A Study to Reduce the Reflux After a Sleeve Gastrectomy in Obese Patients
NCT ID: NCT04287972
Last Updated: 2022-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2019-11-08
2022-10-31
Brief Summary
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At 6 months post surgery a gastroscopy, an oesophageal manometry and a PH-study will be perform to detect de novo GastroEsophageal Reflux Disease and hiatal hernia appearance.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LSG-DPC
Laparoscopic Sleeve Gastrectomy and Diaphragmatic Pillar Closure.
DPC
The anterior fat pad is dissected until the left crura is visible, pars flaccida is open and the right crura exposed. Phreno-oesophageal ligament is sectioned starting from the right crura. Posterior and anterior vagal nerve are recognized before the oesophageal dissection. An intra-abdominal oesophagus lengths of 2 or 3 cm is obtained in order to reduce tension. Left and right crura are sutured with 2 or 3 non absorbable 2-0 stitches; an additional anterior stitch is posed if necessary to calibrate hiatus size without oesophageal deviation.
LSG
After omental section close to gastric insertion, gastric stapling is realised with triple line endo stapler (normally 5 or 6 re-loads). The gastrectomy begins 5-6 cm from the pylorus; gastric fundus is totally resected keeping a distance of 5-10 mm from oesophagus. Any bleeding on staple line is controlled with surgical clips or coagulator.
LSG
Laparoscopic Sleeve Gastrectomy
LSG
After omental section close to gastric insertion, gastric stapling is realised with triple line endo stapler (normally 5 or 6 re-loads). The gastrectomy begins 5-6 cm from the pylorus; gastric fundus is totally resected keeping a distance of 5-10 mm from oesophagus. Any bleeding on staple line is controlled with surgical clips or coagulator.
Interventions
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DPC
The anterior fat pad is dissected until the left crura is visible, pars flaccida is open and the right crura exposed. Phreno-oesophageal ligament is sectioned starting from the right crura. Posterior and anterior vagal nerve are recognized before the oesophageal dissection. An intra-abdominal oesophagus lengths of 2 or 3 cm is obtained in order to reduce tension. Left and right crura are sutured with 2 or 3 non absorbable 2-0 stitches; an additional anterior stitch is posed if necessary to calibrate hiatus size without oesophageal deviation.
LSG
After omental section close to gastric insertion, gastric stapling is realised with triple line endo stapler (normally 5 or 6 re-loads). The gastrectomy begins 5-6 cm from the pylorus; gastric fundus is totally resected keeping a distance of 5-10 mm from oesophagus. Any bleeding on staple line is controlled with surgical clips or coagulator.
Eligibility Criteria
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Inclusion Criteria
* Patient with BMI between 35 and 50 Kg/m2 for whom laparoscopic sleeve gastrectomy indication was made
* Patients with no preoperative gastroesophageal reflux disease symptoms
* Hill 2-3 or 4 (with HH \<2 cm) hypogastric valve diagnosed preoperatively
Exclusion Criteria
* Hiatal Hernia \>2cm and/or esophagitis and/or Barrett metaplasia
* Previous bariatric and/or gastric surgery
* Normal gastroesophageal valve (Hill 1)
* Motility disorders of the esophagus (documented on manometry)
* PH-study positive for gastro-oesophageal reflux disease (DeMeester Score \>14.1)
* Contraindications to gastroscopy or manometry or ph-study
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Patient not legally competent
* Pregnancy
18 Years
65 Years
ALL
No
Sponsors
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Fabio Garofalo
OTHER
Responsible Party
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Fabio Garofalo
Sponsor Investigator
Principal Investigators
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Fabio Garofalo
Role: PRINCIPAL_INVESTIGATOR
EOC
Locations
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Ospedale Regionale di Lugano, Civico e Italiano
Lugano, , Switzerland
Countries
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Other Identifiers
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ORL-CHIR-003
Identifier Type: -
Identifier Source: org_study_id
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