Abstract:
OBJECTIVE:To evaluate discrepancies between trial registry entries and final reports of randomized controlled trials (RCTs) published in major general surgical journals. BACKGROUND:Health care decisions are based on published results in peer-reviewed journals. Mandatory trial registration was introduced to increase transparency and reduce publication and outcome reporting bias. METHODS:The discrepancy rate between trial registry entries and final reports of all RCTs published during 2010 in the Annals of Surgery, Archives of Surgery, and British Journal of Surgery was evaluated. RESULTS:Of 596 identified studies, 545 were excluded because they were not RCTs or interim reports/secondary analysis of RCTs or because of missing trial registry information.In the remaining 51 RCTs, prospective registration was found in 9.8% (n = 5), registration during trial conduct in 33.3% (n = 17), and retrospective registration in 56.9% (n = 29), respectively.For the primary and secondary outcomes, there was no discrepancy in 54.9% and 33.3%, complete omission in 7.8% and 31.3%, new introduction in 7.8% and 39.2%, a change in definition in 9.8% and 5.8%, downgrading from primary to secondary in 21.6%, and upgrading from secondary to primary in 13.7%. There were few discrepancies in randomization, blinding, and intervention and some in targeted sample size and inclusion/exclusion criteria. CONCLUSIONS:When interpreting the results of surgical RCTs, the possibility of selective reporting, and thus outcome reporting bias, has to be kept in mind. For future trials, prospective registration should be strictly respected with the ultimate goal to increase transparency and contribute to high-level evidence reports for optimal patient care in surgery.
journal_name
Ann Surgjournal_title
Annals of surgeryauthors
Rosenthal R,Dwan Kdoi
10.1097/SLA.0b013e318283cf7fsubject
Has Abstractpub_date
2013-06-01 00:00:00pages
1007-15issue
6eissn
0003-4932issn
1528-1140journal_volume
257pub_type
杂志文章abstract:BACKGROUND:Pancreatic ductal adenocarcinoma (PDA) is a devastating disease that killed nearly 38,000 people in the United States this past year. OBJECTIVE:Treatment of PDA typically includes surgery and/or chemotherapy with gemcitabine. No reliable biomarker exists for prognosis or response to chemotherapy. Two previo...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/SLA.0b013e3181f1fd44
更新日期:2010-09-01 00:00:00
abstract:OBJECTIVE:To assess surgical aspects in the treatment of children with unilateral Wilms tumor based on data from the Cooperative Tumor Study SIOP 93-01 of the German Society of Pediatric Hematology and Oncology. SUMMARY BACKGROUND DATA:Although multiple international study trials exist for the treatment of nephroblast...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/SLA.0b013e31819ed92b
更新日期:2009-04-01 00:00:00
abstract:OBJECTIVE:To review standardized Nuss correction of pectus excavatum and vacuum bell treatment over the last 10 years. SUMMARY OF BACKGROUND DATA:In 2010, we reported 21 years of the Nuss procedure in 1215 patients. METHODS:Over the last 10 years, 2008-2018, we evaluated 1885 pectus excavatum patients. Surgery was in...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/SLA.0000000000003877
更新日期:2020-03-27 00:00:00
abstract::The accuracy of endoscopy and directed biopsy in the differential diagnosis of gastric lesions was evaluated by comparing the diagnoses of one endoscopic procedure (endoscopy and multiple directed biopsies) with the definitive diagnoses in 333 patients. The overall endoscopic and bioptic accuracy rate for all patients...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/00000658-198202000-00018
更新日期:1982-02-01 00:00:00
abstract:OBJECTIVE:To investigate the safety of radical resection for retroperitoneal sarcoma (RPS). BACKGROUND:The surgical management of RPS frequently involves complex multivisceral resection. Improved oncologic outcomes have been demonstrated with this approach compared to marginal excision, but the safety of radical resec...
journal_title:Annals of surgery
pub_type: 杂志文章,多中心研究
doi:10.1097/SLA.0000000000002250
更新日期:2018-05-01 00:00:00
abstract:OBJECTIVE:Currently single-incision laparoscopic appendectomy (SIL-A) has become an option for treating appendicitis. The aim of this study was to evaluate the safety and feasibility of SIL-A compared with conventional laparoscopic appendectomy (CL-A) on a large experimental cohort. BACKGROUND:Several studies had repo...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/SLA.0000000000001064
更新日期:2015-12-01 00:00:00
abstract::During a 29-month trial, 65 patients with acute gallstone pancreatitis were randomly selected for biliary tract explorations either within 73 hours of admission (36 patients) or at three months following remission with nonoperative measures (29 patients, with five others awaiting elective operation). The details of su...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/00000658-198109000-00008
更新日期:1981-09-01 00:00:00
abstract::The abilities of polymorphonuclear leukocytes (PMN) and pulmonary alveolar macrophages (PAM), to demonstrate chemotaxis, phagocytosis, and superoxide release after bile duct ligation in the rat were investigated to determine the effect of cholestasis on nonspecific cellular immune mechanisms. Chemotactic response to C...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/00000658-198711000-00004
更新日期:1987-11-01 00:00:00
abstract:OBJECTIVE:Our objective was to analyze factors predicting outcomes after a total pancreatectomy and islet autotransplantation (TP-IAT). BACKGROUND:Chronic pancreatitis (CP) is increasingly treated by a TP-IAT. Postoperative outcomes are generally favorable, but a minority of patients fare poorly. METHODS:In our singl...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/SLA.0000000000001453
更新日期:2015-10-01 00:00:00
abstract:OBJECTIVE:Esophagectomy for esophageal cancer is associated with substantial postoperative morbidity as a result of infectious complications. In a prior phase II study, granulocyte colony-stimulating factor (G-CSF) was shown to improve leukocyte function and to reduce infection rates after esophagectomy. The aim of the...
journal_title:Annals of surgery
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1097/01.sla.0000129705.00210.24
更新日期:2004-07-01 00:00:00
abstract::The role of the antrum on vagally mediated pancreatic secretion was studied in 8 conscious dogs prepared with chronic pancreatic and gastric fistulae. After completion of control studies 6 were subjected to antrectomy and 2 to antroneurolysis (to interrupt submucosal nerve connections); secretory studies were repeated...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/00000658-197603000-00005
更新日期:1976-03-01 00:00:00
abstract:OBJECTIVE:To determine prevalence of documented preoperative code status discussions and post-operative outcomes (specifically mortality, readmission and discharge disposition) of patients with completed Medical Orders for Life-Sustaining Treatments (MOLST) forms before surgery. SUMMARY OF BACKGROUND DATA:A MOLST form...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/SLA.0000000000004675
更新日期:2020-12-18 00:00:00
abstract:OBJECTIVE:This study aimed to investigate transitions of recurrence hazard and peak recurrence time in patients with nonmetastatic CRC using the hazard function. SUMMARY OF BACKGROUND DATA:A postoperative surveillance period of 5 years is consistent across major guidelines for patients with nonmetastatic CRC, but surv...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/SLA.0000000000004058
更新日期:2020-06-11 00:00:00
abstract:OBJECTIVE:To evaluate 2- and 12-month outcomes after ligation of the intersphincteric fistula tract (LIFT) in Crohn's disease (CD). BACKGROUND:Surgical approaches to perianal fistulas in CD are frequently ineffective and hampered by concerns over adequate wound healing and sphincter injury. The efficacy of LIFT in CD ...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/SLA.0000000000000479
更新日期:2014-12-01 00:00:00
abstract:OBJECTIVE:The aim of the study was to investigate whether patients who undergo surgery in hospitals experiencing significant length of stay (LOS) reductions over time are exposed to a higher risk of severe adverse events in the postoperative period. SUMMARY BACKGROUND DATA:Surgical care innovation has encouraged hospi...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/SLA.0000000000003206
更新日期:2020-07-01 00:00:00
abstract:OBJECTIVE:This study was designed to determine if resection of positive regional nodes in patients with breast cancer provided a group of cured patients. SUMMARY BACKGROUND DATA:Previous studies of long-term follow-up of patients with breast cancer have demonstrated that 30% of patients with positive nodes may be aliv...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/00000658-199309000-00006
更新日期:1993-09-01 00:00:00
abstract::In a prospective study of 103 patients with carcinoid tumors consecutively referred for medical treatment, the most common sites of the primary tumors were the ileum (73%), bronchi (7%), and jejunum (4%). All patients had local metastases, and 96 (93%) also had liver metastases. The most common initial symptoms were d...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/00000658-198708000-00001
更新日期:1987-08-01 00:00:00
abstract:OBJECTIVES:The aim of this study was to investigate the effect of pylorus resection on postoperative delayed gastric emptying (DGE) after partial pancreatoduodenectomy (PD). BACKGROUND:PD is the standard treatment for tumors of the pancreatic head. Preservation of the pylorus has been widely accepted as standard proce...
