Diverting Loop Ileostomy: With or Without Rod

Rectal Neoplasms Clinical Trial

— ROLLI  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00959738
• Other study ID #: 061/08
• Status: Terminated
• Phase: N/A
• First received: August 14, 2009
• Last updated: November 13, 2014
• Start date: August 2008
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 121
• Est. completion date: November 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ileostomy
• Rectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Switzerland	Bern University Hospital, Dep. of Visceral and Transplant Surgery	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Goldstein ET, Williamson PR. A more functional loop ileostomy rod. Dis Colon Rectum. 1993 Mar;36(3):297-8. — View Citation

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. — View Citation

Moran B, Heald R. Anastomotic leakage after colorectal anastomosis. Semin Surg Oncol. 2000 Apr-May;18(3):244-8. — View Citation

Rosen HR, Schiessel R. [Loop enterostomy]. Chirurg. 1999 Jun;70(6):650-5. Review. German. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of hospital stay, measured in days after intervention		postoperative during 2 weeks, 3 months postoperative	No
Other	Change in eversion of the stoma nipple at postoperative days 2, 4, 6, 8, 14, 30, 60, 90		postoperative days 2, 4, 6, 8, 14, 30, 60, 90	No
Other	Start of stomal activity in hours after intervention		postoperative during 2 weeks, 3 months postoperative	No
Other	Number of stoma bags and self-adhesive plates needed in the first month after the operation		postoperative during 2 weeks, 3 months postoperative	No
Primary	Severe stoma specific morbidity rate		postoperative during 2 weeks, 3 months postoperative	No
Secondary	Rate of patients reaching self-sufficient stoma care		postoperative during 2 weeks	Yes
Secondary	Time used by the stoma nurses for instructing and assisting patients	Measured in total hours from the intervention up to 3 months postoperatively	preoperative, 2 weeks and 3 months postoperative	No
Secondary	Quality of life (QoL) by a stoma quality of life scale		postoperative during 2 weeks, 3 months postoperative	No
Secondary	Predictive factors for stomal complications		postoperative during 2 weeks, 3 months postoperative	Yes