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Minimally Invasive Umbilical Ileostomy Versus Traditional Ileostomy - A Randomised control study targeting patient quality of life

Minimally Invasive Umbilical Ileostomy Versus Traditional Ileostomy - A Randomised control study targeting patient quality of life

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001253291
Enrollment
20
Registered
2018-07-25
Start date
2018-07-26
Completion date
2019-07-19
Last updated
2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of the study is to investigate the impact that ileostomy site placement has on patient quality of life. This study compares the traditional ileostomy in the right lower quadrant to a minimally invasive ileostomy formed through the umbilicus. The hypothesis is that a minimally invasive ileostomy through the umbilicus is better for the patient as: - There is no damage to the muscle when forming this umbilicus - It's midline position makes it easier for patient's to manage - There is not an extra incision made for this (umbilicus is a common site for port placement during laparoscopic (keyhole) surgery - Patient's are able to sleep on either side due to the midline position

Interventions

Intervention - Ileostomy through umbilicus instead of through a standard right lower quadrant position. This will be performed by an experienced colorectal surgeon. This will be performed one at the time of their surgery, usually as a defunctioning stoma for a bowel resection. This will be performed in a standard operating theatre, the only difference being the site of stoma placement, each patient would be receiving an ileostomy regardless of which group they are randomised to. They will b

Intervention - Ileostomy through umbilicus instead of through a standard right lower quadrant position. This will be performed by an experienced colorectal surgeon. This will be performed one at the time of their surgery, usually as a defunctioning stoma for a bowel resection. This will be performed in a standard operating theatre, the only difference being the site of stoma placement, each patient would be receiving an ileostomy regardless of which group they are randomised to. They will be followed up during their hospital admission and in outpatient department following their discharge. A one of quality of life questionaire will be performed after one month to compare impacts of stoma placement on quality of life.

Sponsors

Townsville Hospital and Health Service
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients deemed fit for surgical intervention, no difference between patients, just position of stoma formation.

Exclusion criteria

Patient's undergoing open surgery precluding the use of a minimally invasive umbilical ileostomy

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026