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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000108

Enrollment

Registered

2011-05-06

Start date

2006-06-02

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux Disease (GERD)

Interventions

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 shor

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Countries

Cuba

Contacts

Public ContactMiguel Martinez Alfonso

National Center for Minimal Access Surgery

mangel@cce.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 15, 2026