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Clinical Trial
. 2019 Sep;23(9):853-859.
doi: 10.1007/s10151-019-02059-x. Epub 2019 Aug 21.

Innovative appliance for colostomy patients: an interventional prospective pilot study

P-A Lehur  1 , J-B Deguines  2 , L Montagliani  3 , J-P Duffas  4 , L Bresler  5 , F Mauvais  6 , K Boudjema  7 , E Chouillard  8 ; CC Study Group
Collaborators, Affiliations
Clinical Trial

Innovative appliance for colostomy patients: an interventional prospective pilot study

P-A Lehur et al. Tech Coloproctol. 2019 Sep.

Abstract

Background: The control of body waste emptying is a constant research topic in stoma care. The aim of this pilot study was to assess the efficacy and safety of an innovative colostomy appliance.

Methods: An interventional prospective non-comparative pilot study was conducted in seven French centers. The study device is a new type of two-piece appliance including a base plate and a "capsule cap" (CC) composed of a capsule cover and a folded collecting bag. The device gently seals the stoma to provide stoma output control. When the bowel movement pressure increases the patient may control the deployment of the folded bag and collect stools. Patients with left-sided colostomy all using a flat appliance, were enrolled in a 2-week trial. Outcome measures were type of CC removal and peristomal fecal leaks while wearing the device.

Results: Of 30 patients (females 66.7%), with left-sided colostomy (permanent 76.7%), 23 (76.7%) completed the 2-week trial. A total of 472 CC changes were analyzed.

Efficacy: of 404 (85.5%) CC changes reported in diaries, 302 (74.8%) were linked with stool and/or gas. In 244 (60.3%) changes, the patient controlled stoma bag deployment and it occurred with bowel emptying 301 (74.5%) times. No leaks around the appliance were observed in 400 (85.3%) changes.

Safety: no serious adverse event occurred. Peristomal skin was not modified during the trial.

Conclusions: In the short term this new device has provided an increased control over bowel emptying at no risk in half of the trial population suggesting that an alternative approach to bag wearing is achievable.

Keywords: Appliance; Body image; Colorectal surgery; Colostomy; Output control; Stoma care.

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Conflict of interest statement

P.A. Lehur has a consulting agreement with B. Braun Medical (France) as medical and scientific expert in colorectal surgery. The other authors declare that they have no conflict of interest.

Figures

Fig. 1
Fig. 1
The investigational appliance AOS-C2001-B. Front and fragmented views. The capsule cap is composed of a capsule cover, a closed collecting multilayer-film folded pouch, a passive integrated filter for continuous release of flatus with a gas-release button to evacuate gas manually if necessary, a preliminary seal to hermetically close the stoma, and a coupling system with a guiding tab insuring a good positioning and a safe link of the capsule cap to a flat base plate (Flexima® 3S or Flexima® 3S/R Ø 55 or Ø 65 mm according to the stoma size)
Fig. 2
Fig. 2
Modes of capsule cap removal
See this image and copyright information in PMC

References

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