Considering Value in Rectal Cancer Surgery: An Analysis of Costs and Outcomes Based on the Open, Laparoscopic, and Robotic Approach for Proctectomy.

OBJECTIVE: The aim of the study was to compare value (outcomes/costs) of proctectomy in patients with rectal cancer by 3 approaches: open, laparoscopic, and robotic. BACKGROUND: The role of minimally invasive proctectomy in rectal cancer is controversial. In the era of value-based medicine, costs must be considered along with outcomes. METHODS: Primary rectal cancer patients undergoing curative intent proctectomy at our institution between 2010 and 2014 were included. Patients were grouped by approach [open surgery, laparoscopic surgery, and robotic surgery (RS)] on an intent-to-treat basis. Groups were compared by direct costs of hospitalization for the primary resection, 30-day readmissions, and ileostomy closure and for short-term outcomes. RESULTS: A total of 488 patients were evaluated; 327 were men (67%), median age was 59 (27-93) years, and restorative procedures were performed in 333 (68.2%). Groups were similar in demographics, tumor characteristics, and treatment details. Significant outcome differences between groups were found in operative and anesthesia times (longer in the RS group), and in estimated blood loss, intraoperative transfusion, length of stay, and postoperative complications (all higher in the open surgery group). No significant differences were found in short-term oncologic outcomes. Direct cost of the hospitalization for primary resection and total direct cost (including readmission/ileostomy closure hospitalizations) were significantly greater in the RS group. CONCLUSIONS: The laparoscopic and open approaches to proctectomy in patients with rectal cancer provide similar value. If robotic proctectomy is to be widely applied in the future, the costs of the procedure must be reduced.

Factors associated with the location of local rectal cancer recurrence and predictors of survival.

PURPOSE: The location of locally recurrent rectal cancer (LRRC) may influence survival. This study examines factors affecting the location of LRRC, the effect of LRRC location on survival, and predictive factors for survival in patients with LRRC. METHODS: Patients undergoing initial proctectomy and subsequent management of LRRC at the Cleveland Clinic (1980-2011) were included. Data regarding index surgery, LRRC, and survival were obtained from a prospectively maintained database. RESULTS: One hundred and fifty-seven patients were identified with a mean follow-up 59.8 ± 50.1 months and time to LRRC of 31.7 ± 30.1 months. Sixty patients underwent surgery with curative intent. Anastomotic leak and retrieving less than 12 lymph nodes at index proctectomy were associated with posterior (P = 0.019) and lateral (P = 0.036) recurrences, respectively. Having an axial relative to an anterior, posterior, or lateral recurrence was associated with improved overall survival (P = 0.001). On multivariable analysis, undergoing primarily palliative treatment (OR, 5.2; 95 % confidence interval (CI), 3.2-8.4; P < 0.001), age at LRRC >60 years (OR, 1.9; 95 % CI, 1.3-2.7, P < 0.001), advanced primary tumour stage (OR, 1.5; 95 % CI, 1.1-2.1; P = 0.021), and anastomotic leak at index surgery (OR, 1.8; 95 % CI, 1.2-2.7; P = 0.008) were associated with reduced LRRC 5-year survival. CONCLUSIONS: The current study suggests that features of the primary tumour and technical factors at the time of index proctectomy influence both the location of LRRC and survival.

Risk and location of cancer in patients with preoperative colitis-associated dysplasia undergoing proctocolectomy.

OBJECTIVE: To evaluate the influence of preoperative dysplasia grade, appearance, and site on risk and location of cancer in patients with colitis. BACKGROUND: The ability to predict the presence and location of cancer in colitis patients with dysplasia is essential to facilitate recommendations regarding the necessity and type of surgery. METHODS: Ulcerative and indeterminate colitis patients who underwent proctocolectomy for dysplasia were retrospectively selected. Patient characteristics and findings at colonoscopic surveillance were associated with findings on the surgical specimen by regression analysis. RESULTS: From 1984 to 2007, 348 proctocolectomy specimens with preoperative dysplasia showed cancer in 51 (15%) and dysplasia in 172 (49%) cases. Patients with preoperative high-grade dysplasia (HGD) had cancer in 29% compared with 3% in low-grade dysplasia (LGD) (P < 0.001). Patients with preoperative dysplasia-associated lesion/mass (DALM) had cancer in 25% compared with 8% in flat dysplasia (P < 0.001). In LGD with DALM, the risk of cancer was not significantly higher than in flat LGD (7% vs 2%, P = 0.3), but risk of cancer or HGD was higher with a threefold increase (29% vs 9%, P = 0.015). On multivariate analysis, HGD, DALM, and disease duration were independent risk factors for postoperative cancer. In patients with isolated colonic dysplasia above the sigmoid level, postoperative rectal involvement was limited. CONCLUSIONS: Risk of cancer for patients with HGD or DALM is substantial. Despite low risk of cancer in patients with flat LGD, threshold for surgery should be low given the high prevalence of postoperative pathologic findings. Only in selected cases, colonoscopic surveillance after discussion of associated risks may be acceptable, provided high patient compliance can be assured. Surgery should be considered in all other cases, because it is the only modality that can eliminate the risk of cancer. The location of preoperative dysplasia may allow for the clarification of the need for proctectomy especially in the poor risk surgical patient.

