Abdominal Pain and Symptoms Post Gastric Sleeve | NCT03456024

Studies
Abdominal Pain and Symptoms Post Gastric Sleeve

NCT03456024

Sponsor

Oslo University Hospital

Status

Unknown status

Last Update Posted

Nov 24, 2020Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

Abdominal Pain
Quality of Life

Interventions

Questinnaire

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

Nov 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2015Actual

Primary Completion Date

Aug 30, 2020Actual

Completion Date

Dec 31, 2022Estimated

First Submitted Date

Feb 28, 2018

First Submission Date that Met QC Criteria

Feb 28, 2018

First Posted Date

Mar 7, 2018Actual

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

Nov 22, 2020

Last Update Posted Date

Nov 24, 2020Actual

Name	Class
Voss Sykehus	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

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

Exploration of abdominal pain post sleeve gastrectomy in morbid obese patients

Detailed Description

The primary aim is to evaluate abdominal pain in morbid obese patients before and after sleeve gastrectomy. The investigators will especially focus on chronic abdominal pain, and its relation to quality of life and weight loss. In a sub-analysis the investigators will compare the findings of the present cohort with patients operated with Roux-en-Y gastric bypass.

Primary endpoints/outcomes:

- Define the prevalence of chronic abdominal pain 2 years after sleeve gastrectomy

Secondary endpoints/outcomes:

- Evaluate and characterise chronic abdominal pain in regard to:

Weight development
Obesity-related comorbidities
Health-related quality of life
Postoperative complications
Metabolic effects after surgery
Nutritional status
Socioeconomic status

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Name	Type	Description	Arm Group Labels	Other Names
Questinnaire	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Chronic abdominal pain 2 years after gastric sleeve	questionnaire	2 years

Secondary Outcomes

Measure	Description	Time Frame
Quality of life related to abdominal pain and symptoms	questionnaire (SF-36v2, OP scale)	2 years

Other Outcomes

Measure	Description	Time Frame
Comparison to gastric bypass	questionnaire (SF36v2, OP scale)	2 year

Eligibility Module

Eligibility Criteria

Inclusion criteria
- Patients undergoing sleeve gastrectomy at the Center for Morbid Obesity and Bariatric Surgery, Oslo University Hospital and a collaborating center.
- Signed written and informed consent for study enrollment
Exclusion criteria
- Patients who dont understand Norwegian language
- Previous bariatric surgery
- Indication for sleeve gastrectomy for other reasons than for morbid obesity

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Patients scheduled for sleeve gastrectomy for morbid obesity at Oslo University Hospital and Voss sykehus

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tom Mala, MD,Phd	Oslo University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oslo University Hospital		Oslo		0424	Norway

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015746	Abdominal Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided