NoTamp Study. Randomized controlled trial to investigate the need for tamponde dressing after haemorrhoidectomy.

Overview
Related items

The study has the aim to show that using no tamponade dressing after haemorrhoidectomy ist not inferior to the use of a tamponade regarding postoperative bleeding.

Programme: ZKS-UWH

SEEK ID: https://ldh.zks-uwh.imise.uni-leipzig.de/projects/2

Public web page: https://notamp.mediascert.eu/de-DE/

NFDI4Health PALs: Rebekka van Zyl

Project created: 3rd Jun 2025

Extended Metadata (Nfdi4Health MDS 3.3)

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Id of the project(*) : nfdi4health-30011

Resource classification(*)

Type of the resource : Study

Title(s)/name(s) of the Project

Title/name : Randomisierte kontrollierte klinische Prüfung zur Untersuchung der Notwendigkeit einer Tamponade nach Hämorrhoidektomie
Language of the title/name : German

Acronym(s) of the Project

Acronym : NoTamp
Language of the acronym : German

Description(s) of the Project

Description : Die Studie hatte das Ziel, nachzuweisen, dass das Weglassen von Tamponaden nach Hämorrhoidektomie mit entstehender offener Wunde der Nutzung von Tamponaden in Bezug auf postoperative Blutungen bei gleichzeitig geringerem Schmerz nicht unterlegen ist.
Language of the description : German

Keyword(s) describing the Project

Keyword(*) : Hämorrhoidektomie, Tamponade

Language(s) of the project : German

Web page of the project : https://notamp.mediascert.eu/de-DE/

Contributor(s) of the Project

Is it a personal or organisational contribution?(*) : Organisational
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Funder (public)
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Helios Forschungsförderung
Details about the contributing person(s)
Contributor type(*) : Not specified
Given name(*) : Not specified
Family name(s)(*) : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Email address : lars.boenicke@helios-gesundheit.de
Phone number : (0202) 896-20 11
Organisation(s) associated with the contributor
Name(*) : Institutes für Forschung in der Operativen Medizin (IFOM) - Universität Witten/Herdecke
Address : Ostmerheimerstraße, 200, Haus, 38, 51109, Köln, Deutschland
Web page : https://www.uni-wh.de/euer-campus/institute-zentren-und-ags/institut-fuer-forschung-in-der-operativen-medizin-ifom
Digital identifier(s)
Identifier(*) : 00yq55g44
Scheme(*) : ROR

Alternative identifiers

Type of the registry(*) : DRKS
Identifier(*) : DRKS00004568

Characteristics of the Project

Is it an interventional or non-interventional Project? : Interventional
Specification of the type of the Project
Interventional Project type : Parallel
Non-interventional Project type : []
Primary health condition(s) or disease(s) considered in the Project
Primary health condition or disease name(*) : Hämorrhoiden Grad III und IV
Terminology/classification(*) : ICD-10
Code of the health condition or disease : K64
Groups of diseases or conditions(*)
Which groups of diseases or conditions were the data collected on? : Other
On which diseases or conditions were the data collected? : []
Collects mortality data? : Not specified
Administrative information about the Project
Status of the ethics committee approval : Request for approval submitted, approval granted
Overall Project status : Completed: Recruitment, data collection, and data quality management completed normally
Participants enrolled by invitation? : No
Start date : 3 May 2017
End date : 31 December 2020
Mono- or multicentric? : Multicentric
Number of centers : 17
One or more data providers? : Not specified
Number of data providers : Not specified
Primary subject(*) : Person
Eligibility criteria for Project participants
Eligibility criteria: Minimum age
Minimum eligible age(*) : 18
Unit of age(*) : Years
Eligibility criteria: Maximum age
Maximum eligible age(*) : Not specified
Unit of age(*) : Not specified
Eligible gender : []
Inclusion criteria : -Hämorrhoiden Grad III und IV mit terminierter Hämorrhoidektomie nach Milligan Morgan oder Parks; -Alter größer oder gleich 18 Jahre; -Geschäftsfähigkeit; -Vorliegen einer schriftlichen Einwilligungserklärung des Patienten
Exclusion criteria : -Schwangerschaft (gemäß Selbstauskunft der Patientin); -Erwartete Non-Compliance mit dem Studienablauf nach Einschätzung des für die Studie aufklärenden Arztes  Teilnahme an anderen klinischen Prüfungen, bei denen ein Einfluss auf Zielparameter dieser klinischen Prüfung zu erwarten ist; -Personen, die in einem Abhängigkeits- / Arbeits-verhältnis zum Studienleiter oder Prüfer stehen; -Vorliegen entzündlicher Analerkrankungen wie Abszesse, Fisteln oder Gangrän
Population of the Project(*)
Coverage : National
Country(ies) : Germany
Region(s) and/or city(ies) : Not specified
Interventions of the Project
Name of the intervention(*) : Keine Tamponade
Type of the intervention : Procedure/Surgery
Additional information about the intervention : Not specified
Name(s) of the arm(s) associated with the given intervention : Not specified
Exposures of the Project
Name of the exposure : Not specified
Type of the exposure : Not specified
Additional information about the exposure : Not specified
Name(s) of the group(s) associated with the given exposure : Not specified
Outcome measures in the Project
Name of the outcome measure(*) : Not specified
Description of the outcome measure : Not specified
Type of the outcome measure : Not specified
Time point(s) of assessment : Not specified
Additional information about the Project : Not specified
Additional assessments/measurements in the Project : []
Data sharing strategy of the Project(*)
Is it planned to share the data?(*) : No, there is no plan to make data available
Supporting documents available in addition to the data : []
When and for how long will the data be available? : Not specified
Criteria for data access : Not specified
Additional information about data sharing : Not specified
DataSHIELD/Opal infrastructure available? : Not specified
Link to data request application : Not specified
Web page with additional information about data sharing : Not specified
Record linkage possible? : false
Non-interventional aspects of the Project
Temporal design : []
Target follow-up duration of the Project
Target follow-up duration(*) : Not specified
Unit of time(*) : Not specified
Number of follow-ups conducted : Not specified
Biosamples retained in a biorepository : []
Specific types of retained biosamples : Not specified
Interventional aspects of the Project
Numerical phase : Not specified
Masking of intervention(s) assignment
Masking implemented? : false
Who is masked? : []
Additional information about masking : Not specified
Type of allocation of participants to an arm : Not specified
Off-label use of a drug product : Not specified

NoTamp Study. Randomized controlled trial to investigate the need for tamponde dressing after haemorrhoidectomy.

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