Comparing two types of tube feeding in patients with severe swallowing difficulties
| ISRCTN | ISRCTN17642761 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17642761 |
| Secondary identifying numbers | PEG/RIG 2014-281 |
- Submission date
- 28/12/2021
- Registration date
- 04/01/2022
- Last edited
- 01/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
Background and study aims
In patients suffering from severe and chronic dysphagia (swallowing difficulties), a feeding gastrostomy (a special tube placed directly into the stomach) can provide nutritional support. At present, two different types are in clinical use, one type placed by gastroscopy (percutaneous endoscopic gastrostomy [PEG], using a thin, flexible tube called an endoscope) and another type placed using x-ray vision (radiologically inserted gastrostomy [RIG]). The selection of patients to PEG or RIG is often based on rather poorly defined patient factors. The aim of this study is to compare PEG and RIG concerning overall complications, divided into major and minor complications as well as changes in patient-scored health status.
Who can participate?
Patients referred for a feeding gastrostomy and eligible for both methods
What does the study involve?
Participants are randomly allocated to undergo PEG or RIG and are followed up at 10 days in the out-patient department as well as by questionnaire at 30 days after surgery.
What are the possible benefits and risks of participating?
Benefits include an extended and standardised follow up. There are no added risks as both procedures are performed in routine care.
Where is the study run from?
Uppsala University Hospital (Sweden)
When is the study starting and how long is it expected to run for?
March 2013 to December 2022
Who is funding the study?
Uppsala University Hospital (Sweden)
Who is the main contact?
Prof. Magnus Sundbom
magnus.sundbom@surgsci.uu.se
Contact information
Scientific
Dept of Surgical Sciences
Uppsala University
Uppsala
SE-75185
Sweden
| Phone | +46 (0)705432989 |
|---|---|
| magnus.sundbom@surgsci.uu.se |
Principal Investigator
Dept of Surgical Sciences
Uppsala University
Uppsala
SE-75185
Sweden
| Phone | +46 (0)705432989 |
|---|---|
| magnus.sundbom@surgsci.uu.se |
Public
Dept of Surgical Sciences
Uppsala University
Uppsala
SE-75185
Sweden
| Phone | +46 (0)705432989 |
|---|---|
| magnus.sundbom@surgsci.uu.se |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | A prospective randomized trial comparing percutaneous endoscopic gastrostomy to radiologically inserted percutaneous gastrostomy |
| Study acronym | PEG-RIG |
| Study objectives | Percutaneous endoscopic gastrostomy (PEG) is superior to radiologically inserted gastrostomy (RIG) based on overall complications |
| Ethics approval(s) | Approved 21/09/2014, the Regional Ethics Committee of Uppsala (Etikprövningsmyndigheten, Box 2110, SE-750 02 Uppsala, Sweden; +46 (0)8 4587070; registrator@etikprovning.se), ref: Dnr: 2014-281 |
| Health condition(s) or problem(s) studied | Severe dysphagia |
| Intervention | Participants are randomly allocated 1:1 in blocks of 10 with closed envelopes to undergo percutaneous endoscopic gastrostomy (PEG) or radiologically inserted gastrostomy (RIG) and are followed up at 10 days in the out-patient department as well as by questionnaire at 30 days after surgery. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Overall complication rate and major and minor complications occurring early (within 10 days) or late (11-30 days) after gastrostomy placement. Major complications are defined as conditions in potential need of reoperation or cardiovascular support, e.g., gastrointestinal perforations, intrabdominal bleeding, aspiration pneumonia or myocardial infarction, while local and self-limiting problems are to be classified as minor. |
| Secondary outcome measures | Patient-scored health status measured by EQ-5D (EuroQol Research Foundation) at baseline and at 10 and 30 days postoperatively |
| Overall study start date | 14/03/2013 |
| Completion date | 31/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 180 |
| Key inclusion criteria | Patients referred to the department for a feeding gastrostomy due to severe dysphagia, and eligible for both methods (PEG/RIG) |
| Key exclusion criteria | Inability to perform an endoscopy due to pharyngo-esophageal obstruction, total or subtotal gastrectomy, other major upper-abdominal surgery, peritoneal carcinosis or ascites |
| Date of first enrolment | 01/10/2014 |
| Date of final enrolment | 31/12/2021 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Uppsala University
Uppsala
SE-75185
Sweden
Sponsor information
Hospital/treatment centre
VO Kirurgi
Dept of Surgical Sciences
Uppsala University
Uppsala
SE-75185
Sweden
| Phone | +46 (0)18 6110000 |
|---|---|
| registrator@akademiska.se | |
| Website | http://www.akademiska.se/ |
"ROR" |
https://ror.org/01apvbh93 |
Funders
Funder type
Hospital/treatment centre
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Uppsala University Hospital
- Location
- Sweden
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer.reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to patient confidentiality |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 28/02/2023 | 01/03/2023 | Yes | No |
Editorial Notes
01/03/2023: Publication reference added.
29/12/2021: Trial's existence confirmed by the Regional Ethics Committee of Uppsala.
