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1.
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
2.
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
3.
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
4.
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
5.
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
6.
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
7.
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
8.
Dis Colon Rectum ; 63(3): 371-380, 2020 03.
Article in English | MEDLINE | ID: mdl-31842165

ABSTRACT

BACKGROUND: The indications and efficacy of endoluminal vacuum therapy for the management of colorectal/coloanal anastomotic leakage are not well defined. OBJECTIVE: This study aimed to evaluate the efficacy and to define adequate indications of endoluminal vacuum therapy to treat colorectal/coloanal anastomotic leakage. DESIGN: The retrospective cohort evaluated in this study is based on a prospectively maintained database. SETTINGS: This study was conducted in 8 centers from the French GRECCAR study group. PATIENTS: Patients with colorectal/coloanal anastomotic leakage treated with endoluminal vacuum therapy were included. MAIN OUTCOME MEASURES: The primary outcome measured was the success rate of endoluminal vacuum therapy defined by the complete healing of the perianastomotic sepsis and a functional anastomosis. The predictive factors of success of endoluminal vacuum therapy and long-term functional result (low anterior resection syndrome score) were also analyzed. RESULTS: Among 62 patients treated for an anastomotic leakage of colorectal/coloanal anastomosis from 2012 to 2017, 47 fulfilled the inclusion criteria. The patients had a mean of 6.6 (±5.8) replacements for a total of 27 (±34) days treatment duration, associated with diverting stoma in 81%. After 37 months median follow-up, a successful treatment of anastomotic leakage using endoluminal vacuum therapy could be achieved in 26 patients (55%). The success rate was improved in patients undergoing primary endoluminal vacuum therapy compared to salvage endoluminal vacuum therapy (73% vs 33%, p = 0.006) and when endoluminal vacuum therapy was initiated within 15 days compared to more than 15 days after the diagnosis of anastomotic leakage (72.4% vs 27.8%, p = 0.003). At 12 months, 53% of patients who responded had minor low anterior resection syndrome and only 3 necessitated anastomotic stricture dilation. LIMITATIONS: This was a noncomparative cohort study. CONCLUSION: Endoluminal vacuum therapy appears to be effective to treat colorectal anastomotic leakage especially when it is used as primary treatment of the fistula. Long-term functional outcome of patients undergoing conservative management of anastomotic leakage may be improved with endoluminal vacuum therapy. See Video Abstract at http://links.lww.com/DCR/B103. RESULTADOS A CORTO Y LARGO PLAZO DE LA TERAPIA DE VACÍO ENDOLUMINAL PARA LA FUGA ANASTOMÓTICA COLORRECTAL O COLOANAL: RESULTADOS DE UN ESTUDIO DE COHORTE MULTICÉNTRICO A NIVEL NACIONAL DEL GRUPO FRANCÉS GRECCAR: Las indicaciones y la eficacia de la terapia de vacío endoluminal para el tratamiento de la fuga anastomótica colorrectal / coloanal no están bien definidas.Evaluar la eficacia y definir indicaciones adecuadas de la terapia de vacío endoluminal para tratar la fuga anastomótica colorrectal / coloanal.Cohorte retrospectivo basada en una base de datos mantenida prospectivamente.Este estudio se realizó en 8 centros del grupo de estudio Francés GRECCAR.Se incluyeron pacientes con fuga anastomótica colorrectal / coloanal tratados con terapia de vacío endoluminal.Tasa de éxito de la terapia de vacío endoluminal definida por la curación completa de la sepsis perianastomótica y una anastomosis funcional. También se analizaron los factores predictivos del éxito de la terapia de vacío endoluminal y el resultado funcional a largo plazo (puntaje bajo del síndrome de resección anterior).Entre 62 pacientes tratados por una fuga anastomótica de anastomosis colorrectal / coloanal de 2012 a 2017, 47 cumplieron los criterios de inclusión. Los pacientes tuvieron una media de 6.6 (±5.8) reemplazos para un total de 27 (±34) días de duración del tratamiento, asociado con estoma de desvio en el 81%. Después de una mediana de seguimiento de 37 meses, se pudo lograr un tratamiento exitoso de la fuga anastomótica usando terapia de vacío endoluminal en 26 pacientes (55%). La tasa de éxito mejoró en pacientes sometidos a terapia de vacío endoluminal primaria en comparación con la terapia de vacío endoluminal de rescate (73% frente a 33%, p = 0.006) y cuando la terapia de vacío endoluminal se inició dentro de los 15 días en comparación con más de 15 días después del diagnóstico de fuga anastomótica (72.4% vs 27.8%, p = 0.003). A los 12 meses, el 53% de los pacientes que respondieron tenían síndrome de resección anterior baja leve y solo 3 necesitaban dilatación de estenosis anastomótica.Estudio de cohorte no comparativo.La terapia de vacío endoluminal parece ser efectiva para tratar la fuga anastomótica colorrectal, especialmente cuando se usa como tratamiento primario de la fístula. El resultado funcional a largo plazo de los pacientes sometidos a un tratamiento conservador de la fuga anastomótica puede mejorarse con la terapia de vacío endoluminal. Consulte Video Resumen en http://links.lww.com/DCR/B103.


