Evidence map›Paper›PMID 31362007›Full record

Trial reportGastroenterology2019

Clip Closure After Resection of Large Colorectal Lesions With Substantial Risk of Bleeding.

Eduardo Albéniz, Marco Antonio Álvarez, Jorge C Espinós, Oscar Nogales, Carlos Guarner, Pedro Alonso, Manuel Rodríguez-Téllez, Alberto Herreros de Tejada, José Santiago, Marco Bustamante-Balén and 10 more

2 registry-linked trialsOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Gastroenterology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 69 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
69citing papers in PubMed, 3 pooled it
8.0field-weighted citation impact, top 2% 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.

NCT02765022 nacompletednot on this map

Clip Closure of Mucosal Defects After Endoscopic Mucosal Resection of Large Colorectal Lesions as Prophylaxis of Delayed Haemorrhage.

TypeinterventionalSponsorFundacion Miguel ServetRan2016 to 2018Enrolled235ConditionsEndoscopic Resection, Clip, Haemorrhage, Non-pedunculated LesionsArmsClip closure, No clip closure
NCT04559880 phase4completednot on this mapstarted 2020, after this paper: background citation

Tranexamic Acid to Prevent Bleeding After Endoscopic Resection of Large Colorectal Polyps: A Pilot Project

TypeinterventionalSponsorLawrence Charles HookeyRan2020 to 2023Enrolled25ConditionsPolyp, ColorectalArmsTranexamic Acid Injection [Cyklokapron]
3 · Its place in the literature

Who cites it

69 citing papers in PubMed, 3 syntheses or guidelines pooled it, 157 citations in OpenAlex.

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9 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 13 institutions in 1 country.

Eduardo AlbénizComplejo Hospitalario de Navarra, Pamplona, Spain. Electronic address: edualbeniz@hotmail.com.
Marco Antonio ÁlvarezHospital del Mar, Barcelona, Spain.
Jorge C EspinósHospital Universitari Mútua Terrassa, Barcelona, Spain.
Oscar NogalesHospital Gregorio Marañon, Madrid, Spain.
Carlos GuarnerHospital de la Santa Creu i Sant Pau, Barcelona, Spain.
Pedro AlonsoHospital Juan Canalejo, A Coruña, Spain.
Manuel Rodríguez-TéllezHospital Universitario Virgen Macarena, Sevilla, Spain.
Alberto Herreros de TejadaHospital Universitario Puerta de Hierro, Madrid, Spain.
José SantiagoHospital Universitario Puerta de Hierro, Madrid, Spain.
Marco Bustamante-BalénHospital Universitario La Fe, Valencia, Spain.
Joaquín Rodríguez SánchezHospital General de Ciudad Real, Ciudad Real, Spain.
Felipe Ramos-ZabalaHospital Universitario HM Montepríncipe, HM Hospitales, Madrid, Spain.
Eduardo ValdivielsoHospital Juan Canalejo, A Coruña, Spain.
Felipe Martínez-AlcaláClinica de Gastroenterología Integral, Sevilla, Spain.
María FraileHospital San Pedro de Logroño, Logroño, Spain.
Alfonso ElosuaComplejo Hospitalario de Navarra, Pamplona, Spain.
María Fernanda Guerra VelozHospital Universitario Virgen Macarena, Sevilla, Spain.
Berta Ibáñez BeroizNavarrabiomed, Universidad Pública de Navarra, Instituto de Investigación Sanitaria de Navarra, Red de Investigación en Servicios Sanitarios y Enfermedades Crónicas, Pamplona, Spain.
Ferrán CapdevilaNavarrabiomed, Universidad Pública de Navarra, Instituto de Investigación Sanitaria de Navarra, Pamplona, Spain.
Mónica Enguita-GermánNavarrabiomed, Universidad Pública de Navarra, Instituto de Investigación Sanitaria de Navarra, Pamplona, Spain.
Universidad Publica de Navarra · ESComplejo Hospitalario de Navarra · ESHospital San Juan de la Cruz · ESHospital Universitario Puerta de Hierro Majadahonda · ESHospital Universitario Virgen Macarena · ESHospital Del Mar · ESHospital de Sant Pau · ESHospital General Universitario de Ciudad Real · ESHospital General Universitario Gregorio Marañón · ESHospital San Pedro · ESHospital Universitari i Politècnic La Fe · ESHospital Universitario HM Madrid · ESMútua Terrassa · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND &

aimsIt is not clear whether closure of mucosal defects with clips after colonic endoscopic mucosal resection (EMR) prevents delayed bleeding, although it seems to have no protective effects when risk is low. We performed a randomized trial to evaluate the efficacy of complete clip closure of large (≥2 cm) nonpedunculated colorectal lesions after EMR in patients with an estimated average or high risk of delayed bleeding.

methodsWe performed a single-blind trial at 11 hospitals in Spain from May 2016 through June 2018, including 235 consecutive patients who underwent EMR for large nonpedunculated colorectal lesions with an average or high risk of delayed bleeding (based on Spanish Endoscopy Society Endoscopic Resection Group score). Participants were randomly assigned to groups that received closure of the scar with 11-mm through-the-scope clips (treated, n = 119) or no clip (control, n = 116). The primary outcome was proportion of patients in each group with delayed bleeding, defined as evident hematochezia that required medical intervention within 15 days after colonoscopy.

resultsIn the clip group, complete closure was achieved in 68 (57%) cases, with partial closure in 33 (28%) cases and failure to close in 18 (15%) cases. Delayed bleeding occurred in 14 (12.1%) patients in the control group and in 6 (5%) patients in the clip group (absolute risk difference, reduction of 7% in the clip group; 95% confidence interval, -14.7% to 0.3%). After completion of the clip closure, there was only 1 (1.5%) case of delayed bleeding (absolute risk difference, reduction of 10.6%; 95% confidence interval, -4.3% to 17.9%).

conclusionsIn a randomized trial of patients with large nonpedunculated colorectal lesions undergoing EMR, we found that clip closure of mucosal defects in patients with a risk of bleeding can be a challenge, but also reduces delayed bleeding. Prevention of delayed bleeding required complete clip closure. ClinicalTrials.gov ID: NCT02765022.

Indexed as

Surgical InstrumentsAdenocarcinomaAdenomatous PolypsAgedAged, 80 and overColonic PolypsColorectal NeoplasmsEndoscopic Mucosal ResectionEquipment DesignFemaleGastrointestinal HemorrhageHemostasis, SurgicalHumansMaleMiddle AgedPostoperative HemorrhageComplicationGSEED-REPolyp RemovalPrevention

Identifiers

PMID31362007
OpenAlexW2966836610

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.