Evidence map›Paper›PMID 39103661›Full record

Trial reportTechniques in coloproctology2024

Suture reinforcement using a modified cyanoacrylate glue to prevent anastomotic leak in colorectal surgery: a prospective multicentre randomized trial : The Rectal Anastomotic seaL (ReAL) trial.

G Tomasicchio, G Martines, N Tartaglia, M Buonfantino, E Restini, B Carlucci, C Giove, A Dezi, C Ranieri, G Logrieco and 5 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Techniques in coloproctology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03941938 (Prevention of Anastomotic Leak in Colorectal Surgery by Glue Reinforcement. A Prospective Randomized Trial.), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT03941938 naunknown statusnot on this map

Prevention of Anastomotic Leak in Colorectal Surgery by Glue Reinforcement. A Prospective Randomized Trial.

TypeinterventionalSponsorSocieta Italiana di Chirurgia ColoRettaleRan2019 to 2021Enrolled140ConditionsRectal CancerArmsCyanoacrylate reinforcement, No reinforcement
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
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

15 authors.

G Tomasicchio *Department of Precision and Regenerative Medicine and Jonic Area (DiMePRe-J), General Surgery Unit "M. Rubino", University of Bari Aldo Moro, Bari, Italy. giovanni.tomasicchio@uniba.it.ORCID 0000-0001-7017-2690
G Martines *Azienda Ospedaliero Universitaria Policlinico, University of Bari, Piazza G Cesare, 11, 70124, Bari, Italy.
N TartagliaDepartment of Medical and Surgical Sciences, DSMC, University of Foggia, Foggia, Italy.
M BuonfantinoGeneral Surgery Unit, Hospital "San Paolo", Bari, Italy.
E RestiniGeneral Surgery Unit, Hospital "L. Bonomo", Andria, Italy.
B CarlucciDepartment of Precision and Regenerative Medicine and Jonic Area (DiMePRe-J), General Surgery Unit "M. Rubino", University of Bari Aldo Moro, Bari, Italy.
C GioveDepartment of Precision and Regenerative Medicine and Jonic Area (DiMePRe-J), General Surgery Unit "M. Rubino", University of Bari Aldo Moro, Bari, Italy.
A DeziDepartment of Precision and Regenerative Medicine and Jonic Area (DiMePRe-J), General Surgery Unit "M. Rubino", University of Bari Aldo Moro, Bari, Italy.
C RanieriDepartment of Precision and Regenerative Medicine and Jonic Area (DiMePRe-J), General Surgery Unit "M. Rubino", University of Bari Aldo Moro, Bari, Italy.
G LogriecoGeneral Regional Hospital "F. Miulli", Acquaviva delle Fonti, Bari, Italy.
L VincentiGeneral Surgery Unit, IRCCS "Saverio De Bellis", Castellana Grotte, Italy.
A AmbrosiDepartment of Medical and Surgical Sciences, DSMC, University of Foggia, Foggia, Italy.
D F AltomareDepartment of Precision and Regenerative Medicine and Jonic Area (DiMePRe-J), General Surgery Unit "M. Rubino", University of Bari Aldo Moro, Bari, Italy.
M De FazioDepartment of Precision and Regenerative Medicine and Jonic Area (DiMePRe-J), General Surgery Unit "M. Rubino", University of Bari Aldo Moro, Bari, Italy.
A PicciarielloDepartment of Experimental Medicine, University of Salento, Lecce, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAnastomotic leakage (AL) is the most frequent life-threating complication following colorectal surgery. Several attempts have been made to prevent AL. This prospective, randomized, multicentre trial aimed to evaluate the safety and efficacy of nebulised modified cyanoacrylate in preventing AL after rectal surgery.

methodsPatients submitted to colorectal surgery for carcinoma of the high-medium rectum across five high-volume centres between June 2021 and January 2023 entered the study and were randomized into group A (anastomotic reinforcement with cyanoacrylate) and group B (no reinforcement) and followed up for 30 days. Anastomotic reinforcement was performed via nebulisation of 1 mL of a modified cyanoacrylate glue. Preoperative features and intraoperative and postoperative results were recorded and compared. The study was registered at ClinicalTrials.gov (ID number NCT03941938).

resultsOut of 152 patients, 133 (control group, n = 72; cyanoacrylate group, n = 61) completed the follow-up. ALs were detected in nine patients (12.5%) in the control group (four grade B and five grade C) and in four patients (6.6%), in the cyanoacrylate group (three grade B and one grade C); however, despite this trend, the differences were not statistically significant (p = 0.36). However, Clavien-Dindo complications grade > 2 were significantly higher in the control group (12.5% vs. 3.3%, p = 0.04). No adverse effects related to the glue application were reported.

conclusionThe role of modified cyanoacrylate application in AL prevention remains unclear. However its use to seal colorectal anastomoses is safe and could help to reduce severe postoperative complications.

Indexed as

Anastomosis, SurgicalAnastomotic LeakCyanoacrylatesRectumAgedFemaleHumansMaleMiddle AgedProspective StudiesRectal NeoplasmsSuture TechniquesTissue AdhesivesTreatment OutcomeCyanoacrylatesTissue AdhesivesAnastomotic leakageColorectal surgeryCyanoacrylateSuture reinforcement

Identifiers

PMID39103661
PMCPMC11300475

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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.