Tisuacryl® in esophageal surgery

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Use of tissue adhesive Tisuacryl® in the prevention of dehiscences and fistulas of esophageal anastomosis with segments of stomach, jejunum and colon

Secondary indentifying numbers:

EC3

Issuing authority of the secondary identifying numbers:

Center of Biomaterials of Havana University

Source(s) of monetary or material support:

Center of Biomaterials of Havana University

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center of State Control of the medical equipment(CCEEM)

Authorization date :

12/10/1998

Reference number:

N/A

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Rosalba

Last name:

Roque Gonzalez

Medical Specialty :

I Specialist in General Surgery

Affiliation:

National Center for Minimal Access Surgery

Postal address:

Calle Párraga e/ San Mariano y Vista Alegre. 10 de Octubre.

City:

Havana

País:

Cuba

Zip Code:

10500

Telephone:

+53-76495333

Email address:

rrg@infomed.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Havana, Hospital Clinico Quirurgico Docente “Miguel Enriquez”, Dr. Armando Leal Mursuli

Research ethics committees:

Calixto García Hospital, May 13, 1997

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

03/02/1999

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Esophageal cancer or benign stenosis

Health condition(s) code:

Esophageal Neoplasms

Esophageal Stenosis

Gastrointestinal Neoplasms

Digestive System Neoplasms

Esophageal Diseases

Gastrointestinal Diseases

Digestive System Diseases

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.

Intervention code:

Esophagectomy

Anastomosis, Surgical

Tissue Adhesives

Intervention keyword:

Tisuacryl

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Presence of fistula, 25 days

Key secondary outcomes:

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

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

70 years

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

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Single Blind

Control group:

Active

Study design:

Parallel

Phase:

2

Target sample size:

58

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Dr. Rosa

Middle Name:

Mayelín

Last Name:

Guerra Bretaña

Specialty:

Doctor of Chemical Sciences

Affiliation:

Center or Biomaterials of Havana University

Postal Address:

Ave. Universidad e/Ronda y G, Vedado

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

(537)-8735477

Email :

mayelin@biomat.uh.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Rosalba

Last Name:

Roque Gonzalez

Specialty:

I Specialist in General Surgery

Affiliation:

National Center for Minimal Access Surgery

Postal Address:

Calle Párraga e/ San Mariano y Vista Alegre

City:

Havana

País:

Cuba

Zip Code:

10500

Telephone:

(537) 649-5333 | FAX: (537) 649-0150

Email :

rrg@infomed.sld.cu

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000045

Date of Registration in Primary Registry:

2008-09-12

Record Verification Date:

2008-09-03 20:00

Link to the spanish version:

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Tisuacryl® in esophageal surgery

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