Transinguinal preperitoneal (TIPP) vs endoscopic total extraperitoneal (TEP) procedure in unilateral inguinal hernia repair: a randomized controlled trial.

PURPOSE: The Lichtenstein hernioplasty has long been seen as the gold standard for inguinal hernia repair. Unfortunately, this repair is often associated with chronic pain, up to 10-35%. Therefore, several new techniques have been developed, such as the transinguinal preperitoneal patch (TIPP) and the endoscopic total extraperitoneal (TEP) technique. Several studies showed beneficial results of the TIPP and TEP compared to the Lichtenstein hernioplasty; however, little is published on the outcome when comparing the TIPP and TEP procedures. This study aimed to evaluate outcomes after the TIPP vs the TEP technique for inguinal hernia repair. METHODS: A single-center randomized controlled trial was carried out between 2015 and 2020. A total of 300 patients with unilateral inguinal hernia were enrolled and randomized to the TIPP- or TEP technique. Primary outcome was chronic pain (defined as any pain following the last 3 months) and quality of life, assessed with Carolinas comfort scale (CCS) at 12 months. Secondary outcomes were: wound infection, wound hypoesthesia, recurrence, readmission within 30 days, and reoperation. RESULTS: A total of 300 patients were randomized (150 per group). After a follow-up of 12 months, we observed significantly less postoperative chronic groin pain, chronic pain at exertion, wound hypoesthesia, and wound infections after the TEP when compared to the TIPP procedure. No significant differences in quality of life, reoperations, recurrence rate, and readmission within 30 days were observed. CONCLUSION: We showed that the TEP has a favorable outcome compared to the TIPP procedure, leading to less postoperative pain and wound complications, whereas recurrence rates and reoperations were equal in both the groups.

Prognostic implications of occult nodal tumour cells in stage I and II colon cancer: The correlation between micrometastasis and disease recurrence.

INTRODUCTION: Occult nodal tumour cells should be categorised as micrometastasis (MMs) and isolated tumour cells (ITCs). A recent meta-analysis demonstrated that MMs, but not ITCs, are prognostic for disease recurrence in patients with stage I/II colon cancer. AIMS & METHODS: The objective of this retrospective multicenter study was to correlate MMs and ITCs to characteristics of the primary tumour, and to determine their prognostic value in patients with stage I/II colon cancer. RESULTS: One hundred ninety two patients were included in the study with a median follow up of 46 month (IQR 33-81 months). MMs were found in eight patients (4.2%), ITCs in 37 (19.3%) and occult tumour cells were absent in 147 patients (76.6%). Between these groups, tumour differentiation and venous or lymphatic invasion was equally distributed. Advanced stage (pT3/pT4) was found in 66.0% of patients without occult tumour cells (97/147), 72.9% of patients with ITCs (27/37), and 100% in patients with MMs (8/8), although this was a non-significant trend. Patients with MMs showed a significantly reduced 3 year-disease free survival compared to patients with ITCs or patients without occult tumour cells (75.0% versus 88.0% and 94.8%, respectively, p = 0.005). When adjusted for T-stage, MMs independently predicted recurrence of cancer (OR 7.6 95% CI 1.5-37.4, p = 0.012). CONCLUSION: In this study, the incidence of MMs and ITCs in patients with stage I/II colon cancer was 4.2% and 19.3%, respectively. MMs were associated with an reduced 3 year disease free survival rate, but ITCs were not.

Lower muscle density is associated with major postoperative complications in older patients after surgery for colorectal cancer.

BACKGROUND: Reduced muscle density is associated with an increased risk of postoperative complications. We examined the prognostic value of muscle density as a predictor of postoperative complications in elderly patients undergoing surgery for colorectal cancer. METHODS: Patients (≥70 years) who underwent surgery for colorectal cancer between 2006 and 2013 were selected from a prospective single centre database. The Hounsfield Unit Average (HUA or HU/mm2) of the psoas muscles at the level of the third lumbar vertebra was calculated on the scan. High and low muscle density groups were identified based on the lowest gender specific HUAC quartile. Major postoperative complications (Clavien-Dindo (CD) ≥3) within 30 days after surgery were retrospectively documented. Logistic regression analysis was used to identify risk factors for postoperative complications. RESULTS: A total of 373 patients (median age = 78 years) were included in this study. The mean muscle density score was 24.5 ± 4.3 HU/mm2 for males and 26.3 ± 5.0 HU/mm2 for females. The cut-off point for the lowest gender specific quartile was ≤22.0 HU/mm2 for males and ≤23.5 HU/mm2 for females. After multivariable regression, there was a statistically significant association between muscle density and CD ≥ 3 (OR = 1.84 (95% CI 1.11-3.06), p = 0.019). Anastomotic leakage in patients with a primary anastomosis (n = 287) occurred more often in patients with low muscle density (11.7% vs 23.3%, p = 0.016). The associations remained significant after correction for confounders. CONCLUSION: Low muscle density is associated with major postoperative complications in older patients who undergo surgery for colorectal cancer.

Oncological outcome of malignant colonic obstruction in the Dutch Stent-In 2 trial.

BACKGROUND: The Stent-In 2 trial randomized patients with malignant colonic obstruction to emergency surgery or stent placement as a bridge to elective surgery. The aim of this study was to compare the oncological outcomes. METHODS: Disease recurrence, and disease-free, disease-specific and overall survival were evaluated, including a subgroup analysis of patients with a stent- or guidewire-related perforation. RESULTS: Of 98 patients included in the original Stent-In 2 trial, patients with benign (16) or incurable (23) disease were excluded from this study, along with a patient who had withdrawn from the trial. Of the remaining 58 patients, 32 were randomized to emergency surgery (31 resection, 1 stoma only) and 26 to stenting. Unsuccessful stenting required emergency surgery in six patients owing to wire or stent perforation. Locoregional or distant disease recurrence developed in nine of 32 patients in the emergency surgery group and 13 of 26 in the stent group. Disease-free survival was worse in the subgroup with stent- or guidewire-related perforation. Five of six patients in this subgroup developed a recurrence, compared with nine of 32 in the emergency surgery group and eight of 20 who had unperforated stenting. CONCLUSION: Stent placement for malignant colonic obstruction was associated with a risk of recurrence in this trial, but the numbers are small. There is not enough evidence to refute the approach strongly. REGISTRATION NUMBER: ISRCTN46462267 ( http://www.controlled-trials.com).

Intraperitoneal chemotherapy as adjuvant treatment to prevent peritoneal carcinomatosis of colorectal cancer origin: a systematic review.

BACKGROUND: Peritoneal carcinomatosis (PC) of colorectal cancer (CRC) origin is associated with poor outcome. This systematic review evaluates the available evidence about adjuvant (hyperthermic) intraperitoneal chemotherapy ((H)IPEC) to prevent the development of PC. METHODS: A systematic search of literature was conducted in August 2013 in PubMed, Embase, and the Cochrane database for studies on (H)IPEC to prevent PC in patients who underwent curative surgery for primary CRC. RESULTS: Seven comparative studies and five cohort studies were selected. Treatment schedules varied between repeated fluoropyrimidine-based IPEC administration in the ambulatory setting to intra-operative (H)IPEC procedures using mitomycin-C or oxaliplatin. The reported rates of major complications related to adjuvant (H)IPEC was low. Four out of five evaluable comparative studies reported a significant difference in the incidence of PC in favour of (H)IPEC. All three comparative studies reporting on survival after intra-operative (H)IPEC showed a significant survival benefit in favour of the experimental arm. Substantial heterogeneity in patient selection, treatment protocols, and treatment effect evaluation among studies was observed. CONCLUSIONS: The currently available evidence about adjuvant (H)IPEC in high-risk CRC is limited and subject to bias, but points towards improved oncological outcome and supports further randomised studies.

Feasibility of adjuvant laparoscopic hyperthermic intraperitoneal chemotherapy in a short stay setting in patients with colorectal cancer at high risk of peritoneal carcinomatosis.

INTRODUCTION: Treatment of peritoneal carcinomatosis (PC) of colorectal cancer (CRC) origin is relatively ineffective and associated with morbidity. This raises the question whether we should focus on prevention of the development of PC. We determined the feasibility of adjuvant laparoscopic hyperthermic intraperitoneal chemotherapy (HIPEC) in a short stay setting. METHODS: A prospective single centre pilot study was conducted between January 2011 and July 2012. Ten patients at risk of developing PC of CRC origin were included. Laparoscopic HIPEC using Mitomycin-C (90 min; inflow temperature 42-43 °C) was performed within several weeks after primary resection of CRC and was considered feasible when postoperative hospital stay was three days or shorter in at least six patients, and if a maximum of one conversion and one re-admission within 30 days occurred. RESULTS: HIPEC was performed after a median of 6 weeks (range 3-9 weeks). Postoperatively, five patients were discharged at day one, four patients at day two and one patient at day three. Laparoscopic adhesiolysis resulted in small bowel injury in one patient, but no conversion to open surgery and no postoperative complications were observed. One patient was readmitted within 30 days due to a clostridium infection. The postoperative course was uneventful for the remaining patients. CONCLUSION: Adjuvant laparoscopic HIPEC appeared to be feasible in a short stay setting based on this small pilot study. The necessity of adhesiolysis determines the complexity of the procedure and requires an operating team with experience in minimally invasive abdominal surgery.

Bridge-to-surgery stent placement versus emergency surgery for acute malignant colonic obstruction.

BACKGROUND: Endoscopic self-expanding metal stent (SEMS) placement as a bridge to surgery is an option for acute malignant colonic obstruction. There is ongoing debate regarding the superiority and oncological safety of SEMS placement compared with emergency surgery. This retrospective study aimed to compare outcomes of these treatment approaches. METHODS: Patients were identified from cohorts treated between 2005 and 2012 in two teaching hospitals, of which one used emergency surgery only in patients with large bowel obstruction, whereas the other attempted SEMS placement. Only patients treated with curative intent were included. RESULTS: The study included 59 patients in whom SEMS placement was attempted and 51 who underwent surgery alone. The successful primary anastomosis rate was higher in the SEMS group than in the surgery-alone group among patients with left-sided obstruction (30 of 43 versus 10 of 34 respectively; P = 0.001), whereas stoma formation was less common (11 of 43 versus 23 of 34; P < 0.001). Such differences were not apparent in patients with right-sided obstruction. Secondary stoma rates were comparable between treatment approaches (left-sided: 11 of 43 versus 13 of 34, P = 0.322; right-sided: 1 of 16 versus 1 of 17, P = 1.000). There were no significant differences in morbidity, mortality, recurrence or survival. CONCLUSION: Endoscopic SEMS placement increased the primary anastomosis rate in patients with left-sided large bowel obstruction.

Lymph node size as a predictor of lymphatic staging in colonic cancer.

BACKGROUND: In colonic cancer, the number of harvested lymph nodes is associated with prognosis. The aim of this study was to determine the contribution of small lymph nodes to pathological staging, and to analyse the hypothesis that node size is a confounder in the relationship between prognosis and nodal harvest. METHODS: Nodal harvest and size were analysed in patients who underwent elective surgery for colonic cancer. Visible and palpable nodes were harvested without fat clearance techniques, and conventional histology was performed. RESULTS: Metastases were found in 99 of 2043 measured lymph nodes in 150 patients. Lymph nodes smaller than 3 mm were positive in 8.0 per cent of patients (12 of 150), but were the sole reason for upstaging in only 1.3 per cent (2 of 150). No metastases were found among 95 nodes of 1 mm or less. Metastatic nodes were larger than those without metastasis (median (i.q.r.) 5.0 (3.2-7.0) versus 3.8 (2.4-5.2) mm; P < 0·001), but a receiver operating characteristic (ROC) curve did not identify a relevant cut-off point to predict metastatic involvement. A hazard ratio of 0.71 (95 per cent confidence interval 0.50 to 1.01) was suggestive of an association between disease recurrence and increased node size, although not significant (P = 0.056). In patients with N0 disease, there was a correlation between node size and harvest (Pearson's correlation 0.317, P = 0.002), and a nodal yield of at least 12 was associated with a larger median node size (4.3 (3.3-5.0) versus 3.4 (2.7-4.0) mm; P = 0.015). CONCLUSION: The contribution of lymph nodes smaller than 3 mm to nodal staging is limited. Increased node size is associated with increased nodal yield, and could be a confounder in the relationship between prognosis and nodal harvest in patients with N0 disease.

The prognostic value of micrometastases and isolated tumour cells in histologically negative lymph nodes of patients with colorectal cancer: a systematic review and meta-analysis.

INTRODUCTION: Detection of occult tumour cells in lymph nodes of patients with stage I/II colorectal cancer is associated with decreased survival. However, according to recent guidelines, occult tumour cells should be categorised in micrometastases (MMs) and isolated tumour cells (ITCs). This meta-analysis evaluates the prognostic value of MMs and of ITCs, separately. METHODS: PubMed, Embase, Biosis and the World Health Organization International Trials Registry Platform were searched for papers published until April 2013. Studies on the prognostic value of MMs and ITCs in lymph nodes of stage I/II colorectal cancer patients were included. Odds ratios (ORs) for the development of disease recurrence were calculated to analyse the predictive value of MMs and ITCs. RESULTS: From five papers, ORs for disease recurrence could be calculated for MMs and ITCs separately. In patients with colorectal cancer, disease recurrence was significantly increased in the presence of MMs in comparison with absent occult tumour cells (OR 5.63; 95%CI 2.4-13.13). This was even more pronounced in patients with colon cancer (OR 7.25 95% CI 1.82-28.97). In contrast, disease recurrence was not increased in the presence of ITCs (OR 1.00 95% CI 0.53-1.88). CONCLUSION: Patients with stage I/II colorectal cancer and MMs have a worse prognosis than patients without occult tumour cells. However, ITCs do not have a predictive value. The distinction between ITCs and MMs should be made if the detection of occult tumour cells is incorporated in the clinical decision for adjuvant treatment.

Optimal time interval between neoadjuvant chemoradiotherapy and surgery for rectal cancer.

BACKGROUND: Neoadjuvant chemoradiotherapy (CRT) has been proven to increase local control in rectal cancer, but the optimal interval between CRT and surgery is still unclear. The purpose of this study was to analyse the influence of variations in clinical practice regarding timing of surgery on pathological response at a population level. METHODS: All evaluable patients who underwent preoperative CRT for rectal cancer between 2009 and 2011 were selected from the Dutch Surgical Colorectal Audit. The interval between radiotherapy and surgery was calculated from the start of radiotherapy. The primary endpoint was pathological complete response (pCR; pathological status after chemoradiotherapy (yp) T0 N0). RESULTS: A total of 1593 patients were included. The median interval between radiotherapy and surgery was 14 (range 6-85, interquartile range 12-16) weeks. Outcome measures were calculated for intervals of less than 13 weeks (312 patients), 13-14 weeks (511 patients), 15-16 weeks (406 patients) and more than 16 weeks (364 patients). Age, tumour location and R0 resection rate were distributed equally between the four groups; significant differences were found for clinical tumour category (cT4: 17·3, 18·4, 24·5 and 26·6 per cent respectively; P = 0·010) and clinical metastasis category (cM1: 4·4, 4·8, 8·9 and 14·9 per cent respectively; P < 0·001). Resection 15-16 weeks after the start of CRT resulted in the highest pCR rate (18·0 per cent; P = 0·013), with an independent association (hazard ratio 1·63, 95 per cent confidence interval 1·20 to 2·23). Results for secondary endpoints in the group with an interval of 15-16 weeks were: tumour downstaging, 55·2 per cent (P = 0·165); nodal downstaging, 58·6 per cent (P = 0·036); and (near)-complete response, 23·2 per cent (P = 0·124). CONCLUSION: Delaying surgery until the 15th or 16th week after the start of CRT (10-11 weeks from the end of CRT) seemed to result in the highest chance of a pCR.

Treatment of chronic presacral sinus after low anterior resection.

AIM: The aim of this retrospective study was to determine patient and treatment characteristics with corresponding clinical outcome of symptomatic chronic presacral sinus after low anterior resection. METHOD: Twenty-two patients were treated for a presacral sinus persisting for at least 12 months after low anterior resection for rectal carcinoma between January 2005 and March 2012. Patient charts were reviewed and analysed using descriptive statistics. RESULTS: Fistula formation was the most frequently observed secondary complication in 55% of patients. A median of 6 (1-44) surgical, endoscopic or radiological interventions related to the presacral sinus were performed. Overall, the chronic presacral sinus healed after multimodality treatment in nine (41%) patients at a median interval from primary surgery of 45 (24-93) months. If basic treatment principles were followed (anastomotic reconstruction or completion proctectomy with filling of the cavity), healing rate of the sinus was higher than where these principles were not adhered to (62% vs 11%). CONCLUSION: Successful treatment of a chronic presacral sinus after low anterior resection appears to be achieved by salvage surgery with anastomotic reconstruction in highly selected patients or intersphincteric completion proctectomy and omentoplasty.

Perineal hernia repair after abdominoperineal resection: a pooled analysis.

AIM: The purpose of this study was to determine treatment characteristics and clinical outcome for patients with perineal hernia after abdominoperineal excision (APE). METHOD: A systematic search of the literature revealed 40 individually documented patients, published between 1944 and 2010. Three additional patients treated at our centre were added. Patient characteristics, type of repair and outcome were entered into a database and a pooled analysis of these 43 patients was performed. RESULTS: The pooled analysis revealed a median time interval of 8 months between APE and surgical repair of perineal hernia. The surgical approaches were perineal in 22 patients, open abdominal in 11, open abdominoperineal in three, laparoscopic in five and laparoscopic-perineal in two patients. A primary recurrence was documented in 13 patients and a second recurrence in three. The recurrence rate was 5/25 for synthetic or biological mesh, 6/12 for primary closure and 2/6 for the remaining techniques. Recurrent perineal hernia was repaired using a synthetic or biological mesh (n = 6), primary closure (n = 5) or a muscle flap (gluteus or gracilis; n = 4). CONCLUSION: From these limited and biased data based on published case descriptions, it appears that the recurrence rate of primary perineal hernia repair after APE is lower with the use of a mesh or other assisted closure than with primary suture repair.