NCT04287972

Brief Summary

This is a monocentric randomized controlled prospective study. A total of 122 patients will be recruited and randomized 1: 1 in the experimental group - Laparoscopic Sleeve Gastrectomy and Diaphragmatic Pillar Closure - or in the control group - Laparoscopic Sleeve Gastrectomy. 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 8, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 27, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

April 4, 2022

Status Verified

March 1, 2022

Enrollment Period

3 years

First QC Date

January 21, 2020

Last Update Submit

March 22, 2022

Conditions

Gastroesophageal RefluxObesity

Outcome Measures

Primary Outcomes (1)

  • De novo GastroEsophageal Reflux Disease (GERD) onset

    At 6 months post surgery a gastroscopy, an oesophageal manometry and a PH-study will be perform to detect de novo GERD (GastroEsophageal Reflux Disease)

    6 months post surgery

Secondary Outcomes (4)

  • hiatal hernia appearance

    6 months post surgery

  • change in patient-reported quality of life using Gastroparesis Cardinal Symptom Index (GCSI) questionnaire

    baseline and 6 months post surgery

  • change in patient-reported quality of life using GERD-Health Related Quality of Life Questionnaire (GERD-HRQL) questionnaire

    baseline and 6 months post surgery

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    6 months post surgery

Study Arms (2)

LSG-DPC

EXPERIMENTAL

Laparoscopic Sleeve Gastrectomy and Diaphragmatic Pillar Closure.

Procedure: DPCProcedure: LSG

LSG

ACTIVE COMPARATOR

Laparoscopic Sleeve Gastrectomy

Procedure: LSG

Interventions

DPCPROCEDURE

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-DPC
LSGPROCEDURE

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.

LSGLSG-DPC

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18-65 years
  • 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

You may not qualify if:

  • Gastroesophageal reflux disease with daily symptoms or daily use of proton pump inhibitors drugs or daily use of anti-H2 drugs
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Regionale di Lugano, Civico e Italiano

Lugano, 6900, Switzerland

Location

MeSH Terms

Conditions

Gastroesophageal RefluxObesity

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Fabio Garofalo

    EOC

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor Investigator

Study Record Dates

First Submitted

January 21, 2020

First Posted

February 27, 2020

Study Start

November 8, 2019

Primary Completion

October 31, 2022

Study Completion

October 31, 2022

Last Updated

April 4, 2022

Record last verified: 2022-03

Locations

CH(1)