Diverting Loop Ileostomy: With or Without Rod (ROLLI)

• 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 ]

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.

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.

• Ileostomy
• Rectal Neoplasms

• Procedure: Diverting loop ileostomy with rod
  Diverting loop ileostomy with rod
• Procedure: diverting loop ileostomy without rod
  diverting loop ileostomy without rod

• A
  diverting loop ileostomy with rod
  Intervention: Procedure: Diverting loop ileostomy with rod
• B
  diverting loop ileostomy without rod
  Intervention: Procedure: diverting loop ileostomy without rod

• Rosen HR, Schiessel R. [Loop enterostomy] Chirurg. 1999 Jun;70(6):650-5. Review. German.
• Gastinger I, Marusch F, Steinert R, Wolff S, Koeckerling F, Lippert H; Working Group 'Colon/Rectum Carcinoma'. Protective defunctioning stoma in low anterior resection for rectal carcinoma. Br J Surg. 2005 Sep;92(9):1137-42.
• Moran B, Heald R. Anastomotic leakage after colorectal anastomosis. Semin Surg Oncol. 2000 Apr-May;18(3):244-8.
• Karanjia ND, Corder AP, Bearn P, Heald RJ. Leakage from stapled low anastomosis after total mesorectal excision for carcinoma of the rectum. Br J Surg. 1994 Aug;81(8):1224-6.
• Silva MA, Ratnayake G, Deen KI. Quality of life of stoma patients: temporary ileostomy versus colostomy. World J Surg. 2003 Apr;27(4):421-4.
• Amin SN, Memon MA, Armitage NC, Scholefield JH. Defunctioning loop ileostomy and stapled side-to-side closure has low morbidity. Ann R Coll Surg Engl. 2001 Jul;83(4):246-9.
• Edwards DP, Leppington-Clarke A, Sexton R, Heald RJ, Moran BJ. Stoma-related complications are more frequent after transverse colostomy than loop ileostomy: a prospective randomized clinical trial. Br J Surg. 2001 Mar;88(3):360-3.
• Bada-Yllán O, García-Osogobio S, Zárate X, Velasco L, Hoyos-Tello CM, Takahashi T. [Morbi-mortality related to ileostomy and colostomy closure] Rev Invest Clin. 2006 Nov-Dec;58(6):555-60. Spanish.
• Goldstein ET, Williamson PR. A more functional loop ileostomy rod. Dis Colon Rectum. 1993 Mar;36(3):297-8.
• Unti JA, Abcarian H, Pearl RK, Orsay CP, Nelson RL, Prasad ML, Duarte B, Leff MM, Tan AB. Rodless end-loop stomas. Seven-year experience. Dis Colon Rectum. 1991 Nov;34(11):999-1004.

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