Subject(s)
Anastomotic Leak/therapy , Colectomy , Negative-Pressure Wound Therapy/methods , Proctectomy , Aged , Female , France , Humans , Male , Middle Aged , Retrospective Studies , Vacuum , Wound Healing
9.
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
10.
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
11.
Ann Surg ; 270(5): 827-834, 2019 11.
Article in English | MEDLINE | ID: mdl-31567506

ABSTRACT

OBJECTIVE: The aim of this study was to assess recurrence risk factors following ileocolonic resection (ICR) for Crohn disease (CD) in a nationwide cohort study SUMMARY BACKGROUND DATA:: Recurrence rate after ICR for CD can be up to 60%, but its predictive factors have never been evaluated in large prospective cohort studies. METHODS: From 2013 to 2015, 346 consecutive patients undergoing ICR for CD and a postoperative ileocoloscopy within 6 to 12 months after surgery at 19 academic French centers were included prospectively. RESULTS: Twelve-month postoperative endoscopic (Rutgeerts score ≥i2) and clinical recurrence rates were 57.6% [95% confidence interval (CI), 54.2-61.0] and 11.3% (95% CI, 9-13.6), respectively. A total of 185 patients (54%) had a postoperative CD prophylaxis, comprising thiopurine in 69 (20%), or anti-tumor necrosis factor (TNF) therapy in 93 (27%). In multivariate Cox regression analysis, absence of postoperative smoking {odds ratio [OR] = 0.60 (95% CI, 0.40-0.91); P = 0.016}, postoperative prophylaxis [OR = 0.60 (95% CI, 0.41-0.88); P = 0.009], and penetrating disease behavior [OR = 0.58 (95% CI, 0.39-0.86); P = 0.007] were the only independent predictors of reduced endoscopic recurrence risk. Postoperative prophylaxis [OR 0.31 (95% CI, 0.15-0.66); P = 0.002), and penetrating behavior [OR = 00.36 (95% CI, 0.16-0.81); P = 0.013), were the only independent predictors of reduced clinical recurrence risk. Postoperative anti-TNF therapy was associated with a significant reduction of both 12-month risks of endoscopic (P < 0.001) and clinical (P = 0.019) recurrences. CONCLUSION: Absence of postoperative smoking, CD prophylaxis, and penetrating disease behavior could be independent predictors of reduced postoperative recurrence after ICR for CD. Prophylactic anti-TNF therapy reduces both endoscopic and clinical recurrence rates. It suggests that upfront surgery followed by postoperative anti-TNF therapy is probably the best therapeutic approach for complex CD (penetrating disease behavior).


