mdl-35258254

ABSTRACT

Rectal cancer: is the era for de-escalation arrived? The reference treatment of rectal cancer relies on carcinologic resection including total mesorectal excision. In patients with locally advanced rectal cancer (cT3T4 and/or cN+), preoperative treatment is used to improve outcome and includes radiochemotherapy to optimize local control and systemic chemotherapy to decrease metastatic recurrence. The combination of these treatments with rectal cancer surgery induces short term and long-term toxicities potentially leading to treatment related sequelae on digestive and genitourinary function. Lastly, time is coming for de-escalation for the treatment to rectal cancer. For patients with small tumors (cT2T3 inférieur 4 cm) who respond to radiochemotherapy, organ preservation avoiding rectal resection can be discussed. In patients with locally advanced resectable rectal cancer, preoperative chemotherapy without pelvic irradiation could be used before total mesorectal excision to decrease the risk of long-term side effects. In patients with more advanced, primarily non resectable rectal cancer, a tailored strategy based on tumor response to chemotherapy could be used to rationalize the use of preoperative irradiation. New treatment strategies are constantly proposed and the optimal treatment option should be decided on a per patient basis during multidisciplinary discussion.


PERSPECTIVES: vers une désescalade thérapeutique dans le cancer du rectum ? Le traitement de référence des cancers du rectum repose sur l'exérèse carcinologique (exérèse totale du mésorectum). En cas de tumeur localement évoluée (cT3T4 et/ou N+), une radiochimiothérapie précédée ou suivie d'une chimiothérapie est utilisée en préopératoire pour améliorer le contrôle local et réduire le risque de récidive métastatique ; sa combinaison à une chirurgie lourde est associée à une toxicité à court et à long termes, avec un risque de séquelles fonctionnelles digestives et génito-urinaires. Actuellement, la prise en charge évolue vers une désescalade thérapeutique. En cas de tumeur T2T3 de petite taille (inférieure à 4 cm) répondant bien au traitement, une stratégie de préservation rectale évitant la chirurgie d'exérèse peut se discuter. Pour les tumeurs plus évoluées, une chirurgie d'exérèse précédée d'une chimiothérapie, sans irradiation pelvienne, pourrait limiter les séquelles à long terme. En cas de tumeur non résécable d'emblée, une démarche personnalisée, fondée sur l'intensité de la réponse tumorale à la chimiothérapie, permettrait un recours sélectif à l'irradiation pelvienne. Compte tenu des nombreuses nouvelles approches qui peuvent être proposées, une discussion pluridisciplinaire est absolument nécessaire pour optimiser la prise en charge des patients.


Subject(s)
Proctectomy , Rectal Neoplasms , Chemoradiotherapy , Humans , Neoadjuvant Therapy/adverse effects , Neoplasm Recurrence, Local/drug therapy , Neoplasm Recurrence, Local/pathology , Neoplasm Recurrence, Local/surgery , Neoplasm Staging , Rectal Neoplasms/drug therapy , Rectal Neoplasms/pathology , Rectum/pathology , Rectum/surgery
12.
Colorectal Dis ; 24(5): 594-600, 2022 05.
Article in English | MEDLINE | ID: mdl-35038368

ABSTRACT

AIM: To determine the safety of performing an anastomosis after rectal cancer (RC) resection in patients with a previously treated prostate cancer (PC). METHODS: Patients with a previously treated PC who underwent rectal resection from 2008 to 2018 were retrospectively included. Outcomes were compared between patients who underwent rectal resection with anastomosis (restorative surgery, RS+ group) and those with a definitive stoma (RS- group). In the RS+ group, anastomotic leak (AL) rates were assessed according to the type of reconstruction. RESULTS: A total of 126 patients underwent rectal surgery for mid-low RC after a previous PC treated by radiotherapy (RT) and/or radical prostatectomy. Overall, 80 patients (63%) underwent a RS and 46 patients (37%) underwent rectal surgery with a definitive stoma. There was no statistical difference between the two groups in terms of intraoperative data, except for the type of resection with more multivisceral resection in the RS- group (p < 0.01). In the RS+group, a diverting stoma was performed in 74% of cases. No difference between the two groups in terms of overall morbidity was found. In the RS+group (n = 80), 17 patients (21%) experienced AL. Of these, none was observed when delayed coloanal anastomosis was performed (p = 0.16). Long-term permanent stoma in the RS+ group was 16% (n = 13). CONCLUSION: Restorative surgery after resection for RC in patients with a previous history of RT and/or radical prostatectomy for PC is safe without additional morbidity. In selected patients for restorative surgery, performing delayed coloanal anastomosis may represent a promising option.


