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Completed

NCT Number: NCT01741441

Laparoscopic Total Fundoplication for Duodenogastroesophageal Reflux

After laparoscopic total fundoplication (LTF) 12-15% of patients have persistent reflux symptoms and 20-25% develop gas-related symptoms. Reflux symptoms, gas bloating and inability to belch occurring after surgery have been associated with mixed (acid and weakly acid) (MR) or weakly acidic reflux (WAR). To date, few studies have evaluated functional outcome after LTF in patients with MR or WAR, with the majority reporting only short-term results.

It has been shown that delayed gastric emptying (DGE) might also be an important factor for abdominal distension and adverse outcome after LTF.9,10 However, the correlation between poor long-term outcome after LTF and DGE is controversial. In addition, the effect of DGE in patients with MR or WAR is poorly investigated.

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Key information

Conditions

Duodenogastric Reflux Digestive System Diseases Duodenal Diseases Gastrointestinal Diseases Intestinal Diseases Stomach Diseases

Age range

14 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Digestive, Colorectal, Oncologic and Minimally Invasive Surgery, Department of Surgical Sciences

Turin, 10126, Italy

About this study

In the last years the study of gastro-oesophageal reflux has been revolutionized by the development of combined 24-h esophageal pH and multichannel intraluminal impedance (MII) monitoring.

Combined esophageal MII and pH-monitoring allow for the timed correlation of esophageal pH changes with reflux events and achieve high sensitivity for the detection of acid (pH <4), weakly acidic (pH 4-7) and weakly alkaline (pH >7) reflux episodes. Use of this technology is bringing into focus the potential role of weakly acidic and weakly alkaline reflux in symptoms that persist despite acid suppressive therapy or anti-reflux surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The study population consisted of consecutive patients with weakly acidic gastroesophageal reflux (GER) confirmed by 24 hour pH and impedance monitoring and eligible for laparoscopic antireflux surgery (LARS).

Exclusion criteria

  • Exclusion criteria were presence of severe gastric emptying, functional heartburn, giant hiatal hernia, underlying primary esophageal motility disorder, American Association of Anaesthetists (ASA) score IV, previous upper abdominal surgery, and contraindications to pneumoperitoneum.

Treatment and study plan

laparoscopic total fundoplication

Procedure

LTF was performed using a standard five-trocar technique in all cases and carried out by two expert surgeons who had previously performed more than 50 laparoscopic fundoplications. A floppy 360° total fundoplication of 2-2,5 cm was constructed after full esophageal mobilization and posterior crural repair with nonabsorbable sutures.

Other names: Laparoscopic Nissen fundoplication, Laparoscopic 360° degree fundoplication

Primary outcomes

  1. number of acidic and weakly acidic reflux

    Time frame: 60 months after LTF

    number of acidic and weakly acidic reflux at 24 hour pH impedance monitoring

Secondary outcomes

  1. GERD Health related quality of Life score

    Time frame: 60 months after LTF

    Standard and previous validate questionnaire was employed in the study to assess gastroesophageal function and quality of life

  2. Gastro-esophageal junction pressure

    Time frame: 60 months after surgery

    Gastroesophageal junction pressure was evaluated with esophageal manometry

  3. Gastric emptying

    Time frame: 1 months before surgery

    Gastric emptying was evaluated with gastric scintigraphy before LTF

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study title

Study of Prognostic Factors for Long Term Results of Total Laparoscopic Fundoplication for Weakly Acidic or Mixed Reflux

Important dates

Study start
2002
Primary completion
2007
Study completion
2012
First posted
Dec 5, 2012
Registry last updated
Dec 5, 2012

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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