Best Management of Sigmoid Volvulus: a Prospective Randomized Trial

乙状结肠扭转的最佳治疗：前瞻性随机试验

• 批准号: 8436983
• 负责人: Jonathan Charles Samuel
• 金额: $ 14.02万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-20 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8436983
• 关键词: Acquired Immunodeficiency Syndrome; Acute; Address; Affect; Age; Anastomosis - action; Anesthetics; Attention; Award; Biometry; Biopsy; Burn injury; Caring; Cause of Death; Cessation of life; Clinical Research; Colostomy Procedure; Communicable Diseases; Country; Critical Care; Data; Databases; Decision Making; Developing Countries; Disease; Diverticulitis; Edema; Emergency Situation; Enrollment; Ethics; Excision; Faculty; Foundations; Funding Agency; Grant; Hernia; Hospital Departments; Hospitals; Incidence; Individual; Infection; International; Intestinal Obstruction; Intestinal Volvulus; Intestines; K-Series Research Career Programs; Large Intestine; Leadership; Left; Left colon; Life; Malawi; Measures; Medical Students; Mentors; Mentorship; Monoclonal Antibody R24; Morbidity - disease rate; Necrosis; Nigeria; North Carolina; Operative Surgical Procedures; Outcome Measure; Patient Care; Patients; Peritoneal; Peritonitis; Population; Postoperative Period; Procedures; Process; Ptosis; Publications; Randomized; Randomized Controlled Trials; Recovery; Recurrence; Registries; Research; Research Design; Research Personnel; Resected; Residencies; Resolution; Risk; Role; Science; Scientist; Side; Sigmoid colon; Site; Staging; Stenosis; Supervision; Surgeon; Time; Training; Trauma; Tropical Medicine; United States; Universities; University Hospitals; Work; career; clinical care; doctoral student; follow-up; instructor; medical schools; mortality; neglect; operation; primary outcome; programs; prospective; randomized trial; ranpirnase; research and development; secondary outcome; standard of care; symposium; theories; treatment strategy; tumor; two-arm study

DESCRIPTION (provided by applicant): Dr Jonathan Samuel is a rising surgical critical care fellow and currently completing his general surgery residency at the Department of Surgery at the University of North Carolina (UNC). Since 2007 he has been conducting research with UNC through a partnership with Kamuzu Central Hospital (KCH) Department of Surgery in Lilongwe, Malawi. He lived in Lilongwe, Malawi for two years and was instrumental in establishing a partnership between the Departments of Surgery at KCH and UNC. He developed and implemented both a trauma registry and burn database. During his second year he was awarded the prestigious Fogarty International Clinical Research Fellow award (2009-2010; R24 TW007988) in addition to receiving his first year the Center for AIDS Research development award at the University of North Carolina (P30 AI50410) and the UNC School of Medicine Alumni Foundation grant. So far he has had nine first author publications and one second author publication in which he served as a mentor for a medical student research trainee. He also assisted in collaborative work with other UNC faculty and Fogarty trainees by assisting in biopsies of tumors and guidance and advice on project implementation. He was instrumental in developing a surgical residency program for Malawian doctors at KCH. Though he already has an MPH and a strong research record, he will undergo additional training in tropical medicine, biostatistics, ethics and leadership, and become active in national committees and conference sessions. To fully develop his career as a surgeon scientist leading an interdisciplinary team studying surgical diseases such as sigmoid volvulus, traumatic injury and burns with bidirectional applicability, Dr Samuel requires further mentorship from established leaders in international research. Dr William Miller and Dr Anthony Charles at UNC will serve as US and LMIC mentors, respectively. Dr Samuel and his primary mentors are part of an already established group which includes Malawian surgeons and faculty from the UNC Division of Infectious Diseases and the UNC Department of Surgery. Dr Miller, a leader in international clinical research including several large studies in Malawi, will continue to provide oversight and guidance including study design and execution. He is an expert mentor, instructor and investigator. He is course director of the KL2 seminar at UNC and has mentored more MPH, K award, and doctoral students than anyone else at UNC. Dr Anthony Charles, born and raised in Nigeria, has successfully mentored the applicant and several other US and Malawian trainees in both clinical care and research and continues to provide on-site supervision at KCH. Dr Samuel plans to study sigmoid volvulus which is the leading cause of large bowel obstruction in Malawi and many other countries, with an unacceptably high mortality rate of 20-25%. At KCH there are approximately 60 cases per year with 15 deaths, mostly among otherwise healthy and productive individuals. Operative decisions in sigmoid volvulus are analogous to those of perforated diverticulitis, another left-sided colonic emergency. Diverticulitis is common in the United States with an increasing incidence with age to upwards of 65% among those older than 85. The proposed research will guide management of not only sigmoid volvulus but also perforated diverticulitis, which is critical as our population ages. Despite sigmoid volvulus being a frequent cause of death in many developing countries, only one prospective randomized trial has ever been conducted and this trial suffered from several limitations including insufficient enrollment and limited data related to morbidity and follow-up. The neglect of this often fatal disease process is in part because it is predominately a disease of developing countries and has not received attention from skilled investigators and funding agencies. Sigmoid volvulus can be classified at the time of surgery as either non-gangrenous (NG-SV) or gangrenous (G-SV). NG-SV is treated with either mesosigmoidopexy or resection and anastomosis (single-stage). Additionally, in managing NG-SV some clinicians recommend preoperative colonic decompression, but this practice is neither universally applied nor has it been studied by any good prospective trials. G-SV is treated with either resection and anastomosis (single-stage) or resection and colostomy followed by colostomy reversal (two-stage). In NG-SV, mesosigmoidopexy has the advantage of being a shorter procedure with faster recovery, lower surgical infection rate, and lower mortality, but a higher disease recurrence rate (compared to single-stage). In G-SV, single-stage has the advantage of avoiding a temporary colostomy, but likely has a higher initial mortality rate. Subjects will be allocated at the time of surgery to on of two study arms, G-SV or NG-SV. Subjects in G-SV will be randomized to either single-stage or two-stage, and subjects in NG-SV will be randomized to either single-stage or mesosigmoidopexy. The aims of the proposed study are to (1) determine the mortality difference (defined as survival to discharge) in NG-SV managed by single-stage or mesosigmoidopexy, (2) determine mortality difference (defined as survival to colostomy-free discharge) in G-SV managed by single- stage or two-stage, and (3) determine the effect of preoperative colonic decompression on survival to discharge. PUBLIC HEALTH RELEVANCE: Developing countries have a high burden of surgical disease predominantly in acute surgical conditions including sigmoid volvulus. Understanding the ideal management of sigmoid volvulus is necessary to provide the best care to patients with this and related conditions affecting the left colon such as sigmoid diverticulitis, and will advance surgicl sciences and benefit patients in both Malawi and the United States.

描述（由申请人提供）：Jonathan Samuel博士是一名正在崛起的外科重症监护研究员，目前正在北卡罗来纳大学（UNC）外科学系完成普通外科住院医师实习期。自2007年以来，他一直通过与马拉维利隆圭Kamuzu中心医院（KCH）外科的合作伙伴关系与UNC进行研究。他在马拉维的利隆圭生活了两年，并在KCH和UNC的外科部门之间建立伙伴关系方面发挥了重要作用。他开发并实施了创伤登记和烧伤数据库。在他的第二年，他获得了著名的福格蒂国际临床研究员奖（2009-2010;R24 TW007988），此外还获得了北卡罗莱纳大学艾滋病研究发展中心奖（P30 AI50410）和北卡罗来纳大学医学院校友基金会资助。到目前为止，他已经发表了九篇第一作者出版物和一篇第二作者出版物，他在其中担任一名医学生研究实习生的导师。他还协助与其他北卡罗来纳大学教师和福格蒂学员的合作工作，协助肿瘤活检，并就项目实施提供指导和建议。他在KCH为马拉维医生制定外科住院医师计划方面发挥了重要作用。虽然他已经拥有公共卫生硕士学位和良好的研究记录，但他将接受热带医学、生物统计学、伦理和领导方面的额外培训，并积极参与国家委员会和会议。为了充分发展他作为一名外科科学家的职业生涯，领导一个跨学科的团队研究外科疾病，如乙状结肠扭转、创伤性损伤和双向适用性烧伤，Samuel博士需要国际研究领域的知名领导者的进一步指导。北卡罗来纳大学的William Miller博士和Anthony Charles博士将分别担任美国和LMIC的导师。Samuel博士和他的主要导师是一个已经建立的小组的一部分，该小组包括来自UNC传染病司和UNC外科的马拉维外科医生和教员。Miller博士是国际临床研究（包括在马拉维进行的几项大型研究）的领导者，他将继续提供监督和支持