Gastro Oesophageal Reflux Disease
Conditions
Keywords
Gastro Oesophageal Reflux Disease, Nissen Fundoplication
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.
Interventions
PROCEDURENissen Fundoplication with wrap fixation
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.
PROCEDURENissen Fundoplication without wrap fixation
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.
Sponsors
Grubnik Volodymyr
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence rate of hiatal hernia | 60 months | Recurrence of hiatal hernia will be assessed by barium contrast swallow study |
| Slipped wrap | 60 months | Slipped wrap will be assessed by barium contrast swallow study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life and satisfaction | 60 months | 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. |
Outcome results
None listed