Clinical trial NCT01669330: Laparoscopic Nissen Versus Anterior Partial Fundoplication
Official title: Comparison of Laparoscopic Nissen Versus Anterior Partial Fundoplication ad Modum Watson, A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux
Keywords: Gastroesophageal Reflux
Fundoplication
Surgical Procedures
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2012-08-21
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Aim: To establish if there is a difference in the incidence of postoperative flatulence after the two different operative techniques. The secondary aims are to establish differences in relapse of reflux, incidence of postoperative dysphagia, dyspepsia, quality of life, hospital stay, sick-leave and complications.

Method: All patients operated on for reflux disease in Lund, Malmö,Trollättan and Kalmar are randomised between the two operations. Postoperatively, telephone interview is performed weekly the first two months. One year and ten years postoperatively. The patients are investigated with endoscopy, esophageal manometry, 24 hour pH-monitoring and symptom evaluation.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Postoperative flatulence?
timeFrame: Postoperative one year
Secondary outcomes:
measure: Relapse? Complications? Functional problems?
timeFrame: Postoperatively three months, one year and ten years
Other outcomes:
Locations:
city: Kalmar
country: Sweden
facility: Department of Surgery
city: Lund
country: Sweden
facility: Department of Surgery
city: Malmö
country: Sweden
facility: Department of Surgery
city: Trollhättan
country: Sweden
facility: Department of Surgery
Study officials:
affiliation: Region Skane
name: Pauline Djerf, Md
role: PRINCIPAL_INVESTIGATOR
References: