Short term morbidity with defunctioning stomas in anterior resection
Research type
Research Study
Full title
A comparison of the short term post-operative complications in patients with rectal cancer treated by elective low anterior resection with and without a defunctioning stoma.
IRAS ID
164512
Contact name
Andrew Emmanuel
Contact email
Sponsor organisation
King's College Hospital NHS Foundation Trust
Duration of Study in the UK
0 years, 3 months, 22 days
Research summary
Many people who have an operation to remove a portion of the bowel to treat rectal cancer (an anterior resection) will have their bowel joined back together with stitches or staples (an anastomosis). Many of these people will have a stoma formed which is believed to protect the join in the bowel (anastomosis) from a leakage until it has had a chance to heal. Currently more than 3 out of 4 people who undergo such an operation will have a stoma formed. However, there is some debate as to how beneficial it is to form a stoma in so many patients and it is not clear whether having a stoma significantly increases a patient’s risk of complications in the period following their operation.
This study aims to determine if having a stoma significantly increases the chance of having a complication following the operation by a clinically meaningful amount.
The study will examine the clinical records of patients who have undergone an operation to remove the bowel for rectal cancer over a certain time period. The study will be retrospective and only patients who have already had an operation will be involved. Data will be collected on patient demographics, routine pre-operative investigations such as MRI scans and the post-operative outcome. Only pateinets with an anastomosis (join) low in the pelvis will be included as it is these patients who are routinely considered for a stoma. This will be determined by the level of the tumour on MRI scan. The data will be analysed to compare the overall post-operative complication rate of patients with and without stomas as a primary outcome, as well as comparing secondary outcomes including mortality, length of hospital stay, anastomotic leak rates, and re-admission and re-operation rates.
REC name
London - Hampstead Research Ethics Committee
REC reference
15/LO/1630
Date of REC Opinion
11 Sep 2015
REC opinion
Favourable Opinion