Difference found in interim analysis, not ethical to continue
ROLLI
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
Sponsor study identifier
interventional
121
1 country
1
Study Start
August 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2014
Actual (reported)Study Completion
November 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2008
Date type not reportedThis date has not been verified as actual or estimated.
August 14, 2009
Actual (reported)August 17, 2009
Actual (reported)July 2014
Actual (reported)November 2014
Actual (reported)Severe stoma specific morbidity rate
postoperative during 2 weeks, 3 months postoperative
Rate of patients reaching self-sufficient stoma care
postoperative during 2 weeks
Time used by the stoma nurses for instructing and assisting patients
preoperative, 2 weeks and 3 months postoperative
Quality of life (QoL) by a stoma quality of life scale
postoperative during 2 weeks, 3 months postoperative
Predictive factors for stomal complications
postoperative during 2 weeks, 3 months postoperative
Length of hospital stay, measured in days after intervention
postoperative during 2 weeks, 3 months postoperative
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
Start of stomal activity in hours after intervention
postoperative during 2 weeks, 3 months postoperative
diverting loop ileostomy with rod
diverting loop ileostomy without rod
Diverting loop ileostomy with rod
diverting loop ileostomy without rod
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Bern University Hospital, Dep. of Visceral and Transplant Surgery
Bern, 3010, Switzerland
Rosen HR, Schiessel R. [Loop enterostomy]. Chirurg. 1999 Jun;70(6):650-5. doi: 10.1007/s001040050701. 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. doi: 10.1002/bjs.5045.
Moran B, Heald R. Anastomotic leakage after colorectal anastomosis. Semin Surg Oncol. 2000 Apr-May;18(3):244-8. doi: 10.1002/(sici)1098-2388(200004/05)18:33.0.co;2-6.
Lukas E Bruegger, MD
Bern University Hospital,Dep. of Visceral and Transplant Surgery Switzerland
121 participants (actual enrollment reported by the registry).
First Submitted
August 14, 2009
First Posted
August 17, 2009
Study Start
August 2008
Date type not reportedThis date has not been verified as actual or estimated.
Effectiveness and Tolerability of an Oral Nutritional Supplement (PreOP Booster) Given Before Surgery
Contact the study team to confirm eligibility.
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. doi: 10.1002/bjs.1800810850.
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. doi: 10.1007/s00268-002-6699-4.
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. doi: 10.1046/j.1365-2168.2001.01727.x.
Bada-Yllan O, Garcia-Osogobio S, Zarate 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. doi: 10.1007/BF02053516.
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. doi: 10.1007/BF02049964.
Primary Completion
July 2014
Actual (reported)Study Completion
November 2014
Actual (reported)Last Updated
November 14, 2014
Record last verified: 2014-11
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: