Evidence map›Paper›PMID 18365278›Full record

Trial reportSurgical endoscopy2008

The use of fibrin sealant to prevent major complications following laparoscopic gastric bypass: results of a multicenter, randomized trial.

Gianfranco Silecchia, Cristian Eugeniu Boru, Jean Mouiel, Marco Rossi, Marco Anselmino, Mario Morino, Mario Toppino, Achille Gaspari, Paolo Gentileschi, Roberto Tacchino and 1 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Surgical endoscopy, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03733639 (The Use of Fibrin Glue Sealant), which is not on this map. Cited by 37 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 4 pooled it
6.1field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03733639 phase4unknown statusnot on this mapstarted 2020, after this paper: background citation

The Use of Fibrin Glue Sealant (Tisseel®) as a Reinforcement of Esophagojejunal Anastomoses Will Decrease the Rate of Anastomotic Leak.

TypeinterventionalSponsorGermans Trias i Pujol HospitalRan2020 to 2022Enrolled146ConditionsGastric Cancer, Anastomotic LeakArmsTisseel, No Tisseel
3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 4 syntheses or guidelines pooled it, 85 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Obesity in adults.BMJ clinical evidence · 2011
    Pooled it
  5. Trial
  6. Trial
  7. Trial
  8. Article
  9. Article
  10. New Technologies to Prevent Anastomotic Leak.Clinics in colon and rectal surgery · 2021
    Review
  11. Observational
  12. Review
  13. Review
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Emerging Trends in the Etiology, Prevention, and Treatment of Gastrointestinal Anastomotic Leakage.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2016
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 6 institutions in 2 countries.

Gianfranco SilecchiaDepartment of Surgery P. Stefanini, Policlinico Umberto I, University La Sapienza, Viale Policlinico 155, Rome, 00161, Italy. gianfranco.silecchia@uniroma1.it
Cristian Eugeniu Boru
Jean Mouiel
Marco Rossi
Marco Anselmino
Mario Morino
Mario Toppino
Achille Gaspari
Paolo Gentileschi
Roberto Tacchino
Nicola Basso
Policlinico Umberto I · ITOspedale Santa Chiara · ITUniversity of Rome Tor Vergata · ITUniversity of Turin · ITUniversità Cattolica del Sacro Cuore · ITUniversité Côte d'Azur · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPublished interim results have shown that fibrin sealant (Tissucol/Tisseel Baxter AG, Vienna, Austria) may be effective in preventing anastomotic leaks and internal hernias following laparoscopic Roux-en-Y gastric bypass (LRYGBP). We report the final results of a multicenter, randomized clinical trial evaluating the use of fibrin sealant in LRYGBP.

methodsBetween January 2004 and December 2005, 340 patients aged 21-65 years with a body mass index (BMI) of 40-59 kg/m(2) undergoing LRYGBP were randomized (1:1) to two treatment groups: fibrin sealant group (applied to gastrojejunal and jejunojejunal anastomoses and over mesenteric openings), and control group (no fibrin sealant; suture of the mesenteric openings). Operative time, early and late complications, reinterventions, time to oral diet initiation, and length of stay were assessed.

resultsOverall, 320 patients were included into the study: 160 in the control group and 160 in the fibrin sealant group. All patients completed follow-up assessments at 6 and 12 months, and 60.9% completed assessments at 24 months. There were no significant differences between groups with respect to demographics, operative time, oral diet initiation, hospital stay, and BMI reduction at 6, 12, and 24 months. The incidence of anastomotic leak was numerically, but not significantly, greater in the control group. The overall reintervention rate for specific early complications (<30 days) was significantly higher in the control group (p = 0.016). No deaths or conversions to open laparotomy occurred.

conclusionThe use of fibrin sealant in laparoscopic RYGBP may be beneficial in reducing the reintervention rate for major perioperative (<30 days) complications. Larger studies are needed.

Indexed as

AdultAgedAnastomosis, SurgicalChi-Square DistributionFemaleFibrin Tissue AdhesiveFranceGastric BypassHumansIncidenceItalyLaparoscopyLength of StayMaleMiddle AgedPostoperative ComplicationsFibrin Tissue Adhesive

Identifiers

PMID18365278
OpenAlexW2152524422

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.