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

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 Surg

journal_title

Annals of surgery

authors

Rosenthal R,Dwan K

doi

10.1097/SLA.0b013e318283cf7f

subject

Has Abstract

pub_date

2013-06-01 00:00:00

pages

1007-15

issue

6

eissn

0003-4932

issn

1528-1140

journal_volume

257

pub_type

杂志文章
  • Operative treatment of Crohn's ileocolitis complicated by ileosigmoid and ileovesical fistulae.

    abstract::Ileovesical and ileosigmoid fistulae were found to coexist in 22 patients with Crohn's ileocolitis. Persistent or recurrent urinary tract infection was a complaint in all cases, and 11 patients reported pneumaturia and/or fecaluria. Thus, bladder involvement was either suspected or clinically apparent in each patient....

    journal_title:Annals of surgery

    pub_type: 杂志文章

    doi:10.1097/00000658-198801000-00010

    authors: Schraut WH,Chapman C,Abraham VS

    更新日期:1988-01-01 00:00:00

  • Cancer-associated venous thrombosis in the surgical setting.

    abstract:OBJECTIVE:Cancer patients are at a relatively high risk of venous thromboembolism (VTE), and this has implications for surgical outcome. DATA SOURCE:English literature search including the keywords cancer, surgery and VTE was undertaken to review the risk, etiology, prevention and treatment of VTE in surgical oncology...

    journal_title:Annals of surgery

    pub_type: 杂志文章

    doi:10.1097/SLA.0b013e318195c50c

    authors: Behranwala KA,Williamson RC

    更新日期:2009-03-01 00:00:00

  • The 100 Most Cited Papers in the History of the American Surgical Association.

    abstract:OBJECTIVE:The aim of this study was to determine characteristics of the most cited publications in the history of the American Surgical Association (ASA). SUMMARY BACKGROUND DATA:The Annals of Surgery has served as the journal of record for the ASA since 1928, with a special issue each year dedicated to papers present...

    journal_title:Annals of surgery

    pub_type: 历史文章,杂志文章

    doi:10.1097/SLA.0000000000003633

    authors: Landreneau JP,Weaver M,Delaney CP,Aminian A,Dimick JB,Lillemoe KD,Schauer PR

    更新日期:2020-04-01 00:00:00

  • Effect of intravascular volume expansion on renal function during prolonged CO2 pneumoperitoneum.

    abstract:OBJECTIVE:To evaluate whether intravascular volume expansion would improve renal blood flow and function during prolonged CO2 pneumoperitoneum. SUMMARY BACKGROUND DATA:Although laparoscopic living donor nephrectomies have a considerably reduced risk of complications for the donors, significant concerns exist regarding...

    journal_title:Annals of surgery

    pub_type: 杂志文章

    doi:10.1097/00000658-200002000-00007

    authors: London ET,Ho HS,Neuhaus AM,Wolfe BM,Rudich SM,Perez RV

    更新日期:2000-02-01 00:00:00

  • Perforated stress ulcer in infants: a silent threat.

    abstract::Stress ulcer has become an important clinical entity and its two major complications--bleeding and perforation--are among the most baffling problems, in terms of management, in clinical practice. Perforation, though the less common of the two, is perhaps the most formidable particularly when this occurs in a very sick...

    journal_title:Annals of surgery

    pub_type: 杂志文章

    doi:10.1097/00000658-197912000-00006

    authors: Adeyemi SD,Ein SH,Simpson JS

    更新日期:1979-12-01 00:00:00

  • The effect of complications on length of stay.

    abstract:OBJECTIVES:The authors determined the effect of complications on length of stay (LOS) in surgical patients. SETTING:From 1987 to 1990, in the Professional General Surgical Unit of Royal Victoria Hospital, a retrospective survey was conducted on 5128 consecutively admitted patients with 396 different diagnosis; 228 dif...

    journal_title:Annals of surgery

    pub_type: 杂志文章

    doi:10.1097/00000658-199412000-00006

    authors: McAleese P,Odling-Smee W

    更新日期:1994-12-01 00:00:00

  • An evaluation of information transfer through the continuum of surgical care: a feasibility study.

