Laparoscopic assisted reversal of ileostomy versus traditional open reversal
| ISRCTN | ISRCTN46101203 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46101203 |
| Secondary identifying numbers | NA |
- Submission date
- 06/06/2010
- Registration date
- 11/11/2010
- Last edited
- 30/10/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Paul Neary
Scientific
Scientific
Dept of Surgery
AMNCH Tallaght
Dublin
24
Ireland
| paulcneary@msn.com |
Study information
| Study design | Single centre two arm randomised active controlled parallel group 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 contact details below to request a patient information sheet |
| Scientific title | Laparoscopic assisted reversal of ileostomy versus traditional open reversal: a pilot study |
| Study acronym | LARI |
| Study objectives | To show that laparoscopic assisted reversal of ileostomy versus traditional open reduces hospital stay and morbidity. Discharge criteria: having tolerated 2 large meals without nausea/vomiting, passed a bowel motion and adequate pain control on oral analgesia Please note that as of 14/09/2012, the following changes were made to the record: 1. The scientific title of this trial was changed from "Laparoscopic assisted reversal of ileostomy versus traditional open reversal: a randomised control trial" 2. The target number of participants was changed from 46 to 70 |
| Ethics approval(s) | The Adelaide and Meath incorporating the National Children's Hospital (AMNCH) Ethics Committee, Tallaght Hospital approved on the 23rd of February 2010 |
| Health condition(s) or problem(s) studied | Ileostomy |
| Intervention | Patients undergoing surgery for reversal of ileostomy will be randomised to receive either: 1. Traditional: Ileostomy mobolised from skin. Ileostomy excised followed by side to side anastomosis using GIA. Fascia and peritoneum closed and wound left to heal by secondary intention. 2. Laparoscopic assisted: Ileostomy mobolised from skin. Ileostomy excised followed by side to side anastomosis using GIA. One 5 mm port inserted contra-laterally with pneumoperitoneum. Reversal site checked for any omentum or bowel stuck to sutures. The whole abdominal cavity will be checked for any evidence of metastatic disease. Extra 5mm ports inserted and any adhesions present will be divided as well as any further intervention. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Length of stay |
| Secondary outcome measures | Morbidity, Diagnostic tool |
| Overall study start date | 01/10/2009 |
| Completion date | 30/06/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 85 Years |
| Sex | Both |
| Target number of participants | 46 |
| Key inclusion criteria | 1. Any person with a loop ileostomy who has been passed fit for surgery 2. Age 18-85 |
| Key exclusion criteria | 1. Inability to give informed consent (eg. Dementia) 2. American Society of Anaesthesiologists (ASA) greater than 3 |
| Date of first enrolment | 01/10/2009 |
| Date of final enrolment | 30/06/2011 |
Locations
Countries of recruitment
- Ireland
Study participating centre
Dept of Surgery
Dublin
24
Ireland
24
Ireland
Sponsor information
Adelaide and Meath Hospital, Incorporating the National Children's Hospital (AMNCH) (Ireland)
Not defined
Not defined
c/o Mr Paul Neary
Dept of Surgery
Dublin
24
Ireland
| paulcneary@msn.com | |
"ROR" |
https://ror.org/01fvmtt37 |
Funders
Funder type
Hospital/treatment centre
Adelaide and Meath Hospital, Incorporating the National Children's Hospital (AMNCH) (Ireland) - departmental and personal funds
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2013 | Yes | No |