Subject(s)
Colon/surgery , Crohn Disease/diagnosis , Crohn Disease/surgery , Digestive System Surgical Procedures/methods , Ileum/surgery , Intestinal Perforation/surgery , Academic Medical Centers , Adult , Analysis of Variance , Anastomosis, Surgical/methods , Cohort Studies , Databases, Factual , Digestive System Surgical Procedures/adverse effects , Female , France , Humans , Incidence , Intestinal Perforation/diagnosis , Male , Middle Aged , Multivariate Analysis , Postoperative Complications/epidemiology , Postoperative Complications/physiopathology , Prognosis , Prospective Studies , Recurrence , Severity of Illness Index , Treatment Outcome , Young Adult
12.
BMC Cancer ; 19(1): 1185, 2019 Dec 04.
Article in English | MEDLINE | ID: mdl-31801485

ABSTRACT

BACKGROUND: Several multicenter randomized controlled trials comparing laparoscopy and conventional open surgery for colon cancer have demonstrated that laparoscopic approach achieved the same oncological results while improving significantly early postoperative outcomes. These trials included few elderly patients, with a median age not exceeding 71 years. However, colon cancer is a disease of the elderly. More than 65% of patients operated on for colon cancer belong to this age group, and this proportion may become more pronounced in the coming years. In current practice, laparoscopy is underused in this population. METHODS: The CELL (Colectomy for cancer in the Elderly by Laparoscopy or Laparotomy) trial is a multicenter, open-label randomized, 2-arm phase III superiority trial. Patients aged 75 years or older with uncomplicated colonic adenocarcinoma or endoscopically unresectable colonic polyp will be randomized to either colectomy by laparoscopy or laparotomy. The primary endpoint of the study is overall postoperative morbidity, defined as any complication classification occurring up to 30 days after surgery. The secondary endpoints are: 30-day and 90-day postoperative mortality, 30-day readmission rate, quality of surgical resection, health-related quality of life and evolution of geriatric assessment. A 35 to 20% overall postoperative morbidity rate reduction is expected for patients operated on by laparoscopy compared with those who underwent surgery by laparotomy. With a two-sided α risk of 5% and a power of 80% (ß = 0.20), 276 patients will be required in total. DISCUSSION: To date, no dedicated randomized controlled trial has been conducted to evaluate morbidity after colon cancer surgery by laparoscopy or laparotomy in the elderly and the benefits of laparoscopy is still debated in this context. Thus, a prospective multicenter randomized trial evaluating postoperative outcomes specifically in elderly patients operated on for colon cancer by laparoscopy or laparotomy with curative intent is warranted. If significant, such a study might change the current surgical practices and allow a significant improvement in the surgical management of this population, which will be the vast majority of patients treated for colon cancer in the coming years. TRIAL REGISTRATION: ClinicalTrials.gov NCT03033719 (January 27, 2017).


Subject(s)
Colectomy/methods , Colonic Neoplasms/surgery , Aged , Aged, 80 and over , Clinical Trials, Phase III as Topic , Colectomy/adverse effects , Colonic Neoplasms/pathology , Geriatric Assessment , Humans , Laparoscopy , Laparotomy , Postoperative Complications/epidemiology , Quality of Life , Randomized Controlled Trials as Topic
13.
Ann Surg ; 267(2): 221-228, 2018 02.
Article in English | MEDLINE | ID: mdl-29300710

ABSTRACT

OBJECTIVE: To determine the risk factors of morbidity after surgery for ileocolonic Crohn disease (CD). SUMMARY BACKGROUND DATA: The risk factors of morbidity after surgery for CD, particularly the role of anti-TNF therapy, remain controversial and have not been evaluated in a large prospective cohort study. METHODS: From 2013 to 2015, data on 592 consecutive patients who underwent surgery for CD in 19 French specialty centers were collected prospectively. Possible relationships between anti-TNF and postoperative overall morbidity were tested by univariate and multivariate analyses. Because treatment by anti-TNF is possibly dependent on the characteristics of the patients and disease, a propensity score was calculated and introduced in the analyses using adjustment of the inverse probability of treatment-weighted method. RESULTS: Postoperative mortality, overall and intra-abdominal septic morbidity rates in the entire cohort were 0%, 29.7%, and 8.4%, respectively; 143 (24.1%) patients had received anti-TNF <3 months prior to surgery. In the multivariate analysis, anti-TNF <3 months prior to surgery was identified as an independent risk factor of the overall postoperative morbidity (odds-ratio [OR] =1.99; confidence interval [CI] 95% = 1.17-3.39, P = 0.011), with preoperative hemoglobin <10 g/dL (OR = 4.77; CI 95% = 1.32-17.35, P = 0.017), operative time >180 min (OR = 2.71; CI 95% = 1.54-4.78, P < 0.001) and recurrent CD (OR = 1.99; CI 95% = 1.13-3.36, P = 0.017). After calculating the propensity score and adjustment according to the inverse probability of treatment-weighted method, anti-TNF <3 months prior to surgery remained associated with a higher risk of overall (OR = 2.98; CI 95% = 2.04-4.35, P <0.0001) and intra-abdominal septic postoperative morbidities (OR = 2.22; CI 95% = 1.22-4.04, P = 0.009). CONCLUSIONS: Preoperative anti-TNF therapy is associated with a higher risk of morbidity after surgery for ileocolonic CD. This information should be considered in the surgical management of these patients, particularly with regard to the preoperative preparation and indication of temporary defunctioning stoma.


