MedDataX Logo

Sprayshield as Adhesion Barrier System for Obese Patients

NCT ID: NCT02142660

Last Updated: 2014-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The application of SprayShield during a laparoscopic band removal (first surgical step) will be evaluated to see if the postoperative adhesions between the stomach, the left liver and the diaphragm are not severe, facilitating the surgical surgical step of a gastric bypass or a sleeve gastrectomy.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Monocenter and observational study on 20 obese patients, requiring removal of the gastric band for poor results (weight regain or insufficient weight-loss) or mechanical complications of the band ( slippage, esophageal dilation) and schedule for a second step surgery of gastric bypass or sleeve gastrectomy 2 months later.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Severe Obesity

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Adhesion barrier system Bariatric surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sprayshield

Applied to the operating zone during an ablation of gastric died ring at obese patients programmed for the second bariatric surgery to type of bypass gastric or of gastrectomie

ablation of gastric

Intervention Type PROCEDURE

Applied to the operating zone during an ablation of gastric died ring at obese patients programmed for the second bariatric surgery to type of bypass gastric or of gastrectomie in wing

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ablation of gastric

Applied to the operating zone during an ablation of gastric died ring at obese patients programmed for the second bariatric surgery to type of bypass gastric or of gastrectomie in wing

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Obese male or female who would benefit from a gastric band removal and for whom a second surgical step with conversion to sleeve gastrectomy or bypass is scheduled

Exclusion Criteria

* The patients having an ablation of ring motivated for an infectious complication
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jean Michel FABRE

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Digestive Surgery A, Saint Eloi Hospital

Montpellier, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

Nocca D, Guillaume F, Noel P, Picot MC, Aggarwal R, El Kamel M, Schaub R, de Seguin de Hons C, Renard E, Fabre JM. Impact of laparoscopic sleeve gastrectomy and laparoscopic gastric bypass on HbA1c blood level and pharmacological treatment of type 2 diabetes mellitus in severe or morbidly obese patients. Results of a multicenter prospective study at 1 year. Obes Surg. 2011 Jun;21(6):738-43. doi: 10.1007/s11695-011-0385-2.

Reference Type RESULT
PMID: 21468625 (View on PubMed)

Fezzi M, Kolotkin RL, Nedelcu M, Jaussent A, Schaub R, Chauvet MA, Cassafieres C, Lefebvre P, Renard E, Bringer J, Fabre JM, Nocca D. Improvement in quality of life after laparoscopic sleeve gastrectomy. Obes Surg. 2011 Aug;21(8):1161-7. doi: 10.1007/s11695-011-0361-x.

Reference Type RESULT
PMID: 21298508 (View on PubMed)

Blanc PM, Lagoutte JM, Picot MC, Deneve E, de Seguin C, Fabre JM, Nocca D. Preliminary results of the laparoscopic adjustable gastric banding procedure by a new generation of silicone band: MIDBAND. Obes Surg. 2008 May;18(5):569-72. doi: 10.1007/s11695-008-9441-y.

Reference Type RESULT
PMID: 18340499 (View on PubMed)

Nocca D, Krawczykowsky D, Bomans B, Noel P, Picot MC, Blanc PM, de Seguin de Hons C, Millat B, Gagner M, Monnier L, Fabre JM. A prospective multicenter study of 163 sleeve gastrectomies: results at 1 and 2 years. Obes Surg. 2008 May;18(5):560-5. doi: 10.1007/s11695-007-9288-7.

Reference Type RESULT
PMID: 18317859 (View on PubMed)

Nocca D, Aggarwal R, Blanc P, Gallix B, Di Mauro GL, Millat B, Seguin des De Hons C, Deneve E, Rodier JG, Tincani G, Pierredon MA, Fabre JM. Laparoscopic vertical banded gastroplasty. A multicenter prospective study of 200 procedures. Surg Endosc. 2007 Jun;21(6):870-4. doi: 10.1007/s00464-006-9048-0. Epub 2006 Nov 14.

Reference Type RESULT
PMID: 17103270 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UF8744

Identifier Type: -

Identifier Source: org_study_id