Partial Versus Total Fundoplication in the Surgical Repair of Para-esophageal Hernia.
Primary Purpose
Paraesophageal Hernia, Gastro Esophageal Reflux
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Addition of 360 fundoplication after crural closure
Addition of 180 posterior fundoplication after crural closure
Sponsored by
About this trial
This is an interventional treatment trial for Paraesophageal Hernia focused on measuring Nissen fundoplication, Toupet fundoplication, crural repair, Quality of Life
Eligibility Criteria
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
Sites / Locations
- Ersta Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Nissen fundoplication
Toupet fundoplication
Arm Description
Addition of 360 fundoplication after crural closure
Addition of 180 posterior fundoplication after crural closure
Outcomes
Primary Outcome Measures
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 .
Secondary Outcome Measures
intra-and postoperative courses
Peri and postoperative complications.
length of hospital stay
postoperative length of hospital stay
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.
Acid reflux control
24-hour pH monitoring
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.
Radiology
Radiologically verified recurrent hiatal hernia
Full Information
NCT ID
NCT04436159
First Posted
June 16, 2020
Last Updated
August 28, 2021
Sponsor
Karolinska University Hospital
Collaborators
Ersta Hospital, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT04436159
Brief Title
Partial Versus Total Fundoplication in the Surgical Repair of Para-esophageal Hernia.
Official Title
Partial Versus Total Fundoplication in the Surgical Repair of Para-esophageal Hernia. Results of a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2009 (Actual)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital
Collaborators
Ersta Hospital, Sweden
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Short-term follow up after surgery of para-esophageal hernia comparing two different types of fundoplication
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paraesophageal Hernia, Gastro Esophageal Reflux
Keywords
Nissen fundoplication, Toupet fundoplication, crural repair, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nissen fundoplication
Arm Type
Active Comparator
Arm Description
Addition of 360 fundoplication after crural closure
Arm Title
Toupet fundoplication
Arm Type
Active Comparator
Arm Description
Addition of 180 posterior fundoplication after crural closure
Intervention Type
Procedure
Intervention Name(s)
Addition of 360 fundoplication after crural closure
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Addition of 180 posterior fundoplication after crural closure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ogilvie dysphagia score
Description
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 .
Time Frame
6 months
Secondary Outcome Measure Information:
Title
intra-and postoperative courses
Description
Peri and postoperative complications.
Time Frame
6 mohths
Title
length of hospital stay
Description
postoperative length of hospital stay
Time Frame
6 months
Title
Watson dysphagia score
Description
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.
Time Frame
6 months
Title
Acid reflux control
Description
24-hour pH monitoring
Time Frame
6 months
Title
Quality of Life (SF-36)
Description
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.
Time Frame
6 months
Title
Radiology
Description
Radiologically verified recurrent hiatal hernia
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Lundell, professor
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ersta Hospital
City
Stockholm
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35511051
Citation
Analatos A, Lindblad M, Ansorge C, Lundell L, Thorell A, Hakanson BS. Total versus partial posterior fundoplication in the surgical repair of para-oesophageal hernias: randomized clinical trial. BJS Open. 2022 May 2;6(3):zrac034. doi: 10.1093/bjsopen/zrac034.
Results Reference
derived
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Partial Versus Total Fundoplication in the Surgical Repair of Para-esophageal Hernia.
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