Adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with colon cancer at high risk of peritoneal carcinomatosis; the COLOPEC randomized multicentre trial

Background: The peritoneum is the second most common site of recurrence in colorectal cancer. Early detection of peritoneal carcinomatosis (PC) by imaging is difficult. Patients eventually presenting with clinically apparent PC have a poor prognosis. Median survival is only about five months if untreated and the benefit of palliative systemic chemotherapy is limited. Only a quarter of patients are eligible for curative treatment, consisting of cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CR/HIPEC). However, the effectiveness depends highly on the extent of disease and the treatment is associated with a considerable complication rate. Methods/Design: The aim of this study is to determine the effectiveness of adjuvant HIPEC in preventing the development of PC in patients with colon cancer at high risk of peritoneal recurrence. This study will be performed in the nine Dutch HIPEC centres, starting in April 2015. Eligible for inclusion are patients who underwent curative resection for T4 or intra-abdominally perforated cM0 stage colon cancer. After resection of the primary tumour, 176 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 or shortly after the primary resection. Oxaliplatin will be used as chemotherapeutic agent, for 30 min at 42-43 °C. Just before HIPEC, 5-fluorouracil and leucovorin will be administered intravenously. Primary endpoint is peritoneal disease-free survival at 18 months. Diagnostic laparoscopy will be performed routinely after 18 months postoperatively in both arms of the study in patients without evidence of disease based on routine follow-up using CT imaging and CEA. Discussion: Adjuvant HIPEC is assumed to reduce the expected 25 % absolute risk of PC in patients with T4 or perforated colon cancer to a risk of 10 %. This reduction is likely to translate into a prolonged overall survival. Trial registration number: NCT02231086 (Clinicaltrials.gov)

Perineal wound closure using gluteal turnover flap or primary closure after abdominoperineal resection for rectal cancer: study protocol of a randomised controlled multicentre trial (BIOPEX-2 study)

BACKGROUND: Abdominoperineal resection (APR) for rectal cancer is associated with high morbidity of the perineal wound, and controversy exists about the optimal closure technique. Primary perineal wound closure is still the standard of care in the Netherlands. Biological mesh closure did not improve wound healing in our previous randomised controlled trial (BIOPEX-study). It is suggested, based on meta-analysis of cohort studies, that filling of the perineal defect with well-vascularised tissue improves perineal wound healing. A gluteal turnover flap seems to be a promising method for this purpose, and with the advantage of not having a donor site scar. The aim of this study is to investigate whether a gluteal turnover flap improves the uncomplicated perineal wound healing after APR for rectal cancer. METHODS: Patients with primary or recurrent rectal cancer who are planned for APR will be considered eligible in this multicentre randomised controlled trial. Exclusion criteria are total exenteration, sacral resection above S4/S5, intersphincteric APR, biological mesh closure of the pelvic floor, collagen disorders, and severe systemic diseases. A total of 160 patients will be randomised between gluteal turnover flap (experimental arm) and primary closure (control arm). The total follow-up duration is 12 months, and outcome assessors and patients will be blinded for type of perineal wound closure. The primary outcome is the percentage of uncomplicated perineal wound healing on day 30, defined as a Southampton wound score of less than two. Secondary outcomes include time to perineal wound closure, incidence of perineal hernia, the number, duration and nature of the complications, re-interventions, quality of life and urogenital function. DISCUSSION: The uncomplicated perineal wound healing rate is expected to increase from 65 to 85% by using the gluteal turnover flap. With proven effectiveness, a quick implementation of this relatively simple surgical technique is expected to take place. TRIAL REGISTRATION: The trial was retrospectively registered at Clinicaltrials.gov NCT04004650 on July 2, 2019

Short term outcome of loop ileostomy closure under local anaesthesia: results of a feasibility study.

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Prudent application of radiofrequency ablation in resectable colorectal liver metastasis.

Contains fulltext : 52974.pdf (publisher's version ) (Closed access)Radiofrequency ablation (RFA) for liver metastasis of colorectal (H-CRC) origin is a well-documented technique in surgically unresectable disease. Overall recurrence figures appear inferior to resection but are based on a selection of patients with unresectable disease, often due to multiple localisations of extensive disease. Lesion based recurrence is probably more appropriate to predict results of RFA in surgically resectable H-CRC and figures may be good enough to consider RFA an alternative treatment in high risk patients

Doppler-guided intra-operative fluid management during major abdominal surgery: a systematic review and meta-analysis (Int J Clin Pract 2007; November 21: Epub ahead of print).

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Systematic review and meta-analysis for laparoscopic versus open colon surgery with or without an ERAS programme

Contains fulltext : 152774.pdf (publisher's version ) (Open Access)BACKGROUND: In recent years, conventional colorectal resection and its aftercare have increasingly become replaced by laparoscopic surgery and enhanced recovery after surgery (ERAS) pathways, respectively. OBJECTIVE: To ascertain whether combining laparoscopy and ERAS have additional value within colorectal surgery. METHODS: A systematic review with meta-analysis was performed with two primary research questions; does laparoscopy offer an advantage when all patients receive ERAS perioperative care and does ERAS offer advantages in a laparoscopically operated patient population. All randomised and controlled clinical trials were identified using MEDLINE, EMBASE and Cochrane databases. RESULTS: Primary search resulted in 319 hits. After inclusion criteria were applied, three RCTs and six CCTs were included in the meta-analysis. For laparoscopically operated patients with/without ERAS, no differences in morbidity were found and postoperative hospital stay favoured ERAS (MD -2.34 [-3.77, -0.91], Z = 3.20, p = 0.001). When comparing laparoscopy and open surgery within ERAS, major morbidity was significantly reduced in the laparoscopic group (OR 0.42 [0.26, 0.66], Z = 3.73, p = 0.006). Other outcome parameters showed no differences. Quality of included studies was considered moderate to poor overall with small sample sizes. CONCLUSION: When laparoscopy and ERAS are combined, major morbidity and hospital stay are reduced. The reduction in morbidity seems to be due to laparoscopy rather than ERAS, so laparoscopy by itself offers independent advantages beyond ERAS care. Quality of included studies was moderate to poor, so conclusions should be regarded with some reservations

Laparoscopic sigmoid resection for diverticulitis decreases major morbidity rates: a randomized controlled trial.

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