    abstract:OBJECTIVE:To evaluate information transfer and communication (ITC) across the surgical care pathway with the use of Information Transfer and Communication Assessment Tool for Surgery (ITCAS). BACKGROUND:Communication failures are the leading cause of surgical errors and adverse events. It is vital to assess the ITC ac...

    journal_title:Annals of surgery

    pub_type: 杂志文章

    doi:10.1097/SLA.0b013e3181e986df

    authors: Nagpal K,Vats A,Ahmed K,Vincent C,Moorthy K

    更新日期:2010-08-01 00:00:00

  • "Sideways": results of repair of biliary injuries using a policy of side-to-side hepatico-jejunostomy.

    abstract:BACKGROUND:The Hepp-Couinaud technique describes side-to-side HJ to the main left hepatic duct but a side-to-side approach is not consistently used when repairing other ducts. Compared with end-to-side repairs, side-to-side anastomoses require less dissection, theoretically preserving blood supply to the bile ducts, an...

    journal_title:Annals of surgery

    pub_type: 杂志文章

    doi:10.1097/SLA.0b013e31819a6b2e

    authors: Winslow ER,Fialkowski EA,Linehan DC,Hawkins WG,Picus DD,Strasberg SM

    更新日期:2009-03-01 00:00:00

  • Association of adult celiac disease with surgical abdominal pain: a case-control study in patients referred to secondary care.

    abstract:BACKGROUND:Acute abdominal pain is the most common indication for surgical admission. Nonspecific abdominal pain (NSAP) may account for up to 40% of cases. There has been no published prospective study in which adult patients presenting with acute abdominal pain are investigated for celiac disease. AIMS:We aimed to as...

    journal_title:Annals of surgery

    pub_type: 杂志文章

    doi:10.1097/01.sla.0000171301.35513.cf

    authors: Sanders DS,Hopper AD,Azmy IA,Rahman N,Hurlstone DP,Leeds JS,George RR,Bhala N

    更新日期:2005-08-01 00:00:00

  • Femoroperoneal bypass: evaluation of potential for revascularization of the severely ischemic lower extremity.

    abstract::In 79 patients in whom distal small vessel bypass with autogenous vein was used for revascularization because of gangrene, gangrenous ulceration or rest pain, 14 had femoroperoneal bypasses. Femorotibial or femoroperoneal bypasses were performed in those patients in whom no popliteal runoff was present on pre-operativ...

    journal_title:Annals of surgery

    pub_type: 杂志文章

    doi:10.1097/00000658-197502000-00010

    authors: Reichle FA,Tyson RR

    更新日期:1975-02-01 00:00:00

  • The impact of perioperative risk, tumor pathology and surgical complications on disease recurrence following potentially curative resection of colorectal cancer.

    abstract:OBJECTIVE:The objective of the study was to identify determinants of disease recurrence after potentially curative resection of colorectal cancer. SUMMARY BACKGROUND DATA:The identification of patients at increased risk of disease recurrence is currently based on pathological factors. Recently, there has been consider...

    journal_title:Annals of surgery

    pub_type: 杂志文章

    doi:10.1097/SLA.0b013e31821fd469

    authors: Richards CH,Platt JJ,Anderson JH,McKee RF,Horgan PG,McMillan DC

    更新日期:2011-07-01 00:00:00

  • Incorporation of Procedure-specific Risk Into the ACS-NSQIP Surgical Risk Calculator Improves the Prediction of Morbidity and Mortality After Pancreatoduodenectomy.

    abstract:OBJECTIVE:This multicenter study sought to evaluate the accuracy of the American College of Surgeons National Surgical Quality Improvement Program's (ACS-NSQIP) surgical risk calculator for predicting outcomes after pancreatoduodenectomy (PD) and to determine whether incorporating other factors improves its predictive ...

    journal_title:Annals of surgery

    pub_type: 杂志文章,多中心研究

    doi:10.1097/SLA.0000000000001796

    authors: McMillan MT,Allegrini V,Asbun HJ,Ball CG,Bassi C,Beane JD,Behrman SW,Berger AC,Bloomston M,Callery MP,Christein JD,Dickson E,Dixon E,Drebin JA,Fernandez-Del Castillo C,Fisher WE,Fong ZV,Haverick E,Hollis RH,House MG

    更新日期:2017-05-01 00:00:00

  • An in vitro evaluation of the stability of mechanical properties of surgical suture materials in various pH conditions.

    abstract::The effects of pH on the tensile properties of eight commonly used 2-0 suture materials--plain catgut, Dexon, Vicryl, silk, Nurolon, Ethilon, Mersilene, and Prolene--were examined. The pH level ranged from 3.0 to 10.0. In general, absorbable suture materials were more sensitive to pH than non-absorbable suture materia...

    journal_title:Annals of surgery

    pub_type: 杂志文章

    doi:10.1097/00000658-198308000-00019

    authors: Chu CC,Moncrief G

    更新日期:1983-08-01 00:00:00

  • Surgeon-related factors and outcome in rectal cancer.

    abstract:OBJECTIVE:To determine whether surgical subspecialty training in colorectal surgery or frequency of rectal cancer resection by the surgeon are independent prognostic factors for local recurrence (LR) and survival. SUMMARY BACKGROUND DATA:Variation in patient outcome in rectal cancer has been shown among centers and am...

    journal_title:Annals of surgery

    pub_type: 杂志文章,多中心研究

    doi:10.1097/00000658-199802000-00001

    authors: Porter GA,Soskolne CL,Yakimets WW,Newman SC

    更新日期:1998-02-01 00:00:00

  • A prospective study on fish bone ingestion. Experience of 358 patients.

    abstract::A prospective study was performed on 358 patients to examine the diagnosis, management, and natural history of fish bone ingestion. All patients admitted with the complaint had a thorough oral examination. Flexible endoscopy under local pharyngeal anesthesia would be performed on patients with negative findings. Of 11...

    journal_title:Annals of surgery

    pub_type: 杂志文章

    doi:10.1097/00000658-199004000-00012

    authors: Ngan JH,Fok PJ,Lai EC,Branicki FJ,Wong J

    更新日期:1990-04-01 00:00:00

  • Surgical aspects of sclerosing cholangitis. Results in 178 patients.

    abstract::Of 178 patients with sclerosing cholangitis treated since 1950, 88 patients had associated inflammatory bowel disease, 72 had no such history, and 18 had iatrogenic injury or stone disease. A total of 233 biliary operations were performed, with a 75% rate of temporary improvement after initial operation. Subsequent op...

    journal_title:Annals of surgery

    pub_type: 杂志文章

    doi:10.1097/00000658-199010000-00017

    authors: Martin FM,Rossi RL,Nugent FW,Scholz FJ,Jenkins RL,Lewis WD,Gagner M,Foley E,Braasch JW

    更新日期:1990-10-01 00:00:00

  • Complications of vagotomy in the treatment of hiatal hernia.

    abstract::Inclusion of vagotomy and pyloroplasty in the surgical treatment of gastroesophageal reflux associated with hiatal hernia has long been controversial. To evaluate the morbidity of vagotomy in the treatment of reflux esophagitis, a retrospective study of 311 patients treated by the Hill posterior gastropexy technique o...

    journal_title:Annals of surgery

    pub_type: 杂志文章

    doi:10.1097/00000658-197606000-00003

    authors: Vansant JH,Baker JW Jr

    更新日期:1976-06-01 00:00:00

  • Randomized Trial of Laparoscopic Nissen vs. Anterior 180 Degree Partial Fundoplication - Late Clinical Outcomes at 15-20 years.

    abstract:OBJECTIVE:To determine very late clinical outcomes at up to 20 years follow-up from a randomized controlled trial of Nissen vs. anterior 180-degree partial fundoplication. SUMMARY BACKGROUND DATA:Nissen fundoplication for gastroesophageal reflux can be followed by troublesome side effects. To address this, partial fun...

    journal_title:Annals of surgery

    pub_type: 杂志文章

    doi:10.1097/SLA.0000000000004643

    authors: Rudolph-Stringer V,Bright T,Irvine T,Thompson SK,Devitt PG,Game PA,Jamieson GG,Watson DI

    更新日期:2020-11-18 00:00:00

  • Definitive surgical treatment of infected or exposed ventral hernia mesh.

    abstract:OBJECTIVE:To discuss the difficulties in dealing with infected or exposed ventral hernia mesh, and to illustrate one solution using an autogenous abdominal wall reconstruction technique. SUMMARY BACKGROUND DATA:The definitive treatment for any infected prosthetic material in the body is removal and substitution. When ...

    journal_title:Annals of surgery

    pub_type: 杂志文章

    doi:10.1097/01.SLA.0000055278.80458.D0

    authors: Szczerba SR,Dumanian GA

    更新日期:2003-03-01 00:00:00

  • Meckel's diverticulum--a high-risk region for malignancy in the ileum. Insights from a population-based epidemiological study and implications in surgical management.

    abstract:BACKGROUND:Surgical management of incidental Meckel's diverticulum(MD) is a highly debated controversial issue that has never been discussed from the oncological standpoint. OBJECTIVE:To describe the epidemiology and risk of Meckel's diverticulum cancer (MDC) and compare it with other ileal malignancies. METHODS:Data...

    journal_title:Annals of surgery

    pub_type: 杂志文章

    doi:10.1097/SLA.0b013e3181ef488d

    authors: Thirunavukarasu P,Sathaiah M,Sukumar S,Bartels CJ,Zeh H 3rd,Lee KK,Bartlett DL

    更新日期:2011-02-01 00:00:00

  • Intestinal alkaline phosphatase prevents antibiotic-induced susceptibility to enteric pathogens.

    abstract:OBJECTIVE:To determine the efficacy of oral supplementation of the gut enzyme intestinal alkaline phosphatase (IAP) in preventing antibiotic-associated infections from Salmonella enterica serovar Typhimurium (S. Typhimurium) and Clostridium difficile. BACKGROUND:The intestinal microbiota plays a pivotal role in human ...

    journal_title:Annals of surgery

    pub_type: 杂志文章

    doi:10.1097/SLA.0b013e31828fae14

    authors: Alam SN,Yammine H,Moaven O,Ahmed R,Moss AK,Biswas B,Muhammad N,Biswas R,Raychowdhury A,Kaliannan K,Ghosh S,Ray M,Hamarneh SR,Barua S,Malo NS,Bhan AK,Malo MS,Hodin RA

    更新日期:2014-04-01 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

    doi:10.1097/00000658-197706000-00005

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

    更新日期:1977-06-01 00:00:00

  • Case managers in mass casualty incidents.

    abstract:OBJECTIVE:To examine whether case managers affect patient evaluation/treatment/outcome and staffing requirements during Multiple Casualty Incidents (MCIs). SUMMARY BACKGROUND DATA:Multiple patient relocations during MCIs may contribute to chaos. One hospital changed its MCI patient relocation policy during a wave of M...

    journal_title:Annals of surgery

    pub_type: 杂志文章

    doi:10.1097/SLA.0b013e31819a6f17

    authors: Einav S,Schecter WP,Matot I,Horn JK,Hersch M,Reissman P,Spira RM

    更新日期:2009-03-01 00:00:00

  • Does preoperative radiation therapy enhance the probability of local control and survival in high-risk distal rectal cancer?

    abstract::One hundred forty-eight patients were treated with preoperative radiation therapy and surgery for resectable rectal adenocarcinoma at the University of Florida between 1975 and 1986. All patients had at least 5 years' follow-up; no patient was lost to follow-up. Three treatment protocols were used over the study perio...

    journal_title:Annals of surgery

    pub_type: 临床试验,杂志文章

    doi:10.1097/00000658-199206000-00017

    authors: Mendenhall WM,Bland KI,Copeland EM 3rd,Summers GE,Pfaff WW,Souba WW,Million RR

    更新日期:1992-06-01 00:00:00

  • A randomized, controlled, double-blind crossover study on the effects of 1-L infusions of 6% hydroxyethyl starch suspended in 0.9% saline (voluven) and a balanced solution (Plasma Volume Redibag) on blood volume, renal blood flow velocity, and renal corti

    abstract:OBJECTIVE:We compared the effects of intravenous administration of 6% hydroxyethyl starch (maize-derived) in 0.9% saline (Voluven; Fresenius Kabi, Runcorn, United Kingdom) and a "balanced" preparation of 6% hydroxyethyl starch (potato-derived) [Plasma Volume Redibag (PVR); Baxter Healthcare, Thetford, United Kingdom] o...

    journal_title:Annals of surgery

    pub_type: 杂志文章,随机对照试验

    doi:10.1097/SLA.0000000000000324

    authors: Chowdhury AH,Cox EF,Francis ST,Lobo DN

    更新日期:2014-05-01 00:00:00

  • Failure of institutionally derived predictive models of conversion in laparoscopic colorectal surgery to predict conversion outcomes in an independent data set of 998 laparoscopic colorectal procedures.

    abstract:OBJECTIVE:The aim of this study was to perform an external validation of 2 institutionally derived predictive models of laparoscopic conversion in colorectal surgery using the Mayo Clinic, Rochester (MCR) laparoscopic colon and rectal surgery experience. SUMMARY OF BACKGROUND DATA:Two different predictive scoring syst...

    journal_title:Annals of surgery

    pub_type: 杂志文章

    doi:10.1097/SLA.0b013e3181d355f7

    authors: Cima RR,Hassan I,Poola VP,Larson DW,Dozois EJ,Larson DR,O'Byrne MM,Huebner M

    更新日期:2010-04-01 00:00:00

  • Neurovascular compression in the thoracic outlet: changing management over 50 years.

    abstract:SUMMARY BACKGROUND DATA:During the past five decades, significant improvements have been made in the diagnosis and treatment of thoracic outlet syndrome (TOS) secondary to sports activities, breast implants, or median sternotomy. METHODS, RESULTS, AND CONCLUSIONS:Of more than 15,000 patients evaluated for TOS, 3914 un...

    journal_title:Annals of surgery

    pub_type: 杂志文章,评审

    doi:10.1097/00000658-199810000-00017

    authors: Urschel HC Jr,Razzuk MA

    更新日期:1998-10-01 00:00:00

  • Metabolic consequences from conversion of jejunoileal bypass to gastric bypass.

    abstract::Conversion of jejunoileal bypass to gastric bypass was performed in 11 patients because of metabolic problems and physical discomforts, and in three patients because of insufficient weight loss. There was no mortality and little morbidity after operation. An additional mean weight loss of 6% occurred, and weight stabi...

    journal_title:Annals of surgery

    pub_type: 杂志文章

    doi:10.1097/00000658-198211000-00007

    authors: Ackerman NB

    更新日期:1982-11-01 00:00:00

  • The influence of mechanical bowel preparation in elective lower colorectal surgery.

    abstract:OBJECTIVE:This study evaluates the effects of mechanical bowel preparation (MBP) on anastomosis below the peritoneal verge and questions the influence of MBP on anastomotic leakage in combination with a diverting ileostomy in lower colorectal surgery. SUMMARY BACKGROUND DATA:In a previous large multicenter randomized ...

    journal_title:Annals of surgery

    pub_type: 杂志文章

    doi:10.1097/SLA.0b013e3181c0e75c

    authors: Van't Sant HP,Weidema WF,Hop WC,Oostvogel HJ,Contant CM

    更新日期:2010-01-01 00:00:00

  • Prevalence and Risk Factors for Bariatric Surgery Readmissions: Findings From 130,007 Admissions in the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program.

    abstract:OBJECTIVE:To evaluate readmissions following laparoscopic adjustable gastric banding (LAGB), laparoscopic sleeve gastrectomy (LSG), and laparoscopic Roux-en-Y gastric bypass (LRYGB). BACKGROUND:Few studies have evaluated national readmission rates for primary bariatric surgery with national, bariatric-specific data. ...

    journal_title:Annals of surgery

    pub_type: 杂志文章,多中心研究

    doi:10.1097/SLA.0000000000002079

    authors: Berger ER,Huffman KM,Fraker T,Petrick AT,Brethauer SA,Hall BL,Ko CY,Morton JM

    更新日期:2018-01-01 00:00:00