Partial Versus Total Fundoplication in the Surgical Repair of Para-esophageal Hernia.

Gastro Esophageal Reflux Clinical Trial

Official title:

Partial Versus Total Fundoplication in the Surgical Repair of Para-esophageal Hernia. Results of a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04436159
• Other study ID #: 2008/179-31
• Status: Completed
• Phase: N/A
• Start date: May 1, 2009
• Est. completion date: September 2018

Study information

• Verified date: August 2021
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Short-term follow up after surgery of para-esophageal hernia comparing two different types of fundoplication

Description:

Laparoscopic para-esophageal hernia (PEH) repair has been established as a safe and effective treatment for symptomatic patients. Today, most surgeons agree that a fundoplication should be included in the hiatal reconstruction in order to reduce the risk of postoperative gastroesophageal reflux and hernia recurrence. However, what type of wrap that should be recommend is yet to be determined.

One might argue that the overall durability and effectiveness of a partial fundoplication in the control of reflux might be less reliable than a total wrap, but on the contrary, the latter carries the risk of inducing a pseudoachalasia similar situation in PEH patients.

We therefore designed a double blind randomized clinical trial in which patients with symptomatic paraesophageal hernia to receive either a posterior partial (Toupet) or total (Nissen) fundoplication after hernia reduction and crural repair.

Six months follow up with questionnaires, 24-hour pH monitoring and radiology after surgery of para-esophageal hernia with addition of total fundoplication vs posterial partial fundoplication.

Dysphagia Scores; Ogilvie dysphagia score and Watson dysphagia score. Quality of Life; SF-36:

physical and mental component scores.

Time points: 1, 3 and 6 months after surgery

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing acute or elective surgery for symptomatic PEH at Ersta Hospital and Karolinska University Hospital

Exclusion Criteria:

• age below 18 years

• axial sliding hiatal hernia only (type I)

• missing informed consent

• previous hiatal hernia surgery

• American Society of Anesthesiologists (ASA) score IV or above

• achalasia

• Zollinger-Ellison syndrome

• malignant tumor

• inability or unwillingness to complete questionnaires

Related Conditions & MeSH terms

• Gastro Esophageal Reflux
• Gastroesophageal Reflux
• Hernia
• Hernia, Hiatal
• Paraesophageal Hernia

Intervention

Procedure:
• Addition of 360 fundoplication after crural closure
A total fundoplication was constructed in which the right and left part of the wrap was brought together in front of, and slightly to the right of the esophagus, and sutured with three interrupted stitches of 2-0 unabsorbable sutures from the GEJ and cranially to attain a length between the top and bottom sutures of at the most 2 cm. At least one wrap suture included the esophageal muscle-wall.
• Addition of 180 posterior fundoplication after crural closure
The wrap was pulled dorsally around the distal part of the esophagus and GEJ, which was encircled approximately 180-200 degrees. First, the wrap was anchored with Gore-tex sutures, dorsally to the left crus with 3 sutures and then to the right crus with another 3 sutures. Finally, the wrap was completed with 3-4 sutures, between the edges of the wrap and the right and left side of the esophageal wall, respectively.

Locations

Country	Name	City	State
Sweden	Ersta Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska University Hospital	Ersta Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ogilvie dysphagia score	The Ogilvie dysphagia score is a 5-graded scale 0-4 defined as follows: '0', ability to eat ordinary diet; '1', ability to swallow solid food; '2', ability to swallow semisolids; '3', ability to swallow liquids; '4', total inability to swallow .	6 months
Secondary	intra-and postoperative courses	Peri and postoperative complications.	6 mohths
Secondary	length of hospital stay	postoperative length of hospital stay	6 months
Secondary	Watson dysphagia score	Watson dysphagia score is a validated instrument for benign dysphagia where the patient is asked whether he/she always, sometimes or never has difficulty swallowing nine different groups of liquid and food items.; This gives a score ranging from zero to 45, where 45 represents the worst possible dysphagia.	6 months
Secondary	Acid reflux control	24-hour pH monitoring	6 months
Secondary	Quality of Life (SF-36)	The Swedish version of this validated global questionnaire is presented as physical and mental summary component scores (PCS and MCS, respectively). Each subscale scores reaches a value of at the most 100, where higher values reflect better health status.	6 months
Secondary	Radiology	Radiologically verified recurrent hiatal hernia	6 months