Diverting Loop Ileostomy: With or Without Rod (ROLLI)

• Severe stoma specific morbidity rate [ Time Frame: postoperative during 2 weeks, 3 months postoperative ] [ Designated as safety issue: No ]
  

• postoperative during 2 weeks, 3 months postoperative [ Time Frame: postoperative during 2 weeks ] [ Designated as safety issue: Yes ]
  
• Time used by the stoma nurses for instructing and assisting patients [ Time Frame: preoperative, 2 weeks and 3 months postoperative ] [ Designated as safety issue: No ]
  
• Quality of life (QoL) by a stoma quality of life scale [ Time Frame: postoperative during 2 weeks, 3 months postoperative ] [ Designated as safety issue: No ]
  
• Predictive factors for stomal complications [ Time Frame: postoperative during 2 weeks, 3 months postoperative ] [ Designated as safety issue: Yes ]
  

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

The study is designed as multi-institutional, randomized controlled, two-armed study. Patients scheduled for a protective loop ileostomy and meeting the eligibility criteria will be randomized to creation of a loop ileostomy with or without sustaining rod.