Evidence map›Paper›PMID 35639947›Full record

Trial reportBJS open2022

Tamponade dressing versus no dressing after haemorrhoidectomy: multicentre, randomized clinical trial.

Mike Ralf Langenbach, Razvan-Valentin Florescu, Andreas Köhler, Jörg Barkus, Jörg-Peter Ritz, Eduart Quemalli, Robert Siegel, Hubert Zirngibl, Rolf Lefering, Lars Bönicke

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BJS open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
1.3field-weighted citation impact, top 21% 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

1 citing paper in PubMed, 6 citations in OpenAlex.

  1. 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

10 authors at 7 institutions in 1 country.

Mike Ralf LangenbachEv. Krankenhaus Lippstadt, Department of Surgery II, University of Witten/Herdecke, Lippstadt, Germany.
Razvan-Valentin FlorescuHelios St. Elisabeth Klinik Oberhausen, Department of Surgery II, University of Witten/Herdecke, Oberhausen, Germany.
Andreas KöhlerHelios Klinikum Duisburg, Duisburg, Germany.
Jörg BarkusHelios Klinikum Niederberg, Velbert, Germany.
Jörg-Peter RitzHelios Klinikum Schwerin, Schwerin, Germany.
Eduart QuemalliHelios Klinikum Schwerin, Schwerin, Germany.
Robert SiegelHelios Klinikum Berlin-Buch, Berlin, Germany.ORCID 0000-0002-1259-2379
Hubert ZirngiblHelios Klinikum Wuppertal, Department of Surgery II, University of Witten/Herdecke, Wuppertal, Germany.
Rolf LeferingInstitute for Research in Operative Medicine (IFOM), University of Witten/Herdecke, Cologne, Germany.ORCID 0000-0002-0141-1747
Lars BönickeHelios Klinikum Wuppertal, Department of Surgery II, University of Witten/Herdecke, Wuppertal, Germany.
Helios Hospital Schwerin · DEHelios Universitätsklinikum Wuppertal · DEBG Klinikum Duisburg · DEHamm-Lippstadt University of Applied Sciences · DEHelios Hospital Berlin-Buch · DEHELIOS St. Elisabeth Klinik Oberhausen · DEWitten/Herdecke University · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSymptomatic haemorrhoids are a common anorectal disorder. The aim of the study was to investigate whether the omission of tamponade dressings after haemorrhoidectomy reduces postoperative pain without increasing the risk of severe bleeding.

methodThis was an open-label, randomized clinical trial conducted at 14 German hospitals. All patients with third- or fourth-degree haemorrhoids undergoing haemorrhoidectomy were considered eligible for selection in the intervention (no dressing) or control group (tamponade applied). Two co-primary outcomes were analysed by testing hierarchically ordered hypotheses. First, maximum pain intensity within 48 h after surgery was compared between the groups (superiority). This was followed by an analysis of severe bleeding complications, defined as any bleeding requiring surgical re-intervention within 7 days (non-inferiority). Secondary outcomes included health-related quality of life, patient satisfaction, haemoglobin levels, and adverse events.

resultsOut of 950 patients screened, 754 were randomized and 725 received intervention (366 patients in the intervention and 359 patients in the control group). In the group with tamponade dressings, median pain intensity on the 0 to 10 scale was 6 (interquartile range (i.q.r.) 4-7). Patients without tamponade dressings reported significantly less pain (median 5 (i.q.r. 3-7), P < 0.001). In each group, five patients (1.4 per cent) experienced severe bleeding. The absolute difference for the severe bleeding rate was -0.03 per cent with the 90 per cent confidence interval ranging from -1.47 per cent to +1.41 per cent, in line with the non-inferiority aim. No significant between-group difference was found for secondary outcomes.

conclusionsThe practice of inserting tamponade dressings after haemorrhoidectomy correlates with increased postoperative pain and does not provide benefits in terms of reduced postoperative bleeding. REGISTRATION NUMBER: DRKS00011590.

Indexed as

HemorrhoidectomyHemorrhoidsBandagesHumansPostoperative PainQuality of Life

Identifiers

PMID35639947
PMCPMC9154318
OpenAlexW4225454848

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.