862

Patient Satisfaction and Outcomes Following Stapled Transanal RectalResection (STARR) for Obstructed Defecation SyndromeChirag B. Patel, Madhu Ragupathi, Nilesh Bhoot, Thomas B. Pickron, Eric M. Haas

Background: Obstructed defecation syndrome (ODS) is recognized as both a functional (e.g.,anismus or anal dyssynergia) and anatomic (e.g., rectocele and internal rectal intussusception)defecatory disorder of the pelvic floor. The purpose of this study was to determine outcomesand patient satisfaction following stapled transanal rectal resection (STARR) for the surgicaltreatment of ODS. Methods: Between May 2006 and July 2009, 1,580 patients were evaluatedfor constipation or rectocele-related symptoms. A subset with ODS was assessed with analphysiology studies and defecography. Thirty-seven of these patients were offered STARRprocedure for rectocele and internal intussusception and comprise the cohort of this study.Demographic data and surgical complications were tabulated. Long-term outcomes wereassessed by comparing pre- and post-operative subsets of the Wexner constipation scoringsystem (paired two-tailed Student's t-test) as well as patient satisfaction surveys. Results: Atotal of 37 patients (100% female) with a mean age of 52.9 years (range: 31-74 years)underwent STARR procedure. All patients had clinically significant rectocele as evidencedon defecography and 82% had concomitant intussusception. Postoperative complicationsoccurred in 13 patients (35.1%) during 90-day follow-up (table). Two of these patients(5.4%) required reintervention: dilation of stricture in one and transanal excision of staplegranuloma in another. Long-term follow-up was achieved at a mean of 19.3 months (range:3-36 months) in 84% of patients. Mean pre- and post-operative constipation scores were11.1±3.6 (range: 0-17) and 4.0±3.4 (range: 0-11), respectively (p<1.3x10^-9). Overall out-come was reported as excellent or good in 71% of patients, adequate in 22.5%, and poorin 6.5%. When asked in retrospect if they would undergo the procedure again, 77%responded affirmatively. Of note, 42% of these patients experienced postoperative complica-tions. Conclusions: The STARR procedure for ODS may result in significantly improvedpatient outcomes and satisfaction. Most complications were minor and did not requirereoperative interventions. In appropriately selected patients, the STARR procedure was abeneficial option for the anatomical correction of ODS secondary to rectocele and intussuscep-tion.

Surgical complications following STARR during 90-day follow up (note: some patientsexperienced more than one complication).

863

What Do IBS Symptom Severity Scales Measure? GI Symptoms, Emotions,Cognitions-or Something Else?Jeffrey M. Lackner, Changxing Ma, Charles Baum, Alicia M. Brasel, Amanda Smith,Tatyana Sapaleva, Christopher Radziwon, Susan S. Krasner, Leonard A. Katz, CathrinePowell, Praveen K. Sampath, Michael D. Sitrin

Objective: Patient-reported outcomes (PRO) are incorporated more frequently into random-ized clinical trials. A growing body of evidence suggests that PROs are key to gainingunderstanding of treatment outcomes particularly for functional disorders like IBS that lacka biomarker. According to FDA Guidance, PROs that are valid, meaningful, and sensitiveto treatment effects rest on a clear, empirically validated conceptual model. One such modelcomes from Spiegel & Chang (2009) who conceptualize GI severity as the product of 3interactive and reciprocally related constructs: GI-related symptoms, -emotions, and - cogni-tions. We used this model to test the construct validity of two popular IBS symptom severitymeasures (IBS-SSS, UCLA Severity Scale [UCLA SS]). Design: 105 Rome-diagnosed IBSadults (M = 47 yrs, 85% F) completed baseline assessment of an NIH funded RCT. Measuresincluded the 2 bloating/distension and 7 defecation GSRS-IBS items, UCLA Pain Scale,Coping Strategies Questionnaire, SF-36, Anxiety Sensitivity Inventory, Brief Symptom Invent-ory, State Trait Anxiety Inventory, Penn State Worry Questionnaire, and IBS Locus of Control(LOC). Results: Multivariate regression analyses were used to model both the IBS-SSS andUCLA SS on the covariates as blocks in 4 steps: control variables (age, gender, education,employment, IBS subtype, symptom duration), GI symptoms (e.g., abdominal pain, discom-fort, defecation), emotions (e.g., fear of somatic symptoms, anxiety, depression, fatigue,somatization), and cognitions (LOC, pain catastrophizing, worry, embarrassment). Themodels accounted for 63% and 73% of the variance in scores on the UCLA SS and IBS-SSS, respectively. The greatest amount of variance was accounted for sequentially by theblocks of control variables (14% and 23%), cognitions (13% and 8%), emotions (7% and8%), and GI symptoms (28% and 34%). Model selection analyses were performed toidentify the best 5 specific factors predictive of UCLA SS and IBS-SSS. Illness beliefs (LOC,catastrophizing), fatigue, pain, and altered defecation, accounted for 62% of the variancein the UCLA SS; chronic worry, trait anxiety, fatigue, bloating, and pain accounted for 71%of the variance in IBS-SSS. Discussion: Data suggest that conventional IBS severity measuresdo not simply reflect the severity of IBS symptoms but a broad range of GI- and non-GIsymptoms, beliefs regarding the controllability of IBS, and stable, often intractable personalitytraits. These variables go beyond the circumscribed symptoms for which novel agents aregranted a label claim and underscore the importance of conceptual clarity and psychometricprecision in PRO development.

