NoTamp Trial

Introduction

Up to now tamponade dressings are used as a standard for hemostasis after hemorrhoidectomy, the surgical removal of diseased hemorrhoids. In this study we would like to compare this outdated standard primary care with a supply without the use of tampons.

Pilot Project

Within a monocentral pilot project, 100 patients after Milligan-Morgan hemorrhoidectomy were included in a randomized controlled trial. During surgery, the patients were randomly assigned to one of the two treatment arms, what did mean to use a tamponade dressing at the end of the procedure, or not. Data on pain, complications and wound care were collected.

The findings of this pilot project are now to be verified by means of a multicenter randomized clinical trial.

Study

Through this clinical trial, we hope to gain further insights into the safety and performance of these care alternatives. Within this clinical study, both for the standard therapy and the care alternative the severity of the pain after the operation and how often there is bleeding within 7 days after the surgery which requires surgical follow-up treatment should be determined. The results of the treatment groups are compared to determine whether the omission of tamponades after hemorrhoidectomy is not inferior to the use of tampons with respect to postoperative bleeding, while at the same time there is lower pain.

Financing

The clinical trial is financed by the Helios Research Fund.

Aim

The aim of this study is to demonstrate that the omission of tamponades after hemorrhoidectomy is not inferior to the use of anal tampons regarding postoperative bleeding and pain intensity.