Congenital malrotation in adults
| 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
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
Public
Department of Surgical and Perioperative Sciences
Centre of Surgery, (B91)
University Hospital of Umeå
901 85 Umeå
Sweden
Sweden
Umeå
90185
Sweden
 ORCID ID |
0000-0001-5838-9133 |
|---|
Study information
| Study design | Single-cenre longitudinal study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Congenital intestinal malrotation in adolescent and adult patients – a 12-year clinical and radiological survey |
| Study objectives | Symptomatic 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) studied | 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 |
| 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 study start date | 12/02/2002 |
| Completion date | 31/12/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 39 |
| Total final enrolment | 39 |
| Key inclusion criteria | 1. Aged 16 years or over 2. Abdominal pain 3. Malrotation on CT scan |
| Key exclusion criteria | 1. Not understanding oral or written information 2. Under 15 years of age |
| Date of first enrolment | 12/02/2002 |
| Date of final enrolment | 10/11/2013 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Stockholm
141 86
Sweden
Sponsor information
University/education
Solnavägen 1
171 77 Solna
Sweden
Stockholm
17177
Sweden
| Website | http://ki.se/en/about/startpage |
|---|---|
"ROR" |
https://ror.org/04hmgwg30 |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- Swedish Research Council, VR
- Location
- Sweden
Private sector organisation / Trusts, charities, foundations (both public and private)
- Location
- Sweden
No information available
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- Swedish Society for Medical Research, SSMF
- Location
- Sweden
Government organisation / Local government
- Alternative name(s)
- Karolinska Institute, KI
- Location
- Sweden
Results and Publications
| Intention to publish date | 30/06/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Publication 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.
