Functional Outcomes After Transanal Total Mesorectal Excision (taTME) for Rectal Cancer: Results from the Phase II North American Multicenter Prospective Observational Trial.

OBJECTIVE: To investigate fecal incontinence and defecatory, urinary, and sexual functional outcomes after taTME. SUMMARY BACKGROUND DATA: Proctectomy for rectal cancer may result in alterations in defecatory, urinary, and sexual function that persist beyond 12 months. The recent multicenter Phase II taTME trial demonstrated the safety of taTME in patients with stage I-III tumors. METHODS: Prospectively registered self-reported questionnaires were collected from 100 taTME patients. Fecal continence (FIQL, Wexner), defecatory function (COREFO), urinary function (IPSS), and sexual function (FSFI-female, IIEF-male) were assessed preoperatively (PQ), 3-4 months post-ileostomy closure (FQ1), and 12-18 months post-taTME (FQ2). RESULTS: Among 83 patients who responded at all three time points, FIQL, Wexner, and COREFO significantly worsened post-ileostomy closure. Between FQ1 and FQ2, FIQL lifestyle and coping, Wexner, and COREFO incontinence, social impact, frequency, and need for medication significantly improved, while FIQL depression and embarrassment did not change. IPSS did not change relative to preoperative scores. For females, FSFI declined for desire, orgasm, and satisfaction between PQ and FQ1, and did not improve between FQ1 and FQ2. In males, IIEF declined with no change between FQ1 and FQ2. CONCLUSIONS: Although taTME resulted in initial decline in defecatory function and fecal continence, most functional domains improved by 12 months after ileostomy closure, without returning to preoperative status. Urinary function was preserved while sexual function declined without improvement by 18 months post-taTME. Our results address patient expectations and inform shared decision-making regarding taTME.

Oncologic outcomes following transanal total mesorectal excision: the United States experience.

AIM: The benefits and short-term outcomes of transanal total mesorectal excision (taTME) for rectal cancer have been demonstrated previously, but questions remain regarding the oncologic outcomes following this challenging procedure. The purpose of this study was to analyze the oncologic outcomes following taTME at high-volume centers in the USA. METHODS: This was a multicenter, retrospective observational study of 8 tertiary care centers. All consecutive taTME cases for primary rectal cancer performed between 2011 and 2020 were included. Clinical, histopathologic, and oncologic data were analyzed. Primary endpoints were rate of local recurrence, distal recurrence, 3-year disease recurrence, and 3-year overall survival. Secondary endpoints included perioperative complications and TME specimen quality. RESULTS: A total of 391 patients were included in the study. The median age was 57 years (IQR: 49, 66), 68% of patients were male, and the median BMI was 27.4 (IQR: 24.1, 31.0). TME specimen was complete or near complete in 94.5% of cases and the rates of positive circumferential radial margin and distal resection margin were 2.0% and 0.3%, respectively. Median follow-up time was 30.7 months as calculated using reverse-KM estimator (CI 28.1-33.8) and there were 9 cases (2.5%) of local recurrence not accounting for competing risk. The 3-year estimated rate of disease recurrence was 19% (CI 15-25%) and the 3-year estimated overall survival was 90% (CI 87-94%). CONCLUSION: This large multicenter study confirms the oncologic safety and perioperative benefits of taTME for rectal cancer when performed by experienced surgeons at experienced referral centers.

Discordance in Total Mesorectal Excision Specimen Grading in a Prospective Phase 2 Multicenter Rectal Cancer Trial: Are We Overestimating the Quality of Our Resections?

OBJECTIVES: To report the results of a rigorous quality control (QC) process in the grading of total mesorectal excision (TME) specimens during a multicenter prospective phase 2 trial of transanal TME. BACKGROUND: Grading of TME specimens is based on the macroscopic assessment of the mesorectum and standardized through synoptic pathology reporting. TME grade is a strong predictor of outcomes with incomplete (IC) TME associated with increased rates of local recurrence relative to complete or near complete (NC) TME. Although TME grade serves as an endpoint in most rectal cancer trials, in protocols incorporating centralized review of TME specimens for quality assurance, discordance in grading and the management thereof has not been previously described. METHODS: A phase 2 prospective transanal TME trial was conducted from 2017 to 2022 across 11 North American centers with TME quality as the primary study endpoint. QC measures included (1) training of site pathologists in TME protocols, (2) blinded grading of de-identified TME specimen photographs by central pathologists, and (3) reconciliation of major discordance before trial reporting. Cohen Kappa statistic was used to assess agreement in grading. RESULTS: Overall agreement in grading of 100 TME specimens between site and central reviewer was rated as fair, (κ = 0.35; 95% CI: 0.10-0.61; P < 0.0001). Concordance was noted in 54%, with minor and major discordance in 32% and 14% of cases, respectively. Upon reconciliation, 13/14 (93%) major discordances were resolved. Pre versus postreconciliation rates of complete or NC and IC TME are 77%/16% and 7% versus 69%/21% and 10%. Reconciliation resulted in a major upgrade (IC-NC; N = 1) or major downgrade (NC/C-IC, N = 4) in 5 cases overall (5%). CONCLUSIONS: A 14% rate of major discordance was observed in TME grading between the site and central reviewers. The resolution resulted in a major change in final TME grade in 5% of cases, which suggests that reported rates or TME completeness are likely overestimated in trials. QC through a central review of TME photographs and reconciliation of major discordances is strongly recommended.

