Evidence map›Paper›PMID 35078510›Full record

ArticleTrials2022

Intraoperative endoluminal pyloromyotomy for reduction of delayed gastric emptying after pylorus preserving partial pancreaticoduodenectomy (PORRIDGE trial): study protocol for a randomised controlled trial.

Matthias C Schrempf, David R M Pinto, Sebastian Wolf, Bernd Geissler, Florian Sommer, Michael Hoffmann, Dmytro Vlasenko, Johanna Gutschon, Matthias Anthuber

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.4field-weighted citation impact, top 39% 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.

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

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. 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

9 authors at 1 institution in 1 country.

Matthias C SchrempfDepartment of General, Visceral and Transplantation Surgery, University Hospital Augsburg, Augsburg, Germany. matthias.schrempf@uk-augsburg.de.ORCID http://orcid.org/0000-0002-2220-6427
David R M PintoDepartment of General, Visceral and Transplantation Surgery, University Hospital Augsburg, Augsburg, Germany.
Sebastian WolfDepartment of General, Visceral and Transplantation Surgery, University Hospital Augsburg, Augsburg, Germany.
Bernd GeisslerDepartment of General, Visceral and Transplantation Surgery, University Hospital Augsburg, Augsburg, Germany.
Florian SommerDepartment of General, Visceral and Transplantation Surgery, University Hospital Augsburg, Augsburg, Germany.
Michael HoffmannDepartment of General, Visceral and Transplantation Surgery, University Hospital Augsburg, Augsburg, Germany.
Dmytro VlasenkoDepartment of General, Visceral and Transplantation Surgery, University Hospital Augsburg, Augsburg, Germany.
Johanna GutschonDepartment of General, Visceral and Transplantation Surgery, University Hospital Augsburg, Augsburg, Germany.
Matthias AnthuberDepartment of General, Visceral and Transplantation Surgery, University Hospital Augsburg, Augsburg, Germany.
University Hospital Augsburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPylorus-preserving pancreaticoduodenectomy (ppPD) is a standard surgical procedure for the treatment of resectable neoplasms of the periampullary region. One of the most common postoperative complications after ppPD is delayed gastric emptying (DGE) which reduces quality of life, prevents a timely return to a solid oral diet and prolongs the length of hospital stay. In a retrospective analysis, intraoperative endoluminal pyloromyotomy was associated with a reduced rate of DGE. The aim of this study is to investigate the effect of intraoperative endoluminal pyloromyotomy on postoperative DGE after ppPD in a randomised and controlled setting.

methodsThis randomised trial features parallel group design with a 1:1 allocation ratio and a superiority hypothesis. Patients with a minimum age of 18 years and an indication for ppPD are eligible to participate in this study and will be randomised intraoperatively to receive either endoluminal pyloromyotomy or atraumatic stretching of the pylorus. The sample size calculation (n=64 per study arm) is based on retrospective data. The primary endpoint is the rate of DGE within 30 days. Secondary endpoints are quality of life, operation time, estimated blood loss, length of hospital stay, morbidity and mortality. DISCUSSION: DGE after ppPD is a common complication with an incomplete understood aetiology. Prevention of DGE could improve outcomes and enhance quality of life after one of the most common procedures in pancreatic surgery. This trial will expand the existing evidence on intraoperative pyloromyotomy, and the results will provide additional data on a simple surgical technique that could reduce the incidence of postoperative DGE.

trial registrationGerman Clinical Trials Register DRKS00013503 . Registered on 27 December 2017.

Indexed as

GastroparesisPancreatic NeoplasmsPyloromyotomyAdolescentEquivalence Trials as TopicGastric EmptyingHumansPancreaticoduodenectomyPostoperative ComplicationsPylorusQuality of LifeRandomized Controlled Trials as TopicRetrospective StudiesDelayed gastric emptyingPyloromyotomyPylorus-preserving pancreaticoduodenectomyRandomised controlled trial

Identifiers

PMID35078510
PMCPMC8787914
OpenAlexW4207079939

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Registered trials

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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.