Best Management of Sigmoid Volvulus: a Prospective Randomized Trial

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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.