Martin Rudnicki Professor, MD DM Sci Ass. Editor Sarah C. B. Jeppesen Department of Obstetrics and Gynecology Odense University Hospital, Sdr. Boulevard 29 5000 Odense,
Projektet i tal
OPEN undersøgelse/kliniske data
Forventet # af deltagere
Inkluderet antal deltagere
Inkluderede deltagere med prøver
Contained morcellation in hysterectomies of big uteri (COMBU-trial) - A randomized
controlled trial evaluating contained manual or laparoscopic power morcellation
The aim of the study is to compare contained manual via a mini laparotomy or power morcellation of big uteri > 300 g or otherwise challenging for vaginal extraction in relation to postoperative pain on an numerical pain score (NRS). Primary outcome is NRS at 4, 8 and 12 hours, one week and 1 month post-operatively.
Minimally invasive approaches are recommended whenever possible for hysterectomy. If the uterus is too large to extract through the vagina, another extraction route is required. There are different ways to approach this. FDA issued a safety communication in 2014 concerning spread of malignancy via non-contained power morcellation. FDA estimated that 1/350 women undergoing hysterectomy or myomectomy will have unsuspected malignancy. This communication led to a decrease in minimally invasive hysterectomies and major surgical complications increased.
Description of the cohort
The study is a two-center randomized controlled trial, at OUH Denmark and Karolinska, Sweden. Women 18-
50 years old, with uteri > 300 g, will be included at block randomization to either laparoscopic hysterectomy
with in-bag power morcellation or manual suprapubic in-bag morcellation via a mini laparotomy.
Data and biological material
Data will be collected via electronic patient journal and electronic questionnaires, inkl. SF36 before and after the operation.
The pain score the day after the operation will be recorded manually on paper and typed into the database.
Collaborating researchers and departments
Gynekologi och Reproduktionsmedicin Karolinska Universitetssjukhuset