Quality of Life and Symptom Control after Stent Placement or Surgical Palliation of Malignant Colorectal Obstruction

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1 Quality of Life and Symptom Control after Stent Placement or Surgical Palliation of Malignant Colorectal Obstruction Satish Nagula, MD, Nicole Ishill, MS, Carla Nash, MD, Arnold J Markowitz, MD, Mark A Schattner, MD, Larissa Temple, MD, FACS, Martin R Weiser, MD, FACS, Howard T Thaler, PhD, Ann Zauber, PhD, Hans Gerdes, MD BACKGROUND: STUDY DESIGN: RESULTS: CONCLUSIONS: Emergent surgical management of malignant large bowel obstruction (LBO) carries a high rate of morbidity and mortality. Self-expanding metal stents have emerged as an alternative for palliation of malignant LBO. However, there are few long-term studies documenting the effect of surgical palliation or colonic stents on symptoms or quality of life (QoL). Between 2003 and 2006, patients with unresectable-for-cure malignancies presenting with LBO were enrolled in this prospective study. Patients elected to undergo stent placement or surgical palliation. Patients completed a symptom questionnaire and a QoL instrument (Functional Assessment of Cancer Therapy-Colorectal [FACT-C]) at weeks 1, 2, 4, 8, 12, and 24 after palliation. Symptoms were assessed using the Colon Obstruction Score, a novel instrument comprising nausea, vomiting, pain, distension, and bowel movement frequency scores. Thirty patients had successful stent placement; 14 underwent surgical diversion. Colon Obstruction Scores immediately improved after both stent placement and surgery (p 0.05 for all time points). Composite FACT-C scores progressively improved after stent placement (p NS), with the colon symptoms subscale improving after 1 month (p 0.05). FACT-C scores declined initially after surgery and then returned to baseline, with modest improvements seen in the Colon Symptoms subscale (p NS). Both stent placement and surgical diversion provide durable improvement in symptoms from LBO, as readily assessed by the Colon Obstruction Score. QoL is difficult to assess in terminal cancer patients, but colon stent placement is associated with improved overall QoL and QoL related to gastrointestinal symptoms. (J Am Coll Surg 2010;210: by the American College of Surgeons) Open access under CC BY-NC-ND license. Malignant large bowel obstruction (LBO) is a common occurrence in patients with advanced cancer, usually from colorectal and gynecologic malignancies. For patients with Disclosure Information: Nothing to disclose. This study was funded by a grant from the Cancer Treatment Research Foundation, grant #G An interim analysis of this study was presented at the Annual Meeting of the American Society for Gastrointestinal Endoscopy in 2005 and Received July 27, 2009; Revised September 23, 2009; Accepted September 29, From the Departments of Medicine, Gastroenterology, and Nutrition Service (Nagula, Markowitz, Schattner, Gerdes), Epidemiology and Biostatistics (Ishill, Thaler, Zauber), and Surgery, Colorectal Service (Temple, Weiser), Memorial Sloan-Kettering Cancer Center, New York, NY, and Department of Medicine, Division of Gastroenterology, University of Calgary, Calgary, AB, Canada (Nash). Correspondence address: Hans Gerdes, MD, Gastroenterology and Nutrition Service, Memorial Sloan-Kettering Cancer Center, 1275 York Ave, New York, NY gerdesh@mskcc.org colorectal cancer, LBO typically occurs in the left colon. 1,2 Symptoms generally include nausea, vomiting, abdominal pain, distension, and altered bowel function. Complete colonic obstruction is a surgical emergency, which can result in perforation, sepsis, and death. Surgical management varies with site of obstruction, extent of disease, and local expertise. Surgical palliative procedures include the creation of a diverting colostomy/ileostomy or an internal bypass. Emergent surgical management has high morbidity ( 50%) and a 30-day mortality approaching 30%. 3,4 Stoma-related complications, including pain, skin irritation, retraction, herniation, and stricture, occur in 30% to 40% of patients. 5,6 Ostomies can cause psychosocial stress, social restriction, and impact on daily functioning and quality of life (QoL). 7-9 During the past 15 years, self-expanding metal stents have emerged as an alternative to surgery for palliation of malignant LBO. Colon stents are readily inserted with an 2010 by the American College of Surgeons ISSN Published by Elsevier Inc. Open access under CC BY-NC-ND license. 45 doi: /j.jamcollsurg

2 46 Nagula et al Malignant Colorectal Obstruction and Quality of Life J Am Coll Surg Abbreviations and Acronyms FACT-C Functional Assessment of Cancer Therapy- Colorectal LBO large bowel obstruction QoL quality of life endoscopic procedure and provide immediate resolution of obstructive symptoms with a high technical success rate ( 95%) and complication rates of 10%. 10,11 Consequently, colon stent placement offers patients an enticing alternative to surgery, obviating the need for an ostomy. There are few longitudinal studies examining the effect of stent placement or surgical diversion on symptoms or QoL. The aim of the present study is to assess QoL and longitudinal symptom control in patients after colon stent placement or surgical diversion for palliation of malignant LBO. METHODS Study design Approval for this study was provided by the Institutional Review Board of Memorial Sloan-Kettering Cancer Center. The study is a prospective observational cohort study of patients with advanced malignancies undergoing either colon stent insertion or surgical diversion for malignant LBO. Patients were eligible for enrollment if they were older than the age of 18 years with an unresectable-for-cure malignancy with clinical signs or symptoms of LBO between February 2002 and July Symptoms included progressive constipation, multiple small bowel movements daily, abdominal distension, abdominal pain, and nausea and vomiting. LBO was confirmed in all patients by CT scan, gastrograffin enema, or colonoscopy. All patients were provided with detailed information about both surgical diversion and colon stent placement. Patients were excluded if they were unwilling to provide informed consent, had evidence of a perforation, had previous palliation for malignant bowel obstruction, had multifocal obstruction, or obstruction located within 2 cm of the dentate line or proximal to the hepatic flexure. Patients were also excluded if they had a recent myocardial infarction or cerebrovascular accident or uncorrectable coagulopathy. After enrollment, patients were excluded if any palliative procedures for LBO were performed at an outside institution. The study was initially designed as a randomized trial between colonic stent insertion and surgical palliation, with an observational arm for patients declining randomization. Because of patient reluctance to being randomized, and the referring physician s preference for either surgery or stent placement, no patients were enrolled in the randomized trial. Some patients feared the prospect of coping with an ostomy and opted for stent placement; other patients elected for surgical diversion hoping for the possibility of a concurrent resection. As the study progressed, fewer patients were willing to consider surgical diversion, as referring physicians and patients became more familiar with colonic stents. All enrolled patients were prospectively followed for 24 weeks after their intervention. Palliation The technique for endoscopic colon stent insertion has been described previously. 12 Patients received tap-water enemas on the day of the procedure. Intravenous conscious sedation or general anesthesia was administered during the procedure. An Olympus flexible endoscope/colonoscope (GIF-1T40, PCF-140, or CF-140L; Olympus America) was advanced to the site of obstruction. Using fluoroscopic guidance, a guidewire was advanced across the obstructive stricture. The stent deployment device was advanced over the guidewire, and the stent was deployed under endoscopic or fluoroscopic visualization, or both. The stents used were the Colonic Wallstent or the Colonic Ultraflex stent (Boston Scientific) according to the endoscopist s preference. Stent failure was defined as the technical inability to place a stent or no improvement of obstructive symptoms within 48 hours. Patients with stent failure were referred for surgical palliation. Surgical palliative options included minimally invasive or standard open diverting colostomy, diverting ileostomy, or internal bypass. The type of operation and operative technique was chosen by the treating surgeon in discussion with the patient. Standard postoperative management was individualized according to the primary surgical team. Symptom and QoL assessment Baseline clinical and demographic information were collected at the time of study enrollment. Symptoms were assessed using the Colon Obstruction Score, a novel, locally designed questionnaire that semiquantitatively assesses the presence and severity of abdominal pain, distension, nausea, vomiting, and bowel movement frequency (Table 1).Total scores ranged from 0 to 15 points; a score of 1 to 5 represents mild, 6 to 10 is moderate, and 11 to 15 is severe obstructive symptoms. The Functional Assessment of Cancer Therapy-Colorectal (FACT-C) tool is a validated survey instrument designed to assess QoL in cancer patients through physical, functional, social, and emotional well-being subscales, with an additional subscale that evaluates QoL related to gastrointestinal function The FACT-C was initially designed to