Multicenter phase II trial of transanal total mesorectal excision for rectal cancer: preliminary results.

BACKGROUND: Transanal TME (taTME) combines abdominal and transanal dissection to facilitate sphincter preservation in patients with low rectal tumors. Few phase II/III trials report long-term oncologic and functional results. We report early results from a North American prospective multicenter phase II trial of taTME (NCT03144765). METHODS: 100 patients with stage I-III rectal adenocarcinoma located ≤ 10 cm from the anal verge (AV) were enrolled across 11 centers. Primary and secondary endpoints were TME quality, pathologic outcomes, 30-day and 90-day outcomes, and stoma closure rate. Univariable regression analysis was performed to assess risk factors for incomplete TME and anastomotic complications. RESULTS: Between September 2017 and April 2022, 70 males and 30 females with median age of 58 (IQR 49-62) years and BMI 27.8 (IQR 23.9-31.8) kg/m2 underwent 2-team taTME for tumors located a median 5.8 (IQR 4.5-7.0) cm from the AV. Neoadjuvant radiotherapy was completed in 69%. Intersphincteric resection was performed in 36% and all patients were diverted. Intraoperative complications occurred in 8% including 3 organ injuries, 2 abdominal and 1 transanal conversion. The 30-day and 90-day morbidity rates were 49% (Clavien-Dindo (CD) ≥ 3 in 28.6%) and 56% (CD ≥ 3 in 30.4% including 1 mortality), respectively. Anastomotic complications were reported in 18% including 10% diagnosed within 30 days. Higher anastomotic risk was noted among males (p = 0.05). At a median follow-up of 5 (IQR 3.1-7.4) months, 98% of stomas were closed. TME grade was complete or near complete in 90%, with positive margins in 2 cases (3%). Risk factors for incomplete TME were ASA ≥ 3 (p = 0.01), increased time between NRT and surgery (p = 0.03), and higher operative blood loss (p = 0.003). CONCLUSION: When performed at expert centers, 2-team taTME in patients with low rectal tumors is safe with low conversion rates and high stoma closure rate. Mid-term results will further evaluate oncologic and functional outcomes.

Galunisertib plus neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer: a single-arm, phase 2 trial.

