An observational study in Colonic Diseases, Stricture and Occlusion, sponsored by Société Française d'Endoscopie Digestive. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-04-04.
Sponsored by Société Française d'Endoscopie Digestive · Observational
Self-expanding metallic stent placement is a safe and effective endoscopic procedure increasingly used to relieve colonic obstruction. Fully covered metal stents (FCSEMS) and plastic stents have been recently developed to reduce both hyperplastic (non tumoral) and tumoral tissue ingrowth. These fully covered metal or plastic stents have several advantages over non-covered stents, including the possibility of retrieval and limited local tissue reaction, while providing alleviation of obstruction at possibly lower costs. Only few reports of fully covered metal stent placement in patients with benign colorectal strictures are available in the literature. The aim of this study was to assess the effectiveness of FCSEMS in the management of the colonic benign strictures.
It is a national multicentric retrospective study on the use of fully covered metal stent placement in patients with benign colorectal strictures.
Consecutive patients above 18 years of age with a symptomatic benign colonic stricture despite optimal medical and/or endoscopic dilation therapy and which required the use of a FCSEMS were included. All strictures were confirmed to be benign by histology. All details concerning previous history, origins and treatment (medical or endoscopic) of the colonic stenosis were collected from the medical file.
Senior endoscopists with an experience of more than 50 colonic stent placements performed the procedure under general propofol-induced anesthesia with the same technic (The stent was placed under fluoroscopic and videoendoscopic controls).
Patients were required after the procedure to take oral osmotic laxatives regularly. Post-stenting complications were defined as immediate (during the procedure), early (occurring ≤ 30 days) and late (> 30 days) after the procedure. Stent removal and routine follow up endoscopy were scheduled 4 to 6 weeks after placement in most patients or earlier if complications occurred.
All patients were followed up at regular intervals based on their clinical situation. A retrospective chart review was performed to analyze the long-term outcome of the patients.
142 studies on the registry are indexed under Colonic Diseases; 22 are open to participants now.
This study's enrollment of 43 is below the median of 170 across 48 observational studies indexed under Colonic Diseases.
Browse Colonic Diseases studies →Société Française d'Endoscopie Digestive is the lead sponsor of 25 studies on the registry; 5 are open to participants now.
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Patients in universitary tertiary care center benefited from a fully covered metallic colonic stent for treatment of benign stricture
Exclusion Criteria:
Endoscopically insertion of fully covered metallic stent on benign colonic strictures
Device: Fully covered metallic colonic stent
Endoscopically insertion of fully covered metallic colonic stent
Symptom resolution of colonic occlusion
Defined as the clinical (stools, stop pain) and radiological evidence of colonic decompression within 48 hours of stent insertion and without the need for reintervention
Time frame: 48 hours
Successful stent placement
On the first attempt with complete deployment and precise positioning of the stent at the location of the stenosis, which was confirmed by fluoroscopy
Time frame: Immediatly after stent insertion (one minute)
Successful stent retrieval
Possibility of retrieval the stent with a snare or a forceps
Time frame: One minute (during colonoscopy for stent retrieval)
Occurrence of any complication during interventional endoscopy, stent retrieval and the follow-up
Perforation, bleeding, migration, pain, fecal incontinence and foreign body sensation, stent impaction and hyperplastic tissue overgrowth
Time frame: 60 days
Recurrence of colonic occlusion
New episode of occlusion or subocclusion (pain with stool and gas discontinuation and imaging with cecum dilation) after stent retrieval or migration
Time frame: 60 days, 6 months and one year
No study locations are listed for this record.
This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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Société Française d'Endoscopie Digestive