3 Vol. 210, No. 1, January 2010 Nagula et al Malignant Colorectal Obstruction and Quality of Life 47 Table 1. Scoring for the Colon Obstruction Score Category 0 points 1 point 2 points 3 points Abdominal pain (0 [mild] to 10 [severe]) Abdominal distension None Mild Moderate Severe Bowel movement frequency 2 3/d 1/d or none for 2 d 4 8/d or none for 3 d 8/d or none for 4d Nausea None Mild Moderate Severe Vomiting None Mild Moderate Severe Total scores range from 0 to 15 points; a score of 1 to 5 represents mild; 6 to 10 is moderate, and 11 to 15 is severe obstructive symptoms. assess QoL changes in colorectal cancer patients, but it is appropriate for study in patients with any malignancy that affects lower gastrointestinal tract function. Three individual questions were administered along with the FACT-C, evaluating global QoL, global health, and the effort required to cope with illness. 16,17 All patients underwent assessment of their symptoms and QoL using the previously mentioned instruments at baseline before any palliative intervention. The same questionnaires were administered either in person or via telephone at 1, 2, 4, 8, 12, and 24 weeks after stent insertion or surgery. Surgical or endoscopic reinterventions and procedure-related complications were assessed at each follow-up interval. Statistical analysis Overall survival was estimated using the product limit method of Kaplan and Meier and was measured from 1 week after study enrollment until death. This study was not designed as an intent-to-treat comparison between the stent and surgical groups, but rather was designed to assess symptoms and QoL in patients who received colon stents or who required surgical palliation, either initially or after stent failure. A landmark analysis was used to examine differences in survival between final treatment groups, starting at 1 week post-enrollment to account for patients who initially opted for stent placement but ultimately required surgical palliation. Paired t-tests were used to determine whether changes in subscale or symptom scores were substantially improved from baseline to follow-up time points, including only patients who were able to complete questionnaires at those time points. Medians and interquartile ranges were plotted over time for each of the subscales, global questions, and symptom indices. Although missing data occurred in some study patients because of death or increased illness severity, no imputation methods were used, given that the primary goal was to describe the changes in QoL as a result of palliative treatment, especially among those who would survive long enough to benefit from it. All analyses were performed using SAS 9.1 for Windows (SAS Institute). RESULTS Fifty-one patients were initially enrolled in this prospective cohort study. Seven patients were excluded from the final analysis: 1 patient withdrew consent; 2 were lost to follow-up before the first follow-up survey; 1 had a protocol violation, because a surgical procedure was performed at an outside institution; 1 did not have endoscopic evidence of colonic obstruction; and 2 died before first follow-up from nonprocedural complications. Forty-four patients were included in the final analysis (13 men, 31 women, mean age 57 years); clinical and demographic characteristics are shown in Table 2. Enrolled patients had a broad range of cancers, with primary colorectal cancer in 21 patients (48%), ovarian cancer in 9 patients (20%), gastric cancer in 4 patients (9%), and a variety of other malignancies in 10 patients (23%). Stent placement was initially attempted in 38 patients and was successful in 32 (84%), including 100% success in colorectal cancer (16 of 16) and 73% (16 of 22) in extracolonic malignancies. Eight patients experienced stent failure and required surgical palliation, including 6 (16%) who had unsuccessful attempts at stent placement and 2 (5%) who had successful stent placements but inadequate symptom resolution within 48 hours. Six patients chose surgery initially, yielding a total of 14 in the surgery group and 30 in the stent group (Fig. 1). Two patients in the surgical group underwent internal bypass, and the remaining 12 had a diverting colostomy or ileostomy. Eight patients (26%) underwent stent placement as outpatients. For those treated as inpatients, median length of stay was 4 days after stent placement (22 patients) and 7.5 days after surgery (14 patients). There were no procedure-related complications or postoperative deaths in either the stent group or the surgery group. There was 1 postoperative abscess in the surgery group that required drainage. Three patients (10%) in the stent group required repeat colonoscopy with second stent placement: 2 for recurrent obstruction caused by tumor ingrowth of the stent and 1 for stent migration. Small bowel obstruction developed in 3 additional patients in this group; 2 underwent surgical bypass and 1 received a drainage gastrostomy. In the surgical group, inoperable small bowel obstruction also devel-