Less than 12 nodes in the surgical specimen after total mesorectal excision following neoadjuvant chemoradiation: it means more than you think!

BACKGROUND: A minimum of 12 examined lymph nodes (LN) is recommended to ensure adequate staging and oncologic resection of patients undergoing proctectomy for rectal adenocarcinoma. However, a decreased number of LN is not unusual in patients receiving neoadjuvant chemoradiation. PURPOSE: We hypothesized that a decreased number of LN in the proctectomy specimen of these patients may be an indicator of tumor response and be associated with improved prognosis. METHODS: A single-center colorectal cancer database was queried for c-stage II-III rectal cancer patients undergoing neoadjuvant chemoradiation followed by proctectomy between 1997 and 2007. Patients were categorized into two groups according to the number of LN retrieved from the proctectomy specimen: <12 LN versus ≥12 LN. Groups were compared with respect to demographics, tumor and treatment characteristics, and the following oncologic outcomes: overall-survival (OS), cancer-specific-mortality (CSM), cancer-free-survival (CFS), distant (DR), and local recurrences (LR). RESULTS: The query returned 237 patients. There were 173 (73 %) males, and the median age was 57 years [interquartile range (IQR) 49-66 years]. The median number of LN retrieved was 15 (IQR 10-23) and 70 (30 %) patients had less than 12 nodes examined. The <12 nodes group was older [60 (IQR 51-71 years) vs. 55 (IQR 48-65 years), p = 0.009] and had more pathologic complete responders (36 vs. 19 %, p = 0.01). No <12 nodes patient experienced a LR, whereas the 5-year LR rate was 11 % in the ≥12 nodes group (p = 0.004). Other oncologic outcomes were not significantly different. CONCLUSIONS: Retrieval of less than 12 nodes in the proctectomy specimen of rectal cancer patients treated with neoadjuvant chemoradiation does not affect OS, CSM, CFS, or DR and may be a marker of higher tumor response and, consequently, decreased LR rate.

Impact of obesity on operation performed, complications, and long-term outcomes in terms of restoration of intestinal continuity for patients with mid and low rectal cancer.

BACKGROUND: The impact of obesity per se on the surgical strategy, ie, sphincter sacrifice (abdominoperineal resection) vs sphincter-preserving resection, outcomes, and long-term maintenance of intestinal continuity has been poorly studied in patients with mid and low rectal cancer. OBJECTIVE: The aim of this study is to compare the outcomes and long-term maintenance of intestinal continuity for obese and nonobese patients treated surgically for mid and low rectal cancers. DESIGN: This is a retrospective cohort study from a prospectively collected database. SETTING: The investigation took place in a high-volume specialized colorectal surgery department. PATIENTS: All patients who underwent curative surgery for mid or low rectal adenocarcinoma at a single institution from 1976 to 2011 were identified. MAIN OUTCOME MEASURES: Obese (BMI ≥ 30 kg/m) and nonobese patients were matched 1:2 for age, sex, ASA class, location, and stage of tumor. Demographics, use of neoadjuvant chemoradiotherapy, operative and perioperative outcomes, pathology, long-term outcomes including oncologic outcomes, and whether restoration of intestinal continuity was obtained were compared. RESULTS: One hundred fifty-seven obese patients and 314 nonobese patients were included in the study. The groups were similar for matched characteristics. The use of neoadjuvant chemoradiotherapy (p = 0.048) and anastomotic leak (p = 0.0003) rates were higher in obese patients. A similar proportion of nonobese and obese patients underwent sphincter-preserving resection (p > 0.99), and postoperative hospital stay (p = 0.23), 30-day postoperative reoperation (p = 0.83), mortality (p > 0.99), and readmissions (p = 0. 13) were similar. The obese and nonobese groups had similar overall (p = 0.61) and disease-free survival (p = 0.74) at a mean follow-up of 5 years for both groups. LIMITATIONS: This study was limited by its retrospective and nonrandomized nature. CONCLUSION: At a high-volume specialized colorectal unit, proctectomy can be performed in obese patients with similar long-term oncologic outcomes and ability to restore intestinal continuity in comparison with nonobese patients. Proctectomy in obese patients, however, is associated with an increased risk of anastomotic leak in comparison with nonobese patients.

