Laparoscopic Nissen Versus Anterior Partial Fundoplication

NCT01669330 | Completed

• 1 other identifier: NW20012011
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 4

Brief Summary

The most widely used operative technique for gastroesophageal reflux is total fundoplication where the gastric fundus is sutured around the distal esophagus like a wrap. This operation effectively prevents gastroesophageal reflux but gives rise to postoperative symptoms related to over-competence of the gastroesophageal junction. 40% of the operated patients experience increased flatulence and 20% dysphagia. Anterior fundoplication is an alternative technique where the distal esophagus is anchored to the crura of the hiatus esophagi and only a part of the front wall of the esophagus is covered with fundus. An anterior fundoplication is un attempt to create a more physiologic reflux control and less functional problems postoperatively. The aim with this study is to compare the results postoperatively, both short time and long time results.

Conditions

Gastroesophageal Reflux

Keywords

Gastroesophageal Reflux; Fundoplication; Surgical Procedures

Outcome Measures

Primary Outcomes (1)

• Postoperative flatulence?

  To establish if there is a difference in the incidence of postoperative flatulence after the two different operative techniques.

  Postoperative one year

Secondary Outcomes (1)

• Relapse? Complications? Functional problems?

  Postoperatively three months, one year and ten years

Study Arms (2)

Total fundoplication

ACTIVE COMPARATOR

Procedure: Laparoscopic Nissen fundoplication

Procedure: Nissen fundoplication

Anterior partial fundoplication

ACTIVE COMPARATOR

Procedure: Laparoscopic anterior partial fundoplication

Procedure: Laparoscopic antireflux surgery ad modum Watson

Interventions

Nissen fundoplication PROCEDURE

Laparoscopic Nissen fundoplication

Total fundoplication

Laparoscopic antireflux surgery ad modum Watson PROCEDURE

Laparoscopic anterior fundoplication

Anterior partial fundoplication

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age:18-65 years.
• Good results of PPI treatment (\<3 months) resulting in reduced heart burn and acid regurgitations.
• Gastroesophageal reflux disease as evidence by gastroscopy and pH-monitoring.

You may not qualify if:

• Previous surgery on the stomach
• Patients with IBS (criteria ROM II)
• Severe disease, for example diabetes mellitus, cardiopulmonary disease or renal disease, that would influence outcome measurement
• Patients with active ulcer disease
• Paraesophageal hernia
• Patient that are incapable to understand the study information (for example mentally disorder, drug abuse)

Sponsors & Collaborators

• Region Skane: lead

Study Sites (4)

Department of Surgery

Kalmar, Sweden

Location

Department of Surgery

Lund, Sweden

Location

Department of Surgery

Malmo, Sweden

Location

Department of Surgery

Trollhättan, Sweden

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Fundoplication

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Pauline Djerf, Md

  Region Skane

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2011
• First Posted: August 21, 2012
• Study Start: January 1, 2001
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: April 10, 2014

Record last verified: 2014-04

Locations

SE (4)