Prospective and Randomized Comparison of Two Techniques of Staple Line Reinforcement During Open Roux-en-Y Gastric Bypass: Oversewing and Bioabsorbable Seamguard<sup>®</sup>

Wilson, Steven E.; Rosa, Guilherme Vianna; Nonino, Carla Barbosa; Ceneviva, Reginaldo

doi:10.1089/lap.2010.0469

Cited by 6 publications

(2 citation statements)

References 22 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In industry-supported trials, statements such as the following provided full transparency: “Seamguard was provided by Intermedical Corp. and Quixil by Ethicon gratis for the study with the understanding that the results of the study would be published regardless of outcome. All authors do not have any financial interest or relationship with the two companies” [23]. “Alvaro Sanabaria has a conflict of interest due to consulting activities with Johnson & Johnson.…”

Section: Resultsmentioning

confidence: 99%

Conflicts of interest in randomised controlled surgical trials: systematic review and qualitative and quantitative analysis

Probst

Grummich

Klaiber

et al. 2016

Innovative Surgical Sciences

View full text Add to dashboard Cite

Conflicts of interest may lead to biased trial designs and unbalanced interpretation of study results. We aimed to evaluate the reporting of potential conflicts of interest in full publications of surgical randomised controlled trials (RCTs). A systematic literature search was performed in CENTRAL, MEDLINE and EMBASE (1985–2014) to find all surgical RCTs of medical devices and perioperative pharmacological or nutritional interventions. The information on conflicts of interest was evaluated both quantitatively and qualitatively, and the development of stated conflicts over time was studied. Of 7934 articles, 444 met the inclusion criteria. In 93 of 444 trials (20.9%), conflicts of interest were disclosed. In half of the cases, the information provided was insufficient to permit conclusions regarding possible influence on the trials. Information about conflicts of interest has increased continuously during the last decades (1985–1994: 0%, 1995–2004: 2.8% and 2005–2014: 33.0%; p<0.001). Among the 115 industry-funded trials, industry participation was considered as a potential conflict of interest in 24 cases (20.9%). Over the past three decades, only every 10th trial has provided appropriate information on conflicts of interest. However, transparency is crucial for the reliability of evidence-based medicine. There is an urgent need for the full disclosure of all conflicts of interest in surgical publishing and for transparency regarding cooperation between academia and industry.

show abstract

Section: Resultsmentioning

confidence: 99%

Conflicts of interest in randomised controlled surgical trials: systematic review and qualitative and quantitative analysis

Probst

Grummich

Klaiber

et al. 2016

Innovative Surgical Sciences

View full text Add to dashboard Cite

show abstract

“…Various techniques for staple line reinforcement include oversewing, haemostatic clips or synthetic and biological materials (such as tissue sealants or polyglycolide and dehydrated bovine pericardium) 42–44. To reduce variation in staple line reinforcement among surgeons, a guideline with a standardised step-by-step plan for reinforcement has been included in the protocol (online supplemental file 3).…”

Section: Discussionmentioning

confidence: 99%

Peroperative administration of tranexamic acid in Roux-en-Y and one-anastomosis gastric bypass to reduce haemorrhage in patients with morbid obesity: protocol for randomised controlled trial (PATRY trial)

't Hart,

Noordman,

Palsgraaf-Huisbrink

et al. 2024

BMJ Open

View full text Add to dashboard Cite

IntroductionBy implementation of Enhanced Recovery After Bariatric Surgery protocols and day-care surgery, early discharge poses a challenge if excessive bleeding occurs after bariatric surgery. Tranexamic acid (TXA) has demonstrated efficacy in other surgical fields and in bariatric pilot studies. This trial aims to assess the efficacy of peroperative administration of TXA in reducing haemorrhage in patients undergoing gastric bypass surgery.Method and analysisThis is a multicentre, phase III, double-blind randomised controlled trial in six high-volume bariatric centres in the Netherlands. A total of 1524 eligible patients, aged 18 years or older, undergoing primary gastric bypass surgery (either Roux-en-Y gastric bypass or one-anastomosis gastric bypass) will be randomised between TXA and placebo (1:1, variable block, stratified for centre, day-care/overnight stay and type of surgery) after obtaining informed consent (2.5% less haemorrhage, power 80%, 2-sided-α 0.05 and 10% dropout). Exclusion criteria are pregnancy, amedical history of acute bleeding (without cause), venous thrombotic events (VTEs), epilepsy, anticoagulant use and iatrogenic bleeding during surgery (aside from staple line). The primary outcome is postoperative haemorrhage requiring intervention within 30 days postoperatively. Secondary outcome measures are staple line reinforcement, blood loss, duration of surgery, postoperative haemoglobin, vital parameters, minor and major complications, side effects of TXA (nausea, hypotension and VTE), length of hospital stay and directly made costs.Ethics and disseminationWritten informed consent will be obtained from all participants. The protocol has been approved by the Medical Research Ethics Committees United, Nieuwegein, on 7 February 2023 (registration number: R22.102). Results will be disseminated through peer-reviewed publications and conferences.Trial registration numberNCT05464394

show abstract

Randomized Controlled Trials in Bariatric Surgery

et al. 2012

View full text Add to dashboard Cite

To fill a void in the literature, we performed a literature search and subsequently reviewed randomized controlled trials (RCTs) in the field of obesity surgery that were published over the past 40 years. All RCTs published in the English between January 1972 and December 2011 were identified through a literature search using the PubMed database. The following search terms were used: "bariatric surgery", "obesity surgery", and "weight reducing surgery". Studies of basic science and anesthesia-related pain management were excluded. The extracted trials were divided into four groups: comparisons of different interventions, intraoperative surgical techniques, preoperative evaluation, and postoperative care. The literature search produced 753 manuscripts, of which 168 met the eligibility criteria. Among 168 papers, 32 % compared different interventions, 48 % assessed intraoperative surgical techniques, 18 % assessed postoperative care, and the remaining 2 % assessed preoperative evaluation. The RCTs were published in 47 different journals, most commonly in Obesity Surgery (28.6 %) and the Annals of Surgery (11.9 %). Trials were conducted in 25 different countries, with the greatest contribution from the USA (35.1 %). There was a progressive increase in published trials from 1972 to 2011, with 119 RCTs (70.8 %) being published over the last decade. A trend for an increasing number of published RCTs in the field of bariatric surgery was observed over the recent years. Although data from large, adequately powered, long-term RCTs are still lacking, any surgical intervention appears to be more effective than medical care for the treatment of morbid obesity.

show abstract

Prospective and Randomized Comparison of Two Techniques of Staple Line Reinforcement During Open Roux-en-Y Gastric Bypass: Oversewing and Bioabsorbable Seamguard^®

Abstract: In our service, staple line reinforcement in open bariatric surgery with oversewing or Seamguard was considered to be safe. Seamguard application was considered to be easier than oversewing, but more expensive.

Cited by 6 publications

References 22 publications

Conflicts of interest in randomised controlled surgical trials: systematic review and qualitative and quantitative analysis

Conflicts of interest in randomised controlled surgical trials: systematic review and qualitative and quantitative analysis

Peroperative administration of tranexamic acid in Roux-en-Y and one-anastomosis gastric bypass to reduce haemorrhage in patients with morbid obesity: protocol for randomised controlled trial (PATRY trial)

Randomized Controlled Trials in Bariatric Surgery

Contact Info

Product

Resources

About

Prospective and Randomized Comparison of Two Techniques of Staple Line Reinforcement During Open Roux-en-Y Gastric Bypass: Oversewing and Bioabsorbable Seamguard®

Abstract: In our service, staple line reinforcement in open bariatric surgery with oversewing or Seamguard was considered to be safe. Seamguard application was considered to be easier than oversewing, but more expensive.

Cited by 6 publications

References 22 publications

Conflicts of interest in randomised controlled surgical trials: systematic review and qualitative and quantitative analysis

Conflicts of interest in randomised controlled surgical trials: systematic review and qualitative and quantitative analysis

Peroperative administration of tranexamic acid in Roux-en-Y and one-anastomosis gastric bypass to reduce haemorrhage in patients with morbid obesity: protocol for randomised controlled trial (PATRY trial)

Randomized Controlled Trials in Bariatric Surgery

Contact Info

Product

Resources

About

Prospective and Randomized Comparison of Two Techniques of Staple Line Reinforcement During Open Roux-en-Y Gastric Bypass: Oversewing and Bioabsorbable Seamguard^®