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

Symptomatic 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. This was an open-label, randomized clinical trial conducted...

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Bibliographic Details
Published in:BJS open 2022-06, Vol.6 (3)
Main Authors: Langenbach, Mike Ralf, Florescu, Razvan-Valentin, Köhler, Andreas, Barkus, Jörg, Ritz, Jörg-Peter, Quemalli, Eduart, Siegel, Robert, Zirngibl, Hubert, Lefering, Rolf, Bönicke, Lars
Format: Article
Language:English
Subjects:
Bandages - adverse effects
Hemorrhoidectomy - adverse effects
Hemorrhoids - surgery
Humans
Pain, Postoperative - etiology
Pain, Postoperative - prevention & control
Quality of Life
Randomized Clinical Trial
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Summary:Symptomatic 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. This 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. Out 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 
ISSN:2474-9842
2474-9842
DOI:10.1093/bjsopen/zrac070