Endorectal ultrasound does not reliably identify patients with uT3 rectal cancer who can avoid neoadjuvant chemoradiotherapy.

PURPOSE: Neoadjuvant chemoradiation (NCRT) may be avoided in some patients with T3-staged rectal cancer undergoing radical resection. We aimed to evaluate the accuracy of endorectal ultrasound (ERUS) in the nodal staging of uT3 tumors and hence the decision for administration of NCRT. METHODS: Patients with uT3-staged rectal cancer who underwent proctectomy were retrospectively identified. The accuracy of ERUS for detecting nodal involvement was determined for patients who did not undergo NCRT. In order to evaluate the impact of use of NCRT, oncologic outcomes, functional outcomes, and quality of life (QOL) were compared for patients who received NCRT (group A) and those who did not (group B). RESULTS: For 384 patients who were included, ERUS overstaging rate for nodal involvement was 6.3% while understaging rate was 23.2%. For the 289 patients in group A and 95 in group B, Kaplan-Meier analysis showed similar 5-year local recurrence rates (3.5%), overall survival (76.9 vs 75.6%), and disease-free survival (87.9 vs 88.1%). Node positivity on final pathology was however associated with worse 5-year local recurrence (9.3 vs 4.3%). For patients undergoing restorative resection, NCRT was associated with worse functional outcomes but QOL was similar. CONCLUSIONS: ERUS identification of nodal involvement used as a criterion for NCRT carries a greater risk for undertreatment than overtreatment. Undertreatment adversely affects oncologic outcomes. While there is functional impairment related to NCRT, its effect on QOL is non-significant. The decision for omitting neoadjuvant chemoradiation for uT3 rectal cancer should hence not be based on ERUS nodal staging alone.

Dysplasia associated with Crohn's colitis: segmental colectomy or more extended resection?

BACKGROUND AND OBJECTIVE: There is limited data on the appropriate management of dysplasia in Crohn's colitis. An evidence-based surgical strategy is provided. METHODS: Patients with a pathologic diagnosis of dysplasia in Crohn's colitis from 1987 to 2009 were identified. Patients were classified by dysplasia grade (low grade or LGD, high grade or HGD). Clinical, endoscopic, operative, and pathologic data were retrieved. Factors associated with a final cancer diagnosis were analyzed. Survival data on patients undergoing limited versus radical resection for cancer and HGD was compared. RESULTS: From 1987 to 2009, 50 patients underwent a colectomy for Crohn's colitis-associated dysplasia. The predictive value of HGD for a final HGD or cancer diagnosis was 73%. The predictive value of LGD on biopsy for HGD in the colectomy was 36%. Sixteen patients (44%) who underwent a total proctocolectomy (TPC) or subtotal colectomy (STC) had multifocal dysplasia. Four of 10 (40%) cancer patients had evidence of dysplasia remote from cancer site on pathologic examination. During follow-up, there were 3 cancer-related deaths. One patient died of metachronous cancer after STC. CONCLUSIONS: The findings confirm the risk of cancer in patients with CD dysplasia. Because of the multifocal nature of dysplasia in Crohn's colitis, TPC is recommended in good-risk patients. In specific circumstances, such as poor-risk patients especially in the setting of LGD, close endoscopic surveillance or alternatively segmental or STC with close postoperative endoscopic surveillance, depending upon the individual circumstance, may be discussed.

Is adjuvant chemotherapy really needed after curative surgery for rectal cancer patients who are node-negative after neoadjuvant chemoradiotherapy?

