Fact or fiction? Does the position of the end-to-end (EEA) stapler spike matter for colorectal anastomoses using a double-stapled technique?

AIM: Surgeons often have strong opinions about how to perform colorectal anastomoses with little data to support variations in technique. The aim of this study was to determine if location of the end-to-end (EEA) stapler spike relative to the rectal transection line is associated with anastomotic integrity. METHOD: This study was a retrospective analysis of a quality collaborative database at a quaternary centre and regional hospitals. Patients with any left-sided colon resection with double-stapled anastomosis were included (December 2019 to August 2022). Our primary endpoint was a composite outcome including positive air insufflation test, incomplete anastomotic donut, or thin/eccentric donut. Our secondary endpoint was clinical leak. RESULTS: Overall, 633 patients were included and stratified by location of the stapler spike relative to the rectal transection line. Of note, 86 patients had an end-colon to anterior rectum ("reverse Baker") anastomosis with no crossing staple lines. The rates of the composite endpoint based on position of the stapler spike were 12.4% (anterior), 8.1% (through), 12.8% (posterior), 5.1% (corner), and 2.3% for the "reverse Baker" (p = 0.03). The overall rate of clinical leak was 3.8% and there were no differences between methods. In a multivariate analysis, the "reverse Baker" anastomosis was associated with decreased odds of poor anastomotic integrity when compared to anastomoses with crossing staple lines (OR 0.20, 95% CI: 0.05-0.87, p = 0.03). CONCLUSIONS: For anastomoses with crossing staple lines, the position of the stapler spike relative to the rectal staple line is not associated with differences in anastomotic integrity. In contrast, anastomoses with no crossing staple lines resulted in significantly lower rates of poor anastomotic integrity, but no difference in clinical leaks.

SafeHeal Colovac Colorectal Anastomosis Protection Device evaluation (SAFE-2) pivotal study: an international randomized controlled study to evaluate the safety and effectiveness of the Colovac Colorectal Anastomosis Protection Device.

AIM: Although proximal faecal diversion is standard of care to protect patients with high-risk colorectal anastomoses against septic complications of anastomotic leakage, it is associated with significant morbidity. The Colovac device (CD) is an intraluminal bypass device intended to avoid stoma creation in patients undergoing low anterior resection. A preliminary study (SAFE-1) completed in three European centres demonstrated 100% protection of colorectal anastomoses in 15 patients, as evidenced by the absence of faeces below the CD. This phase III trial (SAFE-2) aims to evaluate the safety and effectiveness of the CD in a larger cohort of patients undergoing curative rectal cancer resection. METHODS: SAFE-2 is a pivotal, multicentre, prospective, open-label, randomized, controlled trial. Patients will be randomized in a 1:1 ratio to either the CD arm or the diverting loop ileostomy arm, with a recruitment target of 342 patients. The co-primary endpoints are the occurrence of major postoperative complications within 12 months of index surgery and the effectiveness of the CD in reducing stoma creation rates. Data regarding quality of life and patient's acceptance and tolerance of the device will be collected. DISCUSSION: SAFE-2 is a multicentre randomized, control trial assessing the efficacy and the safety of the CD in protecting low colorectal anastomoses created during oncological resection relative to standard diverting loop ileostomy. TRIAL REGISTRATION: NCT05010850.

The colon does not reach! A technical note with tricks to avoid colorectal anastomoses under tension.

AIM: We describe two options for colorectal anastomosis suitable in cases when the colon would reach the pelvis under tension. METHOD: Deloyers procedure and the retro-ileal colorectal anastomosis are presented, focusing on practical tips and tricks to perform them. Insights on patients who underwent the procedures are provided to demonstrate the advantages and feasibility of the techniques. RESULTS: Each step of both techniques is detailed. Ten patients underwent Deloyers procedure and nine underwent retro-ileal anastomosis at our unit. A minimally invasive approach was attempted in 13 patients, of whom five required conversion to open surgery due to the technical complexity of the abdominal procedure. Colorectal anastomosis was successfully performed in all patients. There were no major intra-operative complications, although five patients had postoperative complications requiring further treatment. CONCLUSIONS: Both techniques are effective in patients at risk of receiving a colorectal anastomosis under tension, and a minimally invasive approach can be used. However, owing to the complexity of surgery in this group of patients, the perioperative morbidity is not negligible. Careful postoperative management is advisable, and patients should be informed of the risks. In expert hands, the outcomes are acceptable, avoiding an ileorectal anastomosis and its constraints.

Incidence of anastomotic leakage using powered circular staplers versus manual circular staplers for left colorectal anastomosis: a cost-effectiveness analysis.

BACKGROUND: Colorectal anastomotic leakage causes severe consequences for patients and healthcare system as it will lead to increased consumption of hospital resources and costs. Technological improvements in anastomotic devices could reduce the incidence of leakage and its economic impact. The aim of the present study was to assess if the use of a new powered circular stapler is cost-effective. METHOD: This observational study included patients undergoing left-sided circular stapled colorectal anastomosis between January 2018 and December 2021. Propensity score matching was carried out to create two comparable groups depending on whether the anastomosis was performed using a manual or powered circular device. The rate of anastomotic leakage, its severity, the consumption of hospital resources, and its cost were the main outcome measures. A cost-effectiveness analysis comparing the powered circular stapler versus manual circular staplers was performed. RESULTS: A total of 330 patients were included in the study, 165 in each group. Anastomotic leakage rates were significantly different (p = 0.012): 22 patients (13.3%) in the manual group versus 8 patients (4.8%) in the powered group. The effectiveness of the powered stapler and manual stapler was 98.27% and 93.69%, respectively. The average cost per patient in the powered group was €6238.38, compared with €9700.12 in the manual group. The incremental cost-effectiveness ratio was - €74,915.28 per patient without anastomotic complications. CONCLUSION: The incremental cost of powered circular stapler compared with manual devices was offset by the savings from lowered incidence and cost of management of anastomotic leaks.

Antiperistaltic Transverse Coloplasty: A Salvage Procedure in Extensive Bowel and Colorectal Resections to Avoid Intestinal Failure.

INTRODUCTION: After extensive small and colon resections, quality of life can be affected. We propose the antiperistaltic transverse coloplasty as a solution that allows for preservation of the transverse colon after both right and left colectomies while achieving a tension-free colorectal anastomosis slowing the transit and increasing the absorption time, resulting in better stool consistency and quality of life compared with an ileorectal anastomosis. METHODS: This technique was performed in a 41-year-old woman with Goblet cell adenocarcinoma of the appendix with peritoneal metastasis. The transverse colon is rotated anticlockwise over the axis of the middle colic vessels toward the left parietocolic flank and relocated to the usual position of the descending colon. RESULTS: After 1 year of follow-up, the patient led a normal life without parenteral nutrition with five bowel movements per day and a weight gain of 15%. CONCLUSIONS: The use of an antiperistaltic transverse coloplasty may be worthwhile to perform in cases of extensive bowel resections during cytoreductive surgery leading to short-bowel syndrome to avoid a permanent stoma or intestinal failure and improve patient outcomes.

Intraoperative Anastomotic Evaluation Methods: Rigid Proctoscopy Versus Flexible Endoscopy.

INTRODUCTION: Rigid proctosigmoidoscopy (RP) and flexible sigmoidoscopy (FS) are two modalities commonly used for intraoperative evaluation of colorectal anastomoses. This study seeks to determine whether there is an association between the endoscopic modality used to evaluate colorectal anastomoses and the rate of anastomotic leak (AL), organ space infection, and overall infectious complication. METHODS: The 2012-2018 American College of Surgeons National Surgical Quality Improvement Program database was queried for patients undergoing colorectal anastomoses. Anastomotic evaluation method (RP versus FS) was identified by Current Procedural Terminologycoding and used for group classification. Outcomes measured included AL, organ space infections, and overall infection. Multivariable logistic regression analysis for predicting AL was performed. RESULTS: We identified 7100 patients who underwent a colorectal anastomosis with intraoperative endoscopic evaluation. RP was utilized in 3397 (47.8%) and FS in 3703 (52.2%) patients. RP was used more commonly in diverticulitis (44.5% versus 36.2%, P < 0.01), while FS was used more frequently in malignancy (47.5% versus 36.7%, P < 0.01). Anastomotic evaluation with FS was associated with lower rates of organ space infection (3.8% versus 4.8%, P = 0.025) and AL (2.9% versus 3.8%, P = 0.028) compared to RP. On multivariate logistic regression modeling, anastomotic evaluation with RP was associated with a higher risk of AL (odds ratio 1.403, 95% CI 1.028-1.916, P = 0.033) compared to FS. CONCLUSIONS: Compared to FS, rigid proctosigmoidoscopic evaluation of a colorectal anastomosis was associated with an increased rate of AL and organ space infection.

The role of tissue adhesives and sealants in colorectal anastomotic healing-a scoping review.

PURPOSE: Anastomotic leakage (AL) after colorectal resection is a serious postoperative complication with grave consequences for patients. Despite several efforts to reduce its incidence, AL is still seen among 2-20% of colorectal cancer patients receiving an anastomosis. The use of tissue adhesives and sealants as an extra layer of protection around the anastomosis has shown promising results. We conducted a scoping review to provide an overview of the current knowledge on the effect of tissue adhesives and sealants on colorectal anastomosis healing, as well as their effect on the postoperative outcome. METHODS: The databases of PubMed, Embase, and Cochrane Library were systematically searched on 14/10/2022. Studies addressing the use of a tissue adhesive or tissue sealant applied around a colorectal anastomosis, with the goal to prevent AL or to decrease AL-related complications, were included. We presented an overview of the available studies and summarized their results narratively. RESULTS: Seven studies were included out of the 846 screened. All authors reported the rate of AL in their interventions group. Five of the studies found a decreased rate of AL compared to the control group. One study had no incidences of AL, while the last study had a seemingly low rate of AL but no comparison group. Information on secondary outcomes was sparingly reported, but the results hinted at a positive effect. CONCLUSION: Tissue adhesives and sealants might have a beneficial effect on colorectal anastomosis healing. The literature is sparse, and this review has shown the need for further clinical studies.

Operative management of anastomotic leak after sigmoid colectomy for left-sided diverticular disease: Ileostomy creation may be as safe as colostomy creation.

AIM: The management of anastomotic leak after sigmoid colectomy for diverticular disease has not been well defined. Specifically, there is a lack of literature on optimal types of reoperations for leaks. The aim of this study was to describe and compare reoperative approaches and their postoperative outcomes. METHODS: We performed a retrospective cohort study using the NSQIP Colectomy Module (2012-2019) and single-institution chart review. Patients with diverticular disease who underwent elective sigmoid colectomy were included. Primary outcomes were anastomotic leak requiring reoperation and management of anastomotic leak. RESULTS: Of 37,471 patients who underwent sigmoid colectomy for diverticular disease, 1003 (2.7%) suffered an anastomotic leak, of whom 583 underwent reoperation. Of the 572 patients who were not initially diverted and underwent reoperation for leak, 302 (52.8%) were managed with stoma creation - 200 (35.0%) with colostomy and 102 (17.8%) with ileostomy. The remaining 47.2% underwent colectomy with reanastomosis, suturing of large bowel, and drainage. There were no differences in length of stay, readmission, or mortality between patients who underwent ileostomy or colostomy at reoperation (p > 0.05). Single-institution analysis demonstrated that 100% of patients with ileostomies underwent subsequent ileostomy closure, compared to 60% of patients with colostomies. CONCLUSIONS: In patients who suffer anastomotic leaks after sigmoid colectomy for diverticular disease and undergo reoperations, ileostomy at the time of reoperation appears to be safe, with comparable results to colostomy. Ileostomies were more frequently closed than colostomies. When faced with a colorectal anastomotic leak, ileostomy creation may be considered.

Risk factors affecting benign anastomotic stricture in anterior and low anterior resections for colorectal cancer: a single-center retrospective cohort study.

PURPOSE: Although not as life-threatening as anastomotic leakage, anastomotic stricture reduces the quality of life. The risk factors for such an important life complication have not been revealed. This article examines the risk factors affecting anastomotic strictures due to colorectal cancers. METHODS: Patients who underwent anterior and low anterior resection for colorectal cancer under elective conditions between 2015 and 2021 were included in the study. The patients were divided into two groups, those who developed anastomotic stricture and those who did not. The parameters determined between the two groups were compared, and multivariate analysis of statistically significant parameters was performed. RESULTS: A total of 375 patients were included in the study. The anastomotic stricture was detected in 36 (9.6%) patients. In the multivariate analysis, non-mobilization of the splenic flexure and a proximal clean surgical margin of < 10 cm and a distal surgical margin of < 2 cm were identified as risk factors affecting anastomotic stricture. The risk factor with the highest odds ratio in the development of anastomotic stricture is the non-mobilization of the splenic flexure (p = 0.001, OR 11.375). CONCLUSION: It is recommended that the mobilization of the splenic flexure to reduce the development of strictures. In addition, a clean surgical margin of 10 cm proximally and 2 cm distally and high ligation of the inferior mesenteric artery may reduce the development of stricture.

Real-time semi-quantitative assessment of anastomotic blood perfusion in mini­invasive rectal resections by Sidestream Dark Field (SDF) imaging technology: a prospective in vivo pilot study.

PURPOSE: Anastomotic leakage (AL) is one of the severe complications after rectal surgery, and anastomotic ischemia is one of the main factors. This prospective in vivo pilot study aimed to evaluate the effectiveness of Sidestream Dark Field (SDF) imaging in quantitative assessment of anastomotic microcirculation and to analyze its correlation with AL. METHODS: Thirty-three patients with rectal cancer who underwent laparoscopic low anterior resection from 2019 to 2020 were enrolled. Microcirculation was measured by SDF imaging at the descending colon, the mesocolon transection line (MTL), and 1 cm and 2 cm distal to the MTL. Anastomotic microcirculation was measured at the stapler anvil edge before anastomosis. Quantitative perfusion-related parameters were as follows: microcirculation flow index (MFI), perfused vessel density (PVD), proportion of perfused vessels (PPV), and total vessel density (TVD). RESULTS: All patients obtained stable microcirculation images. Functional microcirculation parameters (MFI, PPV, PVD) decreased successively from the descending colon, the colon at MTL, and 1 cm and 2 cm distal to the MTL (all P < 0.01). Extremely poor microcirculation was found at the intestinal segment 2 cm distal to the MTL. Micro-perfusion was significantly lower at the colonic limb of the anastomosis compared with the descending colon (all P < 0.001). Anastomotic leakage occurred in 3 patients (9.1%) whose anastomotic microcirculation was significantly lower than those without AL (all P < 0.01). Blood perfusion at the colonic limb of the anastomosis was significantly higher in patients with left colic artery preservation than in controls. CONCLUSION: SDF imaging is a promising technique for evaluating anastomotic microcirculation and has potential clinical significance for risk stratification of AL.

Comparison of complications and bowel function among different reconstruction techniques after low anterior resection for rectal cancer: a systematic review and network meta-analysis.

BACKGROUND: Anastomosis for gastrointestinal reconstruction has been contentious after low anterior resection of rectal cancer for the past 30 years. Despite the abundance of randomized controlled trials (RCTs) on colon J-pouch (CJP), straight colorectal anastomosis (SCA), transverse coloplast (TCP), and side-to-end anastomosis (SEA), most studies are small and lack reliable clinical evidence. We conducted a systematic review and network meta-analysis to evaluate the effects of the four anastomoses on postoperative complications, bowel function, and quality of life in rectal cancer. METHODS: We assessed the safety and efficacy of CJP, SCA, TCP, and SEA in adult patients with rectal cancer after surgery by searching the Cochrane Library, Embase, and PubMed databases to collect RCTs from the date of establishment to May 20, 2022. Anastomotic leakage and defecation frequency were the main outcome indicators. We pooled data through a random effects model in a Bayesian framework and assessed model inconsistency using the deviance information criterion (DIC) and node-splitting method and inter-study heterogeneity using the I-squared statistics (I2). The interventions were ranked according to the surface under the cumulative ranking curve (SUCRA) to compare each outcome indicator. RESULTS: Of the 474 studies initially evaluated, 29 were eligible RCTs comprising 2631 patients. Among the four anastomoses, the SEA group had the lowest incidence of anastomotic leakage, ranking first (SUCRASEA = 0.982), followed by the CJP group (SUCRACJP = 0.628). The defecation frequency in the SEA group was comparable to those in the CJP and TCP groups at 3, 6, 12, and 24 months postoperatively. In comparison, the defecation frequency in the SCA group 12 months after surgery all ranked fourth. No statistically significant differences were found among the four anastomoses in terms of anastomotic stricture, reoperation, postoperative mortality within 30 days, fecal urgency, incomplete defecation, use of antidiarrheal medication, or quality of life. CONCLUSIONS: This study demonstrated that SEA had the lowest risk of complications, comparable bowel function, and quality of life compared to the CJP and TCP, but further research is required to determine its long-term consequences. Furthermore, we should be aware that SCA is associated with a high defecation frequency.

Effective initial management of anastomotic leak in the maintenance of functional colorectal or coloanal anastomosis.

PURPOSE: The present study assessed the factors associated with the maintenance of a functional anastomosis in a large consecutive series of patients with anastomotic leakage (AL). METHODS: All consecutive patients presenting with AL after colorectal or coloanal anastomosis (2012-2019) were analyzed. The primary end point was a functional anastomosis without a stoma at 1 year. RESULTS: A total of 156 patients were included. AL was initially treated by antibiotics (38%), drainage (43%) or urgent surgery (19%). Initial treatment of AL was not adequate in 24.3%, and reintervention in the form of drainage or surgery was required. A total of 60.9% of patients had a functional anastomosis without a stoma 1 year after surgery. Factors associated with the risk of anastomotic failure at 1 year were diabetes (odds ratio [OR] = 4.24 [95% confidence interval {CI} 1.39-14.24] p = 0.014), neoadjuvant chemoradiotherapy (OR = 3.03 [95% CI 1.14-8.63] p = 0.03) and Grade B (OR = 6.49 [95% CI 2.23-21.74] p = 0.001) or C leak (OR = 35.35 [95% CI 9.36-168.21] p < 0.001). Among patients treated initially by drainage, side-to-end or J-pouch anastomoses were significantly associated with revision of the anastomosis compared to end-to-end (OR = 12.90, p = 0.04). CONCLUSION: After acute AL following coloanal or colorectal anastomosis, 60.9% of patients had a functional anastomosis without a stoma at the 1 year of follow-up. The type of treatment of AL influenced the risk of anastomotic failure.

Gaining Mesenteric Length following Colorectal Resection: Essential Maneuvers to Avoid Anastomotic Tension.

A surgeon must possess the knowledge and technical skill to obtain length following a left-sided colorectal resection to perform a tension free anastomosis. The distal target organ - either rectum or anus - is fixed in location, and therefore requires surgeons to acquire mastery of proximal mobilization of the colonic conduit. Generally, splenic flexure mobilization (SFM) provides adequate length. Surgeons benefit from clearer understanding of the multiple steps involved in SFM as a result of improved visualization and demonstration of the relevant anatomy - adjacent organs and the attachments, embryologic planes, and mesenteric structures. Much may be attributed to laparoscopic and robotic platforms which provided improved exposure and as a result, development or refinement of novel approaches for SFM with potential advantages. Complete mobilization draws upon the sum or combination of the varied approaches to accomplish the goal. However, in the situation where extended resection is necessary or in the case of re-operative surgery sacrificing either more proximal or distal large intestine often occurs, the transverse colon or even the ascending colon represents the proximal conduit for anastomosis. This challenging situation requires familiarity with special maneuvers to achieve colorectal or coloanal anastomosis using these more proximal conduits. In such instances, operative techniques such as either ileal mesenteric window with retroileal anastomosis or de-rotation of the right colon (Deloyer's procedure) enable the intestinal surgeon to construct such anastomoses and thereby avoid stoma creation or loss of additional large intestine.

The Colorectal Anastomosis: A Timeless Challenge.

Colorectal anastomosis is a sophisticated problem that demands an elaborate discussion and an elegant solution. "Those who forget the past are condemned to repeat it." George Santayana, Life of Reason , 1905.

[ICG angiography in prevention of colorectal anastomotic leakage]. / Rol' ICG-angiografii v profilaktike nesostoyatel'nosti kolorektal'nykh anastomozov.

OBJECTIVE: To evaluate the effectiveness of indocyanine green fluorescence angiography in assessment of colorectal anastomosis perfusion. MATERIAL AND METHODS: A prospective single-center non-randomized comparative study included 85 patients with rectum and sigmoid colon cancer between September 2019 and March 2023. In the main group (n=41), we intraoperatively injected indocyanine green (ICG) IV to assess perfusion in the near infrared spectrum. In the control group (n=44), the same interventions were performed without ICG. RESULTS: In the main group, anterior resection of the rectum was performed in 23 (56.1%) patients with neoplasms of distal sigmoid colon and rectosigmoid tumors. Low anterior resection was performed in 18 (43.9%) cases. In the control group, the same procedures were carried out in 24 (54.5%) and 20 (45.5%) patients, respectively. After mobilization of the colon and ICG injection, we corrected resection line in 4 cases. As soon as anastomosis was formed and blood supply was controlled by ICG fluorescence angiography, we performed a water-bubble test to detect anastomotic leakage. Positive tests were detected in 4 (9.8%) and 5 (11.4%) patients of both groups, respectively. Postoperative complications occurred in 10 (24.4%) and 11 (27.3%) patients, respectively (p=0.94). Anastomosis failure was found in 1 and 7 patients, respectively. Anastomotic leakage grade «B¼ was significantly more common in the control group (2.4 and 13.6%, respectively, p=0.06). Anastomotic leaks were absent in all 4 patients who underwent resection level adjustment after intraoperative ICG angiography. CONCLUSION: Fluorescent luminescence will qualitatively improve intraoperative diagnosis of hypoperfusion of resection edges. Undoubtedly, this will reduce the incidence of colorectal anastomotic leaks caused by ischemia of large bowel wall.

Effect of Doxycycline-Release Anastomotic Augmentation Ring on Porcine Colorectal Anastomosis.

INTRODUCTION: Collagen degradation can lead to early postoperative weakness in colorectal anastomosis. Matrix metalloproteinase inhibitors (MMPIs) are shown to decrease collagen breakdown and enhance healing in anastomosis in animal models. Here, we evaluated the effectiveness of a novel anastomotic augmentation ring (AAR) that releases doxycycline, an MMPI, from a poly(lactic-co-glycolic) acid ring in porcine anastomoses. METHODS: Two end-to-end stapled colorectal anastomoses were performed in 20 Yorkshire-Hampshire pigs. AAR was randomly incorporated into either the proximal or distal anastomosis as treatment, while nonaugmented anastomosis served as a control. Animals were then euthanized on days 3, 4, and 5 before anastomosis explantation and burst pressure measurement. Each anastomosis site was also collected for histology, hydroxyproline content, and gene expression microarray analyses. RESULTS: No abscess or anastomotic leak was detected. Average burst pressures were not significantly different at any time point. There is no statistical difference in collagen content between the treatment group and controls. Gene expression analysis revealed no statistically significant in differentially expressed genes. However, genes related to inflammation, such as C-C motif chemokine ligand 11 (CCL11), CD70, and C-X-C motif chemokine ligand 10 (CXCL10), were upregulated (not statistically significant) in AAR compared to non-AAR anastomosis sites on days 3 and 4. CONCLUSIONS: This pilot study shows that doxycycline-release AAR is feasible and safe. While burst pressure and collagen content did not change significantly with doxycycline treatment, upregulating genes related to the inflammatory process for pathogen and debris clearance in AAR may improve the early stage of colorectal anastomotic healing.

Impact of change in the surgical plan based on indocyanine green fluorescence angiography on the rates of colorectal anastomotic leak: a systematic review and meta-analysis.

BACKGROUND: In the present study, patients with colorectal anastomoses that were assessed with indocyanine green (ICG) fluorescence angiography (FA) were compared to patients who had only white light visual inspection of their anastomosis. The impact of change in surgical plan guided by ICG-FA on anastomotic leak (AL) rates was assessed. METHODS: PubMed, Scopus, Web of Science, and Cochrane Central Register of Controlled Trials were queried for eligible studies. Studies included were comparative cohort studies and randomized trials that compared perfusion assessment of colorectal anastomosis with ICG-FA and inspection under white light. Main outcome measures were change in surgical plan guided by ICG-FA and rates of AL. Risk of bias was assessed using RoB-2 and ROBINS-1 tools. Differences between the two groups in categorical and continuous variables were expressed as odds ratio (OR) with 95% confidence interval (CI) and weighted mean difference. RESULTS: This systematic review included 27 studies comprising 8786 patients (48.5% males). Using ICG-FA was associated with significantly lower odds of AL (OR 0.452; 95% CI 0.366-0.558) and complications (OR 0.747; 95% CI 0.592-0.943) than the control group. The weighted mean rate of change in surgical plan based on ICG-FA was 9.6% (95% CI 7.3-11.8) and varied from 0.64% to 28.75%. A change in surgical plan was associated with significantly higher odds of AL (OR 2.73; 95% CI 1.54-4.82). LIMITATIONS: Technical heterogeneity due to using different dosage of ICG and statistical heterogeneity in operative time and complication rates. CONCLUSION: Assessment of colorectal anastomoses with ICG-FA is likely to be associated with lower odds of anastomotic leak than is traditional white light assessment. Change in plan based on ICG-FA may be associated with higher odds of AL. PROSPERO registration number: CRD42021235644.

Early postoperative endoscopic evaluation of rectal anastomoses: a prospective cross-sectional study.

BACKGROUND: Reported incidence of anastomotic leakage (AL) of rectal anastomoses is up to 29% with an overall mortality up to 12%. Nevertheless, there is no uniform evidence-based diagnostic procedure for early detection of AL. The objective of this prospective clinical trial was to demonstrate the diagnostic value of early postoperative flexible endoscopy for rectal anastomosis evaluation. METHODS: Flexible endoscopy between 5 and 8th postoperative day was performed consecutively in 90 asymptomatic patients. Sample size calculation was made using the two-stage Simon design. Diagnostic value was measured by management change after endoscopic evaluation. Anastomoses were categorized according to a new classification. Study is registered in German Clinical Trials Register (DRKS00019217). RESULTS: Of the 90 anastomoses, 59 (65.6%) were unsuspicious. 20 (22.2%) were suspicious with partial fibrin plaques (n = 15), intramural hematoma and/or local blood coagulum (n = 4) and ischemic area in one. 17 of these anastomoses were treated conservatively under monitoring. In three a further endoscopic re-evaluation was performed and as consequence one patient underwent endoscopic vacuum therapy. 11 (12.2%) AL were detected. Here, two could be treated conservatively under monitoring, four with endoscopic vacuum therapy and five needed revision surgery. No intervention-related adverse events occurred. A change in postoperative management was made in 31 (34.4%) patients what caused a significant improvement of diagnosis of AL (p < 0.001). CONCLUSIONS: Early postoperative endoscopic evaluation of rectal anastomoses is a safe procedure thus allows early detection of AL. Early treatment for suspicious anastomoses or AL could be adapted to avoid severe morbidity and mortality.

Cost analysis of indocyanine green fluorescence angiography for prevention of anastomotic leakage in colorectal surgery.

BACKGROUND: Indocyanine green, near infrared, fluorescence angiography (ICG-FA) is increasingly adopted in colorectal surgery for intraoperative tissue perfusion assessment to reduce anastomotic leakage rates. However, the economic impact of this intervention has not been investigated. This study is a cost analysis of the routine use of ICG-FA in colorectal surgery from the hospital payer perspective. METHODS: A decision analysis model was developed for colorectal resections considering two scenarios: resection without using ICG-FA and resection with intraoperative ICG-FA for anastomotic perfusion assessment. Incorporated into the model were the costs of ICG agent, fluorescence angiography equipment, surgery, anastomotic leak, and the leak rates with and without ICG-FA. All input data were derived from recent publications. RESULTS: The routine use of ICG-FA for colorectal anastomosis is cost saving when cost analysis is performed using the following base case assumptions: 8.6% leak rate without ICG-FA, odds ratio of 0.46 for reduction of leakage with ICG-FA (4.8% leak rate relative to 8.6% base case), cost of ICG-FA of $250, and incremental cost of leak, not requiring reoperation, of $9,934.50. In one-way sensitivity analyses, routine use of ICG-FA was cost saving if the cost of an anastomotic leak is more than $5616.29, the cost of ICG-FA is less than $634.44, the leak rate (without ICG-FA) is higher than 4.9%, or the odds ratio for reduction of leak with ICG-FA is less than 0.69. There is a per-case saving of $192.22 with the use of ICG-FA. CONCLUSION: Using the best available evidence and most conservative base case values, routine use of ICG-FA in colorectal surgery was found to be cost saving. Since the evidence suggests there is a reduction in leak rate, the routine use of ICG-FA is a dominating strategy. However, the overall quality of evidence is low and there is a clear need for prospective, randomized controlled trials.

Comprehensive testing of colorectal anastomosis: results of prospective observational cohort study.

BACKGROUND: Anastomotic leakage remains one of the most threatening complications in colorectal surgery. Intraoperative testing of anastomosis may reduce the postoperative anastomotic leakage rates. This study aimed to investigate a novel comprehensive intraoperative colorectal anastomosis testing technique to detect the failure of the anastomosis construction and to reduce the risk of postoperative leak. METHODS: This multi-centre prospective cohort pilot study included 60 patients who underwent colorectal resection with an anastomosis at or below 15 cm from the anal verge. Comprehensive trimodal testing consisted of indocyanine green fluorescence angiography, tension testing, air-leak, and methylene blue leak tests to evaluate the perfusion, tension, and mechanical integrity of the anastomosis. RESULTS: Ten (16.7%) patients developed an anastomotic leakage. Trimodal test was positive in 16 (26.6%) patients and the operative plan was changed for all of them. Diverting ileostomy was performed in 14 (87.5%) patients. However, two (12.5%) patients still developed clinically significant anastomotic leakage (Grade B). Forty-four (73.4%) patients had a negative trimodal test, preventive ileostomy was performed in 19 (43.2%), and five (11.4%) patients had clinically significant anastomotic leakage (Grade B and C). CONCLUSION: Trimodal testing identifies anastomoses with initial technical failure where reinforcement of anastomosis or diversion can lead to an acceptable rate of anastomotic leakage. Identification of well-performed anastomosis could allow a reduction of ileostomy rate by two-fold. However, anastomotic leakage rate remains high in technically well-performed anastomoses.