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

BACKGROUND

Symptomatic 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.

METHODS

We 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 REGISTRATION

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