Evidence map›Paper›PMID 30940201›Full record

ArticleTrials2019

Tamponade dressings versus no tamponade after hemorrhoidectomy: study protocol for a randomized controlled trial.

Mike Ralf Langenbach, Dörthe Seidel

Erratum issuedOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. 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 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.3field-weighted citation impact, top 20% 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

4 citing papers in PubMed, 10 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

2 authors at 2 institutions in 1 country.

Mike Ralf LangenbachKlinik für Allgemein-/Viszeralchirurgie und Koloproktologie, Helios St. Elisabeth Klinik, Josefstr. 3, 46045, Oberhausen, Germany.
Dörthe SeidelInstitut für Forschung in der Operativen Medizin (IFOM), Universität Witten/Herdecke, Ostmerheimerstraße 200 Haus 38, 51109, Köln, Germany. doerthe.seidel@uni-wh.de.ORCID http://orcid.org/0000-0002-2287-5217
HELIOS St. Elisabeth Klinik Oberhausen · DEWitten/Herdecke University · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSymptomatic hemorrhoids are one of the most common anorectal disorders. Many surgeons use tamponades after open hemorrhoidectomy to manage postoperative bleeding. The question of whether a tamponade is necessary and beneficial after hemorrhoidectomy has not yet been conclusively answered. A previously conducted single-center pilot trial included 100 patients after Milligan-Morgan hemorrhoidectomy. The data indicated that insertion of an anal tamponade after hemorrhoidectomy does not reduce postoperative bleeding but causes significantly more pain. The findings of this pilot trial are now to be verified by means of a multicenter randomized clinical study called NoTamp.

methodsWe plan to include 953 patients after Milligan-Morgan or Parks hemorrhoidectomy in the NoTamp study. The aim is to demonstrate that using no tamponade dressing after open hemorrhoidectomy is not inferior to using tamponades with respect to postoperative bleeding, and that the patients report less pain. Primary endpoints of the trial are the maximum postoperative pain within 48 h and the incidence of severe postoperative bleeding that requires surgical revision within 7 days after the surgical procedure. Secondary endpoints of the study are the use of analgesics in the postoperative course, the lowest hemoglobin documented within 7 days, quality of life and patient satisfaction. Safety analysis includes all adverse and serious adverse events in relation to the study treatment. Further information can be found in the registration at the German Registry of Clinical Studies (DRKS00011590) and on the study webpage ( https://notamp.de/en-GB/trial/main/setLocale/en_GB/ ). The study is financed by the HELIOS research funding. DISCUSSION: The study received full ethics committee approval. The first patient was enrolled on 3 May 2017. This trial will finally answer the question whether the insertion of a tamponade after open hemorrhoidectomy is necessary and beneficial.

trial registrationGerman Clinical Trials Register (Deutsches Register Klinischer Studien (DRKS), DRKS00011590 . Registered on 12 April 2017.

Indexed as

BandagesHemorrhoidectomyTampons, SurgicalAnalgesicsEquivalence Trials as TopicGermanyHemorrhoidsHemostatic TechniquesHumansMulticenter Studies as TopicPatient SatisfactionPostoperative HemorrhagePostoperative PainQuality of LifeTime FactorsTreatment OutcomeAnalgesicsAnal tamponHemorrhoidectomyHemorrhoidsPostoperative bleedingPostoperative painTamponade

Identifiers

PMID30940201
PMCPMC6444871
OpenAlexW2942694020

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.