Sleeve-pex: A Randomized Trial to Reduce Reflux After Sle... | NCT05704348

Studies
Sleeve-pex: A Randomized Trial to Reduce Reflux After Sleeve Gastrectomy

NCT05704348

Sponsor

Helse Forde

Status

Recruiting

Last Update Posted

Oct 30, 2024Actual

Enrollment

550Estimated

Phase

Not Applicable

Conditions

Gastroesophageal Reflux

Interventions

Sleeve gastrectomy with gastropexy
Sleeve gastrectomy without gastropexy

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 4, 2023Actual

Primary Completion Date

Dec 2027Estimated

Completion Date

Dec 2030Estimated

First Submitted Date

Jan 10, 2023

First Submission Date that Met QC Criteria

Jan 19, 2023

First Posted Date

Jan 30, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 28, 2024

Last Update Posted Date

Oct 30, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this clinical trial is to test gastropexy as a measure to reduce reflux in morbidly obese patients being submitted to sleeve gastrectomy. The main questions it aims to answer are:

Does gastropexy reduce reflux symptoms? Does gastropexy reduce objective evidence of reflux? Participants will be randomized to gastropexy or no gastropexy, and researchers will compare these groups to see if reflux (symptoms / objective evidence of) is different in the two groups.

Detailed Description

Laparoscopic sleeve gastrectomy (LSG) has become the most commonly performed bariatric procedure worldwide. LSG consists of a longitudinal resection of the stomach leaving the intestines intact, thereby lowering the risk for side-effects due to rerouting of the small bowel. However, gastro-esopageal reflux disease (GERD) has been reported to increase after LSG. Our hypothesis is that GERD is mainly due to intrathoracic migration of the gastric remnant. The aim of this study is to explore if suturing the gastric remnant to the gastrocolic ligament (gastropexy) will prevent intrathoracic migration and thereby reduce the development of reflux.

Patients planned for a sleeve gastrectomy will be invited to participate, and participating patients will be randomized to pexi or no pexi. According to power calculations a total of 550 patients will be randomized in the study. Follow-up will be at six weeks, one-, two- and five years.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

550Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
No gastropexy	Active Comparator	Sleeve gastrectomy without gastropexy.	Procedure: Sleeve gastrectomy without gastropexy
Gastropexy	Experimental	Sleeve gastrectomy with gastropexy	Procedure: Sleeve gastrectomy with gastropexy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sleeve gastrectomy with gastropexy	Procedure	Gastropexy in this project means suturing the gastric remnant to the gastrocolic ligament.	Gastropexy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants using acid-reducing medication (ARM) or having had reoperations due to GERD	ARM: Daily use of ARM for the last month	Two years

Secondary Outcomes

Measure	Description	Time Frame
Endoscopic findings	Visible oesophagitis according to the LA classification	Two years
Patient related outcome	GerdQ questionnaire

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients planned for bariatric surgery with primary LSG

Exclusion Criteria:

Age below 18 yrs
Use of ARM for other reasons than reflux
Previous antireflux surgery
Inability to comprehend and respon to patient related outcome (PRO) questionnaire

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Villy Vage, MD PhD	Contact	47 90863744		villy.vage@helse-bergen.no
John Andersen, PhD	Contact	47 48278186		john.roger.andersen@helse-forde.no

Overall Officials

Name	Affiliation	Role
Villy Vage, MD PhD	Helse Forde	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Helse Forde	Not yet recruiting	Førde			Norway

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Information about Sleeve-pex will be found at the SOReg-N webpage.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Time Frame

The study protocol including analysis plan and formula for informed consent will be available at the SOReg-N webpage from the beginning of the study.

Access Criteria

The study protocol is available at SOReg-N webpage. Data from the study will be made available for other researchers on request if approved by the ethical review board.

URL

https://helse-bergen.no/avdelinger/laboratorieklinikken/medisinsk-biokjemi-og-farmakologi/norsk-kvalitetsregister-for-fedmekirurgi-soreg-norge

Condition Browse Module

MeSH Terms

ID	Term
D005764	Gastroesophageal Reflux

Ancestor Terms

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D059485	Gastropexy

Ancestor Terms

ID	Term
D013505	Digestive System Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided