Tisuacryl® in esophageal surgery

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000045
• Date of registration: 12/09/2008
• Primary sponsor: Center of Biomaterials of Havana University
• Public title: Tisuacryl® in esophageal surgery
• Scientific title: Use of tissue adhesive Tisuacryl® in the prevention of dehiscences and fistulas of esophageal anastomosis with segments of stomach, jejunum and colon
• Date of first enrolment: 03/02/1999
• Target sample size: 58
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000045-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Single Blind Placebo: Active Assignment: Parallel Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Dr. Rosa Guerra Bretaña
• Affiliation: Center or Biomaterials of Havana University

• Name: Dr. Rosalba Roque González
• Affiliation: National Center for Minimal Access Surgery

Key inclusion & exclusion criteria

Inclusion criteria: Adult patients, between 18 and 70 years old Patients of both sexes Patients that gave their informed consent to participate in the study Patients that fulfill one of the following diagnostic criteria: Resectable esophageal cancer phases I, II or III Benignant stenosis that requires esophageal resection with or without portions of the stomach. Both conditions were diagnosed by endoscopic techniques and biopsy.
Exclusion criteria: Patient whose health conditions do not permit surgical treatment Patients with hypersensitivity to cyanoacrylates Patients with mental illness or severe psychological disorders, Pregnant women or during lactation Patients who don’t consent to participate in the study

Age minimum: 18 years
Age maximum: 70 years
Gender: Both

Health Condition(s) or Problem(s) studied

Esophageal cancer or benign stenosis

Intervention(s)

Esophagueal anastomosis Experimental Group: Partial excision of the esophagus was done by surgical techniques established in the Surgery Service of the Hospital Calixto García (transhiatal esophagectomy) and Hospital Miguel Enriquez (Ivor-Lewis). The esophageal anastomosis to other segments of the digestive tube was done by means of equidistant interrupted inverting sutures in a single layer with non absorbable material. Small drops of the tissue adhesive Tisuacryl® were applied over the suture line as reinforcement. Control Group: The same surgical procedure was follow in the control group, however adhesive Tisuacryl ® was not applied.

Primary Outcome(s)

Presence of fistula, 25 days

Secondary Outcome(s)

Time of appearance of fistula, up to 90 days Stenosis of the anastomosis, 90 days Adverse effects, up to 90 days

Secondary ID(s)

EC3

Source(s) of Monetary Support

Center of Biomaterials of Havana University