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OpenTrials
Completed

NCT Number: NCT03659487

Comparison of Total and Partial Fundoplication During Surgery of Patients With Gastroesophageal Reflux Disease

460 patients who are scheduled for surgical treatment of gastroesophageal reflux disease (GERD) participate in the study following the usual preoperative Clinical routines (Medical history, endoscopy with biopsies, esophageal manometry with 24 hour pH (acidity) registration ). Patients are randomized to fundoplication according to Nissen or modified Toupet. Postoperatively, patients are monitored after 6 weeks 12, 36, 24 and 60 months.

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Key information

Conditions

Reflux, Gastroesophageal Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Patients aged 18-75 years planned for elective surgical treatment of GERD participate in the study. Patients with recurrent reflux disease following prior surgery, ASA (American Society of Anesthesiologists (ASA) Physical Status") class> 3, paraesophageal herniating and / or major herniation without reflux and those with other contraindications against laparoscopic surgery are excluded. In addition, patient completes a QOL protocol. Patients in the study are randomized to laparoscopic fundoplication performed either with a 360 degrees (Nissen) alternatively 270 degree (modified Toupét). Both of these techniques are well established clinical routines. General intubation anesthesia is standardized to all study patients. Discharge from the hospital is typically on the first postoperative day. At a visit, after 6-8 weeks for clinical control, is a QOL protocol is completed as well. After 12 and 36 months, patients undergo upper endoscopy and manometry with 24 hour pH-registration and QOL protocol completion. The latter also occurs after 24 months and 60 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • surgery treatment for GERD
  • laparoscopic surgery

Exclusion criteria

  • previous surgery for GERD
  • ASA classification >3
  • paraesophageal hernias or large hiatal

Treatment and study plan

Nissen

Procedure

Laparoscopic total (Nissen) fundoplication

Toupét

Procedure

Laparoscopic posterior 270 degrees partial fundoplication

Primary outcomes

  1. Esophageal acid exposure

    Time frame: Change from baseline at 6 weeks, 12 and 36 month

    24-hour pH measurement

Secondary outcomes

  1. Recurrens rates

    Time frame: Change from baseline at 6 weeks, 12, 36 and 60 month

    Medical journal or patients description

  2. Dysphagia scoring

    Time frame: Change from baseline at 6 weeks, 12, 36 and 60 month

    Dysphagia for liquids and solids were recorded within a four-graded scale stating the frequency of dysphagia episodes with an arbitrary (empirical) cut off for clinical significance. The same dysphagia scoring was also used in a previous rct, from the same institution, comparing different types of antireflux procedures in open surgery.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Acronym: RefluxII

Important dates

Study start
2001
Primary completion
2011
Study completion
2018
First posted
Sep 6, 2018
Registry last updated
Oct 29, 2018

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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