A Prospective Multicenter Randomized Controlled Clinical Trial to Compare the Method of Protective Diverting Loop Ileostomy With or Without the Support of a Plastic Rod
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 121
- Locations
- 2
- Primary Endpoint
- Severe stoma specific morbidity rate
Study Overview
Brief Summary
Diverting ileostomies are created to protect a rectal anastomosis or in situations with a risk of intestinal perforation. Currently, the application of a rod to hinder slippage of the loop is an established technique to perform a diverting loop ileostomy. However, various "rod-less" techniques have been described and are performed with similar success. The aim of this study is to determine, whether a modification (without rod) of the current standard method of protective loop ileostomy formation (with rod) could improve ileostomy specific morbidity. Secondary endpoints include stoma care, determinants of quality of life and stoma function.
Detailed Description
Background
For rectal anastomoses within 6 cm of the anal verge, leakage rates are up to 15%. Here liberal use of protective stomas is widely accepted. Fecal diversion by loop ostomy may also be performed after extended adhesiolysis with serosal lesions and risk of intestinal perforation, in patients with obstructing rectal tumours requiring neoadjuvant radio-chemotherapy or in patients with complex anorectal injuries or fistulas. Generally, diverting loop ileostomies are secured at skin level by means of a supporting device in order to prevent retraction of the loop ileostomy into the abdomen. Nevertheless, due to the supporting rod, difficulties may occur in applying a stoma bag correctly and leakage of feces onto the skin may occur even with correct eversion of the afferent limb. Despite easier application of stoma bags and therefore reduced risk of skin irritation, none of these alternative techniques are established. In various non-randomized studies rodless loop ileostomies were described with an overall morbidity between 3 and 39%. However definition of morbidity varies significantly in these studies and randomised controlled trials are missing so far.
Objective
The aim of this study is to determine, whether a modification (without rod) of the current standard method of protective loop ileostomy formation (with rod) could improve ileostomy specific morbidity. Secondary endpoints include stoma care, determinants of quality of life and stoma function.
Methods
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients scheduled for planned protective loop ileostomy
- •Exclusion Criteria
- •patients with long-term use of corticosteroids (> 15 mg prednisolone equivalent)
- •immunosuppressive agent rapamune
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Severe stoma specific morbidity rate
Time Frame: postoperative during 2 weeks, 3 months postoperative
Secondary Outcomes
- Time used by the stoma nurses for instructing and assisting patients(preoperative, 2 weeks and 3 months postoperative)
- Predictive factors for stomal complications(postoperative during 2 weeks, 3 months postoperative)
- Rate of patients reaching self-sufficient stoma care(postoperative during 2 weeks)
- Quality of life (QoL) by a stoma quality of life scale(postoperative during 2 weeks, 3 months postoperative)