Prevention of Anastomotic Leak in Gastrointestinal (GI) Anastomosis With the Application of Tisseal in the Anastomotic Line

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by Hospital General Universitario Gregorio Marañon.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital General Universitario Gregorio Marañon
ClinicalTrials.gov Identifier:
NCT01306851
First received: March 1, 2011
Last updated: NA
Last verified: May 2007
History: No changes posted
  Purpose

The anastomotic leak is one of the most feared complications in abdominal surgery. Certain control methods have been described but the incidence of that complication remains high and is the first cause of mortality in operations where gut anastomosis are performed.

With the aim to prove that the use of fibrin glue in the gut anastomosis can improve gut cicatrization, the investigators started the recruitment of patients to that clinical trial in 2007 with the study hypothesis that patients with a gut anastomosis where fibrin glue was used, had less anastomotic leaks than that where the fibrin glue was not used.

The investigators have calculated the number of patients necessaries to have statistical significant differences in 200 patients with a rate anastomotic leak expected to be higher than 10%.

The study include all the patients that usually arrive to our surgery department and that are expected to have a high risk gut anastomosis: rectal anastomosis, GI anastomosis in the obese patient, small bowel anastomosis in the obstructed one and esophageal anastomosis.

The study is randomized, simple blind where the patient does not know if they are in the fibrin glue group or not, and prospectively analyzed. All the clinical and laboratory or radiographic finds relative to the occurrence of an anastomotic leak are recorded.


Condition Intervention Phase
Anastomotic Leak
Drug: Fibrin glue
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Multicenter, Randomized, Controlled, Single Blinded, Phase IV Study Comparing 2 Parallel Groups in the Evaluation of the Prevention of Anastomotic Leaks in GI High Risk Anastomosis, With or Without the Application of Fibrin Glue in the Anastomotic Line

Further study details as provided by Hospital General Universitario Gregorio Marañon:

Primary Outcome Measures:
  • Occurence of anastomotic leak [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    The occurence of anastomotic leak in the 6 months after the surgery is the most important factor to determine if fibrin glue is helpful in the prevention of that complicacion.


Secondary Outcome Measures:
  • Evidence of infectious collections in the anastomotic area [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: June 2007
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fibrin glue Drug: Fibrin glue
In the intervention group, 5 or 10 ml of fibrin glue are applied in the anastomotic line.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing GI surgery where a high risk anastomosis is preview to be done

Exclusion Criteria:

  • Haemodynamic instability
  • Advanced oncologic disease
  • Proteins below 4 gr/ml
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01306851

Contacts
Contact: Lago Jesus, MD +34618302092 jesus.lago@salud.madrid.org

Locations
Spain
Hospital General Universitario Gregorio Marañon Recruiting
Madrid, Spain, 28007
Contact: Lago Jesus, MD    +34618302092    jesus.lago@salud.madrid.org   
Principal Investigator: Lago Jesus, MD         
Sponsors and Collaborators
Hospital General Universitario Gregorio Marañon
  More Information

No publications provided by Hospital General Universitario Gregorio Marañon

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jesús Lago Oliver, Hospital General Universitario "Gregorio Marañón"
ClinicalTrials.gov Identifier: NCT01306851     History of Changes
Other Study ID Numbers: PROTTISUCOL-001
Study First Received: March 1, 2011
Last Updated: March 1, 2011
Health Authority: Spain: Comité Ético de Investigación Clínica
Spain: Spanish Agency of Medicines

Keywords provided by Hospital General Universitario Gregorio Marañon:
fibrin glue
anastomotic leak
gastrointestinal high risk anastomosis

Additional relevant MeSH terms:
Anastomotic Leak
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications
Pathologic Processes
Fibrin Tissue Adhesive
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014