Subject(s)
Antibodies, Monoclonal/adverse effects , Crohn Disease/surgery , Gastrointestinal Agents/adverse effects , Postoperative Complications/chemically induced , Tumor Necrosis Factor-alpha/antagonists & inhibitors , Adolescent , Adult , Aged , Aged, 80 and over , Antibodies, Monoclonal/therapeutic use , Combined Modality Therapy , Crohn Disease/drug therapy , Female , Gastrointestinal Agents/therapeutic use , Humans , Logistic Models , Male , Middle Aged , Postoperative Complications/epidemiology , Preoperative Period , Prospective Studies , Risk Factors , Treatment Outcome , Young Adult
14.
Ann Surg Oncol ; 24(5): 1304-1311, 2017 May.
Article in English | MEDLINE | ID: mdl-28008572

ABSTRACT

BACKGROUND: Patients with ypN0 rectal cancer who have received preoperative chemoradiotherapy can be divided into those who initially were node negative and those whose positive nodes have been sterilized by preoperative therapy. The long-term prognosis for ypN0 patients with sterilized lymph nodes (LNS) is unknown. This study aimed to assess the prognostic value of LNS after preoperative chemoradiotherapy for patients with ypN0 rectal cancer. METHODS: From January 2007 to March 2014, 206 patients with ypN0 tumors of the mid or lower rectum treated by chemoradiotherapy and radical surgery were enrolled in the study. Of these 206 patients, 49 had ypN0 tumors with LNS (LNS+ group), and 157 had ypN0 tumors without LNS (LNS- group). The patients in both groups were comparable in terms of tumor characteristics, type of chemoradiotherapy, type of surgery, R0 resection rate, and postoperative complication rate. RESULTS: The mean follow-up period was 40.5 ± 27 months. The 1- and 3-year OS rates in the LNS+ group were respectively 100 and 95.5% versus 99.4 and 91.6% in the LNS- group (P = 0.549). The 1- and 3-year DFS rates in the LNS+ group were respectively 100 and 94.2% versus 94.7 and 87.1% in the LNS- group (P = 0.117). The multivariate analysis showed that the presence of LNS did not affect OS (P = 0.918) or DFS (P = 0.209). CONCLUSIONS: The prognosis is excellent for patients with ypN0 rectal cancer who have LNS after preoperative chemoradiotherapy. The presence of LNS in ypN0 rectal cancer patients after chemoradiotherapy should not be considered a factor for a poor prognosis.


Subject(s)
Lymph Nodes/pathology , Rectal Neoplasms/pathology , Rectal Neoplasms/therapy , Aged , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Chemoradiotherapy, Adjuvant , Disease-Free Survival , Dose Fractionation, Radiation , Female , Fluorouracil/administration & dosage , Humans , Lymphatic Metastasis , Male , Middle Aged , Neoadjuvant Therapy , Neoplasm, Residual , Preoperative Care , Retrospective Studies , Survival Rate
15.
Scand J Gastroenterol ; 52(1): 5-10, 2017 Jan.
Article in English | MEDLINE | ID: mdl-27553420

