[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT00260559":3,"trial-entities:NCT00260559":140,"trial-summary:NCT00260559":144},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":32,"interventions":35,"primary_outcomes":40,"secondary_outcomes":63,"sex":64,"minimum_age":65,"maximum_age":30,"healthy_volunteers":66,"eligibility_criteria":67,"std_ages":76,"locations":79,"central_contacts":131,"overall_officials":134,"references":138,"see_also_links":139},"NCT00260559","STUDY20040382","Outcomes After Esophagectomy With a Focus on Minimally Invasive Esophagectomy and Quality of Life","RECRUITING","2050-12","2026-03","2026-04-14","1999-05","University of Pittsburgh","OTHER",true,"To assess short and long term outcomes after minimally invasive esophagectomy compared to open esophagectomy. To compare both standard outcome measures as well as patient derived outcome measures, in particular, quality of life (QOL). To look at the applicability of this QOL instrument to this patient group.","Assess short and long term outcomes after minimally invasive esophagectomy(MIE) compared to open esophagectomy. Measure standard observer derived outcomes such as morbidity, mortality, tumor recurrence and also patient derived outcomes, in particular quality of life (QOL) using the MOS SF36 questionnaire. Evaluate whether the SF36 will accurately reflect pre and postoperative changes in clinical status in this patient group.Compare the results of this global QOL instrument (SF 36) to disease specific scales of dysphagia and reflux. Assess the impact of adjuvant or neoadjuvant therapy on QOL in this patient group and determine if any advantages of MIE can be demonstrated.",[18,19],"Esophagectomy","Esophageal Cancer",[18,19,21,22,23,24,25,26,27,28],"Quality of Life","Minimally Invasive Esophagectomy","Laparoscopic Transhiatal Esophagectomy","Open Esophagectomy","Karnofsky Score","Dysphagia score","Heartburn Scale","Nutrition Score","OBSERVATIONAL",null,[],{"count":33,"type":34},3500,"ESTIMATED",[36],{"type":37,"name":38,"description":39},"PROCEDURE","Questionnaires","Quality of life and heartburn assessment questionnaires are administered preoperatively and at set intervals postoperatively.",[41,45,48,51,54,57,60],{"measure":42,"description":43,"timeFrame":44},"Change from baseline in SF36 Quality of Life Questionnaire at 4 month postoperative","The SF36 is an eight dimension Quality of Life Measurement. It provides two main Component scores, Physical Component Summary (PCS) and the Mental Component Summary (MCS). It includes 8 scales or sub-scores: Physical function (PF), role physical (RP), Bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MG). Each scale contributes a different amount to the component scores, which are calculated by a special algorithm that is licensed by Optum. The Component and sub-scales have a minimum of 0 and a maximum of 100. The higher the score represent the higher quality of life\u002Fless disability.","Baseline and 4 month postoperative",{"measure":46,"description":43,"timeFrame":47},"Change from baseline in SF36 Quality of Life Questionnaire at 6 month postoperative","Baseline and 6 month postoperative",{"measure":49,"description":43,"timeFrame":50},"Change from baseline in SF36 Quality of Life Questionnaire at 12 month postoperative","Baseline and 12 month postoperative",{"measure":52,"description":43,"timeFrame":53},"Change from baseline in SF36 Quality of Life Questionnaire at 18 month","Baseline and 18 month postoperative",{"measure":55,"description":43,"timeFrame":56},"Change from baseline in SF36 Quality of Life Questionnaire at 24 month","Baseline and 24 month postoperative",{"measure":58,"description":43,"timeFrame":59},"Change from baseline in SF36 Quality of Life Questionnaire at 30 month","Baseline