Evidence map›Paper›PMID 39083099›Full record

ArticleLangenbeck's archives of surgery2024

Treatment of anastomotic leak in colorectal surgery by endoluminal vacuum therapy with the VACStent avoiding a stoma - a pilot study.

Markus M Heiss, Jonas Lange, Judith Knievel, Alexander Yohannes, Ulrich Hügle, Arno J Dormann, Claus F Eisenberger

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Langenbeck's archives of surgery, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04884334 (Data Collection on the Treatment of Gastrointestinal Leakage by the Use of Combination of Covered Nitinol Stent and Negative Pressure Wound Treatment), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing 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.

NCT04884334 completednot on this map

Data Collection on the Treatment of Gastrointestinal Leakage by the Use of Combination of Covered Nitinol Stent and Negative Pressure Wound Treatment

Typeobservational_patient_registrySponsorMarkus M. HeissRan2020 to 2026Enrolled110ConditionsPerforation of the Oesophagus, Perforation of the ColonArmsVAC-Stent®
3 · Its place in the literature

Who cites it

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

  1. Management of anastomotic leak after elective anterior resection for rectal cancer: A systematic review and pooled analysis.Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland · 2025
    Pooled it
  2. Article
  3. Article
  4. Review
  5. Review
  6. Article
  7. Review
  8. Endoscopic Vacuum Therapy: When and How to Use It?GE Portuguese journal of gastroenterology
    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

7 authors.

Markus M Heiss *Department of Abdominal, Tumor, Transplant and Vascular Surgery, Cologne-Merheim Medical Center, Witten/Herdecke University, Ostmerheimer Strasse 200, D-51109, Cologne, Germany. heissm@kliniken-koeln.de.ORCID http://orcid.org/0000-0002-3374-1150
Jonas Lange *Department of Abdominal, Tumor, Transplant and Vascular Surgery, Cologne-Merheim Medical Center, Witten/Herdecke University, Ostmerheimer Strasse 200, D-51109, Cologne, Germany.ORCID http://orcid.org/0000-0001-7238-3344
Judith KnievelDepartment of Abdominal, Tumor, Transplant and Vascular Surgery, Cologne-Merheim Medical Center, Witten/Herdecke University, Ostmerheimer Strasse 200, D-51109, Cologne, Germany.ORCID http://orcid.org/0000-0002-6213-590X
Alexander YohannesDepartment of Gastroenterology, Cologne-Holweide and Merheim Medical Center, Cologne, Germany.ORCID http://orcid.org/0009-0001-4562-9924
Ulrich HügleDepartment of Gastroenterology, Cologne-Holweide and Merheim Medical Center, Cologne, Germany.
Arno J DormannDepartment of Gastroenterology, Cologne-Holweide and Merheim Medical Center, Cologne, Germany.ORCID http://orcid.org/0000-0002-7751-3029
Claus F EisenbergerDepartment of Abdominal, Tumor, Transplant and Vascular Surgery, Cologne-Merheim Medical Center, Witten/Herdecke University, Ostmerheimer Strasse 200, D-51109, Cologne, Germany.ORCID http://orcid.org/0000-0003-1647-4836

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeAnastomotic leak (AL) represents the most relevant and devastating complication in colorectal surgery. Endoscopic vacuum therapy (EVT) using the VACStent is regarded as a significant improvement in the treatment of upper gastrointestinal wall defects. The innovative concept of the VACStent was transferred to the lower GI tract, gaining initial experience by investigating safety and efficacy in 12 patients undergoing colorectal resections.

methodsThe pilot study, as part of a German registry, began with 2 patients suffering from AL, who were treated with the VACStent after stoma placement. Subsequently, 6 patients with AL were treated with the VACStent omitting a stoma placement, with a focus on fecal passage and wound healing. Finally, the preemptive anastomotic coverage was investigated in 4 patients with high-risk anastomoses to avoid prophylactic stoma placement.

resultsIn total 26 VACStents were placed without problems. The conditioning and drainage function were maintained, and no clogging problems of the sponge cylinder were observed. No relevant clinical VACStent-associated complications were observed; however, in 2 patients, a dislodgement of a VACStent occurred. The 6 patients with AL but without stoma had a median treatment with 3 VACStents per case with a laytime of 17 days, leading to complete wound healing in all cases. The 4 prophylactic VACStent applications were without complications.

conclusionThe clinical application of the VACStent in the lower GI tract shows that successful treatment of anastomotic colonic leaks and avoidance of creation of an anus praeter is possible. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov NCT04884334, date of registration 2021-05-04, retrospectively registered.

Indexed as

Anastomotic LeakAdultAgedAged, 80 and overAnastomosis, SurgicalFemaleHumansMaleMiddle AgedNegative-Pressure Wound TherapyPilot ProjectsSurgical StomasTreatment OutcomeAnastomotic leakage (AL)Anus praeterColorectal surgeryEndoscopic treatment by vacuum therapy (EVT)Lower gastrointestinal wall defectsVACStent

Identifiers

PMID39083099
PMCPMC11291571

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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.