ISRCTN ISRCTN63794639
DOI https://doi.org/10.1186/ISRCTN63794639
Secondary identifying numbers 2012/957-31/3
Submission date
02/11/2015
Registration date
25/02/2016
Last edited
02/04/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Karin Strigård
Public

Department of Surgical and Perioperative Sciences
Centre of Surgery, (B91)
University Hospital of Umeå
901 85 Umeå
Sweden
Sweden
Umeå
90185
Sweden

ORCiD logoORCID ID 0000-0001-5838-9133

Study information

Study designSingle-cenre longitudinal study
Primary study designObservational
Secondary study designLongitudinal study
Study setting(s)Hospital
Study typeTreatment
Scientific titleCongenital intestinal malrotation in adolescent and adult patients – a 12-year clinical and radiological survey
Study objectivesSymptomatic malrotation may be a cause of abdominal pain in adults.
Ethics approval(s)The Regional Ethical Review Board Stockholm (Etikprövningsnämnden Stockholm), 20/06/2012, ref: 2012/957-31/3
Health condition(s) or problem(s) studiedCongenital intestinal malrotation
InterventionAll 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 typeProcedure/Surgery
Primary outcome measureSymptom 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 measuresDegree of malrotation is determined using CT scanning at baseline.
Overall study start date12/02/2002
Completion date31/12/2018

Eligibility

Participant type(s)Patient
Age groupMixed
SexBoth
Target number of participants39
Total final enrolment39
Key inclusion criteria1. Aged 16 years or over
2. Abdominal pain
3. Malrotation on CT scan
Key exclusion criteria1. Not understanding oral or written information
2. Under 15 years of age
Date of first enrolment12/02/2002
Date of final enrolment10/11/2013

Locations

Countries of recruitment

  • Sweden

Study participating centre

Karolinska University Hospital
Hälsovägen 1 - 3
Stockholm
141 86
Sweden

Sponsor information

Karolinska Institutet
University/education

Solnavägen 1
171 77 Solna
Sweden
Stockholm
17177
Sweden

Website http://ki.se/en/about/startpage
ROR logo "ROR" https://ror.org/04hmgwg30

Funders

Funder type

Research council

Swedish Research Council (Vetenskapsrådet)
Government organisation / National government
Alternative name(s)
Swedish Research Council, VR
Location
Sweden
The Foundation Frimurare Barnhuset Stockholm (Stiftelsen Frimurare Barnhuset i Stockholm)
Private sector organisation / Trusts, charities, foundations (both public and private)
Location
Sweden
Stockholm City Council (Kommunfullmäktige, Stockholms Stad)

No information available

Swedish Society for Medical Research (Svenska Sällskapet för Medicinsk Forskning)
Private sector organisation / Associations and societies (private and public)
Alternative name(s)
Swedish Society for Medical Research, SSMF
Location
Sweden
Karolinska Institute (Karoklinska Institutet)
Government organisation / Local government
Alternative name(s)
Karolinska Institute, KI
Location
Sweden

Results and Publications

Intention to publish date30/06/2019
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPublication in two manuscripts detailing study reults and 5 year follow-up.
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/03/2016 02/04/2020 Yes No

Editorial Notes

02/04/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.