Influence of Wrap Fixation Technique on the Results of Fundoplication

Grubnik Volodymyr

Status: Completed

Conditions: Gastro Oesophageal Reflux Disease

Treatments: Procedure: Nissen Fundoplication without wrap fixation; Procedure: Nissen Fundoplication with wrap fixation

Study type: Interventional

Funder types: Other

Identifiers

NCT04335734

ONMedU 1

Details and patient eligibility

About

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.

Enrollment: 138 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

138 participants in 2 patient groups

Nissen fundoplication with fixation of the wrap

Active Comparator group

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. .

Treatment:

Procedure: Nissen Fundoplication with wrap fixation

Nissen fundoplication without fixation of the wrap

Active Comparator group

Description:

Arm included 51 patients, who underwent classic Nissen fundoplication without wrap fixation.

Treatment:

Procedure: Nissen Fundoplication without wrap fixation