4 48 Nagula et al Malignant Colorectal Obstruction and Quality of Life J Am Coll Surg Table 2. Patient Characteristics Stent (n 30)* Surgery (n 14) Total (n 44) Characteristic n % n % n % Gender Male Female Cancer type Colon Ovary Stomach Other Breast Unknown Bladder Cervical Pancreatic Gallbladder Fallopian tube Prostate Clinical stage at LBO III IV Recurrent Previous treatment Surgery Chemotherapy Surgery chemotherapy Chemotherapy radiation Surgery chemotherapy radiation None Site of obstruction Rectum Rectosigmoid Sigmoid Descending colon Splenic flexure Transverse colon Hepatic flexure *Stent median age, 59 y. Surgery median age, 54 y. Total (for group) median age, 57 y. LBO, large bowel obstruction. oped in 3 patients (21%), who were managed with drainage gastrostomy tubes. Compliance with follow-up assessments was very good: 94% (41 of 44) of surviving patients completed surveys at week 1; 81% (34 of 42) at week 2; 74% (28 of 38) at week 4; 76% (25 of 33) at week 8; 74% (20 of 27) at week 12; and 80% (16 of 20) at week 24. Median survival was 6 months and did not differ between the 2 groups (Fig. 2). Components of the Colon Obstruction Score were examined individually; baseline scores are shown in Table 3. All obstructive symptoms improved after the palliative procedure, with most notable improvements in abdominal pain, abdominal distension, and bowel movement frequency scores. Plots of Colon Obstruction Scores over time (Fig. 3) illustrate a marked improvement in obstructive symptoms in both the stent and surgical groups compared with baseline at week 1, week 4, and week 24 (p 0.05 for both groups at all time points; Table 4). Obstruction scores pro-

5 Vol. 210, No. 1, January 2010 Nagula et al Malignant Colorectal Obstruction and Quality of Life 49 Figure 2. Kaplan-Meier survival plots, starting 1 week after study enrollment. Median survival was 6 months for each group. Figure 1. Patient flow diagram. gressively improved in the stent group throughout the study period. Stent placement appeared equally efficacious in patients with either colonic or extracolonic malignancies, although patients with extracolonic cancers had higher baseline scores (Fig. 4). Composite FACT-C scores improved from baseline within 2 weeks of stent placement and continued to progressively improve throughout the study period but did not reach statistical significance (Fig. 5). In the surgery group, composite FACT-C scores initially declined 2 weeks after surgical palliation and then returned to baseline for the remainder of the study. Small improvements were seen in the Physical, Functional, and Emotional subscales of the FACT-C in both groups compared with baseline, with little or no change seen in the Social Well-Being score in either group (Table 4). Progressive improvement in the Colon Symptoms subscale of the FACT-C (Fig. 6) was seen in the stent group throughout the study period (p 0.05 after 2 weeks compared with baseline) and in the surgery group (p 0.05 for all time points up to 12 weeks). Self-rated overall QoL initially improved in both groups but declined after 8 weeks in the surgical group (p 0.05 for the surgery group at 4 and 8 weeks only; Fig. 7). Patients in both groups also reported a mild improvement in the ability to cope with their illness after their respective palliative procedures (p 0.03 for stent group after 2 weeks) and a mild improvement in their overall general health (p NS for both groups). Table 3. Baseline Colon Obstruction Score Components and Total Score Stent (n 30) Surgery (n 14) All (n 44) Category Abdominal pain 2 (2 3) 2 (1 2) 2 (1 3) Distension 2 (1 2) 1 (0 2) 2 (0 3) Bowel movement score 2 (2 3) 2 (1 3) 2 (1 3) Nausea 1 (0 1) 1 (0 1) 1 (0 1) Vomiting 0 (0 1) 0 (0 1) 0 (0 1) Colon Obstruction Score 6.5 (5 10) 6 (4 9) 6 (5 9) Data are shown as median (interquartile range). The maximum score for each component is 3, and the maximum total score is 15. Figure 3. Colon Obstruction Scores for stent and surgery groups (lower scores represent improved obstructive symptoms). Vertical bars represent interquartile range (IQR).

6 50 Nagula et al Malignant Colorectal Obstruction and Quality of Life J Am Coll Surg Table 4. Colon Obstruction Scores, FACT-C Scores, and FACT-C Subscales for Surgery and Stent Group at Baseline, 1 Month, and 6 Months Surgery (n 14) Variable Baseline 1 Month 6 Months Colon Obstruction Score 6.5 ( ) 2.5 ( )* 4.0 (0 5.0)* FACT-C, overall 74.6 ( ) 79.5 ( ) 77.5 ( ) FACT subscales Physical 11.7 ( ) 13.4 ( ) 17.5 ( ) Emotional 12.0 ( ) 12.5 ( ) 16.0 ( ) Functional 11.5 ( ) 14.0 ( ) 15.0 ( ) Social 25.0 ( ) 25.0 ( ) 25.0 ( ) Colon-Symptoms 10.0 ( ) 13.0 ( )* 16.0 ( ) Stent (n 30) Variable Baseline 1 Month 6 Months Colon Obstruction Score 6.0 ( ) 3.5 ( )* 2.0 ( )* FACT-C, overall 72.3 ( ) 89.7 ( ) 95.5 ( ) FACT subscales Physical 11.7 ( ) 15.2 ( ) 18.7 ( ) Emotional 12.0 ( ) 18.0 ( ) 16.0 ( ) Functional 13.0 ( ) 15.0 ( ) 16.0 ( ) Social 23.0 ( ) 24.5 ( ) 23.0 ( ) Colon-Symptoms 11.0 ( ) 14.5 ( )* 21.0 ( )* Data are shown as median (interquartile range). *p 0.05 compared with baseline. FACT-C, Functional Assessment of Cancer Therapy-Colorectal. DISCUSSION The ideal palliative procedure should provide effective relief of symptoms, with a high technical success rate, a low rate of complications, and a substantial improvement in patients QoL. Multiple studies have documented a high technical success rate for stent placement in colonic malignancies, with few complications. Earlier studies were primarily focused on technical success, and recent studies have defined clinical success as relief of obstructive symptoms without additional elaboration Obstructive symptoms can vary between individuals but typically include abdominal pain, distention, nausea, vomiting, or altered bowel movement pattern. Our novel index, the Colon Obstruc- Figure 4. Colon Obstruction Scores, stent patients only, colorectal cancer compared with extracolonic malignancies (lower scores represent improved obstructive symptoms). Vertical bars represent interquartile range (IQR). Figure 5. Composite Functional Assessment of Cancer Therapy- Colorectal (FACT-C) scores (higher scores represent improved quality of life). Vertical bars represent interquartile range (IQR).

7 Vol. 210, No. 1, January 2010 Nagula et al Malignant Colorectal Obstruction and Quality of Life 51 Figure 6. Colon Symptoms subscale of Functional Assessment of Cancer Therapy-Colorectal (higher scores represent improved quality of life). Vertical bars represent interquartile range (IQR). tion Score, semiquantitatively captures this complex constellation of symptoms, which allows for assessment of curative and palliative interventions on symptoms and comparisons between patients and between published trials. The Colon Obstruction Score improved immediately after stent placement and progressively improved throughout the study period, reflecting the efficacy of colonic stents in the palliation of symptoms from LBO. A similar early improvement in the Colon Obstruction Score was seen after surgery, but scores gradually worsened at later time points, possibly reflecting progressive abdominal disease. Miner and colleagues have previously described the profound challenges in assessing QoL in advanced cancer patients. 21 The benefit of a specific palliative procedure on overall QoL is particularly difficult to measure, as declining physical status can dominate any QoL assessments. In addition, the high dropout rate because of patient mortality can artificially inflate median QoL scores at later time points, as sicker patients die earlier in the study period. Given these potential confounding issues, it is difficult to conclude that colon stent placement or surgical diversion for malignant LBO yields a durable improvement in overall QoL in all patients. But for patients with a longer lifespan, colon stent placement is associated with improved overall QoL. One of the advantages of using the FACT-C is its reliance on multiple subscales to derive an overall QoL score. Because terminal cancer patients have multiple healthrelated issues affecting their QoL, it is logical to assume that palliation of colonic obstruction would not necessarily have a dramatic effect on an individual s physical, emotional, functional, and social well-being. However, effective palliation of LBO should not only confer improvement in Figure 7. Self-reported quality of life (QoL; higher scores represent improved QoL). Vertical bars represent interquartile range (IQR). obstructive symptoms but should also yield an improvement in the QoL associated with gastrointestinal symptoms, which are measured by the Colon Symptoms subscale. Colon stent placement was associated with a gradual and continuous improvement in Colon Symptom subscale scores