Who is sponsoring TISSEEL?

TISSEEL is sponsored by Centre Hospitalier Universitaire, Amiens.

What condition does TISSEEL study?

TISSEEL studies Morbid Obesity.

What drugs are being tested in TISSEEL?

Interventions: tisseel, no tisseel.

What is the status of TISSEEL?

TISSEEL is currently COMPLETED.

Last reviewed 2020-07-13 · How we verify

Randomized Prospective Clinical Study Evaluating the Usefulness of Fibrin Glue (TISSEEL® KIT) to Prevent Gastric Fistula, Intra Abdominal Haemorrhage and Intra Abdominal Loco Regional Collections After Laparoscopic Sleeve Gastrectomy

NCT01613664 Phase 3 COMPLETED

Laparoscopic Sleeve Gastrectomy has emerged over the last 20 years as a treatment of choice in the surgical management of patients with morbid obesity. However, this restrictive procedure is accompanied by outcomes such as gastric fistula (5%), postoperative hemorrhage (1%) and intra-abdominal loco regional collections (1%). At present, there is no sufficiently reliable technique to prevent these complications.

Details

Lead sponsor	Centre Hospitalier Universitaire, Amiens
Phase	Phase 3
Status	COMPLETED
Enrolment	597
Start date	2014-02
Completion	2018-05-15

Conditions

Morbid Obesity

Interventions

tisseel
no tisseel

Primary outcomes

presence of post-operative complications — post operative day 30
The primary endpoint corresponds to the presence of complications after laparoscopic sleeve gastrectomy during the follow up period. A complication is considered as "present" if at least one of the following three items is present: * Gastric fistula * Postoperative hemorrhage * intra-abdominal locoregional collection

Countries

France