journal_title:Annals of surgery
pub_type: 杂志文章,随机对照试验
doi:10.1097/SLA.0000000000002480
更新日期:2018-06-01 00:00:00
abstract:OBJECTIVE:To assess the mechanistic role of group IIA phospholipase A2 (PLA2) in the process of local and distant organ injury after intestinal ischemia-reperfusion. SUMMARY BACKGROUND DATA:Intestinal ischemia-reperfusion produces lung injury by a mechanism that involves PLA2 activation, but it is unclear which isozym...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/00000658-200007000-00013
更新日期:2000-07-01 00:00:00
abstract:OBJECTIVE:To clarify the optimal surgical strategy for Bismuth type I and II hilar cholangiocarcinomas. SUMMARY BACKGROUND DATA:Local or hilar resections is often performed for Bismuth type I and II tumors; however, reported outcomes have been unsatisfactory with a high recurrence and low survival rate. To improve sur...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/SLA.0b013e318142d97e
更新日期:2007-12-01 00:00:00
abstract:OBJECTIVE:To determine if 5-year surgeon cumulative and annual volumes predict improved early postoperative outcomes in patients with rectal cancer. BACKGROUND:Operative experience has been shown to effect surgical outcomes. The differential role of cumulative versus annual volume has not yet been explored for rectal ...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/SLA.0000000000001672
更新日期:2017-01-01 00:00:00
abstract:OBJECTIVE:To investigate the workup/treatment provided to pregnant motor vehicle accident (MVA) casualties in a mature trauma system. Adherence to recommendations was used to measure quality of care. BACKGROUND:MVAs affect approximately 3% of pregnant women. Trauma casualty outcome improves after implementation of gui...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/SLA.0b013e31822638d4
更新日期:2011-08-01 00:00:00
abstract::Forty-nine patients undergoing elective or emergent gastric surgery have been included in this study. Gastric needle aspiration was performed at the time of surgery in each case, followed by qualitative aerobic and anaerobic bacteriologic analysis. In 18 patients undergoing elective operation for chronic nonobstructin...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/00000658-197511000-00004
更新日期:1975-11-01 00:00:00
abstract::A total of 360 patients underwent preoperative cardiac risk assessment using 23 clinical parameters, seven multivariate clinical scoring systems, and quantitative dipyridamole-thallium imaging to predict postoperative and long-term myocardial infarction and cardiac death after noncardiac surgery. There were 30 postope...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/00000658-199208000-00010
更新日期:1992-08-01 00:00:00
abstract:OBJECTIVE:To prospectively evaluate the oncologic and functional outcomes of laparoscopic total mesorectal excision (TME) with colonic J-pouch reconstruction. BACKGROUND:TME is considered the established gold standard in rectal cancer surgery. However, data on laparoscopic sphincter-preserving TME are limited. METHOD...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/01.sla.0000202180.16723.03
更新日期:2006-03-01 00:00:00
abstract:OBJECTIVE:The aim of this study was to emphasize the importance of a subclassification in the TNM staging system of rectal cancer. BACKGROUND:The clinical significance of the mesorectal extension of rectal cancer is unclear. PATIENTS AND METHODS:Data from 463 consecutive patients with stage IIa disease (T3N0) undergo...
journal_title:Annals of surgery
pub_type: 杂志文章,多中心研究
doi:10.1097/SLA.0b013e3182119331
更新日期:2011-04-01 00:00:00
abstract:OBJECTIVE:To evaluate the effect of anesthesia induced mild systemic hypothermia on hepatic injury in lean and obese rats during warm ischemia. SUMMARY BACKGROUND DATA:Hepatic warm ischemia during surgery remains a significant problem, particularly in organs with presumed baseline dysfunction. METHODS:The left and me...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/01.sla.0000154259.73060.f1
更新日期:2005-03-01 00:00:00
abstract:OBJECTIVE:To evaluate whether intraoperative subcutaneous wound irrigation with 0.04% polyhexanide can reduce surgical site infection (SSI) in elective laparotomies compared to saline. BACKGROUND:SSI is a common complication after gastrointestinal surgery. To date, there is a lack of evidence whether subcutaneous woun...
journal_title:Annals of surgery
pub_type: 杂志文章,随机对照试验
doi:10.1097/SLA.0000000000003645
更新日期:2020-07-01 00:00:00
abstract::Segments of rat inferior vena cava were modified by proteolytic digestion and dialdehyde starch tanning in an attempt to alter their antigenic nature and increase their tensile strength. These tissues were found to retain their ability to sensitize allogeneic recipients in both the intradermal and intra-aortic positio...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/00000658-197708000-00018
更新日期:1977-08-01 00:00:00
abstract:OBJECTIVE:These studies were designed to elucidate the mechanism by which signals delivered by anti-CD2 monoclonal antibody (MoAb) interfere with activational signals delivered by anti-CD3 MoAb and induce long-term graft survival and tolerance. SUMMARY BACKGROUND DATA:Anti-CD2 or anti-CD3 MoAb can prolong allograft su...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/00000658-199310000-00009
更新日期:1993-10-01 00:00:00