BACKGROUND: TGF-ß is an immunosuppressive cytokine that is upregulated in colorectal cancer. TGF-ß blockade improved response to chemoradiotherapy in preclinical models of colorectal adenocarcinoma. We aimed to test the hypothesis that adding the TGF-ß type I receptor kinase inhibitor galunisertib to neoadjuvant chemoradiotherapy would improve pathological complete response rates in patients with locally advanced rectal cancer. METHODS: This was an investigator-initiated, single-arm, phase 2 study done in two medical centres in Portland (OR, USA). Eligible patients had previously untreated, locally advanced, rectal adenocarcinoma, stage IIA-IIIC or IV as per the American Joint Committee on Cancer; Eastern Cooperative Oncology Group status 0-2; and were aged 18 years or older. Participants completed two 14-day courses of oral galunisertib 150 mg twice daily, before and during fluorouracil-based chemoradiotherapy (intravenous fluorouracil 225 mg/m2 over 24 h daily 7 days per week during radiotherapy or oral capecitabine 825 mg/m2 twice per day 5 days per week during radiotherapy; radiotherapy consisted of 50·4-54·0 Gy in 28-30 fractions). 5-9 weeks later, patients underwent response assessment. Patients with a complete response could opt for non-operative management and proceed to modified FOLFOX6 (intravenous leucovorin 400 mg/m2 on day 1, intravenous fluorouracil 400 mg/m2 on day 1 then 2400 mg/m2 over 46 h, and intravenous oxaliplatin 85 mg/m2 on day 1 delivered every 2 weeks for eight cycles) or CAPEOX (intravenous oxaliplatin 130 mg/m2 on day 1 and oral capecitabine 1000 mg/m2 twice daily for 14 days every 3 weeks for four cycles). Patients with less than complete response underwent surgical resection. The primary endpoint was complete response rate, which was a composite of pathological complete response in patients who proceeded to surgery, or clinical complete response maintained at 1 year after last therapy in patients with non-operative management. Safety was a coprimary endpoint. Both endpoints were assessed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT02688712, and is active but not recruiting. FINDINGS: Between Oct 19, 2016, and Aug 31, 2020, 38 participants were enrolled. 25 (71%) of the 35 patients who completed chemoradiotherapy proceeded to total mesorectal excision surgery, five (20%) of whom had pathological complete responses. Ten (29%) patients had non-operative management, three (30%) of whom ultimately chose to have total mesorectal excision. Two (67%) of those three patients had pathological complete responses. Of the remaining seven patients in the non-operative management group, five (71%) had clinical complete responses at 1 year after their last modified FOLFOX6 infusion. In total, 12 (32% [one-sided 95% CI ≥19%]) of 38 patients had a complete response. Common grade 3 adverse events during treatment included diarrhoea in six (16%) of 38 patients, and haematological toxicity in seven (18%) patients. Two (5%) patients had grade 4 adverse events, one related to chemoradiotherapy-induced diarrhoea and dehydration, and the other an intraoperative ischaemic event. No treatment-related deaths occurred. INTERPRETATION: The addition of galunisertib to neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer improved the complete response rate to 32%, was well tolerated, and warrants further assessment in randomised trials. FUNDING: Eli Lilly via ExIST program, The Providence Foundation.

Transanal total mesorectal excision outcomes for advanced rectal cancer in a complex surgical population.

BACKGROUND: Total mesorectal excision (TME) is the gold standard for oncologic resection in low and mid rectal cancers. However, abdominal approaches to TME can be hampered by poor visibility, inadequate retraction, and distal margin delineation. Transanal TME (taTME) is a promising hybrid technique that was developed to mitigate the difficulties of operating in the low pelvis and to optimize the circumferential resection and distal margins. METHODS: The objective of this study was to characterize our experience implementing taTME at our institution in a technically challenging patient population. We performed a retrospective review of consecutive patients who underwent taTMEs between November 2013 and May 2019 for rectal cancer at a tertiary community cancer center. Outcome measures included pathologic grading of TME specimen, post-operative complications, and oncologic outcomes. RESULTS: Forty-four patients with mid and low rectal cancer underwent low anterior resection via taTME. The most common staging modality was rectal MRI which demonstrated T3 or T4 tumors in 89% of our patients prior to neoadjuvant. Eighty-six percent of patients underwent neoadjuvant chemoradiation. The initial cases were performed sequentially as a single team, but we later transitioned to a synchronous, two-team approach. Ninety-one percent of TME grades were complete or near complete. Only one patient (2.3%) had a positive circumferential margin. Six patients developed anastomotic leaks with an overall anastomotic complication rate of 18.2%. Two patients (4.5%) with primary rectal cancer developed local recurrence, one of which developed multifocal local recurrence. CONCLUSIONS: Using the taTME approach on selected locally advanced low rectal cancers, especially in technically complex irradiated and obese male patients, has yielded comparably safe and effective outcomes to laparoscopic proctectomy.

The SAGES MASTERS program presents: the 10 seminal articles for the Laparoscopic Right Colectomy Pathway.

BACKGROUND: As one of the 12 clinical pathways of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Masters Program, the Colorectal Pathway intends to deliver didactic content organized along 3 levels of performance (competency, proficiency and mastery) each represented by an anchoring procedure (laparoscopic right colectomy, laparoscopic left/sigmoid colectomy, and intracorporeal anastomosis during minimally invasive (MIS) ileocecal or right colon resection). In this article, the SAGES Colorectal Task Force presents focused summaries of the top 10 seminal articles selected for laparoscopic right colectomy which surgeons should be familiar with. METHODS: Using a systematic literature search of Web of Science, the most cited articles on laparoscopic right colectomy were identified, reviewed, and ranked by the SAGES Colorectal Task Force and invited subject experts. Additional articles not identified in the literature search were included if deemed impactful by expert consensus. The top 10 ranked articles were then summarized, with emphasis on relevance and impact in the field, findings, strengths and limitations, and conclusions. RESULTS: The top 10 seminal articles selected for the laparoscopic right colectomy anchoring procedure include articles on surgical techniques for benign and malignant disease, with anatomical and video illustrations, comparative outcomes of laparoscopic vs open colectomy, variations in technique with impact on clinical outcomes, and assessment of the learning curve. CONCLUSIONS: The top 10 seminal articles selected for laparoscopic right colectomy illustrate the diversity both in content and format of the educational curriculum of the SAGES Masters Program to support practicing surgeon progression to mastery within the Colorectal Pathway.