throughout the entire study period, reaching statistical significance after 4 weeks. Patients in the surgical group demonstrated an early improvement in Colon Symptom subscale scores, which subsequently decreased and plateaued after 2 months. Because these questionnaires can be difficult to administer in sick patients and might not provide a precise answer to the effect of palliative treatments, we also used 3 simple questions to assess self-rated global QoL, global health, and the effort required to cope with illness. These questions seemed to parallel the results seen with the FACT-C. Although they were easier to administer than the FACT-C, they offered only a small perspective of the effects that palliative interventions have on patients. The technical success rate for stent placement in patients with colorectal cancer in this study is similar to previously published reports (between 90% and 100%). Colon stent placement in patients with extracolonic malignancies is a novel concept, with few reports in the literature More than half of the patients in this study (n 23) had extracolonic malignancies, with a lower technical success rate for stent placement compared with colorectal cancer patients (72% vs 100%). The extrinsic compression and colonic invasion by these malignancies distorts the usual colonic and pelvic anatomy, resulting in sharp angulation; colonic fixation; and long, nontraversable strictures, markedly limiting stent placement. In patients for whom stent placement was successful, the improvement in the Colon Obstruction Score and composite FACT-C score was similar,

8 52 Nagula et al Malignant Colorectal Obstruction and Quality of Life J Am Coll Surg demonstrating colon stents are equally efficacious regardless of cancer type. This is in contrast to a recent study that suggests colon stents are ineffective in patients with LBO from extracolonic malignancies. 25 This prospective study was initially designed as a randomized controlled trial between endoscopic and surgical palliation of malignant LBO. Patients and their physicians declined to have the selection of their treatment subjected to randomization, thus introducing a self-selection bias. The study was not powered to draw statistical conclusions between the stent and surgery groups or to detect small changes in the Colon Obstruction Score or FACT-C. Despite high compliance with survey completion, the substantial patient dropout rate because of the high mortality related to advanced malignancy limited our ability to draw statistical conclusions, especially at the later time points (at 8, 12, and 24 weeks). Statistically significant p values achieved at the later time points should be interpreted with caution. This is the first prospective study evaluating QoL and symptoms in patients undergoing palliation for malignant LBO. Both colon stent placement and surgical diversion are equally efficacious at palliating the symptoms of LBO, as readily assessed by the Colon Obstruction Score. Although neither stent placement nor surgery is associated with improvement in overall QoL, stent placement is associated with improved QoL related to gastrointestinal function. The decision to proceed with either colon stent placement or surgical diversion should be individualized to each particular patient. The mode of palliation should be chosen after careful discussion with the patient and the oncologist about the potential limitations of each procedure. Sicker patients who might not withstand an operation might be better suited for colon stent placement; but long-term definitive palliation of bowel obstruction in younger, healthier patients can best be achieved with surgical diversion. The need for immediate postprocedure chemotherapy favors stent placement. The natural progression of disease that occurs in patients with advanced abdominal malignancies will inevitably result in development of additional or recurrent symptoms, regardless of the method of palliation chosen. 21 Although one-fifth of patients in the original stent group ultimately required surgical palliation, colon stent placement remains a viable primary palliative option, given its high technical success rate, low complication rate, high efficacy in symptom palliation, improvement in QoL, and reduction in hospital length of stay. Additionally, we have introduced the Colon Obstruction Score as a novel symptom index that could be additionally validated and used in future prospective studies evaluating outcomes in the management of malignant LBO. This report adds to the growing body of literature supporting use of colonic stents for palliation of malignant colonic obstruction. Author contributions Study conception and design: Nash, Weiser, Thaler, Zauber, Gerdes Acquisition of data: Nagula, Ishill, Nash, Markowitz, Schattner, Temple, Weiser, Gerdes Analysis and interpretation of data: Nagula, Ishill, Thaler, Zauber, Gerdes Drafting of manuscript: Nagula, Ishill, Gerdes Critical revision: Nagula, Ishill, Nash, Markowitz, Schattner, Temple, Weiser, Thaler, Zauber, Gerdes Acknowledgment: We thank the Tavel-Reznik Fund for Colorectal Cancer Research for their ongoing support. REFERENCES 1. Phillips RKS, Hittinger R, Fry JS, Fielding LP. Malignant large bowel obstruction. Br J Surg 1985;72: Chen HS, Sheen-Chen SM. Obstruction and perforation in colorectal adenocarcinoma: an analysis of prognosis and current trends. Surgery 2000;127: Buechter KJ, Boustany C, Caillouette R, Cohn I Jr. Surgical management of the acutely obstructed colon. Am J Surg 1988; 156: Targownik LE, Spiegel BM, Sack J, et al. Colonic stent vs. emergency surgery for management of acute left-sided malignant colonic obstruction: a decision analysis. Gastrointes Endosc 2004;60: Porter JA, Salvati EP, Rubin RJ, Eisenstat TE. Complications of colostomies. Dis Colon Rectum 1989;32: Park JJ, Del Pino A, Orsay CP, et al. Stoma complications: the Cook County Hospital experience. Dis Colon Rectum 1999;42: Nugent KP, Daniels P, Stewart B, et al. Quality of life in stoma patients. Dis Colon Rectum 1999;42: Krouse R, Grant M, Ferrell B, et al. Quality of life outcomes in 599 cancer and non-cancer patients with colostomies. J Surg Res 2007;138: Sideris L, Zenasni F, Vernerey D, et al. Quality of life of patients operated on for low rectal cancer: impact of the type of surgery and patients characteristics. Dis Colon Rectum 2005;48: Khot UP, Lang W, Murali K, Parker MC. Systematic review of the efficacy and safety of colorectal stents. Br J Surg 2002;89: Watt AM, Faragher IG, Griffin TT, et al. Self-expanding metallic stents for relieving malignant colorectal obstruction: a systematic review. Ann Surg 2007;246:24 30.

9 Vol. 210, No. 1, January 2010 Nagula et al Malignant Colorectal Obstruction and Quality of Life Baron TH. Colonic stenting: technique, technology and outcomes for malignant and benign disease. Gastrointest Endoscopy Clin N Am 2005;15: Cella DF, Tulsky DS, Gray G, et al. The Functional Assessment of Cancer Therapy Scale: development and validation of the general measure. J Clin Oncol 1993;11: Ward WL, Hahn EA, Mo F, et al. Reliability and validity of the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) quality of life instrument. Qual Life Res 1999;8: Yoo HJ, Kim JC, Eremenco S, Han OS. Quality of life in colorectal cancer patients with colectomy and the validation of the Functional Assessment of Cancer Therapy-Colorectal (FACT- C), Version 4. J Pain Symptom Manage 2005;30: Hürny C, Bernhard J, Bacchi M, et al. The Perceived Adjustment to Chronic Illness Scale (PACIS): a global indicator of coping for operable breast cancer patients in clinical trials. Swiss Group for Clinical Cancer Research (SAKK) and the International Breast Cancer Study Group (IBCSG). Support Care Cancer 1993;1: Weeks JC, Nelson H, Gelber S, et al. Short-term quality-of-life outcomes following laparoscopic-assisted colectomy vs. open colectomy for colon cancer. JAMA 2002;287: Baron TH, Dean PA, Yates MR 3 rd, et al. Expandable metal stents for the treatment of colonic obstruction: techniques and outcomes. Gastrointest Endosc 1998;47: Ptok H, Meyer F, Marusch F, et al. Palliative stent implantation in the treatment of malignant colorectal obstruction. Surg Endosc 2006;20: Repici A, Fregonese D, Costamagna G, et al. Ultraflex precision colonic stent for palliation of malignant colonic obstruction: a prospective multicenter study. Gastrointest Endosc 2007;66: Miner TJ, Brennan MF, Jacques DP. A prospective, symptom related, outcomes analysis of 1022 palliative procedures for advanced cancer. Ann Surg 2004;240: Pothuri B, Guirguis A, Gerdes H, et al. The use of colorectal stents for the palliation of large bowel obstruction due to recurrent gynecologic cancer. Gynecol Oncol 2004;95: Caceres A, Zhou Q, Iasonos A, et al. Colorectal stents for palliation of large-bowel obstruction in recurrent gynecologic cancer: an updated series. Gynecol Oncol 2008;108: Shin SJ, Kim TI, Kim BC, et al. Clinical application of selfexpandable metallic stent for treatment of colorectal obstruction caused by extrinsic invasive tumors. Dis Colon Rectum 2008; 515: Keswani RN, Azar RR, Edmundowicz SA, et al. Stenting for malignant colonic obstruction: a comparison of efficacy and complications in colonic versus extracolonic malignancy. Gastrointest Endosc 2009;69:

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