Subtotal Colectomy Clinical Trial
Official title:
RISK FACTORS FOR ANASTOMOTIC LEAKAGE FOLLOWING TOTAL OR SUBTOTAL COLECTOMY (RIALTCOT)
Higher anastomotic leakage (AL) rate is reported after ileosigmoid (ISA) or ileorectal
anastomosis (IRA) in total or subtotal colectomy (TSC) compared to colonic or colorectal
anastomosis. An AL reduction in these cases may improve short and long terms outcomes
significantly. Current evidence remains insufficient to assess AL risk after TSC, based on
single-center studies or small cases series. The investigators aim to analyse and identify
potential risk factors to AL following TSC and ISA or IRA, both preoperative and
intraoperative in order to prevent surgical complications.
The study is set up as a retrospective multicentre observational study. Inclusion criteria
are patients (1) over 18 years old, (2) underwent restorative TSC with ISA or IRA
anastomosis, (3) with/without loop ileostomy (4) between 2013-2019. Exclusion criteria are:
(1) non-restorative TSC, (2) previous colorectal resection, (3) deferred anastomosis in
trauma surgery and (4) other surgical resection in the same procedure.
AL will be defined as a defect of the integrity of the intestinal wall at the anastomotic
site leading to a communication of the intra and extraluminal or a pelvic abscess adjacent to
the anastomosis according to the definition set by de International Study Group of Rectal
Cancer. AL requiring no active therapeutic intervention will be classified as Grade A. AL
requiring active therapeutic intervention (antibiotics and percutaneous drainage) but
manageable without relaparotomy will be classified as Grade B and AL requiring
re-intervention were classified as Grade C.
Multivariable logistic regression model will be used in order to assess potential AL risk
factors. p value <0,05 will be consider to indicate statistical significance.
Primary outcome is to assess potential risk factors to AL after restorative (ISA or IRA) TSC.
Secondary outcomes are to identify risk factors to associated postoperative morbidity,
mortality and re-admissions.
Data will be collected in each participating center enrolled in the study by the assigned
principal investigator, confidentially and codified. Data will be sent to the study principal
investigator. Database, patients code and email address will be provided at the study
inclusion.
Ileorectal (IRA) or ileosigmoid anastomosis (ISA) following Total or Subtotal Colectomy (TSC)
are frequently performed in inflammatory bowel disease (IBD) (Crohn´s disease, ulcerative
colitis and indeterminate colitis), familiar adenomatous polyposis or colonic polyposis
syndromes and colorectal cancer (CRC). TSC is less frequently performed in refractory
constipation and ischemic colitis.
Anastomotic leakage (AL) is a significant complication associate with increased mortality,
reoperation and derivative morbidity and is also related to poor long term outcomes in
oncological resections. Although, the formation of IRA or ISA is anatomically easy to
performed, pelvic dissection is not mandatory, there is no tension at the anastomosis and a
blood supply is theoretically ensured, higher AL risk is reported after IRA or ISA (6.5-21%)
compared to colonic or colorectal anastomosis with lower AL rate, mainly under 15%.
Regardless of the indication, similar AL rates are seen after TSC in IBD (4-12%), polyposis
(20%) and colon cancer (6-21%). Reducing AL rates might improve short, long term and
functional outcomes after IRA or ISA There is not a wide evidence about determinants for AL
following colectomy with IRA or ISA.
The impact of the anastomosis (ISA or ISA) on AL is controversial with no findings any in the
most recent studies. Great number of studies have been published about risk factors for AL
after colectomy, but the majority are focused in colorectal cancer patients. IRA or ISA
results after TSC are mixed with other anastomosis sites and the reported results are hardly
clear and conclusive.
For this reason, The investigators aim to assess potential risk factors to AL in restorative
TSC, including every surgical main reason.
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