Disease-free Survival and Local Recurrence for Laparoscopic Resection Compared With Open Resection of Stage II to III Rectal Cancer: Follow-up Results of the ACOSOG Z6051 Randomized Controlled Trial.

OBJECTIVE: To determine the disease-free survival (DFS) and recurrence after the treatment of patients with rectal cancer with open (OPEN) or laparoscopic (LAP) resection. BACKGROUND: This randomized clinical trial (ACOSOG [Alliance] Z6051), performed between 2008 and 2013, compared LAP and OPEN resection of stage II/III rectal cancer, within 12 cm of the anal verge (T1-3, N0-2, M0) in patients who received neoadjuvant chemoradiotherapy. The rectum and mesorectum were resected using open instruments for rectal dissection (included hybrid hand-assisted laparoscopic) or with laparoscopic instruments under pneumoperitoneum. The 2-year DFS and recurrence were secondary endpoints of Z6051. METHODS: The DFS and recurrence were not powered, and are being assessed for superiority. Recurrence was determined at 3, 6, 9, 12, and every 6 months thereafter, using carcinoembryonic antigen, physical examination, computed tomography, and colonoscopy. In all, 486 patients were randomized to LAP (243) or OPEN (243), with 462 eligible for analysis (LAP = 240 and OPEN = 222). Median follow-up is 47.9 months. RESULTS: The 2-year DFS was LAP 79.5% (95% confidence interval [CI] 74.4-84.9) and OPEN 83.2% (95% CI 78.3-88.3). Local and regional recurrence was 4.6% LAP and 4.5% OPEN. Distant recurrence was 14.6% LAP and 16.7% OPEN.Disease-free survival was impacted by unsuccessful resection (hazard ratio [HR] 1.87, 95% CI 1.21-2.91): composite of incomplete specimen (HR 1.65, 95% CI 0.85-3.18); positive circumferential resection margins (HR 2.31, 95% CI 1.40-3.79); positive distal margin (HR 2.53, 95% CI 1.30-3.77). CONCLUSION: Laparoscopic assisted resection of rectal cancer was not found to be significantly different to OPEN resection of rectal cancer based on the outcomes of DFS and recurrence.

Effect of Laparoscopic-Assisted Resection vs Open Resection of Stage II or III Rectal Cancer on Pathologic Outcomes: The ACOSOG Z6051 Randomized Clinical Trial.

IMPORTANCE: Evidence about the efficacy of laparoscopic resection of rectal cancer is incomplete, particularly for patients with more advanced-stage disease. OBJECTIVE: To determine whether laparoscopic resection is noninferior to open resection, as determined by gross pathologic and histologic evaluation of the resected proctectomy specimen. DESIGN, SETTING, AND PARTICIPANTS: A multicenter, balanced, noninferiority, randomized trial enrolled patients between October 2008 and September 2013. The trial was conducted by credentialed surgeons from 35 institutions in the United States and Canada. A total of 486 patients with clinical stage II or III rectal cancer within 12 cm of the anal verge were randomized after completion of neoadjuvant therapy to laparoscopic or open resection. INTERVENTIONS: Standard laparoscopic and open approaches were performed by the credentialed surgeons. MAIN OUTCOMES AND MEASURES: The primary outcome assessing efficacy was a composite of circumferential radial margin greater than 1 mm, distal margin without tumor, and completeness of total mesorectal excision. A 6% noninferiority margin was chosen according to clinical relevance estimation. RESULTS: Two hundred forty patients with laparoscopic resection and 222 with open resection were evaluable for analysis of the 486 enrolled. Successful resection occurred in 81.7% of laparoscopic resection cases (95% CI, 76.8%-86.6%) and 86.9% of open resection cases (95% CI, 82.5%-91.4%) and did not support noninferiority (difference, -5.3%; 1-sided 95% CI, -10.8% to ∞; P for noninferiority = .41). Patients underwent low anterior resection (76.7%) or abdominoperineal resection (23.3%). Conversion to open resection occurred in 11.3% of patients. Operative time was significantly longer for laparoscopic resection (mean, 266.2 vs 220.6 minutes; mean difference, 45.5 minutes; 95% CI, 27.7-63.4; P < .001). Length of stay (7.3 vs 7.0 days; mean difference, 0.3 days; 95% CI, -0.6 to 1.1), readmission within 30 days (3.3% vs 4.1%; difference, -0.7%; 95% CI, -4.2% to 2.7%), and severe complications (22.5% vs 22.1%; difference, 0.4%; 95% CI, -4.2% to 2.7%) did not differ significantly. Quality of the total mesorectal excision specimen in 462 operated and analyzed surgeries was complete (77%) and nearly complete (16.5%) in 93.5% of the cases. Negative circumferential radial margin was observed in 90% of the overall group (87.9% laparoscopic resection and 92.3% open resection; P = .11). Distal margin result was negative in more than 98% of patients irrespective of type of surgery (P = .91). CONCLUSIONS AND RELEVANCE: Among patients with stage II or III rectal cancer, the use of laparoscopic resection compared with open resection failed to meet the criterion for noninferiority for pathologic outcomes. Pending clinical oncologic outcomes, the findings do not support the use of laparoscopic resection in these patients. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00726622.

A natural orifice transrectal approach for oncologic resection of the rectosigmoid: an experimental study and comparison with conventional laparoscopy.

BACKGROUND: A transrectal (TR) approach for natural orifice translumenal endoscopic surgery (NOTES) makes sense for colorectal surgery because the colotomy can be incorporated into subsequent anastomosis. Because cancer is a primary indication for left-sided colon resection, oncologic standards will have to be met by a NOTES procedure. This study aimed to assess whether pure TR rectosigmoidectomy can be performed with strict adherence to oncologic principles compared with a conventional laparoscopically assisted approach (LAP). METHODS: Human male cadavers were allocated to either TR (n = 4) or LAP (n = 2). A simulated sigmoid lesion was created at 25 cm. Transrectal retrograde mobilization of the rectosigmoid was performed using conventional transanal endoscopic microsurgery (TEM) instrumentation. After ligation of the superior hemorrhoidal artery and further mobilization, the specimen was delivered transanally and divided extracorporeally. Using a circular stapler, NOTES colorectal anastomosis was performed. Lymph node yield, adequate resection margins, and operative time were compared with LAP. RESULTS: Transrectal retrograde rectosigmoid dissection was achieved in all attempts (4/4) and showed numbers of lymph nodes (median, 5; range, 3-6) similar to the LAP group (median, 4.5; range, 2-7). One pure TR approach failed to resect the lesion. Three TR procedures required additional mobilization via an abdominal approach to provide adequate margins. The mean length of TR specimens was 16 ± 4 cm compared with 31 ± 9 cm achieved by LAP (p < 0.01). The TR operative time was significantly longer (247 ± 15 vs 110 ± 14 min). CONCLUSION: Lymph node yield during TR rectosigmoidectomy was similar to that achieved by the LAP approach. However, conventional TEM instrumentation alone did not permit adequate colon mobilization. This indicates a need for flexible instrumentation or other technical solutions to perform true NOTES colectomies.

TGFß suppresses CD8+ T cell expression of CXCR3 and tumor trafficking.

Transforming growth factor beta (TGFß) is a multipotent immunosuppressive cytokine. TGFß excludes immune cells from tumors, and TGFß inhibition improves the efficacy of cytotoxic and immune therapies. Using preclinical colorectal cancer models in cell type-conditional TGFß receptor I (ALK5) knockout mice, we interrogate this mechanism. Tumor growth delay and radiation response are unchanged in animals with Treg or macrophage-specific ALK5 deletion. However, CD8αCre-ALK5flox/flox (ALK5ΔCD8) mice reject tumors in high proportions, dependent on CD8+ T cells. ALK5ΔCD8 mice have more tumor-infiltrating effector CD8+ T cells, with more cytotoxic capacity. ALK5-deficient CD8+ T cells exhibit increased CXCR3 expression and enhanced migration towards CXCL10. TGFß reduces CXCR3 expression, and increases binding of Smad2 to the CXCR3 promoter. In vivo CXCR3 blockade partially abrogates the survival advantage of an ALK5ΔCD8 host. These data demonstrate a mechanism of TGFß immunosuppression through inhibition of CXCR3 in CD8+ T cells, thereby limiting their trafficking into tumors.

Transanal endoscopic microsurgical platform for natural orifice surgery.

BACKGROUND: The excitement surrounding natural orifice transluminal endoscopic surgery (NOTES) remains tempered by concerns over safe access and closure of transvisceral enterotomies. Research in NOTES has commonly been described as using an oral transgastric access point. Transanal endoscopic microsurgery (TEM) is a minimally invasive technique for a full-thickness resection of rectal tumors and with suture closure of the resultant defect with highly specialized instruments. This technique has been used clinically in human beings for more than 2 decades. Entry into the peritoneal cavity during a resection of rectosigmoid lesions has been described, and safe closure can be obtained. OBJECTIVE: To assess the feasibility of transrectal NOTES procedures by using TEM instrumentation. DESIGN: Three porcine and 3 human cadaver models were studied by using standard TEM instrumentation and flexible endoscopes. NOTES peritoneal access, a peritoneoscopy, a liver biopsy, and colorectal resections were performed. RESULTS: True NOTES procedures facilitated with TEM instrumentation were successfully completed. LIMITATIONS: This was a preclinical study, and several challenges to bridging to human clinical use exist: TEM instruments are currently designed for intraluminal tasks low in the pelvis, with 5-mm to 10-mm port sizes; the cost of the TEM instruments and insufflation system; and the learning curve to perform TEM closure. CONCLUSIONS: Our preclinical study demonstrated the feasibility of several transrectal NOTES procedures, colorectal resection, and anastomosis when using TEM instrumentation. We, therefore, suggest TEM as a portal for NOTES.

Transanal endoscopic microsurgery (TEM) resection of rectal tumors.

Local excision of rectal cancer is an attractive alternative to avoid the morbidity associated with radical rectal surgery. Oncologic concerns, specifically the inability to fully assess the status of the perirectal lymph nodes and the risk of local recurrence after local excision remain significant barriers to widespread adoption of this technique. Transanal endoscopic microsurgery is an alternative minimally invasive technique used for transanal excision of rectal polyps and tumors. It offers the advantage of better exposure, magnified stereoscopic view, and greater reach into the middle and upper rectum. This technique, combined with careful patient selection, has demonstrated optimistic results compared to standard transanal techniques and even total mesorectal excision when utilized for certain early rectal cancers.

Full-thickness intraperitoneal excision by transanal endoscopic microsurgery does not increase short-term complications.

PURPOSE: Transanal endoscopic microsurgery (TEM) is a minimally invasive technique for full-thickness excision of benign and malignant rectal neoplasms located 4 to 24 cm above the anal verge. Entrance into the peritoneal cavity during TEM has been regarded as a complication that mandates conversion to open laparotomy for adequate repair of the defect. This study compares the rate of complications arising from TEM with and without intraperitoneal entry. METHODS: Patients undergoing peritoneal entry were compared to those who did not. RESULTS: No perioperative deaths occurred. There was no significant difference in the incidence of postoperative complications. No major complications occurred with peritoneal entry, and all peritoneal entries were closed transanally via endoscope. CONCLUSIONS: Entry into the peritoneum during TEM is not associated with an increased incidence of complication. Entry into the peritoneum during TEM excision does not mandate conversion to open laparotomy but may be safely repaired endoscopically. Lesions likely to be above the peritoneal reflection and within reach of the endoscope (4 to 24 cm) should be considered for TEM excision.

The rational use of computed tomography scans in the diagnosis of appendicitis.

BACKGROUND: Recently, limited abdominal computed tomography (CT) scans have been reported (Rao, New England Journal of Medicine, 1998) to have accuracy as high as 98%. We compare our hospital's CT accuracy ordered by emergency room (ER) physicians with that of experienced surgeons provided only with the ER history and physical examination in the evaluation of appendicitis. METHODS: All charts of patients 16 years or older with limited CT scans ordered by ER from January 1, 1996, through February 28, 1998, were reviewed. CT scans ordered when appendicitis was not in the differential were excluded from analysis. Pathology and clinical follow-up were criterion standards. Four surgeons reviewed ER history and physical and placed them into one of three categories: appendectomy, observe to rule out appendicitis, or discharge with follow-up (included admitting to another service or treating for another disorder). RESULTS: A total of 526 charts were reviewed; 129 met the criteria for the study. The accuracy of CT scans as used by our ER was not as high as reported in the literature. In addition, surgeon accuracy approached that of the CT scan even without the ability to evaluate the patients in person. Noncontrast CTs were ordered before surgical evaluation in contrast to the Rao protocol, likely reducing their accuracy. CONCLUSIONS: Ordering CT scans to evaluate for appendicitis prior to surgical evaluation is of limited value.

Prospective study of colorectal enhanced recovery after surgery in a community hospital.

IMPORTANCE: Enhanced recovery after surgery (ERAS) colorectal programs have shown to be successful at reducing length of stay in many international and academic centers; however, their efficacy in a community hospital setting remains unclear. OBJECTIVE: To determine if favorable results could be reproduced in a community hospital setting using our ERAS program, which was developed using core ERAS guidelines with the goal of accelerated recovery while also addressing other important outcomes affecting patient experience and safety. DESIGN, SETTING, AND PARTICIPANTS: Prospective study of ERAS program, a multidisciplinary effort involving anesthesia, preadmission staff, nursing, and surgery staff at a community hospital. The program was initiated in 2010 and was in full practice by 2011. We assessed practice patterns and patient outcomes for all elective colon and rectal resection cases performed in 2009 (prior to ERAS implementation), 2011, and 2012. MAIN OUTCOMES AND MEASURES: Laparoscopic approach, narcotic use, length of stay, 30-day readmission, ileus (defined as reinsertion of nasogastric tube), and intra-abdominal infection and association between colorectal cancer (CRC) diagnosis and these outcomes. RESULTS: From 2009 to 2012, the use of laparoscopy increased from 57.4% to 88.8% (P < .001). Length of stay decreased significantly (6.7 days vs 3.7 days, P < .001), without an increase in 30-day readmission rate (17.6% vs 12.5%, P = .49). Use of patient-controlled narcotic analgesia and duration of use decreased (63.2% of patients vs 15%, P < .001; 67.8 hours vs 47.1 hours, P = .02). Ileus rate decreased from 13.2% to 2.5% (P = .02). Intra-abdominal infection decreased from 7.4% to 2.5% (P = .24). When comparing laparoscopic cases alone, similar results were observed. Following regression analysis, there were no statistically significant differences between CRC diagnosis and LOS, 30-day readmission rates, ileus, and intra-abdominal infection (all P's > .05). Length of stay reductions resulted in an estimated cost savings of $3202 per patient (2011) and $4803 per patient (2012). CONCLUSIONS AND RELEVANCE: Implementation of this patient care-directed enhanced recovery program is feasible in a community hospital setting, and it is associated with decreased LOS without increased readmission or morbidity, as well as significant decreases in narcotic use and cost. Improved outcomes are independent of the laparoscopic approach and CRC diagnosis.

ß-blocker continuation after noncardiac surgery: a report from the surgical care and outcomes assessment program.

BACKGROUND: Despite limited evidence of effect, ß-blocker continuation has become a national quality improvement metric. OBJECTIVE: To determine the effect of ß-blocker continuation on outcomes in patients undergoing elective noncardiac surgery. DESIGN, SETTING, AND PATIENTS: The Surgical Care and Outcomes Assessment Program is a Washington quality improvement benchmarking initiative based on clinical data from more than 55 hospitals. Linking Surgical Care and Outcomes Assessment Program data to Washington's hospital admission and vital status registries, we studied patients undergoing elective colorectal and bariatric surgical procedures at 38 hospitals between January 1, 2008, and December 31, 2009. MAIN OUTCOME MEASURES: Mortality, cardiac events, and the combined adverse event of cardiac events and/or mortality. RESULTS: Of 8431 patients, 23.5% were taking ß-blockers prior to surgery (mean [SD] age, 61.9 [13.7] years; 63.0% were women). Treatment with ß-blockers was continued on the day of surgery and during the postoperative period in 66.0% of patients. Continuation of ß-blockers both on the day of surgery and postoperatively improved from 57.2% in the first quarter of 2008 to 71.3% in the fourth quarter of 2009 (P value <.001). After adjusting for risk characteristics, failure to continue ß-blocker treatment was associated with a nearly 2-fold risk of 90-day combined adverse event (odds ratio, 1.97; 95% CI, 1.19-3.26). The odds were even greater among patients with higher cardiac risk (odds ratio, 5.91; 95% CI, 1.40- 25.00). The odds of combined adverse events continued to be elevated 1 year postoperatively (odds ratio, 1.66; 95% CI, 1.08-2.55). CONCLUSIONS: ß-Blocker continuation on the day of and after surgery was associated with fewer cardiac events and lower 90-day mortality. A focus on ß-blocker continuation is a worthwhile quality improvement target and should improve patient outcomes.

Routine leak testing in colorectal surgery in the Surgical Care and Outcomes Assessment Program.

OBJECTIVE: To evaluate the effect of routine anastomotic leak testing (performed to screen for leaks) vs selective testing (performed to evaluate for a suspected leak in a higher-risk or technically difficult anastomosis) on outcomes in colorectal surgery because the value of provocative testing of colorectal anastomoses as a quality improvement metric has yet to be determined. DESIGN: Observational, prospectively designed cohort study. SETTING: Data from Washington state's Surgical Care and Outcomes Assessment Program (SCOAP). PATIENTS: Patients undergoing elective left-sided colon or rectal resections at 40 SCOAP hospitals from October 1, 2005, to December 31, 2009. INTERVENTIONS: Use of leak testing, distinguishing procedures that were performed at hospitals where leak testing was selective (<90% use) or routine (≥ 90% use) in a given calendar quarter. MAIN OUTCOME MEASURE: Adjusted odds ratio of a composite adverse event (CAE) (unplanned postoperative intervention and/or in-hospital death) at routine testing hospitals. RESULTS: Among 3449 patients (mean [SD] age, 58.8 [14.8] years; 55.0% women), the CAE rate was 5.5%. Provocative leak testing increased (from 56% in the starting quarter to 76% in quarter 16) and overall rates of CAE decreased (from 7.0% in the starting quarter to 4.6% in quarter 16; both P ≤ .01) over time. Among patients at hospitals that performed routine leak testing, we found a reduction of more than 75% in the adjusted risk of CAEs (odds ratio, 0.23; 95% CI, 0.05-0.99). CONCLUSION: Routine leak testing of left-sided colorectal anastomoses appears to be associated with a reduced rate of CAEs within the SCOAP network and meets many of the criteria of a worthwhile quality improvement metric.

Adoption of laparoscopy for elective colorectal resection: a report from the Surgical Care and Outcomes Assessment Program.

BACKGROUND: The purpose of this study was to evaluate the adoption of laparoscopic colon surgery and assess its impact in the community at large. STUDY DESIGN: The Surgical Care and Outcomes Assessment Program (SCOAP) is a quality improvement benchmarking initiative in the Northwest using medical record-based data. We evaluated the use of laparoscopy and a composite of adverse events (ie, death or clinical reintervention) for patients undergoing elective colorectal surgery at 48 hospitals from the 4th quarter of 2005 through 4th quarter of 2010. RESULTS: Of the 9,705 patients undergoing elective colorectal operations (mean age 60.6 ± 15.6 years; 55.2% women), 38.0% were performed laparoscopically (17.8% laparoscopic procedures converted to open). The use of laparoscopic procedures increased from 23.3% in 4th quarter of 2005 to 41.6% in 4th quarter of 2010 (trend during study period, p < 0.001). After adjustment (for age, sex, albumin levels, diabetes, body mass index, comorbidity index, cancer diagnosis, year, hospital bed size, and urban vs rural location), the risk of transfusions (odds ratio [OR] = 0.52; 95% CI, 0.39-0.7), wound infections (OR = 0.45; 95% CI, 0.34-0.61), and composite of adverse events (OR = 0.58; 95% CI, 0.43-0.79) were all significantly lower with laparoscopy. Within those hospitals that had been in SCOAP since 2006, hospitals where laparoscopy was most commonly used also had a substantial increase in the volume of all types of colon surgery (202 cases per hospital in 2010 from 112 cases per hospital in 2006, an 80.4% increase) and, in particular, the number of resections for noncancer diagnoses and right-sided pathology. CONCLUSIONS: The use of laparoscopic colorectal resection increased in the Northwest. Increased adoption of laparoscopic colectomies was associated with greater use of all types of colorectal surgery.

Perianal abscess/fistula disease.

Perirectal abscesses and fistulas represent the acute and chronic manifestations of the same disease process, an infected anal gland. They have beleaguered patients and physicians for millennia. A thorough understanding of the anatomy and pathophysiology of the disease process is critical for optimal diagnosis and management. Abscess management is fairly straightforward, with incision and drainage being the hallmark of therapy. Fistula management is much more complicated. It requires striking a balance between rates of healing and potential alteration of fecal continence. This, therefore, requires much more finesse. Many techniques are now available in the armamentarium of the surgeon who treats fistula-in-ano. Although no single technique is appropriate for all patients and all fistula types, appropriate selection of patients and choice of repair technique should yield higher success rates with lower associated morbidity.