Plain English Summary
Background and study aims
Congenital intestinal malrotation, or congenital bowel malrotation, is a condition in which the intestines are twisted. It usually happens when the intestine fails to coil into the correct position in a developing foetus (at around the tenth week of development). In most cases, malrotation is detected within the first month of life however in some people it is not diagnosed until adulthood. When it is diagnosed, the only appropriate treatment option is corrective surgery. During this surgery, the intestine is untwisted and placed into its correct position, or segments are removed if they are damaged and unable to work properly. As the condition usually discovered in childhood, when an adult is suffering from abdominal pain congenital intestinal malrotation is not usually suspected. This means that in many cases it is only discovered in if it is spotted on a scan looking for something else (incidental finding). The aim of this study is to find out how many cases of abdominal pain in adults is due to congenital intestinal malrotation. The study will also look at whether having corrective surgery when malrotation is detected has an effect of their abdominal pain in the long-run.
Who can participate?
Patients over 16 years of age who have intestinal malrotation and are suffering from abdominal pain.
What does the study involve?
Patients who have agreed to take part in the study have a CT scan of their abdomen in order to assess how severe the malrotation is. The patients are then split into three groups based on their age in order to find out if there is a link between the degree of malrotation and their age. The patients then undergo their corrective surgery as planned. During 2012 and 2013, patients who have had corrective surgery between 1 and 12 years previously are contacted by telephone in order to find out if their condition has improved. The patients are asked whether they have experienced pain, nausea, vomiting or constipation, since their surgery.
What are the possible benefits and risks of participating?
There are no direct benefits or risks to patients taking part in this study.
Where is the study run from?
Karolinska Institute (Sweden)
When is the study starting and how long is it expected to run for?
December 2002 to December 2018
Who is funding the study?
1. Swedish Research Council (Sweden)
2. The Foundation Frimurare Barnhuset Stockholm (Sweden)
3. Stockholm City Council (Sweden)
4. Swedish Society for Medical Research (Sweden)
5. Karolinska Institute (Sweden)
Who is the main contact?
Dr Karin Strigård
Trial website
Contact information
Type
Public
Primary contact
Dr Karin Strigård
ORCID ID
http://orcid.org/0000-0001-5838-9133
Contact details
Department of Surgical and Perioperative Sciences
Centre of Surgery
(B91)
University Hospital of Umeå
901 85 Umeå
Sweden
Sweden
Umeå
90185
Sweden
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2012/957-31/3
Study information
Scientific title
Congenital intestinal malrotation in adolescent and adult patients – a 12-year clinical and radiological survey
Acronym
Study hypothesis
Symptomatic malrotation may be a cause of abdominal pain in adults.
Ethics approval
The Regional Ethical Review Board Stockholm (Etikprövningsnämnden Stockholm), 20/06/2012, ref: 2012/957-31/3
Study design
Single-cenre longitudinal study
Primary study design
Observational
Secondary study design
Longitudinal study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Congenital intestinal malrotation
Intervention
All medical records are evaluated with regards to symptoms, surgical procedures, previous disorders and outcomes. For analysis of differences according to age, the patients were divided into three groups (15-20 years, 21-50 years, 51- 67 years). Symptomatic malrotation is then treated by corrective surgery, and routinely assessed six weeks, six months and 12 months after surgery.
During 2012-2013 (1 to 12 years after surgery) a research nurse performed telephone interviews with a semi-structured concept concerning the patients’ past and present situation and possible remaining symptoms after surgery. The questions focused on remaining intense or chronic pain, postprandial nausea, vomiting and constipation. Patients were also asked whether they regarded their general physical condition as improved to a high degree, improved with some reservation or without any notable improvement.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Symptom resolution following surgery is determined using semi-structured telephone interviews with a research nurse, during 2012-2013 (1 to 12 years after surgery).
Secondary outcome measures
Degree of malrotation is determined using CT scanning at baseline.
Overall trial start date
12/02/2002
Overall trial end date
31/12/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 16 years or over
2. Abdominal pain
3. Malrotation on CT scan
Participant type
Patient
Age group
Mixed
Gender
Both
Target number of participants
39
Participant exclusion criteria
1. Not understanding oral or written information
2. Under 15 years of age
Recruitment start date
12/02/2002
Recruitment end date
10/11/2013
Locations
Countries of recruitment
Sweden
Trial participating centre
Karolinska University Hospital
Hälsovägen 1 - 3
Stockholm
141 86
Sweden
Sponsor information
Organisation
Karolinska Institutet
Sponsor details
Solnavägen 1
171 77 Solna
Sweden
Stockholm
17177
Sweden
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Swedish Research Council (Vetenskapsrådet)
Alternative name(s)
Swedish Research Council, VR
Funding Body Type
government organisation
Funding Body Subtype
federal/national government
Location
Sweden
Funder name
The Foundation Frimurare Barnhuset Stockholm (Stiftelsen Frimurare Barnhuset i Stockholm)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
Sweden
Funder name
Stockholm City Council (Kommunfullmäktige, Stockholms Stad)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Swedish Society for Medical Research (Svenska Sällskapet för Medicinsk Forskning)
Alternative name(s)
Swedish Society for Medical Research, SSMF
Funding Body Type
private sector organisation
Funding Body Subtype
professional associations and societies
Location
Sweden
Funder name
Karolinska Institute (Karoklinska Institutet)
Alternative name(s)
Karolinska Institute, KI
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
Sweden
Results and Publications
Publication and dissemination plan
Publication in two manuscripts detailing study reults and 5 year follow-up.
Intention to publish date
30/06/2019
Participant level data
Available on request
Basic results (scientific)
Publication list