PURPOSE: Adjuvant chemotherapy is currently offered, as standard, after curative resection for patients with rectal cancer who receive neoadjuvant chemoradiation (NCRT). We postulate that adjuvant chemotherapy adds minimal oncologic benefit for patients who undergo total mesorectal excision who are node-negative after neoadjuvant chemoradiation. METHODS: From a prospective, institutional cancer database, rectal cancer patients who completed neoadjuvant chemoradiation and curative surgery (2000-2008) and were node-negative on final pathology were identified. Patient, tumor, treatment characteristics, and oncologic outcomes were compared for patients who completed intended adjuvant chemotherapy (group chemo) or did not receive any chemotherapy (group no-chemo). RESULTS: Chemo (n=58) and no-chemo (n=70) patients had similar age (P=0.13), gender (P=0.67), body mass index (P=0.46), American Society of Anesthesiologists class (P=0.67), preoperative tumor stage (P=0.16), type of surgery (P=0.76), and postoperative complications. The no-chemo group had greater complete pathologic response (n=34, 48.6% vs. n=14, 24.1%). After prolonged follow-up, local recurrence (P=1), disease-free survival (P=0.41), and overall survival (P=0.52) were similar. Oncologic benefits of adjuvant chemotherapy were especially questionable for patients with complete pathologic response (chemo vs. no-chemo, local recurrence at 5 years: 0 vs. 2.9%, P>0.99), disease-free (79.1% vs. 88%, P=0.51), and overall survival (90.9% vs. 95.2%, P=0.41). CONCLUSIONS: These results question the routine use of adjuvant chemotherapy for patients with rectal cancer who undergo curative surgery who have been rendered node-negative by neoadjuvant chemoradiation.

Effects of chronic immunosuppression on long-term oncologic outcomes for colorectal cancer patients undergoing surgery.

INTRODUCTION: The effects of chronic immunosuppressive therapy (CIST) on long-term oncologic outcomes for patients who undergo surgery for colorectal cancer are not known. We investigate whether CIST affects these outcomes. METHODS: From a prospective colorectal cancer database, patients undergoing colorectal resection for cancer between 1996 and 2005 and on CIST (steroids and/or cyclosporine, azathioprine, 6-mercaptopurine, FK-506, methotrexate) were identified and compared with a control group matched for age(±5 year), gender, type, and year (±2 year) of operation; American Society of Anesthesiology score; cancer stage; differentiation; vascular invasion; blood transfusion; and postoperative adjuvant therapy. The groups were compared for early and long-term outcomes. Cox models produced hazard ratios and Wald P values to assess associations between survival and the presence of immunosuppressive treatment. RESULTS: Fifty-five (20 female and 35 male) patients were on CIST for inflammatory disease, transplantation, chronic obstructive lung disease, other cancers, and hypopituitarism. Both groups were comparable for the matched characteristics. Chronic immunosuppressive therapy and control groups had similar overall postoperative morbidity (36.4% vs 27.3%, P = 0.3) and wound infection rates (14.5% vs 5.5%, P = 0.13). Chronic immunosuppressive therapy group had significantly lower 3- and 5-year overall (49.1% vs 76.3%, and 45.1% vs 66.2%, respectively, P = 0.003) and disease-free survival (45.5% vs 69.1%, and 41.7% vs 63.3%, respectively, P = 0.005) than the control group. Local recurrence was similar between groups. CONCLUSION: Patients on chronic immunosuppression tolerate colorectal cancer resection but have significantly worse long-term oncologic outcomes.These findings need careful consideration when evaluating the relative roles of the various treatment modalities for this group of patients presenting with colorectal cancer.

Preoperative colorectal neoplasia increases risk for pouch neoplasia in patients with restorative proctocolectomy.

BACKGROUND & AIMS: Restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) has substantially reduced the risk for ulcerative colitis (UC)-associated dysplasia or cancer (neoplasia). We characterized features, risk factors, and outcomes of pouch neoplasia in patients with inflammatory bowel disease in a historical cohort study. METHODS: A total of 3203 patients with a preoperative diagnosis of inflammatory bowel disease underwent restorative proctocolectomy with IPAA from 1984 to 2009 at the Cleveland Clinic. Demographic, clinical, and endoscopic data were reviewed and samples were examined by histological analyses. Univariable and Cox regression analyses were performed. RESULTS: Cumulative incidences for pouch neoplasia at 5, 10, 15, 20, and 25 years were 0.9%, 1.3%, 1.9%, 4.2%, and 5.1%, respectively. Thirty-eight patients (1.19%) had pouch neoplasia, including 11 (0.36%) with adenocarcinoma of the pouch and/or the anal-transitional zone (ATZ), 1 (0.03%) with pouch lymphoma, 3 with squamous cell cancer of the ATZ, and 23 with dysplasia (0.72%). In the Cox model, the risk factor associated with pouch neoplasia was a preoperative diagnosis of UC-associated cancer or dysplasia, with adjusted hazard ratios of 13.43 (95% confidence interval: 3.96-45.53; P < .001) and 3.62 (95% confidence interval: 1.59-8.23; P = .002), respectively. Mucosectomy did not protect against pouch neoplasia. CONCLUSIONS: Risk for neoplasia in patients with UC and IPAA is small and not eliminated by colectomy or mucosectomy. A preoperative diagnosis of dysplasia or cancer of colon or rectum is a risk factor for pouch dysplasia or adenocarcinoma.