Efficacy of laparoscopic Nissen -Rossetti fundoplication in the treatment of gastroesophageal reflux disease.

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:

Efficacy of laparoscopic Nissen-Rossetti fundoplication in the treatment of gastroesophageal reflux disease.

Secondary indentifying numbers:

cncma 003, National Center for Minimal Access Surgery

Issuing authority of the secondary identifying numbers:

National Center for Minimal Access Surgery

Source(s) of monetary or material support:

Ministry of Public Health (MINSAP)

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:

Only approved by Ethics Committees

Principal investigator

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

First name:

MD. Miguel Angel Martinez Alfonso

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

Country:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered [1]

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:

Not applicable

Research ethics committees:

National Center for Minimal Access Surgery, May 14, 2005

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

02/06/2006

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:

Gastroesophageal Reflux Disease (GERD)

Intervention(s):

Randomly evaluated two treatment groups: A control group who underwent laparoscopic Nissen technique, which consists of a 360 ° fundoplication where ligation is routinely performed and section of short vessels. An experimental group who underwent the laparoscopic Nissen-Rossetti technique, which consists of a 360 ° fundoplication where ligation is not performed and section of short vessels.

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):

Heartburn: Presence of a burning sensation behind the sternum. Measuring time: 1, 3, 6 and 12 months. Regurgitation: Sensing the flow of gastric contents into the oral cavity or pharynx. Measuring time: 1, 3, 6 and 12 months. Postoperative dysphagia: Feeling like a difficult to swallow food, to pass from mouth to stomach for solids, it can be exclusively or simultaneously for solids and liquids. Measuring time: 1, 3, 6 and 12 months.

Key secondary outcomes:

Surgical time, surgical timing in minutes required to perform the procedure, from the creation of pneumoperitoneum until the moment when surgical access was closed. Measuring time: at the end of surgery. Adverse Event: Any sign or symptom that appears in the patient related or unrelated to the procedure used. Measuring time: Since the inclusion of the patient until the final evaluation (12 months).

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:

80 years

Inclusion criteria:

1. Patients with typical symptoms of GERD and esophageal motor disorders, who had indication for surgical treatment. 2. Adult patients gave their written consent to participate. 3. Patients aged between 18 and 80 years inclusive

Exclusion criteria:

1. Patients with atypical symptoms of GERD. 2. Patients with recurrence of GERD after antireflux surgery. 3. Patients with peptic esophageal stricture as a complication of GERD. 4. Patients who refused to participate in the study. 5. Persons with mental disability, severe mental disorders or both. 6. Pregnant or breastfeeding

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:

Target sample size:

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:

Miguel

Middle Name:

Angel

Last Name:

Martinez Alfonso

Affiliation:

National Center for Minimal Access Surgery

Postal Address:

Calle Párraga 215 entre Vista Alegre y San Mariano. 10 de Octubre. La Habana. Cuba

City:

Havana City

Country:

Cuba

Zip Code:

10700

Telephone:

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

Email :

mangel@cce.sld.cu [2]

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:

Miguel

Middle Name:

Angel

Last Name:

Martinez Alfonso

Affiliation:

National Center for Minimal Access Surgery

Postal Address:

Calle Párraga 215 entre Vista Alegre y San Mariano. 10 de Octubre. La Habana. Cuba

City:

Havana City

Country:

Cuba

Zip Code:

10700

Telephone:

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

Email :

mangel@cce.sld.cu [2]

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:

RPCEC00000108

Date of Registration in Primary Registry:

2011-05-06

Record Verification Date:

2011-04-20 20:00

Link to the spanish version:

Click here [3]