and 30 month postoperative",{"measure":61,"description":43,"timeFrame":62},"Change from baseline in SF36 Quality of Life Questionnaire at 36 month","Baseline and 36 month postoperative",[],"ALL","18 Years",false,{"inclusion":68,"exclusion":72,"raw_text":75},[69,70,71],"Patients scheduled for MIE (Minimally Invasive Esophagectomy)","Patients scheduled for open esophagectomy","Signed informed consent",[73,74],"Patients who are unable to comprehend or complete the QOL instruments.","Patients less than 18 years of age.","Inclusion Criteria:\n\n* Patients scheduled for MIE (Minimally Invasive Esophagectomy)\n* Patients scheduled for open esophagectomy\n* Signed informed consent\n\nExclusion Criteria:\n\n* Patients who are unable to comprehend or complete the QOL instruments.\n* Patients less than 18 years of age.",[77,78],"ADULT","OLDER_ADULT",[80,125],{"facility":81,"status":7,"city":82,"state":83,"zip":84,"country":85,"contacts":86,"geoPoint":122},"University of Pittsburgh Medical Center - Department of Cardiothoracic Surgery","Pittsburgh","Pennsylvania","15213","United States",[87,92,95,98,100,102,104,106,108,110,112,114,116,118,120],{"name":88,"role":89,"phone":90,"email":91},"Julie A. Ward, BSN","CONTACT","412-647-8583","wardj@upmc.edu",{"name":93,"role":94},"James D. Luketich, MD","PRINCIPAL_INVESTIGATOR",{"name":96,"role":97},"Neil A. Christie, MD","SUB_INVESTIGATOR",{"name":99,"role":97},"Arjun Pennathur, MD",{"name":101,"role":97},"Matthew Schuchert, MD",{"name":103,"role":97},"Ryan Levy, MD",{"name":105,"role":97},"Omar Awais, DO",{"name":107,"role":97},"Kevin McGrath, MD",{"name":109,"role":97},"Tadeusz Witek, MD",{"name":111,"role":97},"Evan Alicuben, MD",{"name":113,"role":97},"Christian Otero, MD",{"name":115,"role":97},"Renee Levesque, MD",{"name":117,"role":97},"James Ackerman, MD",{"name":119,"role":97},"Thomas Melvin, MD",{"name":121,"role":97},"Navid Ajabshir, MD",{"lat":123,"lon":124},40.44062,-79.99589,{"facility":126,"status":7,"city":82,"state":83,"zip":127,"country":85,"contacts":128,"geoPoint":130},"UPMC - Hillman Cancer Center","15232",[129],{"name":88,"role":89,"phone":90,"email":91},{"lat":123,"lon":124},[132],{"name":133,"role":89,"phone":90,"email":91},"Julie A Ward, BSN",[135],{"name":136,"affiliation":137,"role":94},"James D Luketich, MD","UPMC - Department of Cardiothoracic Surgery",[],[],{"nct_id":4,"conditions":141,"biomarkers":143},[142],"Esophageal Carcinoma",[],{"nct_id":4,"found":14,"summary":145,"prompt_version":155},{"design":146,"status":147,"heading":148,"summary":149,"follow_up":150,"word_count":151,"commitments":152,"compensation":153,"drugs_mentioned":154},"This is an observational study, meaning researchers will watch and collect information without giving you a specific treatment. It plans to enroll about 3500 participants.","completed","Outcomes After Esophagectomy for Esophageal Cancer","This observational study is looking at the results of surgery for esophageal cancer, specifically comparing two types of surgery: minimally invasive esophagectomy (MIE) and open esophagectomy. Researchers want to understand both standard medical outcomes (like complications or how long people live) and how these surgeries affect your quality of life. You might be able to join if you are 18 or older and are scheduled for either MIE or open esophagectomy. The study will measure changes in your quality of life using questionnaires at 4, 6, and 12 months after surgery. The current status of this study is unclear, and it aims to include about 3500 participants.","Your quality of life will be measured at 4, 6, and 12 months after your surgery.",107,"You would complete quality of life and heartburn questionnaires before your surgery and at set times afterwards.","Not stated in the trial record.",[38],"v2"]