ABSTRACT

OBJECTIVE: Exclusive polymeric diet enriched with transforming growth factor-beta 2 (ANS-TGF-ß2) has been used for remission induction and maintenance in pediatric Crohn's disease (CD). Its use in the preoperative setting has never been evaluated. The aim of this study was to evaluate preoperative ANS-TGF-ß2 to decrease postoperative complications after surgery for complicated ileocolonic CD. METHODS: From 2011 to 2015, data of all consecutive patients who underwent elective surgery for ileocolonic CD were collected prospectively. Preoperative, exclusive ANS-TGF-ß2 was administered in high-risk patients with complicated CD. Complicated CD was defined by the presence of obstructive symptoms, and/or steroid treatment, and/or preoperative weight loss >10% and/or perforating CD. Outcomes of high-risk patients receiving preoperative ANS-TGF-ß2 were compared to those of low-risk patients with no complicated CD who underwent upfront surgery. RESULTS: Fifty-six patients underwent surgery for ileocolonic CD. Among them, 35 high-risk patients received preoperative ANS-TGF-ß2 and 21 low-risk patients underwent upfront surgery. Preoperative full-dose ANS-TGF-ß2 was feasible in 34/35 high-risk patients. Discontinuation of steroids during preoperative ANS-TGF-ß2 could be achieved in 10/16 patients (62.5%). Postoperative complications rates were 8/35 (23.8%) and 5/21 (22.9%) in high-risk and low-risk patients, respectively (p = 1). Temporary ileocolostomy rates in high-risk patients and in low-risk patients were 4/35 (11%) and 0/21, respectively (p = 0.286) Conclusion: Preoperative ANS-TGF-ß2 is feasible in most high-risk patients with complicated ileocolonic CD and could limit the deleterious effects of risk factors of postoperative morbidity. These results need to be confirmed in a large randomized controlled trial.


Subject(s)
Crohn Disease/therapy , Diet , Dietary Supplements , Elective Surgical Procedures/adverse effects , Postoperative Complications/epidemiology , Transforming Growth Factor beta2/therapeutic use , Adult , Aged , Crohn Disease/surgery , Enteral Nutrition/methods , Female , France , Humans , Logistic Models , Male , Middle Aged , Morbidity , Multivariate Analysis , Prospective Studies , Remission Induction , Risk Factors , Young Adult
16.
Int J Colorectal Dis ; 32(5): 699-707, 2017 May.
Article in English | MEDLINE | ID: mdl-28124742

ABSTRACT

PURPOSE: The aim of this prospective study was to assess the influence of morphological characteristics of anastomotic doughnuts on the risk of anastomotic leakage (AL) after double-stapled colorectal anastomosis. METHODS: This single-center prospective study enrolled all patients undergoing double-stapled colorectal anastomosis between December 2012 and December 2015. Maximal diameter and minimal and maximal heights and widths of both colonic and rectal doughnuts were measured by surgeons in the operating room. Their influence on the risk of AL was analyzed on uni- and multivariate models. RESULTS: One hundred fifty-four patients were included; 92 (59.7%) were operated on for malignancy. Colorectal anastomoses > and <10 cm above the anal verge were performed in 96 (62.3%) and 58 (37.7%) patients, respectively. AL occurred in 17 (11.0%). The minimal height of the colonic doughnut (CD) was the only measurement significantly associated with an increased risk of AL (p = 0.026). A cutoff value of 4.5 mm for the CD determined on the ROC curve (AUC 0.685, p = 0.013) yielded the best sensitivity (61.4%) and specificity (82.4%) to predict AL. On multivariate analysis, a height of the CD <4.5 mm (OR 5.743, 95% IC 1.476-22.346, p = 0.012), malignant disease (OR 8.821, 95% IC 1.051-74.006, p = 0.045), and American Society of Anesthesiologists score >2 (OR 3.408, 95% IC 1.017-11.418, p = 0.047) were the only independent risk factors of AL. CONCLUSION: The CD's minimal height influences the risk of AL. Its routine measurement during operation, along with other risk factors, could help to decide which patients could benefit from a diverting stoma or the creation of a new anastomosis.


