Condition category
Surgery
Date applied
06/06/2010
Date assigned
11/11/2010
Last edited
30/10/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Paul Neary

ORCID ID

Contact details

Dept of Surgery
AMNCH Tallaght
Dublin
24
Ireland
paulcneary@msn.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NA

Study information

Scientific title

Laparoscopic assisted reversal of ileostomy versus traditional open reversal: a pilot study

Acronym

LARI

Study hypothesis

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

The Adelaide and Meath incorporating the National Children's Hospital (AMNCH) Ethics Committee, Tallaght Hospital approved on the 23rd of February 2010

Study design

Single centre two arm randomised active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

Length of stay

Secondary outcome measures

Morbidity, Diagnostic tool

Overall trial start date

01/10/2009

Overall trial end date

30/06/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Any person with a loop ileostomy who has been passed fit for surgery
2. Age 18-85

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

46

Participant exclusion criteria

1. Inability to give informed consent (eg. Dementia)
2. American Society of Anaesthesiologists (ASA) greater than 3

Recruitment start date

01/10/2009

Recruitment end date

30/06/2011

Locations

Countries of recruitment

Ireland

Trial participating centre

Dept of Surgery
Dublin
24
Ireland

Sponsor information

Organisation

Adelaide and Meath Hospital, Incorporating the National Children's Hospital (AMNCH) (Ireland)

Sponsor details

c/o Mr Paul Neary
Dept of Surgery
Dublin
24
Ireland
paulcneary@msn.com

Sponsor type

Not defined

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Adelaide and Meath Hospital, Incorporating the National Children's Hospital (AMNCH) (Ireland) - departmental and personal funds

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23939842

Publication citations

  1. Results

    Royds J, O'Riordan JM, Mansour E, Eguare E, Neary P, Randomized clinical trial of the benefit of laparoscopy with closure of loop ileostomy., Br J Surg, 2013, 100, 10, 1295-1301, doi: 10.1002/bjs.9183.

Additional files

Editorial Notes