S-119 AGA Abstracts

864

Which Clinical Symptoms Reflect Postoperative Recovery of GastrointestinalMotility?Sjoerd van Bree, Laurens Nijhuis, Malaika Vlug, Willem Bemelman, Wouter de Jonge,Susanne A. Snoek, Esmerij P. van der Zanden, Frans O. The, Markus W. Hollmann,Roelof J. Bennink, Guy E. Boeckxstaens

Introduction: Impaired gastrointestinal (GI) transit or postoperative ileus (POI) largely deter-mines clinical recovery and duration of hospitalization after abdominal surgery. As colonicmotility is the main determinant of clinical recovery, first defecation and flatus are oftenused as primary outcome parameters in clinical trials. However, whether they actuallycorrelate with GI transit remains unclear. Especially as new potential treatments for POI areemerging, there is a definite need for accurate and reliable outcome variables to objectivelyevaluate new treatments. Aim: To study the relationship between GI transit and clinicalsymptoms after GI surgery and to evaluate which symptoms/signs are reliable markers ofGI recovery. Methods: Between Oct 2005 and Aug 2009, 85 patients (26-81 y) undergoingsegmental colectomy for malignant colorectal disease were included. Clinical symptoms ofupper- and lower GI motility were evaluated daily using self-designed questionnaires. 24 hafter surgery, patients underwent a solid gastric emptying test (99mTc labelled pancake,115 Kcal) and ingested 60 ml of indium-111 labelled water to assess colonic transit onpostoperative day 2 and 3. The latter was measured by calculating the geometrical center(GC) of activity (segment 0=small intestine; 1=proximal-; 2=distal colon; 3=toilet). A compos-ite score of upper- and lower GI recovery was calculated as time until tolerance of solidfood in combination with defecation. Statistical analysis was done using Spearman's rankcorrelation. Results: On postoperative day 1, only nausea correlated with gastric retention(r=0.30, p=0.010). Similarly, first flatus (r=-0.27, p=0.022) and first day of tolerance ofsolid food (r=-0.33, p=0.004) showed a weak correlation with colonic transit on day 3. Onthe other hand, colonic transit correlated significantly with time until discharge (r= -0.55,p<0.001), time to first defecation (r=-0.46, p<0.001), and the composite score (r=-0.45,p<0.001). 7 patients developed a major complication (i.e. anastomosis leakage and hernia)with paralytic ileus requiring a nasogastric tube on day 3. In these patients indium-111 hadnot reached the colon at day 3 corresponding to a colonic GC of 0. Conclusions: Paralyticileus is a distinct type of POI characterized by total inhibition of GI motility. Time untilfirst defecation and time to tolerance of solid food in combination with defecation correlatesignificantly with colonic GC at day 3 and are the most reliable parameters to indirectlyevaluate GI transit. In contrast, time to first flatus is an inaccurate surrogate marker ofcolonic transit and should not be included in clinical trials.

865

Patient-Reported Symptom Relief From Current Therapy is a Robust Markerof Illness Severity in IBSBrennan M. Spiegel, Roger E. Bolus, Lucinda A. Harris, Susan L. Lucak, Eric Esrailian,William D. Chey, Anthony Lembo, Hetal A. Karsan, Kirsten Tillisch, Jennifer Talley, LinChang

Background: There is debate about how best to measure “severity” in IBS. Although this islargely an academic debate tied to patient reported outcome development, there are immediateclinical implications because measuring severity is vital for creating treatment plans. Also,availability of restricted access drugs, such as alosetron, requires clinicians to accuratelyselect the most severe patients when deciding whether to use these agents. Existing severitymeasures are onerous for everyday use. Instead, clinicians might estimate severity by simplyasking patients to report their degree of relief from current therapy. We tested this hypothesisin an IBS cohort. Methods: We surveyed Rome III IBS subjects from the Patient ReportedObserved Outcomes and Function Cohort - a multicenter IBS registry. We asked patientsif they were currently receiving therapy for IBS; those on active therapy were asked: Howmuch relief does your current treatment provide for your IBS symptoms? Responses were: completerelief; considerable; some; slight; none. We evaluated statistical & clinical (measured withCohen effect size) relationships between symptom relief & severity metrics, including IBSSS,severity numeric rating scale (NRS), pain NRS, IBS-QOL, HAD, VSI, & work productivity(WPAI). We analyzed relief using binary (t-tests of considerable relief vs lower relief) &continuous (Spearman r-value) scales. Results: There were 157 patients receiving >1 activeIBS therapy (age=43; 82% F; 17% IBS-C; 33% IBS-D; 50% IBS-M; mean # txs=2.4). 32%achieved at least considerable relief. The table shows the relationship between relief &severity metrics. Other than anxiety, all relationships were significant with medium-to-largeclinical effect sizes (ie >0.5 SD). Conclusions: Patient-reported symptom relief from currenttherapy is a robust marker of illness severity in IBS. Those with lower relief have higherseverity scores, lower quality of life, higher visceral (but not generic) anxiety, & higher workimpairment from IBS. This supports use of patient-reported relief as a practical, rapid &valid surrogate measure of IBS severity.Association between Relief and Severity Metrics

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