Subject(s)
Anastomosis, Surgical/adverse effects , Anastomotic Leak/etiology , Colon/pathology , Colon/surgery , Colorectal Surgery/adverse effects , Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Multivariate Analysis , Postoperative Care , Postoperative Complications/etiology , Prospective Studies , ROC Curve , Risk Factors , Treatment Outcome
17.
Int J Colorectal Dis ; 31(10): 1693-9, 2016 Oct.
Article in English | MEDLINE | ID: mdl-27631642

ABSTRACT

PURPOSE: This prospective study aimed to compare outcomes after laparoscopic peritoneal lavage (LPL) and sigmoid resection with primary colorectal anastomosis (RPA). METHODS: From June 2010 to June 2015, 40 patients presenting with Hinchey III peritonitis from perforated diverticulitis underwent LPL or RPA. Patients with Hinchey II or IV peritonitis and patients who underwent an upfront Hartmann procedure were excluded. Primary endpoint was overall 30-day or in-hospital postoperative morbidity after surgical treatment of peritonitis. RESULTS: Twenty-five patients underwent RPA and 15 LPL. Overall postoperative morbidity and mortality rates were not significantly different after RPA and LPL (40 vs 67 %, p = 0.19; 4 vs 6.7 %, p = 1, respectively). Intra-abdominal morbidity and reoperation rates were significantly higher after LPL compared to RPA (53 vs 12 %, p < 0.01; 40 vs 4 %, p = 0.02, respectively). Multivariate analysis showed that LPL (p = 0.028, HR = 18.936, CI 95 % = 1.369-261.886) was associated with an increased risk of postoperative intra-abdominal septic morbidity. Among 6 patients who underwent reoperation after LPL, 4 had a Hartmann procedure. All surviving patients who had a procedure requiring stoma creation underwent stoma reversal after a median delay of 92 days after LPL and 72 days after RPA (p = 0.07). CONCLUSION: LPL for perforated diverticulitis is associated with a high risk of inadequate intra-abdominal sepsis control requiring a Hartmann procedure in up to 25 % of patients. RPA appears to be safer and more effective. It may represent the best option in this context.


Subject(s)
Colon, Sigmoid/surgery , Diverticulitis/surgery , Ileostomy/methods , Intestinal Perforation/surgery , Laparoscopy , Peritoneal Lavage , Peritonitis/surgery , Adult , Aged , Aged, 80 and over , Anastomosis, Surgical , Diverticulitis/complications , Female , Humans , Intestinal Perforation/complications , Male , Middle Aged , Multivariate Analysis , Peritonitis/complications , Postoperative Care , Preoperative Care , Prospective Studies , Risk Factors , Treatment Outcome
19.
Ann Diagn Pathol ; 18(5): 266-70, 2014 Oct.
Article in English | MEDLINE | ID: mdl-25205085

ABSTRACT

Tumor response to neoadjuvant therapy is a significant predictive indicator of recurrence-free survival. We measured tumor response using residual tumor thickness at the tumor-normal tissue interface (TNI) and evaluated its association with outcome in patients with liver metastasis of breast cancer. We included 48 patients who underwent neoadjuvant therapy followed by partial liver resection at MD Anderson Cancer Center between 1997 and 2010. The hematoxylin-eosin-stained tumor sections were evaluated for both pathologic response and the residual tumor thickness at the TNI by 3 pathologists who were blinded to the clinical information, treatment regimen, and patient outcome. The residual tumor thickness at the TNI was correlated with recurrence-free survival using Kaplan-Meier method and log-rank test. Cox proportional hazard model was used to identify predictors of recurrence-free survival. All patients were women with a median age of 43 years. The median duration of follow-up was 52.1 months. Residual tumor thickness less than or equal to 3 mm at the TNI correlated with major pathologic response and was associated with longer recurrence-free survival in both univariate and multivariate analyses. Residual tumor thickness at the TNI predicts recurrence-free survival and provides an objective outcome end point in patients who underwent neoadjuvant therapy and liver resection of metastatic breast cancer. We suggest using both the pathologic response and the residual tumor thickness at the TNI to measure tumor response to therapy to improve accuracy.


Subject(s)
Breast Neoplasms/pathology , Liver Neoplasms/secondary , Neoplasm, Residual/mortality , Neoplasm, Residual/pathology , Adult , Combined Modality Therapy , Disease-Free Survival , Female , Humans , Kaplan-Meier Estimate , Liver Neoplasms/mortality , Liver Neoplasms/therapy , Middle Aged , Neoadjuvant Therapy , Proportional Hazards Models , Retrospective Studies
20.
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
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