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OpenTrials
Completed

NCT Number: NCT00852098

Laparoscopic Nissen Fundoplication Comparing Division Versus Non-Division of Short Gastric Vessels

Recently, total fundoplication followed by laparoscopic esophageal hiatoplasty has been the most common surgical treatment for gastro-esophageal reflux. Although this procedure is effective, some patients still develop complications. Indeed, dividing the short gastric vessels is claimed by many authors to confer benefit to patients even it could not be proved in other studies. In an attempt to evaluate the role of dividing the short gastric vessels and its long-term impact on the surgical treatment of the gastro-esophageal reflux, the investigators initiated a randomized clinical trial to clarify this important fact. Patients were recruited for this trial and short-term results had been already published in a national journal. The investigators are now registering this study which particularly focuses on the endoscopic outcome evaluated on long-term basis after gastro-esophageal reflux surgical treatment.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of São Paulo - UNIFESP, São Paulo, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • objective gastroesophageal reflux in adults

Exclusion criteria

  • esophageal motility disorder
  • hard stenosis
  • previous antireflux surgery

Treatment and study plan

Lap Nissen fundoplication with division of short gastric vessels

Procedure

Dividing short gastric vessels

Other names: Fundoplication, Gastroesophageal Reflux,Surgery

Laparoscopic Nissen fundoplication without division of short gastric vessels

Procedure

non-dividing short gastric vessels

Other names: Fundoplication, Gastroesophageal Reflux,Surgery

Primary outcomes

  1. Evaluate outcomes after Laparoscopic Nissen comparing division and non-division of short gastric vessels.

    Time frame: two years

Secondary outcomes

  1. Long-term clinical and endoscopic outcome

    Time frame: 8-10 years

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • Hospital State Public

Registry information

Official study title

Randomized Clinic Trial of Total Fundoplication and Fundal Mobilization With or Without Division of Short Gastric Vessels: Long-Term Endoscopic Evaluation

Important dates

Study start
1997
Primary completion
2000
Study completion
2008
First posted
Feb 26, 2009
Registry last updated
Feb 26, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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