Back to resultsInfluence of Wrap Fixation Technique on the Results of Fundoplication
Primary Purpose
Gastro Oesophageal Reflux Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nissen Fundoplication with wrap fixation
Nissen Fundoplication without wrap fixation
Sponsored by
About this trial
This is an interventional treatment trial for Gastro Oesophageal Reflux Disease focused on measuring Gastro Oesophageal Reflux Disease, Nissen Fundoplication
Eligibility Criteria
Inclusion Criteria:
- Age: 20 - 80 years;
- Gastroesophageal reflux disease as evidence by gastroscopy and pH-monitoring;
- HH type I, II
Exclusion Criteria:
- Age < 20 years and > 80 years;
- Unable to undergo laparoscopic fundoplication due to: severe comorbidities (ASA III and more), previous major surgery with severe adhesions, etc.;
- HH type III, IV;
- BMI < 16 and > 45 kg/m²;
- Pregnancy (in females);
- Oesophageal motility disorders;
- Oesophageal peptic strictures;
- Oesophageal diverticula, other types (i.e. non-reflux) of chronic esophagitis, connective tissue disorders (e.g. scleroderma);
- History of oesophageal/gastric/duodenal surgery including vagotomy;
- Relapsing course of ulcer disease/hyperacid gastritis including complicated by delayed gastric/duodenal emptying
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Nissen fundoplication with fixation of the wrap
Nissen fundoplication without fixation of the wrap
Arm Description
In this arm, which included 87 patients we performed the following manipulations: NF was supplemented with suturing wrap to the diaphragmatic crura (52 patients) on each side using two non-absorbable stitches. In case of weak conditions of crura or short esophagus (35 patients) fundoplication wrap was sutured to the body of stomach using two non-absorbable stitches on each side. .
Arm included 51 patients, who underwent classic Nissen fundoplication without wrap fixation.
Outcomes
Primary Outcome Measures
Recurrence rate of hiatal hernia
Recurrence of hiatal hernia will be assessed by barium contrast swallow study
Slipped wrap
Slipped wrap will be assessed by barium contrast swallow study
Secondary Outcome Measures
Quality of life and satisfaction
Quality of life and satisfaction will be assessed by Gastroesophageal reflux disease - health-related quality of life (GERD-HRQL) score. The scale has 11 items,each item is scored from 0 to 5. A higher score indicating a better quality of life.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04335734
Brief Title
Influence of Wrap Fixation Technique on the Results of Fundoplication
Official Title
Influence of Wrap Fixation Technique on the Results of Fundoplication
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2012 (Actual)
Primary Completion Date
October 1, 2014 (Actual)
Study Completion Date
May 28, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Grubnik Volodymyr
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Patients who underwent anti-reflux surgery were divided into two groups. In the I group Nissen fundoplication was supplemented with suturing wrap to the crura or the body of stomach using two non-absorbable stitches on each side. Control group included patients who underwent classic Nissen fundoplication without wrap fixation. All patients were assessed before and after surgery using validated symptoms and quality of life (GERD-HRQL) questionnaires, 24-h impedance-pH monitoring and barium-swallow.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastro Oesophageal Reflux Disease
Keywords
Gastro Oesophageal Reflux Disease, Nissen Fundoplication
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
138 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nissen fundoplication with fixation of the wrap
Arm Type
Active Comparator
Arm Description
In this arm, which included 87 patients we performed the following manipulations: NF was supplemented with suturing wrap to the diaphragmatic crura (52 patients) on each side using two non-absorbable stitches. In case of weak conditions of crura or short esophagus (35 patients) fundoplication wrap was sutured to the body of stomach using two non-absorbable stitches on each side. .
Arm Title
Nissen fundoplication without fixation of the wrap
Arm Type
Active Comparator
Arm Description
Arm included 51 patients, who underwent classic Nissen fundoplication without wrap fixation.
Intervention Type
Procedure
Intervention Name(s)
Nissen Fundoplication with wrap fixation
Intervention Description
Firstly, we performed left crural dissection, division of the short gastric vessels, right crural dissection, and esophageal mobilization. Then repair of HH were made by simple cruroraphy if the size of the defect was less then 10 сm² otherwise mesh for reinforcement of cruroraphy was used. Creation of the wrap was made by passing posterior fundus behind the esophagus from left to right, followed by stitching the edges of the stomach with three interrupted sutures. Wrap was fixated to both diaphragmatic crura or to the body of stomach using two non-absorbable stitches on each side.
Intervention Type
Procedure
Intervention Name(s)
Nissen Fundoplication without wrap fixation
Intervention Description
Firstly, we performed left crural dissection, division of the short gastric vessels, right crural dissection, and esophageal mobilization. Then repair of HH were made by simple cruroraphy if the size of the defect was less then 10 сm² otherwise mesh for reinforcement of cruroraphy was used. Creation of the wrap was made by passing posterior fundus behind the esophagus from left to right, followed by stitching the edges of the stomach with three interrupted sutures.
Primary Outcome Measure Information:
Title
Recurrence rate of hiatal hernia
Description
Recurrence of hiatal hernia will be assessed by barium contrast swallow study
Time Frame
60 months
Title
Slipped wrap
Description
Slipped wrap will be assessed by barium contrast swallow study
Time Frame
60 months
Secondary Outcome Measure Information:
Title
Quality of life and satisfaction
Description
Quality of life and satisfaction will be assessed by Gastroesophageal reflux disease - health-related quality of life (GERD-HRQL) score. The scale has 11 items,each item is scored from 0 to 5. A higher score indicating a better quality of life.
Time Frame
60 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: 20 - 80 years;
Gastroesophageal reflux disease as evidence by gastroscopy and pH-monitoring;
HH type I, II
Exclusion Criteria:
Age < 20 years and > 80 years;
Unable to undergo laparoscopic fundoplication due to: severe comorbidities (ASA III and more), previous major surgery with severe adhesions, etc.;
HH type III, IV;
BMI < 16 and > 45 kg/m²;
Pregnancy (in females);
Oesophageal motility disorders;
Oesophageal peptic strictures;
Oesophageal diverticula, other types (i.e. non-reflux) of chronic esophagitis, connective tissue disorders (e.g. scleroderma);
History of oesophageal/gastric/duodenal surgery including vagotomy;
Relapsing course of ulcer disease/hyperacid gastritis including complicated by delayed gastric/duodenal emptying
12. IPD Sharing Statement
Learn more about this trial
Influence of Wrap Fixation Technique on the Results of Fundoplication
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