NCT01997684|UnknownDMC
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Sponsor study identifier
interventional
200
1 country
9
Study Start
July 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The use of colonic stenting with elective surgery has been suggested as an alternative management for acute malignant colonic obstruction, as emergency surgery has a high risk of morbidity and mortality. However, the available body of literature addressing their benefit in this setting is contradictory. The purpose of this study is to determine the efficacy and safety of colonic stenting with elective surgery versus emergency surgery in the management of acute malignant colonic obstruction.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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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.
July 2013
Date type not reportedThis date has not been verified as actual or estimated.
November 18, 2013
Actual (reported)November 28, 2013
Actual (reported)July 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Rates of primary colorectal anastomosis
The primary colorectal anastomosis was defined as: the patients received one-stage surgery and colorectal anastomosis by whatever elective or emergency surgery.
From date of randomization until the first follow-up ended, assessed up to 30 days
Stoma rates
From date of randomization until the follow-up ended, assessed up to 2 years
Mortality
From date of randomization until the date of death from any cause, assessed up to 2 years
Procedure related complication
From date of randomization until the first follow-up ended, assessed up to 30 days
Re-operation rates
From date of randomization until the follow-up ended, assessed up to 2 years
R0 resection
From date of randomization until the first follow-up ended, assessed up to 30 days
Technical success
From date of randomization until the first follow-up ended, assessed up to 30 days
Clinical success
From date of randomization until the first follow-up ended, assessed up to 30 days
In the experimental group, the patients will undergo colonic stenting within 24 h of inclusion. For this study, the WallFlex ™ Colonic Stent (Boston Scientific, Natick, MA) will be employed. Candidates for elective surgery, after clinical success of colonic stenting, will be preferably operated on 5-14 days after inclusion, and no later than 4 weeks. Type and extent of the elective surgery will be selected by the surgeon. In this group, unplanned emergency surgery will be indicated in case of technical failure of colonic stenting, iatrogenic morbidity, or clinical failure. In case of a primary colostomy, restoration of bowel continuity was attempted within 3-6 months.
In the comparator group, patients will be undergo emergency surgery. Surgical options including but not limited to: loop colostomy, Hartmann's procedure, and (sub) total colectomy with ileostomy or ileorectal anastomosis. In case of a primary colostomy, restoration of bowel continuity was attempted within 3-6 months.
After preparation of the distal colon with an enema, the colonoscope will be introduced up to the site of the obstruction. The colonic stent will be placed along a guide wire through the lesion under radiologic or endoscopic guidance. A colonic stent will be chosen which was at least 3 cm longer than the lesion (1.5 cm at either end). When the colonic stent did not cover the entire length of the lesion, a second overlapping stent will be placed. If the colonic stenting failed (technical failure) or symptoms of colonic obstruction did not resolve within 3 days (clinical failure), patients were indicated for emergency surgery. Candidates for elective surgery were preferably operated on 5-14 days after colonic stenting, and no later than 4 weeks. Type and extent of the surgery were selected by the surgeon, including but not limited to: loop colostomy, Hartmann's procedure, and (sub) total colectomy with ileostomy or ileorectal anastomosis.
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
Fujian Provincial Hospital
Fuzhou, Fujian, 350001, China
Guangdong Province Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, 510120, China
van Hooft JE, Bemelman WA, Oldenburg B, Marinelli AW, Lutke Holzik MF, Grubben MJ, Sprangers MA, Dijkgraaf MG, Fockens P; collaborative Dutch Stent-In study group. Colonic stenting versus emergency surgery for acute left-sided malignant colonic obstruction: a multicentre randomised trial. Lancet Oncol. 2011 Apr;12(4):344-52. doi: 10.1016/S1470-2045(11)70035-3.
Pirlet IA, Slim K, Kwiatkowski F, Michot F, Millat BL. Emergency preoperative stenting versus surgery for acute left-sided malignant colonic obstruction: a multicenter randomized controlled trial. Surg Endosc. 2011 Jun;25(6):1814-21. doi: 10.1007/s00464-010-1471-6. Epub 2010 Dec 18.
Side Liu, M.D.
Department of Gastroenterology, Nanfang Hospital, Southern Medical University
First Submitted
November 18, 2013
First Posted
November 28, 2013
Study Start
July 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2016
Estimated (date passed)Effectiveness of Gum Chewing on Ileus in Chinese Colorectal Patients Underwent Laparoscopic Colorectal Surgery
Type and extent of the surgery were selected by the surgeon, including but not limited to: loop colostomy, Hartmann's procedure, and (sub) total colectomy with ileostomy or ileorectal anastomosis.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510180, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510655, China
Xiangya hospital central-south university
Changsha, Hunan, 410008, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004, China
Renji Hospital, Medical College of Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200032, China
Ghazal AH, El-Shazly WG, Bessa SS, El-Riwini MT, Hussein AM. Colonic endolumenal stenting devices and elective surgery versus emergency subtotal/total colectomy in the management of malignant obstructed left colon carcinoma. J Gastrointest Surg. 2013 Jun;17(6):1123-9. doi: 10.1007/s11605-013-2152-2. Epub 2013 Jan 29.
Cheung HY, Chung CC, Tsang WW, Wong JC, Yau KK, Li MK. Endolaparoscopic approach vs conventional open surgery in the treatment of obstructing left-sided colon cancer: a randomized controlled trial. Arch Surg. 2009 Dec;144(12):1127-32. doi: 10.1001/archsurg.2009.216.
Alcantara M, Serra-Aracil X, Falco J, Mora L, Bombardo J, Navarro S. Prospective, controlled, randomized study of intraoperative colonic lavage versus stent placement in obstructive left-sided colonic cancer. World J Surg. 2011 Aug;35(8):1904-10. doi: 10.1007/s00268-011-1139-y.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 20, 2015
Record last verified: 2015-11
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