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The use of obstetric balloon as a pelvic spacer in preventing empty pelvis syndrome after total pelvic exenteration in rectal cancers – A prospective safety and efficacy study for Bakri balloon

Colorectal Dis. 2022 Nov 21. doi: 10.1111/codi.16424. Online ahead of print.

ABSTRACT

INTRODUCTION: Empty pelvis syndrome is a source of considerable morbidity following a total pelvic exenteration. None of the available methods have been universally successful in mitigating this problem. We aimed to evaluate the safety and efficacy of the obstetric Bakri balloon in preventing empty pelvis syndrome.

METHODS: Combined prospective and retrospective study of all total pelvic exenterations for rectal cancers from a single institution was performed between October 2013 to May 2022. Bakri balloon was used since December 2019 in all patients that provided consent. Empty pelvis syndrome within 90 days was the primary end point, and included bowel obstruction, pelvic collection, and entero-perineal fistula. Comparison with the patients that did not have a Bakri balloon was performed.

RESULTS: Seventy-five patients with Bakri balloon were compared with 96 patients without the balloon placed after pelvic exenterations. No patient experienced an untoward complication from balloon deployment. The incidence of empty pelvis syndrome was 13.3% and 22.9% in the Bakri and no Bakri cohort, respectively (p-0.110). Every component of empty pelvis syndrome was proportionally lower without statistical significance. The number needed to treat to prevent EPS using the Bakri balloon was ten based on point estimates.

CONCLUSIONS: The use of Bakri balloon was safe without serious adverse events. The incidence of EPS after TPE was not statistically different with the use of Bakri Balloon despite a 9.6% reduction. A larger comparative study is needed to evaluate the efficacy of the balloon.

PMID:36408669 | DOI:10.1111/codi.16424

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