welcome to oneFAPvoice- a positively charged Familial Adenomatous Polyposis community.
- join today!
An Evaluation of SprayShield in Reducing Post-Operative Adhesion Formation Following Major Open Abdominal Surgery
study id #: NCT01002287
condition: Ulcerative Colitis, Familial Polyposis
This will be a prospective, multi-center, randomized, single blind study to collect and evaluate post-market clinical data on the SprayShield Adhesion Barrier System as an adjuvant to good surgical technique for the reduction of postoperative adhesion formation following major open abdominal surgery.
Device: SprayShield Adhesion Barrier System Procedure: Good Surgical Technique Alone
start date: October 2009
estimated completion: May 2011
last updated: November 20, 2014
phase of development: Not Available
size / enrollment: 11
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
- The Incidence of Adhesions, Defined as the Proportion of Subjects Presenting at the Follow-up Surgery (10-12 Weeks) With One or More Adhesions to the Midline Incision, Regardless of Extent and/or Severity. [ Time Frame: 10-12 Weeks post Initial Surgery for J-Pouch ] [ Designated as safety issue: No ]
- Severity of Adhesions [ Time Frame: Average 10-12 weeks post surgery ] [ Designated as safety issue: No ]
Worst midline adhesion severity score. The severity of adhesions was categorized as filmy thickness, avascular; moderate thickness, limited vascularity; and dense thickness, vascularised. The corresponding numeric severity ratings are ""1"", ""2"", and ""3"". Subjects without adhesions were assigned a severity rating of ""0"".
- Adhesion Involvement Along the Midline Incision (Percentage) [ Time Frame: average 10-12 weeks post surgery ] [ Designated as safety issue: No ]
The proportion of the total length of the initial midline incision associated with any adhesion at the time of the follow-up surgery, as determined by dividing the length of the incision associated with adhesions (cm) by the overall initial midline incision length (cm). This calculates the extent of adhesion involvement as a percentage.
- Mobilization Time [ Time Frame: average 10-12 weeks post surgery ] [ Designated as safety issue: No ] The time (minute) required to incise and mobilize the ileal loop in preparation for reanastomosis for ileostomy closure.
- Diagnosis of ulcerative colitis or familial polyposis and require two-stage surgery for treatment of either of these disorders will be eligible
expertly curated content related to this topic
Dietary Calcium Supplementation for Preventing Colorectal Cancer and Adenomatous PolypsBACKGROUND : Several dietary factors hav...
Clinical Management of Hereditary Colorectal Cancer SyndromesHereditary factors are involved in the d...
Evaluation of Management of Desmoid Tumours Associated with Familial Adenomatous Polyposis in Dutch PatientsBACKGROUND : The optimal treatment of de...
Desmoid Clinical Trial Update & Stuff!https://www.youtube.com/watch?v=uaMKoMHE...
A Total Laparoscopic Approach Reduces the Infertility Rate after Ileal Pouch-Anal Anastomosis: A 2-Center StudyOBJECTIVE: To assess the infertility ra...
The Ileo Neo Rectal Anastomosis: Long-term Results of Surgical Innovation in Patients After Ulcerative Colitis and F...PURPOSE: Restorative proctocolectomy wi...
An International Randomised Trial of Celecoxib versus Celecoxib plus Difluoromethylornithine in Patients with Famili...BACKGROUND AND AIM : Although Non-steroi...