Management of acute and chronic pelvic sepsis after total mesorectal excision for rectal cancer-a 10-year experience of a national referral centre.

AIM: Uncontrolled pelvic sepsis following rectal cancer surgery may lead to dramatic consequences with significant impact on patients' quality of life. The aim of this retrospective observational study is to evaluate management of pelvic sepsis after total mesorectal excision for rectal cancer at a national referral centre. METHOD: Referred patients with acute or chronic pelvic sepsis after sphincter preserving rectal cancer resection, with the year of referral between 2010 and 2014 (A) or between 2015 and 2020 (B), were included. The main outcome was control of pelvic sepsis at the end of follow-up, with healed anastomosis with restored faecal stream (RFS) as co-primary outcome. RESULTS: In total 136 patients were included: 49 in group A and 87 in group B. After a median follow-up of 82 months (interquartile range 35-100) in group A and 42 months (interquartile range 22-60) in group B, control of pelvic sepsis was achieved in all patients who received endoscopic vacuum assisted surgical closure (7/7 and 2/2), in 91% (19/21) and 89% (31/35) of patients who received redo anastomosis (P = 1.000) and in 100% (18/18) and 95% (41/43) of patients who received intersphincteric resection (P = 1.000), respectively. Restorative procedures resulted in a healed anastomosis with RFS in 61% (17/28) of patients in group A and 68% (25/37) of patients in group B (P = 0.567). CONCLUSION: High rates of success can be achieved with surgical salvage of pelvic sepsis in a dedicated tertiary referral centre, without significant differences over time. In well selected and motivated patients a healed anastomosis with RFS can be achieved in the majority.

Ferric carboxymaltose infusion versus oral iron supplementation for preoperative iron deficiency anaemia in patients with colorectal cancer (FIT): a multicentre, open-label, randomised, controlled trial.

BACKGROUND: A third of patients with colorectal cancer who are eligible for surgery in high-income countries have concomitant anaemia associated with adverse outcomes. We aimed to compare the efficacy of preoperative intravenous and oral iron supplementation in patients with colorectal cancer and iron deficiency anaemia. METHODS: In the FIT multicentre, open-label, randomised, controlled trial, adult patients (aged 18 years or older) with M0 stage colorectal cancer scheduled for elective curative resection and iron deficiency anaemia (defined as haemoglobin level of less than 7·5 mmol/L (12 g/dL) for women and less than 8 mmol/L (13 g/dL) for men, and a transferrin saturation of less than 20%) were randomly assigned to either 1-2 g of ferric carboxymaltose intravenously or three tablets of 200 mg of oral ferrous fumarate daily. The primary endpoint was the proportion of patients with normalised haemoglobin levels before surgery (≥12 g/dL for women and ≥13 g/dL for men). An intention-to-treat analysis was done for the primary analysis. Safety was analysed in all patients who received treatment. The trial was registered at ClincalTrials.gov, NCT02243735, and has completed recruitment. FINDINGS: Between Oct 31, 2014, and Feb 23, 2021, 202 patients were included and assigned to intravenous (n=96) or oral (n=106) iron treatment. Treatment began a median of 14 days (IQR 11-22) before surgery for intravenous iron and 19 days (IQR 13-27) for oral iron. Normalisation of haemoglobin at day of admission was reached in 14 (17%) of 84 patients treated intravenously and 15 (16%) of 97 patients treated orally (relative risk [RR] 1·08 [95% CI 0·55-2·10]; p=0·83), but the proportion of patients with normalised haemoglobin significantly increased for the intravenous treatment group at later timepoints (49 [60%] of 82 vs 18 [21%] of 88 at 30 days; RR 2·92 [95% CI 1·87-4·58]; p<0·0001). The most prevalent treatment-related adverse event was discoloured faeces (grade 1) after oral iron treatment (14 [13%] of 105), and no treatment-related serious adverse events or deaths were observed in either group. No differences in other safety outcomes were seen, and the most common serious adverse events were anastomotic leakage (11 [5%] of 202), aspiration pneumonia (5 [2%] of 202), and intra-abdominal abscess (5 [2%] 202). INTERPRETATION: Normalisation of haemoglobin before surgery was infrequent with both treatment regimens, but significantly improved at all other timepoints following intravenous iron treatment. Restoration of iron stores was feasible only with intravenous iron. In selected patients, surgery might be delayed to augment the effect of intravenous iron on haemoglobin normalisation. FUNDING: Vifor Pharma.

Iatrogenic injury of the urinary tract during salvage procedures for pelvic sepsis: Experience of a national referral centre.

AIM: This study aimed to determine the incidence, consequences and outcomes of iatrogenic urinary tract injury (IUI) during salvage surgery for pelvic sepsis. METHOD: Patients who underwent salvage surgery for pelvic sepsis after prior low anterior resection or Hartmann's procedure for rectal cancer were prospectively maintained in a database between 2010 and 2020 and reviewed retrospectively. The primary endpoint was the incidence of IUI. Secondary endpoints were timing of diagnosis (intra- vs. postoperative), reinterventions related to the IUI and healing of IUI. RESULTS: In total 126 consecutive patients were included, and IUI occurred in 13 patients (10%). A ureteric injury occurred in eight patients, bladder injury in four patients and a urethral injury in one patient. All patients with an IUI had radiotherapy as neoadjuvant treatment. The IUI was diagnosed postoperatively in 63% (n = 8/13) with a median duration between surgery and diagnosis of the IUI of 10 days (IQR: 6-15). The median number of reinterventions was five (range 1-31) in the group with a postoperative diagnosis and one (range 0-1) in the group with an intraoperative diagnosis. Four patients required a surgical reintervention, all concerning injuries diagnosed postoperatively. At the end of follow-up, 85% of patients (n = 11/13) had a healed IUI. CONCLUSION: Iatrogenic urinary tract injury is not uncommon in salvage procedures for pelvic sepsis, even in an experienced tertiary referral centre. Most injuries were diagnosed postoperatively which affects the severity of these complications, emphasising the need to improve intraoperative diagnostic modalities.

Endoscopic vacuum-assisted surgical closure (EVASC) of anastomotic defects after low anterior resection for rectal cancer; lessons learned.

BACKGROUND: Endoscopic vacuum-assisted surgical closure (EVASC) is an emerging treatment for AL, and early initiation of treatment seems to be crucial. The objective of this study was to report on the efficacy of EVASC for anastomotic leakage (AL) after rectal cancer resection and determine factors for success. METHODS: This retrospective cohort study included all rectal cancer patients treated with EVASC for a leaking primary anastomosis after LAR at a tertiary referral centre (July 2012-April 2020). Early initiation (≤ 21 days) or late initiation of the EVASC protocol was compared. Primary outcomes were healed and functional anastomosis at end of follow-up. RESULTS: Sixty-two patients were included, of whom 38 were referred. Median follow-up was 25 months (IQR 14-38). Early initiation of EVASC (≤ 21 days) resulted in a higher rate of healed anastomosis (87% vs 59%, OR 4.43 [1.25-15.9]) and functional anastomosis (80% vs 56%, OR 3.11 [1.00-9.71]) if compared to late initiation. Median interval from AL diagnosis to initiation of EVASC was significantly shorter in the early group (11 days (IQR 6-15) vs 70 days (IQR 39-322), p < 0.001). A permanent end-colostomy was created in 7% and 28%, respectively (OR 0.18 [0.04-0.93]). In 17 patients with a non-defunctioned anastomosis, and AL diagnosis within 2 weeks, EVASC resulted in 100% healed and functional anastomosis. CONCLUSION: Early initiation of EVASC for anastomotic leakage after rectal cancer resection yields high rates of healed and functional anastomosis. EVASC showed to be progressively more successful with the implementation of highly selective diversion and early diagnosis of the leak.

Endoscopic vacuum therapy and early surgical closure after pelvic anastomotic leak: meta-analysis of bowel continuity rates.

BACKGROUND: Endoscopic vacuum therapy (EVT) with or without early surgical closure (ESC) is considered an effective option in the management of pelvic anastomotic leakage. This meta-analysis evaluated the effectiveness of EVT in terms of stoma reversal rate and the added value of ESC. METHODS: A systematic search of PubMed, MEDLINE, and the Cochrane Library was conducted in November 2021 to identify articles on EVT in adult patients with pelvic anastomotic leakage. The primary outcome was restored continuity rate. Following PRISMA guidelines, a meta-analysis was undertaken using a random-effects model. RESULTS: Twenty-nine studies were included, accounting for 827 patients with leakage who underwent EVT. There was large heterogeneity between studies in design and reported outcomes, and a high risk of bias. The overall weighted mean restored continuity rate was 66.8 (95 per cent c.i. 58.8 to 73.9) per cent. In patients undergoing EVT with ESC, the calculated restored continuity rate was 82 per cent (95 per cent c.i. 50.1 to 95.4) as compared to 64.7 per cent (95 per cent c.i. 55.7 to 72.7) after EVT without ESC. The mean number of sponge exchanges was 4 (95 per cent c.i. 2.7 to 4.6) and 9.8 (95 per cent c.i. 7.3 to 12.3), respectively. Sensitivity analysis showed a restored continuity rate of 81 per cent (95 per cent c.i. 55.8 to 99.5) for benign disease, 69.0 per cent (95 per cent c.i. 57.3 to 78.7) for colorectal cancer, and 65 per cent (95 per cent c.i. 48.8 to 79.1) if neoadjuvant radiotherapy was given. CONCLUSION: EVT is associated with satisfactory stoma reversal rates that may be improved if it is combined with ESC.

The use of fluorescence angiography to assess bowel viability in the acute setting: an international, multi-centre case series.

INTRODUCTION: Assessing bowel viability can be challenging during acute surgical procedures, especially regarding mesenteric ischaemia. Intraoperative fluorescence angiography (FA) may be a valuable tool for the surgeon to determine whether bowel resection is necessary and to define the most appropriate resection margins. The aim of this study is to report on FA use in the acute setting and to judge its impact on intraoperative decision making. MATERIALS AND METHODS: This is a multi-centre, retrospective case series of patients undergoing emergency abdominal surgery between February 2016 and 2021 in three general/colorectal units where intraoperative FA was performed to assess bowel viability. Primary endpoint was change of management after the FA assessment. RESULTS: A total of 93 patients (50 males, 66.6 ± 19.2 years, ASA score ≥ III in 85%) were identified and studied. Initial surgical approach was laparotomy in 66 (71%) patients and laparoscopy in 27 (29% and seven, 26% conversions). The most common aetiologies were mesenteric ischaemia (n = 42, 45%) and adhesional/herniae-related strangulation (n = 41, 44%). In 50 patients a bowel resection was performed. Overall rates of anastomosis after resection, reoperation and 30-day mortality were 48% (n = 24/50, one leak), 12% and 18%, respectively. FA changed management in 27 (29%) patients. In four patients (4% overall), resection was avoided and in 21 (23%) extra bowel length was preserved (median 50 cm of bowel saved, IQR 28-98) although three patients developed further ischaemia. FA prompted extended resection (median of 20 cm, IQR 10-50 extra bowel) in six (6%) patients. CONCLUSION: Intraoperative use of FA impacts surgical decisions regarding bowel resection for intestinal ischaemia, potentially enabling bowel preservation in approximately one out of four patients. Prospective studies are needed to optimize the best use of this technology for this indication and to determine standards for the interpretation of FA images and the potential subsequent need for second-look surgeries.

Quantifying displacement of urogenital organs after abdominoperineal resection for rectal cancer.

AIM: This study aimed to quantify displacement of urogenital organs after abdominoperineal resection (APR), and to explore patient and treatment characteristics associated with displacement. METHOD: Patients from 16 centres who underwent APR for primary or recurrent rectal cancer (2001-2018) with evaluable preoperative and 6-18 months postoperative radiological imaging were included in the study. Anatomical landmarks on sagittal images were related to a coordinate system based on reference lines between fixed bony structures and absolute displacements were calculated using the Pythagorean theorem. Rotation of landmarks was measured relative to a pubic-S5 reference line. RESULTS: There were 248 patients included of which 171 were men and 77 women. The median displacement of the internal urethral orifice was 25 mm in men (maximum 65), and 17 mm in women (maximum 50). Rotation of the internal urethral orifice was in a caudal direction in 160/170 (94%) of men and 65/73 (89%) of women, with a median of 32 degrees (maximum 85) and 33 degrees (maximum 83), respectively. Displacements of the posterior bladder wall, distal end of prostatic urethra and cervix were significantly correlated with the internal urethral orifice. In linear regression analysis, biological mesh reconstruction of the pelvic floor and visceral interposition were significantly associated with increased displacement of the internal urethral orifice, and female gender and any filling of the presacral space with decreased displacement. CONCLUSIONS: Substantial absolute displacement and rotation of urogenital organs after APR for rectal cancer were observed, but with high variability among both men and women, and being significantly associated with reconstructive interventions.

Definition of large bowel obstruction by primary colorectal cancer: A systematic review.

AIM: Controversies on therapeutic strategy for large bowel obstruction by primary colorectal cancer mainly concern acute conditions, being essentially different from subacute obstruction. Clearly defining acute obstruction is important for design and interpretation of studies as well as for guidelines and daily practice. This systematic review aimed to evaluate definitions of obstruction by colorectal cancer in prospective studies. METHOD: A systematic search was performed in PubMed, Embase and the Cochrane Library. Eligibility criteria included randomized or prospective observational design, publication between 2000 and 2019, and the inclusion of patients with an obstruction caused by colorectal cancer. Provided definitions of obstruction were extracted with assessment of common elements. RESULTS: A total of 16 randomized controlled trials (RCTs) and 99 prospective observational studies were included. Obstruction was specified as acute in 28 studies, complete/emergency in five, (sub)acute or similar terms in four and unspecified in 78. Five of 16 RCTs (31%) and 37 of 99 cohort studies (37%) provided a definition. The definitions included any combination of clinical symptoms, physical signs, endoscopic features and radiological imaging findings in 25 studies. The definition was only based on clinical symptoms in 11 and radiological imaging in six studies. Definitions included a radiological component in 100% of evaluable RCTs (5/5) vs. 54% of prospective observational studies (20/37, P = 0.07). CONCLUSION: In this systematic review, the majority of prospective studies did not define obstruction by colorectal cancer and its urgency, whereas provided definitions varied hugely. Radiological confirmation seems to be an essential component in defining acute obstruction.

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.