Status:
COMPLETED
Influence of Wrap Fixation Technique on the Results of Fundoplication
Lead Sponsor:
Grubnik Volodymyr
Conditions:
Gastro Oesophageal Reflux Disease
Eligibility:
All Genders
20-80 years
Phase:
NA
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-abso...
Eligibility Criteria
Inclusion
- Age: 20 - 80 years;
- Gastroesophageal reflux disease as evidence by gastroscopy and pH-monitoring;
- HH type I, II
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2019
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT04335734
Start Date
November 1 2012
End Date
May 28 2019
Last Update
April 6 2020
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