HIPECT4: multicentre, randomized clinical trial to evaluate safety and efficacy of Hyperthermic intra-peritoneal chemotherapy (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal carcinoma.

BACKGROUND: Local relapse and peritoneal carcinomatosis (PC) for pT4 colon cancer is estimated in 15,6% and 36,7% for 12 months and 36 months from surgical resection respectively, achieving a 5 years overall survival of 6%. There are promising results using prophylactic HIPEC in this group of patients, and it is estimated that up to 26% of all T4 colon cancer could benefit from this treatment with a minimal morbidity. Adjuvant HIPEC is effective to avoid the possibility of peritoneal seeding after surgical resection. Taking into account these results and the cumulative experience in HIPEC use, we will lead a randomized controlled trial to determine the effectiveness and safety of adjuvant treatment with HIPEC vs. standard treatment in patients with colon cancer at high risk of peritoneal recurrence (pT4). METHODS/DESIGN: The aim of this study is to determine the effectiveness and safety of adjuvant HIPEC in preventing the development of PC in patients with colon cancer with a high risk of peritoneal recurrence (cT4). This study will be carried out in 15 Spanish HIPEC centres. Eligible for inclusion are patients who underwent curative resection for cT4NxM0 stage colon cancer. After resection of the primary tumour, 200 patients will be randomized to adjuvant HIPEC followed by routine adjuvant systemic chemotherapy in the experimental arm, or to systemic chemotherapy only in the control arm. Adjuvant HIPEC will be performed simultaneously after the primary resection. Mitomycin C will be used as chemotherapeutic agent, for 60 min at 42-43 °C. Primary endpoint is loco-regional control (LC) in months and the rate of loco-regional control (%LC) at 12 months and 36 months after resection. DISCUSSION: We assumed that adjuvant HIPEC will reduce the expected absolute risk of peritoneal recurrence from 36% to 18% at 36 months for T4 colon-rectal carcinoma. TRIAL REGISTRATION: NCT02614534 ( clinicaltrial.gov ) Nov-2015.

Validation in colorectal procedures of a useful novel approach for the use of C-reactive protein in postoperative infectious complications.

AIM: Our aim was to validate a novel use of C-reactive protein (CRP) measurement to identify postoperative infectious complications in patients undergoing colorectal surgery, and to compare the predictive value in this setting against white blood cell (WBC) count and neutrophil-to-lymphocyte ratio (NLR). METHOD: This was a retrospective study of CRP, NLR and WBC measurements in patients undergoing colorectal surgery. CRP, NLR and WBC were recorded on the second postoperative day and on the day of infectious complication (patients who developed infectious complications) or within 3 days prior to discharge (subjects with no complications). The test for detecting infectious complications consisted of comparing the value of the inflammatory marker on the day on which a complication was suspected against the value recorded on the second postoperative day. The test was considered positive if a given value was higher than the registered peak at postoperative day 2. Factors influencing the postoperative peak CRP were also studied. RESULTS: A total of 254 patients were retrospectively studied. Patients whose CRP value was higher than on the second postoperative day had a diagnostic accuracy for infectious complications of up to 94.4% and sensitivity, specificity, positive predictive value and negative predictive value of up to 97.4%, 93.4%, 85.7% and 99.1%, respectively. Poorer results were observed when WBC count and NLR were used rather than CRP measurement. Multiple linear regression analysis showed that surgical procedure and approach, as well as additional resections, were independent factors for 48 h peak CRP. CONCLUSION: C-reactive protein is a better parameter than WBC count and NLR for detecting infectious complications. Our proposed methodology presents good diagnostic accuracy and performance and could potentially be used for any surgical procedure.

Laparotomía urgente en un caso de paniculitis mesentérica / No disponible

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