Subject(s)
Proctectomy , Prostatic Neoplasms , Rectal Neoplasms , Anal Canal/surgery , Anastomosis, Surgical/adverse effects , Anastomotic Leak/etiology , Anastomotic Leak/surgery , Colon/surgery , Humans , Male , Proctectomy/adverse effects , Prostatic Neoplasms/surgery , Rectal Neoplasms/etiology , Rectal Neoplasms/surgery , Retrospective Studies
13.
Dig Liver Dis ; 53(9): 1128-1135, 2021 Sep.
Article in English | MEDLINE | ID: mdl-33931341

ABSTRACT

BACKGROUND: Restorative proctocolectomy with ileal-pouch anal-anastomosis (IPAA) is the operation of choice for patients with ulcerative colitis (UC) or with inflammatory bowel diseases unclassified (IBDU). AIMS: to assess the incidence and risk factors of chronic pouchitis (CP) and Crohn's disease of the pouch (CDP) in patients with UC or IBDU. METHODS: We conducted a retrospective study. We included consecutive patients who underwent IPAA between 2011 and 2019. The main outcome was the occurrence of CP or CDP. We looked for risk factors with multivariable and a least absolute shrinkage and selection operator (LASSO) Cox models. RESULTS: 247 patients were included. The 5-year cumulative incidence of CP or CDP was 35.3% (95%CI: 26.2-43.2). In multivariable analysis, diagnosis of IBDU, age less than 35 years at surgery and extra-intestinal manifestations other than articular and primary sclerosing cholangitis were associated with higher incidence. The LASSO analysis identified these three prognostic factors and articular manifestations. In patients with two or more prognostic factors, 5-year cumulative incidence, was 65.2% (95%CI: 41.8-79.2). CONCLUSIONS: Five years after IPAA, approximately one-third of patients had either CP or CDP. Risk factors were IBDU, an age less than 35 years at surgery, articular manifestations and other extra-intestinal manifestations.


Subject(s)
Crohn Disease/epidemiology , Pouchitis/epidemiology , Proctocolectomy, Restorative/adverse effects , Adult , Crohn Disease/diagnosis , Disease Progression , Female , Humans , Incidence , Male , Middle Aged , Pouchitis/diagnosis , Pouchitis/etiology , Proctocolectomy, Restorative/statistics & numerical data , Retrospective Studies , Risk Factors
14.
Colorectal Dis ; 23(6): 1451-1462, 2021 06.
Article in English | MEDLINE | ID: mdl-33624371

ABSTRACT

AIM: Postoperative morbidity is high in patients operated on for Crohn's disease (CD) complicated by malnutrition. This study aimed to evaluate the impact of preoperative enteral nutritional support (PENS) on postoperative outcome in patients with CD complicated by malnutrition included in a prospective nationwide cohort. METHOD: Malnutrition was defined as body mass index <18 kg/m2 and/or albuminaemia <30 g/L and/or weight loss >10%. Failure of PENS was defined as the requirement for additional preoperative parenteral nutrition to PENS. Univariate analysis of the risk factors for PENS failure was performed. Propensity score matching (PSM) was used to compare the outcomes between 'upfront surgery' and 'PENS' groups. The primary endpoint was the rate of intra-abdominal septic morbidity and/or temporary defunctioning stoma. RESULTS: Among 592 patients included, 149 were selected. In the intention-to-treat population including 20 (13.4%) patients with PENS failure after PSM, 78 'upfront surgery' and 71 'PENS'-matched patients were compared, with no significant difference in the primary endpoint. Perforating CD and preoperative intra-abdominal fistula were associated with PENS failure [37.5 vs 16.1% (P = 0.047) and 41.2% vs 16.2% (P = 0.020), respectively]. After exclusion of these 20 patients, PSM was used to compare 45 'upfront surgery' and 51 'PENS'-matched patients, with a significantly decreased rate of intra-abdominal septic complications and/or temporary defunctioning stoma in the PENS group (19.6 vs 42.2%, P = 0.016). CONCLUSION: Preoperative enteral nutritional support is associated with a trend but no conclusive evidence of a reduction in intra-abdominal septic complications and/or requirement for defunctioning stoma. Patients with perforating CD complicated with malnutrition are at risk of PENS failure.


Subject(s)
Crohn Disease , Malnutrition , Crohn Disease/complications , Crohn Disease/surgery , Humans , Malnutrition/etiology , Malnutrition/therapy , Nutritional Support , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Prospective Studies , Registries
15.
World J Surg ; 45(3): 822-830, 2021 Mar.
Article in English | MEDLINE | ID: mdl-33210163

ABSTRACT

BACKGROUND: To report the current clinical practice of French physicians for metachronous resectable liver metastasis (LM) occurring after a FOLFOX adjuvant chemotherapy for primary cancer. METHODS: Twenty four clinical situations were proposed to a panel of experts via 4 learned societies. Clinical situations varied according time of recurrence (early between 6 and 12 month or > 12 month), extension of LM (limited ≤ 2 or extended > 2 lesions), presence of a neuropathy or not, and of a RAS or BRAF mutation. RESULTS: A total of 157 physicians participated in this study. A consensus was reached in 17 (71%) clinical situations. For an early limited recurrence, whatever presence of neuropathy, the preferred therapeutic approach (45%) was upfront surgery. For an early extended recurrence, whatever presence of neuropathy, there was a consensus (64%) for a preoperative chemotherapy by FOLFIRI + biologic agent. For a late recurrence without neuropathy, there was a consensus (50%) for a preoperative FOLFOX chemotherapy, whatever the extension of LM. For a late recurrence with neuropathy, upfront surgery was chosen (52%) for limited LM, and preoperative chemotherapy by FOLFIRI + biologic agent (73%) for extended LM. No response was influenced by the RAS mutation status. There was a strong consensus for intensified preoperative chemotherapy in all clinical situations for BRAF-mutated LM. CONCLUSIONS: This national survey provides an overview of the practice patterns in the treatment of LM occurring after adjuvant FOLFOX for primary. It could be a basis to establish expert's recommendations for the clinical practice.


Subject(s)
Colorectal Neoplasms , Liver Neoplasms , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Chemotherapy, Adjuvant , Colorectal Neoplasms/drug therapy , Fluorouracil/therapeutic use , Humans , Leucovorin/therapeutic use , Liver Neoplasms/drug therapy , Liver Neoplasms/surgery , Neoplasm Recurrence, Local , Oxaliplatin/therapeutic use
16.
Int J Colorectal Dis ; 35(7): 1291-1299, 2020 Jul.
Article in English | MEDLINE | ID: mdl-32361939

ABSTRACT

PURPOSE: Nausea and vomiting is the main cause of failure of enhanced recovery protocol (ERP) after right hemicolectomy. METHODS: From January 2013 to January 2018, all patients undergoing right hemicolectomy were prospectively included. Patients undergoing emergency surgery, additional complex procedure or temporary stoma, nasogastric tube (NGT) maintenance, or abdominal drainage were excluded. Failure of ERP was defined as nausea/vomiting precluding oral feeding after POD3 and/or the occurrence of postoperative ileus requiring NGT and/or length of stay (LOS) ≥ 8 days except for patients awaiting admission in rehabilitation unit. Risk factors of failure of ERP were identified using univariate and multivariate analysis. RESULTS: Among 306 patients undergoing right hemicolectomy, 140 fulfilled the inclusion criteria. Postoperative morbidity was 31%, and the mortality rate was nil. The mean postoperative hospital stay was 7 days (range 2-30). Successful ERP was achieved in 83 patients (59%). Causes of failure were major nausea/vomiting precluding oral feeding after POD3 in 36, postoperative ileus requiring NGT in 16 and LOS ≥ 8 days in 36. On multivariate analysis, preoperative anemia (OR 5.2; CI 95%, 1.3-21.1, p = 0.02) and platelet anti-aggregant/anti-coagulant (OR 4.5; CI 95%, 1.7-12.1, p = 0.003) were associated with the risk of failure of ERP. CONCLUSION: This study shows that anemia and medication with antiplatelet/anticoagulation therapy increase the risk of failure of ERP after right hemicolectomy that translates most of the time by nausea/vomiting and postoperative ileus. The presence of these factors should lead to adapt the strategy to improve outcome rather than be considered as contraindication to ERP.


Subject(s)
Colectomy , Ileus , Colectomy/adverse effects , Humans , Ileus/etiology , Length of Stay , Postoperative Complications/etiology , Prospective Studies , Risk Factors
17.
BMC Cancer ; 20(1): 485, 2020 May 29.
Article in English | MEDLINE | ID: mdl-32471382

ABSTRACT

BACKGROUND: Preoperative radiochemotherapy (RCT) is recommended in France prior to total mesorectal excision in patients with mid or low locally advanced rectal cancer (LARC) (cT3/T4 and/or N+) because it has been shown to improve local control. Preoperative RCT has also disadvantages including the absence of proven impact on metastatic recurrence and the risk of late side effects on bowel and genitourinary function. In patients with primarily resectable LARC, preoperative systemic chemotherapy without pelvic irradiation could be used as an alternative to RCT. METHODS: This study is a multicenter, open-label randomized, 2-arm phase III non-inferiority trial. Patients with mid or low resectable LARC (cT3N0 or cT1-T3N+ with circumferential resection margin [CRM] > 2 mm on pretreatment MRI) will be randomized to either modified FOLFIRINOX for 3 months or RCT (Cap50 intensified-modulated radiotherapy). All patients have restaging MRI after preoperative treatment. The primary endpoint is 3-year progression-free survival (PFS) from the time to randomization including progression during preoperative treatment. Secondary endpoints are treatment related toxicity, treatment compliance, R0 resection rate, sphincter saving surgery rate, postoperative morbidity and mortality rates, loco-regional recurrence free survival, overall survival, bowel and sexual functions at diagnosis, quality of life, radiologic and pathologic response after preoperative treatment. The number of patients required is 574. DISCUSSION: The choice of modified FOLFIRINOX for preoperative chemotherapy is supported by recent and consistent data on safety and efficacy of this regimen on rectal cancer. The use of preoperative chemotherapy instead of RCT could be associated with pronounced advantages in terms of functional results and quality of life in cancer survivors. However and first of all, the non-inferiority of preoperative chemotherapy compared to RCT on oncologic outcome has to be validated. If this study demonstrates the non-inferiority of chemotherapy compared to RCT, this can lead to a crucial change in clinical practice in a large subset of rectal cancer patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT03875781 (March 15, 2019). Version 1.1.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Neoadjuvant Therapy/adverse effects , Neoplasm Recurrence, Local/epidemiology , Postoperative Complications/epidemiology , Rectal Neoplasms/therapy , Adult , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Chemoradiotherapy, Adjuvant/adverse effects , Chemoradiotherapy, Adjuvant/methods , Chemoradiotherapy, Adjuvant/statistics & numerical data , Chemotherapy, Adjuvant/adverse effects , Chemotherapy, Adjuvant/methods , Chemotherapy, Adjuvant/statistics & numerical data , Clinical Trials, Phase III as Topic , Disease-Free Survival , Drug Administration Schedule , Equivalence Trials as Topic , Female , Fluorouracil/administration & dosage , Fluorouracil/adverse effects , Follow-Up Studies , Humans , Irinotecan/administration & dosage , Irinotecan/adverse effects , Leucovorin/administration & dosage , Leucovorin/adverse effects , Male , Middle Aged , Multicenter Studies as Topic , Neoadjuvant Therapy/methods , Neoadjuvant Therapy/statistics & numerical data , Neoplasm Recurrence, Local/prevention & control , Neoplasm Staging , Oxaliplatin/administration & dosage , Oxaliplatin/adverse effects , Patient Compliance/statistics & numerical data , Postoperative Complications/etiology , Preoperative Period , Proctectomy/adverse effects , Progression-Free Survival , Quality of Life , Randomized Controlled Trials as Topic , Rectal Neoplasms/mortality , Rectal Neoplasms/pathology , Rectum/drug effects , Rectum/pathology , Rectum/radiation effects , Rectum/surgery
18.
Ann Surg Oncol ; 27(8): 2877-2885, 2020 Aug.
Article in English | MEDLINE | ID: mdl-32144619

ABSTRACT

BACKGROUND: The clinical significance of discordant radiological and pathological response to preoperative chemotherapy of colorectal liver metastases (CLM) is unknown. METHODS: From 2011 to 2016, all eligible patients undergoing resection for CLM after preoperative chemotherapy were included at two centres. Patients were categorized according to radiologic response using RECIST as Rad-responders (complete/partial response) or Rad-non responders (stable disease) and according to Blazer et al. pathologic response grade as Path-responders (complete/major response) or Path-non responders (minor response). Survival outcome was analysed according to radiologic and pathologic response. RESULTS: Among 413 patients undergoing resection of CLM, 119 fulfilled the inclusion criteria. Among these, 52 (44%) had discordant radiologic and pathologic response including 27 Rad-non responders/path responders and 25 Rad-responders/Path-non responders. Rad-non responders/path responders and Rad-responders/Path-non responders had similar characteristics except for the proportion receiving more than 6 cycles of preoperative chemotherapy (7/27 vs 16/25; P = 0.017). Median disease-free survival was not different in patients with or without discordant radiologic and pathologic responses (P = 0.195) but the type of discordance had an impact on oncologic outcome as median disease-free survival was 13.9 months (95% CI 5.7-22.2 months) in Rad-non responders/Path responders and 8.6 (6.2 - 10.9 months) in Rad-responders/Path-non responders (P = 0.034). Univariate and multivariate analysis showed that major pathologic response was associated with improved disease-free survival (OR 0.583, 95% CI 0.36-0.95, P = 0.031). CONCLUSION: A discordant radiologic and pathologic response is common after preoperative chemotherapy for CLM. In these patients, pathologic response drives oncologic outcome.


Subject(s)
Colorectal Neoplasms , Liver Neoplasms , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Colorectal Neoplasms/diagnostic imaging , Colorectal Neoplasms/drug therapy , Colorectal Neoplasms/surgery , Hepatectomy , Humans , Liver Neoplasms/diagnostic imaging , Liver Neoplasms/drug therapy , Liver Neoplasms/secondary , Liver Neoplasms/surgery , Prognosis , Retrospective Studies , Treatment Outcome
20.
World J Surg ; 44(7): 2394-2400, 2020 07.
Article in English | MEDLINE | ID: mdl-32107592

ABSTRACT

BACKGROUND: There are no specific guidelines for ventral hernia management in Crohn's disease (CD) patients. We aimed to assess the risk of septic morbidity after mesh repair in CD. METHODS: This was a retrospective multicentre study comparing CD and non-CD patients undergoing mesh repair for ventral hernia (primary or incisional hernia). Controls were matched 1:1 for the presence of a stoma, history of surgical sepsis, hernia size and Ventral Hernia Working Group (VHWG) score. All demographic, pre-, intra- and postoperative data were retrieved, including long-term data. RESULTS: We included 234 patients, with 114 CD patients. Both groups had comparable VHWG scores (p = 0.12), hernia sizes (p = 0.11), ASA scores ≥ 3 (p = 0.70), body mass index values (p = 0.14), presence of stoma (CD 21.9% vs. controls 15%, p = 0.16), history of sepsis (14% vs. 6.7%, p = 0.23), rates of malnutrition (4.4% vs. 1.7%, p = 0.46), rates of incisional hernia (93% vs. 95%, p = 0.68) and concomitant procedures (18.4% vs. 11.7%, p = 0.12). CD patients carried a higher risk of postoperative septic morbidity (18.4% vs. 5%, p = 0.001), entero-prosthetic fistula (7% vs. 0, p < 0.01) and mesh withdrawals (5.3% vs. 0, p = 0.011). Ventral hernia recurrence rates were similar (14% vs. 8.3%, p = 0.15). In the univariate analysis, the risk factors for septic morbidity were CD (p = 0.001), malnutrition (p = 0.004), use of biological mesh (p < 0.0001) and concomitant procedure (p = 0.004). The mesh position, the means used for mesh fixation as well as the presence of a stoma were not identified as risk factors. CONCLUSIONS: CD seems to be a risk factor for septic morbidity after mesh repair.


Subject(s)
Crohn Disease/complications , Hernia, Ventral/surgery , Herniorrhaphy/methods , Postoperative Complications , Sepsis/etiology , Surgical Mesh , Adolescent , Adult , Aged , Case-Control Studies , Female , Follow-Up Studies , Hernia, Ventral/etiology , Herniorrhaphy/instrumentation , Humans , Incisional Hernia/epidemiology , Incisional Hernia/surgery , Male , Matched-Pair Analysis , Middle Aged , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Retrospective Studies , Risk Factors , Sepsis/epidemiology , Treatment Outcome , Young Adult
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