Evidence map›Paper›PMID 29808305›Full record

Trial reportInternational journal of colorectal disease2018

A comparison of surgical devices for grade II and III hemorrhoidal disease. Results from the LigaLongo Trial comparing transanal Doppler-guided hemorrhoidal artery ligation with mucopexy and circular stapled hemorrhoidopexy.

Aurelien Venara, Juliette Podevin, Philippe Godeberge, Yann Redon, Marie-Line Barussaud, Igor Sielezneff, Michel Queralto, Cecile Bourbao, Anne Chiffoleau, Paul A Lehur and 1 more

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

Trial report in International journal of colorectal disease, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01240772 (Cost-effectiveness of New Surgical Treatments for Haemorrhoidal Disease - Randomized Controlled Trial Comparing Transanal Doppler-guided Arterial Ligation With Mucopexy and Stapled Haemorrhoidopexy), which is not on this map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 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.

NCT01240772 phase3completednot on this map

Cost-effectiveness of New Surgical Treatments for Haemorrhoidal Disease - Randomized Controlled Trial Comparing Transanal Doppler-guided Arterial Ligation With Mucopexy and Stapled Haemorrhoidopexy (Longo's Technique)

TypeinterventionalSponsorNantes University HospitalRan2010 to 2014Enrolled407ConditionsSymptomatic Haemorrhoidal Disease Requiring Surgical ManagementArmsdoppler-guided arterial ligation with mucopexy, stapled haemorrhoidopexy according to Longo
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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

Aurelien VenaraColorectal Unit, Institut des Maladies de l'Appareil Digestif (IMAD), University Hospital of Nantes, Nantes, France.
Juliette PodevinColorectal Unit, Institut des Maladies de l'Appareil Digestif (IMAD), University Hospital of Nantes, Nantes, France.
Philippe GodebergeProctology, Institut Mutualiste Montsouris, Paris, France.
Yann RedonDepartment of Digestive Surgery, Pôle Hospitalier Mutualiste, St Nazaire, France.
Marie-Line BarussaudDepartment of Visceral Surgery, CHD, La Roche/Yon, France.
Igor SielezneffDepartment of General and Digestive Surgery, La Timone University Hospital, Marseilles, France.
Michel QueraltoProctology - Department of Digestive Surgery, University Hospital of Toulouse, Toulouse, France.
Cecile BourbaoDepartment of Digestive Surgery, University Hospital of Tours, Tours, France.
Anne ChiffoleauOffice of Research, University Hospital of Nantes, Nantes, France.
Paul A LehurColorectal Unit, Institut des Maladies de l'Appareil Digestif (IMAD), University Hospital of Nantes, Nantes, France. paulantoine.lehur@chu-nantes.fr.
LigaLongo Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeLittle is presently known on the impact of device type for Doppler-guided hemorrhoidal artery ligation/mucopexy (DGHAL) or circular stapled hemorrhoidopexy (CSH) when a surgical treatment is considered for hemorrhoidal disease (HD). In this study, we aimed to compare the outcome in terms of adverse events and recurrence rate, of patients included in the multicenter LigaLongo RCT ( ClinicalTrials.gov NCT01240772) according to the type of devices used.

methodsIn the DGHAL arm (N = 193), the procedure was done with transanal hemorrhoidal dearterialization (THD)™ (THD, Correggio, Italy) (104 patients) and with HAL-RAR™ (Agency for Medical Innovations (AMI) GmbH, Feldkirch, Austria) (89 patients). In the CSH arm (N = 184), procedure for prolapse and hemorrhoids (PPH)-03™ (Ethicon Endo-Surgery, Cincinnati OH) and hemorrhoidopexy and prolapse (HEM)™ (Covidien, Inc.) staplers were used in respectively 106 and 78 cases. Surgery-related morbidity at 90 postoperative days (POD) based on the Clavien-Dindo procedure-related complication score and clinical outcome in terms of recurrence and reoperation rate at 12 postoperative months (POM) was collected.

resultsThree hundred and seventy-seven patients were randomized according to HD grade. In the DGHAL arm, the number of ligations and mucopexies was higher in the AMI group (p < 0.0001); at 90 POD, the overall morbidity was similar between the two groups. In the CSH arm, donut sizes were similar; at 90 POD, the PPH group had a higher risk of postoperative grade 1 morbidity (anal urgency or incontinence) compared to the HEM group (p = 0.003). At 12 POM, no statistical difference was found between the two groups of each arm in terms of grade III recurrence or reoperation.

conclusionPostoperative morbidity and outcome at 1 year were similar regardless of the type of devices used. These findings suggest that device type has little impact on HD treatment results.

trial registrationclinicaltrials.gov -Identifier NCT01240772.

Indexed as

AdultArteriesDigestive System Surgical ProceduresHemorrhoidsHumansLigationRectumSuturesTreatment OutcomeCircular staplersComparative outcomeDoppler-guided artery ligation devicesHemorrhoidal diseaseMulticenter randomized trial

Identifiers

What OpenQuestion holds

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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.