Evidence map›Paper›PMID 26134780›Full record

ArticleEndoscopy international open2015

Prospective randomized comparison of gastrotomy closure associating tunnel access and over-the-scope clip (OTSC) with two other methods in an experimental ex vivo setting.

Jean-Michel Gonzalez, Kayoko Saito, Changdon Kang, Mark Gromski, Mandeep Sawhney, Ram Chuttani, Kai Matthes

Erratum issuedAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Endoscopy international open, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors.

Jean-Michel GonzalezDepartment of Medicine, Division of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
Kayoko SaitoDepartment of Medicine, Division of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
Changdon KangDepartment of Medicine, Division of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
Mark GromskiDepartment of Medicine, Division of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
Mandeep SawhneyDepartment of Medicine, Division of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
Ram ChuttaniDepartment of Medicine, Division of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
Kai MatthesDepartment of Medicine, Division of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA ; Department of Anesthesiology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSafe transgastric natural orifice transluminal endoscopic surgery (NOTES) procedures require a reliable closure of the gastrotomy. Recently a novel peritoneal access method via a submucosal tunnel has been described with encouraging preliminary results.

aimThe aim is to compare a submucosal tunnel access plus over-the-scope clip (OTSC) system for closure with two other closure modalities. PATIENTS AND

methodsThis is a prospective ex vivo study conducted on 42 porcine stomach models equally randomized into three groups in an academic medical center. The procedures performed in each group included: (1) Tunnel (6 cm) + endoclips; (2) Knife + balloon dilation access + OTSC; and (3) Tunnel + OTSC. A pressurized air-leak test was performed to evaluate the strength of the closure. Stomach volumes, procedure times, number of clips, and incision sizes were also registered.

resultsThe mean air-leak pressure was statistically higher in Group 3 than in Groups 1 and 2-95.2 ± 19.3 mmHg versus 72.5 ± 35.2 and 79.0 ± 24.5 mmHg (P < 0.05). The gastrotomy creation times for Groups 1, 2, and 3 were 28.0 ± 10.1, 4.3 ± 1.4, and 20.1 ± 10.6 minutes, respectively, with significantly lower time in Group 2 (P < 0.001). The closure times were 16.1 ± 6.1, 6.5 ± 1.2, and 5.3 ± 3.0 minutes, respectively, and significantly longer in the endoclip group (P < 0.001). There were no differences in the volumes and the incision sizes among the three groups.

conclusionThe combination of a submucosal tunnel access and OTSC offers a stronger closure than the other methods studied.

Identifiers

PMID26134780
PMCPMC4423288

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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.