Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ISRCTN |
Last refreshed on:
|
8 January 2024 |
Main ID: |
ISRCTN17263619 |
Date of registration:
|
15/03/2017 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Does muscle strength and abdominal wall function improve with weight loss after gastric bypass?
|
Scientific title:
|
Does muscle strength and abdominal wall function improve with weight loss after gastric bypass? A clinical observational study |
Date of first enrolment:
|
30/09/2016 |
Target sample size:
|
100 |
Recruitment status: |
Ongoing |
URL:
|
https://www.isrctn.com/ISRCTN17263619 |
Study type:
|
Observational |
Study design:
|
Clinical observational study and semi-structured interviews with qualitative content analysis (Treatment)
|
Phase:
|
Not Applicable
|
|
Countries of recruitment
|
Sweden
| | | | | | | |
Contacts
|
Name:
|
Ulf
Gunnarsson |
Address:
|
Department of Surgery and Perioperative Sciences
Umeå University
901 87
Umeå
Sweden |
Telephone:
|
+46 (0)90 7852909 |
Email:
|
Ulf.Gunnarsson@umu.se |
Affiliation:
|
|
|
Name:
|
Jeff
Wennerlund |
Address:
|
Department of Surgery and Orthopedics
Lycksele Hospital
92182
Lycksele
Sweden |
Telephone:
|
+46 (0)950 39124 |
Email:
|
Jeff.Wennerlund@umu.se |
Affiliation:
|
|
| |
Key inclusion & exclusion criteria
|
Inclusion criteria: 1. Patients eligible for primary laparoscopic gastric bypass 2. All patients undergoing primary laparoscopic gastric bypass at Lycksele Hospital are eligible for recruitment 3. Patients undergoing surgery in Uppsala are eligible for collection of blood and tissue samples only 4. All ages
Exclusion criteria: If, after inclusion, no or different surgery is planned
Age minimum:
Age maximum:
Gender:
Both
|
Health Condition(s) or Problem(s) studied
|
Obesity, weight loss, muscle strength Nutritional, Metabolic, Endocrine Obesity
|
Intervention(s)
|
Current interventions as of 13/12/2023: Blood samples are collected to analyze matrix metalloproteinases, hyaluron och associated biomarkers before surgery, as well as 1 month, 3 months, 6 months, plus 2 and 3 years after. Abdominal wall muscle and fascia biopsies are also collected during surgery for analysis. Abdominal wall and thigh strength are measured with the use of BioDex System 3 before, 6 months, and 3-6 years after gastric bypass. Physical ability and abdominal wall function are also measured using the Ventral Hernia Pain Questionnaire (VHPQ), International Physical Ability Questionnaire (IPAQ) and Visual Analog Scale for abdominal wall function (VAS), all once before, 6 months and 3-6 years after surgery.
Two qualitative interview studies using Qualitative Content Analysis designed to capture experiences of change of bodily function after weight loss induced by gastric bypass surgery. The first study will take place one to three years postoperatively and focus on the changes in physical activity. A later interview study 3 to 6 years after surgery will focus on abdominal wall function.
______
Previous interventions as of 03/03/2022:
Blood samples are collected to analyze matrix metalloproteinases before surgery, as well as 2 weeks, 1 month, 3 months, 6 months, and 2 years after. Abdominal wall muscle and fascia biopsies are collected during surgery for analysis of matrix metalloproteinases. Abdominal wall and thigh strength are measured with the use of BioDex System 3 before and 6 months after gastric bypass. Physical ability and abdominal wall function are also measured using the Ventral Hernia Pain Questionnaire (VHPQ), International Physical Ability Questionnaire (IPAQ) and Visual Analog Scale for abdominal wall function (VAS), all once before and once
|
Primary Outcome(s)
|
Current primary outcome measure as of 13/12/2023: 1. Matrix metalloproteinases, hyaluron and associated biomarkers measured from blood samples taken at baseline (pre-operatively) and 1 month, 3 months, 6 months, and 2 and 3 years postoperatively 2. Abdominal wall and thigh muscle strength, measured with the BioDex System 3 at baseline (pre-operatively), 6 months and 3-6 years postoperatively 3. Physical ability and abdominal wall function, measured using the Ventral Hernia Pain Questionnaire (VHPQ), International Physical Activity Questionnaire (IPAQ), and Visual Analog Scale (VAS) for abdominal wall function at baseline (pre-operatively), 6 months and 3-6 years postoperatively 4. Semi-structured interviews describing the change in muscle strength, physical activity ability and abdominal wall function after gastric bypass surgery
_____
Previous primary outcome measure as of 03/03/2022:
1. Matrix metalloproteinases, measured from blood samples taken at baseline (pre-operatively) and 2 weeks, 1 month, 3 months, 6 months, and 2 years postoperatively 2. Abdominal wall and thigh muscle strength, measured with the BioDex System 3 at baseline (pre-operatively) and 6 months postoperatively 3. Physical ability and abdominal wall function, measured using the Ventral Hernia Pain Questionnaire (VHPQ), International Physical Activity Questionnaire (IPAQ), and Visual Analog Scale (VAS) for abdominal wall function at baseline (pre-operatively) and 6 months postoperatively 4. Semi-structured interviews describing the change in muscle strength and physical activity ability after gastric bypass surgery
_____
Previous primary outcome measure as of 21/04/2020:
1. Matrix metalloproteinases, measured from blood samples taken at baseline (pre-operatively) and 2 weeks, 1 month, 3 months, 6 months, and 2 years postoperatively 2. Abdominal wall and thigh muscle strength, measured with the BioDex System 3 at baseline (pre-operatively) and 6 months post-operatively 3. Physical ability and abdominal wall function, measured using the Ventral Hernia Pain Questionnaire (VHPQ), International Physical Activity Questionnaire (IPAQ), and Visual Analog Scale (VAS) for abdominal wall function at baseline (pre-operatively) and 6 months postoperatively
_____
Previous primary outcome measure:
1. Matrix metalloproteinases, measured from blood samples taken at baseline (pre-operatively) and 2 weeks, 1 month, 3 months and 6 months postoperatively 2. Abdominal wall and thigh muscle strength, measured with the BioDex System 3 at baseline (pre-operatively) and 6 months post-operatively 3. Physical ability and abdominal wall function, measured using the Ventral Hernia Pain Questionnaire (VHPQ), International Physical Activity Questionnaire (IPAQ), and Visual Analog Scale (VAS) for abdominal wall function at baseline (pre-operatively) and 6 months postoperatively
|
Secondary Outcome(s)
|
There are no secondary outcome measures
|
Secondary ID(s)
|
GUMP
|
Nil known
|
Source(s) of Monetary Support
|
Umeå Universitet
|
Ethics review
|
Status:
Approval date:
Contact:
Old ethics approval format; Approved 10/01/2016, Regional Ethics Review Board, Umeå (Samverkanshuset, Umeå University, Umeå, 901 87, Sweden; +46 (0)10-4750800; registrator@etikprovning.se), ref: 2015/367-31
Since this approval, this regional board has been replaced by a national agency, the Swedish Ethical Review Authority
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
31/12/2027 |
URL:
|
|
|
|