RISK FACTORS FOR ANASTOMOTIC LEAKAGE FOLLOWING TOTAL OR SUBTOTAL COLECTOMY (RIALTCOT) (RIALTCOT)
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|ClinicalTrials.gov Identifier: NCT04512326|
Recruitment Status : Unknown
Verified August 2020 by Juan Ocaña Jiménez, Hospital Universitario Ramon y Cajal.
Recruitment status was: Enrolling by invitation
First Posted : August 13, 2020
Last Update Posted : August 13, 2020
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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.
|Condition or disease||Intervention/treatment|
|Total Colectomy Subtotal Colectomy||Procedure: Total or Subtotal colectomy|
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.
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||RISK FACTORS FOR ANASTOMOTIC LEAKAGE FOLLOWING TOTAL OR SUBTOTAL COLECTOMY (RIALTCOT)|
|Actual Study Start Date :||August 10, 2020|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||November 30, 2021|
Total or subtotal colectomy
Total or subtotal colectomy with ileorectal or ileosigmoid anastomosis
Procedure: Total or Subtotal colectomy
Total or subtotal colectomy (emergent or elective) with primary anastomosis (ileorectal or ileosigmoid)
- Anastomotic Leakage [ Time Frame: 90 days postoperatively ]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 will be classified as Grade C
- Risk factors associated to postoperative morbidity [ Time Frame: 90 days postoperatively ]Morbidity by Clavien-Dindo scale
- Risk factors associated to mortality [ Time Frame: 90 days postoperatively ]Mortality in postoperatively
- Risk factors associated to re-admissions. [ Time Frame: 90 days postoperatively ]Re-admissions after discharge within 90 days postoperatively
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- (1) over 18 years old
- (2) underwent restorative TSC with ISA or IRA anastomosis (emergent or elective)
- (3) with/without loop ileostomy
- (4) between 2013-2019
- (1) non-restorative TSC
- (2) previous colorectal resection
- (3) deferred anastomosis in trauma surgery and
- (4) other surgical resection in the same procedure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04512326
|Hospital Universitario Ramón y Cajal|
|Madrid, Spain, 28034|
|Principal Investigator:||Juan Ocaña, MD||H.U Ramon y Cajal|
|Responsible Party:||Juan Ocaña Jiménez, Principal Investigator, Hospital Universitario Ramon y Cajal|
|Other Study ID Numbers:||
|First Posted:||August 13, 2020 Key Record Dates|
|Last Update Posted:||August 13, 2020|
|Last Verified:||August 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|