Comparison of randomized controlled trial registry entries and content of reports in surgery journals.


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.


Ann Surg


Annals of surgery


Rosenthal R,Dwan K




Has Abstract


2013-06-01 00:00:00












  • Sentinel lymph node biopsy in patients with thin primary cutaneous melanoma.

    abstract:OBJECTIVES:To determine the rate and clinicopathologic factors predictive of sentinel lymph node (SLN) positivity, regional lymph node recurrence, and survival in a large series of patients with thin primary cutaneous melanoma who underwent SLN biopsy (SLNB). METHODS:Patients with thin (≤1 mm) melanomas who underwent ...

    journal_title:Annals of surgery

    pub_type: 杂志文章


    authors: Murali R,Haydu LE,Quinn MJ,Saw RP,Shannon K,Spillane AJ,Stretch JR,Thompson JF,Scolyer RA

    更新日期:2012-01-01 00:00:00

  • Subtotal versus total gastrectomy for gastric cancer: five-year survival rates in a multicenter randomized Italian trial. Italian Gastrointestinal Tumor Study Group.

    abstract:OBJECTIVE:To evaluate the impact of subtotal (SG) versus total (TG) gastrectomy on the oncologic outcome of patients with cancer of the distal stomach from 28 Italian institutions. SUMMARY BACKGROUND DATA:There is controversy over whether SG and TG have a different impact on the 5-year survival probability of patients...

    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


    authors: Bozzetti F,Marubini E,Bonfanti G,Miceli R,Piano C,Gennari L

    更新日期:1999-08-01 00:00:00

  • Variation in practice and resource utilization associated with the diagnosis and management of appendicitis at freestanding children's hospitals: implications for value-based comparative analysis.

    abstract:OBJECTIVE:To characterize the scope and magnitude of practice variation associated with the diagnosis and treatment of appendicitis at freestanding children's hospitals. BACKGROUND:Variation in care has been associated with poor outcomes and is believed to be a key driver of excess health care spending. METHODS:Retro...

    journal_title:Annals of surgery

    pub_type: 杂志文章,多中心研究


    authors: Rice-Townsend S,Barnes JN,Hall M,Baxter JL,Rangel SJ

    更新日期:2014-06-01 00:00:00

  • Prognostic Implications of Pathological Response to Neoadjuvant Chemoradiation in Pathologic Stage III Rectal Cancer.

    abstract:OBJECTIVE:To evaluate the independent prognostic ability of the American Joint Committee on Cancer (AJCC) tumor regression scores within pathologic stage II and III rectal cancers. BACKGROUND:Response to neoadjuvant chemoradiation (nCRT) has been debated as a biologic surrogate for tumor biology and prognosis in recta...

    journal_title:Annals of surgery

    pub_type: 杂志文章


    authors: Karagkounis G,Thai L,Mace AG,Wiland H,Pai RK,Steele SR,Church JM,Kalady MF

    更新日期:2019-06-01 00:00:00

  • A statewide, population-based time-series analysis of the outcome of ruptured abdominal aortic aneurysm.

    abstract:OBJECTIVES:The purpose of this study was to perform the first statewide, population-based, time-series analysis of the frequency of ruptured abdominal aortic aneurysm (RAAA), to determine the outcomes of RAAA, and to assess the association of patient, physician, and hospital factors with survival after RAAA. The hypoth...

    journal_title:Annals of surgery

    pub_type: 杂志文章


    authors: Rutledge R,Oller DW,Meyer AA,Johnson GJ Jr

    更新日期:1996-05-01 00:00:00

  • Analysis of long-term outcomes of 3200 liver transplantations over two decades: a single-center experience.

    abstract:OBJECTIVE:Few studies have evaluated long-term outcomes after orthotopic liver transplantation (OLT). This work analyzes the experience of nearly 2 decades by the same team in a single center. Outcomes of OLT and factors affecting survival were analyzed. METHODS:Retrospective analysis of 3200 consecutive OLTs that wer...

    journal_title:Annals of surgery

    pub_type: 杂志文章


    authors: Busuttil RW,Farmer DG,Yersiz H,Hiatt JR,McDiarmid SV,Goldstein LI,Saab S,Han S,Durazo F,Weaver M,Cao C,Chen T,Lipshutz GS,Holt C,Gordon S,Gornbein J,Amersi F,Ghobrial RM

    更新日期:2005-06-01 00:00:00

  • Patterns of failure in patients with resected stage I and II non-small-cell carcinoma of the lung. The Ludwig Lung Cancer Study Group.

    abstract::The pattern of failure was studied in 1012 patients with resected Stage I or II non-small-cell carcinoma of the lung. Initial intrathoracic failure (41%) was more common than initial extrathoracic failure (34%) even though a complete resection was the intent in all patients. The most frequent sites of initial failure ...

    journal_title:Annals of surgery

    pub_type: 杂志文章



    更新日期:1987-01-01 00:00:00

  • Pancreatic Cancer Surgery: The New R-status Counts.

    abstract:OBJECTIVE:To assess the relevance of resection margin status for survival outcome after resection and adjuvant therapy for pancreatic cancer. BACKGROUND:The definitions for R0 and R1 margin status after resection for pancreatic cancer are controversial. The strict definition of R0 requiring a 1 mm tumor-free margin is...

    journal_title:Annals of surgery

    pub_type: 杂志文章


    authors: Strobel O,Hank T,Hinz U,Bergmann F,Schneider L,Springfeld C,Jäger D,Schirmacher P,Hackert T,Büchler MW

    更新日期:2017-03-01 00:00:00

  • Gastrointestinal adaptation following small bowel bypass for obesity.

    abstract::Small intestinal morphologic and biochemical changes were studied following jejuno-ileal bypass for obesity after body weight stabilization had occurred. Four patients underwent biopsy of in-continuity and bypassed jejunal and ileal segments of the small intestine 11 to 22 months after the bypass operation. Microscopi...

    journal_title:Annals of surgery

    pub_type: 杂志文章


    authors: Dudrick SJ,Daly JM,Castro G,Akhtar M

    更新日期:1977-06-01 00:00:00

  • The potential of organizations of fee-for-service physicians for achieving significant decreases in hospitalization.

    abstract::Because hospitalization is a key factor in controlling health care costs and because fee-for-service remains the predominant mode of physician payment, a study was undertaken of the hospitalization experiences of open panel fee-for-service health maintenance organizations (IPA-HMOs) and Foundations for Medical Care (F...

    journal_title:Annals of surgery

    pub_type: 杂志文章


    authors: Edgahl RH,Taft CH,Friedland J,Linde K

    更新日期:1977-09-01 00:00:00

  • Treatment of intra-abdominal and abdominal wall desmoid tumors with drugs that affect the metabolism of cyclic 3',5'-adenosine monophosphate.

    abstract::A female patient with Gardner's syndrome was treated with delta1-testololactone (200 mg daily) because of growth of a large desmoid tumor in the pelvis and lower abdomen and a tumor in a scar from a previous laparotomy. There was also pain and swelling of the left leg. An immediate effect of the drug therapy was compl...

    journal_title:Annals of surgery

    pub_type: 杂志文章


    authors: Waddell WR

    更新日期:1975-03-01 00:00:00

  • Impact of Surgical Quality Improvement on Payments in Medicare Patients.

    abstract:OBJECTIVE:To examine the financial impact of quality improvement using Medicare payment data. BACKGROUND:Demonstrating a business case for quality improvement--that is, that fewer complications translates into lower costs--is essential to justify investment in quality improvement. Prior research is limited to cross-se...

    journal_title:Annals of surgery

    pub_type: 杂志文章


    authors: Scally CP,Thumma JR,Birkmeyer JD,Dimick JB

    更新日期:2015-08-01 00:00:00

  • Alvimopan, a novel, peripherally acting mu opioid antagonist: results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial of major abdominal surgery and postoperative ileus.

    abstract:OBJECTIVE:To demonstrate that alvimopan (6 or 12 mg) accelerates recovery of gastrointestinal (GI) function in patients undergoing laparotomy for bowel resection or radical hysterectomy. SUMMARY BACKGROUND DATA:Postoperative ileus (POI) following laparotomy may increase morbidity and extend hospitalization. Opioids ca...

    journal_title:Annals of surgery

    pub_type: 临床试验,杂志文章,meta分析,随机对照试验


    authors: Wolff BG,Michelassi F,Gerkin TM,Techner L,Gabriel K,Du W,Wallin BA,Alvimopan Postoperative Ileus Study Group.

    更新日期:2004-10-01 00:00:00

  • A systematic study of host defense processes in badly injured patients.

    abstract::A prospective study of factors predisposing to infection in badly injured patients has disclosed: the dominant roles of two specific parameters: monocyte antigen presenting capacity, and opsonic capacity of diluted serum; the potential value of further assessment of: the predictive value of plots of activated T-cells/...

    journal_title:Annals of surgery

    pub_type: 杂志文章


    authors: Polk HC Jr,George CD,Wellhausen SR,Cost K,Davidson PR,Regan MP,Borzotta AP

    更新日期:1986-09-01 00:00:00

  • Molecules, cancer, and the surgeon. A review of molecular biology and its implications for surgical oncology.

    abstract::Interactions between molecules control intra- and intercellular physiology. Cancer is emerging as a disease in which individual molecules are either overproduced, mutated, expressed at inappropriate stages of development, or lost due to inheritance or aberrant mitotic division. The major players in this contest of cel...

    journal_title:Annals of surgery

    pub_type: 杂志文章,评审


    authors: Arbeit JM

    更新日期:1990-07-01 00:00:00

  • Influence of total parenteral nutrition on tissue lipoprotein lipase activity during chronic and acute illness.

    abstract::This study examines the influence of total parenteral nutrition (TPN) compared with 5% dextrose (D5) infusion on skeletal muscle and adipose tissue lipoprotein lipase (LPL) activity in nutritionally depleted, injured and infected patients. The plasma concentrations of glucose, free fatty acid (FFA), triglyceride and i...

    journal_title:Annals of surgery

    pub_type: 杂志文章


    authors: Robin AP,Greenwood MR,Askanazi J,Elwyn DH,Kinney JM

    更新日期:1981-12-01 00:00:00

  • Plasma cholecystokinin and pancreatic polypeptide response after radical pancreatoduodenectomy with Billroth I and Billroth II type of reconstruction.

    abstract::This study was conducted to elucidate plasma cholecystokinin (CCK) and pancreatic polypeptide (PP) response after pancreatoduodenectomy and to compare response of CCK and PP in patients who had pancreatoduodenectomy with Billroth I and Billroth II type of reconstruction. Basal levels of plasma CCK were significantly l...

    journal_title:Annals of surgery

    pub_type: 杂志文章


    authors: Inoue K,Tobe T,Suzuki T,Hosotani R,Kogire M,Fuchigami A,Miyashita T,Tsuda K,Seino Y

    更新日期:1987-08-01 00:00:00

  • Surgical management of carcinoma of the junction of the main hepatic ducts.

    abstract::Twenty-six patients are reviewed who had primary carcinomas involving the junction of the hepatic ducts. The majority had had an initial procedure of palliative biliary diversion elsewhere and were referred for further treatment. In three cases, en bloc resection of the tumor with total hepatectomy and orthotopic live...

    journal_title:Annals of surgery

    pub_type: 杂志文章


    authors: Fortner JG,Kallum BO,Kim DK

    更新日期:1976-07-01 00:00:00

  • Endothelial-directed hepatic regeneration after partial hepatectomy.

    abstract:OBJECTIVE:To determine the role of the microvascular endothelium in the regulation of regenerating liver mass after partial hepatectomy. SUMMARY BACKGROUND DATA:Angiogenesis is critical for both pathologic and physiologic processes. The ability of certain tissues, such as the liver, kidney, and spleen, to regenerate a...

    journal_title:Annals of surgery

    pub_type: 杂志文章


    authors: Greene AK,Wiener S,Puder M,Yoshida A,Shi B,Perez-Atayde AR,Efstathiou JA,Holmgren L,Adamis AP,Rupnick M,Folkman J,O'Reilly MS

    更新日期:2003-04-01 00:00:00

  • Integrative marker analysis allows risk assessment for metastasis in stage II colon cancer.

    abstract:OBJECTIVES:Individualized risk assessment in patients with UICC stage II colon cancer based on a panel of molecular genetic alterations. BACKGROUND:Risk assessment in patients with colon cancer and localized disease (UICC stage II) is not sufficiently reliable. Development of metachronous metastasis is assumed to be g...

    journal_title:Annals of surgery

    pub_type: 杂志文章


    authors: Nitsche U,Rosenberg R,Balmert A,Schuster T,Slotta-Huspenina J,Herrmann P,Bader FG,Friess H,Schlag PM,Stein U,Janssen KP

    更新日期:2012-11-01 00:00:00

  • Adenocarcinoma of the esophagus.

    abstract::Adenocarcinoma involving the distal esophagus usually is far advanced when the patient is first seen. Adenocarcinoma differs from squamous carcinoma of the esophagus since it is relatively unresponsive to radiation therapy or chemotherapy. Adenocarcinoma of the esophagus resembles gastric cancer in its tendency to for...

    journal_title:Annals of surgery

    pub_type: 杂志文章


    authors: Mahoney JL,Condon RE

    更新日期:1987-05-01 00:00:00

  • Surgical management of primary hyperparathyroidism: the case for giving up quick intraoperative PTH assay in favor of routine PTH measurement the morning after.

    abstract:OBJECTIVE:To analyze the utility of quick intraoperative parathyroid hormone (PTH) measurement in the surgical management of primary hyperparathyroidism. BACKGROUND DATA:The use of intraoperative PTH monitoring is well established in the surgery of primary hyperparathyroidism. However, some false-negative predictions ...

    journal_title:Annals of surgery

    pub_type: 杂志文章


    authors: Mozzon M,Mortier PE,Jacob PM,Soudan B,Boersma AA,Proye CA

    更新日期:2004-12-01 00:00:00

  • The core competencies of James Marion Sims, MD.

    abstract::The concept of core competencies in graduate medical education was introduced by the Accreditation Council for Graduate Medical Education of the American Medical Association to semiquantitatively assess the professional performance of students, residents, practitioners, and faculty. Many aspects of the career of J. Ma...

    journal_title:Annals of surgery

    pub_type: 传,历史文章,杂志文章


    authors: Straughn JM Jr,Gandy RE,Rodning CB

    更新日期:2012-07-01 00:00:00

  • Identification, characterization, and quantitation of soluble HLA antigens in the circulation and peritoneal dialysate of renal patients.

    abstract::Human lymphocyte antigen (HLA) class I and class II antigens and beta 2 microglobulin (B2M) were identified in peritoneal dialysate (PD) and serum from patients with end-stage renal disease (ESRD) using monoclonal antibodies in an enzyme-linked immunoassay. The HLA class I and class II antigens each exhibited approxim...

    journal_title:Annals of surgery

    pub_type: 杂志文章


    authors: Gelder FB,McDonald JC,Landreneau MD,McMillan RM,Aultman DF

    更新日期:1991-06-01 00:00:00

  • Gastrin release by ethanol in man and in dogs.

    abstract::In man, oral or intravenous administration of ethanol caused a small but definite increase in peripheral serum gastrin concentration (measured by radioimmunoassay). In dogs, perfusion of the antrum with 10% ethanol caused an immediate increase in gastrin levels in the antral venous outflow. Acidification of the perfus...

    journal_title:Annals of surgery

    pub_type: 杂志文章


    authors: Becker HD,Reeder DD,Thompson JC

    更新日期:1974-06-01 00:00:00

  • Operative management of rib fractures in the setting of flail chest: a systematic review and meta-analysis.

    abstract:OBJECTIVE:To perform a systematic review and meta-analysis of studies comparing operative to nonoperative therapy in adult FC patients. Outcomes were duration of mechanical ventilation (DMV), intensive care unit length of stay (ICULOS), hospital length of stay (HLOS), mortality, incidence of pneumonia, and tracheostomy...

    journal_title:Annals of surgery

    pub_type: 杂志文章,meta分析,评审


    authors: Leinicke JA,Elmore L,Freeman BD,Colditz GA

    更新日期:2013-12-01 00:00:00

  • Open Versus Fenestrated Endovascular Repair of Complex Abdominal Aortic Aneurysms.

    abstract:OBJECTIVE:To compare outcomes of fenestrated (FEVAR) and open repairs of complex abdominal aortic aneurysms (cAAA). BACKGROUND:FEVAR has emerged as an alternative to open surgery for treating cAAA, but direct comparisons are limited. METHODS:We studied all repairs of intact or symptomatic cAAA in the Vascular Quality...

    journal_title:Annals of surgery

    pub_type: 杂志文章,多中心研究


    authors: O'Donnell TFX,Boitano LT,Deery SE,Schermerhorn ML,Schanzer A,Beck AW,Green RM,Takayama H,Patel VI

    更新日期:2020-05-01 00:00:00

  • Muscle protein catabolism after severe burn: effects of IGF-1/IGFBP-3 treatment.

    abstract:OBJECTIVE:To determine the effects of recombinant human insulin-like growth factor-1 (IGF-1) complexed with its principal binding protein, IGFBP-3, on skeletal muscle metabolism in severely burned children. SUMMARY BACKGROUND DATA:Severe burns are associated with a persistent hypermetabolic response characterized by h...

    journal_title:Annals of surgery

    pub_type: 临床试验,杂志文章,随机对照试验


    authors: Herndon DN,Ramzy PI,DebRoy MA,Zheng M,Ferrando AA,Chinkes DL,Barret JP,Wolfe RR,Wolf SE

    更新日期:1999-05-01 00:00:00

  • Congenital mixed vascular deformities of the lower limb: the relevance of lymphatic abnormalities to their diagnosis and treatment.

    abstract::Nineteen patients with vascular deformities of the lower extremity were studied and were classified into three groups based on their clinical and angiographic findings. 1) The Klippel or Venous Dysplasia Group (n = 8) demonstrated: cutaneous nevi of metameric distribution, congenital varices (many of which were anomal...

    journal_title:Annals of surgery

    pub_type: 杂志文章


    authors: O'Donnell TF Jr

    更新日期:1977-02-01 00:00:00

  • Regional differences in surgical care based upon uniform physician and hospital discharge abstract data.

    abstract::Population based surgical rates for various common surgical procedures were analyzed on a regional basis by examining select uniform hospital discharge abstract data from Wisconsin hospitals. The surgical asbracts of nearly 64,000 procedures were compared to the supply of physicians and showed a significant variation ...

    journal_title:Annals of surgery

    pub_type: 杂志文章


    authors: Detmer DE,Tyson TJ

    更新日期:1978-02-01 00:00:00