Total ColectomyRIALTCOTNCT04512326
RISK FACTORS FOR ANASTOMOTIC LEAKAGE FOLLOWING TOTAL OR SUBTOTAL COLECTOMY (RIALTCOT)
An observational study of Total Colectomy and Subtotal Colectomy, run by Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Colectomy, Subtotal Colectomy
- What is being tested?
- Total or Subtotal colectomy
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteSpain
- Study dates
- 10 Aug 2020to 30 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients underwent total or subtotal colectomy with primary anastomosis
Who may be able to join
- (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
Who cannot join
- (1) non-restorative TSC
- (2) previous colorectal resection
- (3) deferred anastomosis in trauma surgery and
- (4) other surgical resection in the same procedure.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Total Colectomy, Subtotal Colectomy
- Being tested
- Total or Subtotal colectomy
- Keywords
- Total colectomy, Subtotal colectomy, Ileorectal anastomosis, Ileosigmoid anastomosis, Anastomotic leakage
- Medical subject headings
- Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total or Subtotal colectomyProcedure or surgery
Total or subtotal colectomy (emergent or elective) with primary anastomosis (ileorectal or ileosigmoid)
| Study group | Role | What they receive |
|---|---|---|
| Total or subtotal colectomy | Total or subtotal colectomy with ileorectal or ileosigmoid anastomosis Receives: Procedure: Total or Subtotal colectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomotic Leakage
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
Measured: 90 days postoperatively
Secondary outcomes (3)
Risk factors associated to postoperative morbidity
Morbidity by Clavien-Dindo scale
Measured: 90 days postoperatively
Risk factors associated to mortality
Mortality in postoperatively
Measured: 90 days postoperatively
Risk factors associated to re-admissions.
Re-admissions after discharge within 90 days postoperatively
Measured: 90 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start10 Aug 2020
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Total ColectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Ocaña Jiménez, Hospital Universitario Ramon y Cajal
- Investigators
- Juan Ocaña, MD, Principal investigator, H.U Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04512326
- Sponsor's protocol ID
- 212/20
- Acronym
- RIALTCOT
- Status last verified
- Aug 2020
- First submitted
- 10 Aug 2020
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Elton C, Makin G, Hitos K, Cohen CR. Mortality, morbidity and functional outcome after ileorectal anastomosis. Br J Surg. 2003 Jan;90(1):59-65. doi: 10.1002/bjs.4005.
PubMed 12520576Moszkowicz D, Mariani A, Tresallet C, Menegaux F. Ischemic colitis: the ABCs of diagnosis and surgical management. J Visc Surg. 2013 Feb;150(1):19-28. doi: 10.1016/j.jviscsurg.2013.01.002. Epub 2013 Feb 20.
PubMed 23433833Washington C, Carmichael JC. Management of ischemic colitis. Clin Colon Rectal Surg. 2012 Dec;25(4):228-35. doi: 10.1055/s-0032-1329534.
PubMed 24294125Bakker IS, Grossmann I, Henneman D, Havenga K, Wiggers T. Risk factors for anastomotic leakage and leak-related mortality after colonic cancer surgery in a nationwide audit. Br J Surg. 2014 Mar;101(4):424-32; discussion 432. doi: 10.1002/bjs.9395.
PubMed 24536013Mirnezami A, Mirnezami R, Chandrakumaran K, Sasapu K, Sagar P, Finan P. Increased local recurrence and reduced survival from colorectal cancer following anastomotic leak: systematic review and meta-analysis. Ann Surg. 2011 May;253(5):890-9. doi: 10.1097/SLA.0b013e3182128929.
PubMed 21394013Law WL, Choi HK, Lee YM, Ho JW, Seto CL. Anastomotic leakage is associated with poor long-term outcome in patients after curative colorectal resection for malignancy. J Gastrointest Surg. 2007 Jan;11(1):8-15. doi: 10.1007/s11605-006-0049-z.
PubMed 17390180Lu ZR, Rajendran N, Lynch AC, Heriot AG, Warrier SK. Anastomotic Leaks After Restorative Resections for Rectal Cancer Compromise Cancer Outcomes and Survival. Dis Colon Rectum. 2016 Mar;59(3):236-44. doi: 10.1097/DCR.0000000000000554.
PubMed 26855399Duclos J, Lefevre JH, Lefrancois M, Lupinacci R, Shields C, Chafai N, Tiret E, Parc Y. Immediate outcome, long-term function and quality of life after extended colectomy with ileorectal or ileosigmoid anastomosis. Colorectal Dis. 2014 Aug;16(8):O288-96. doi: 10.1111/codi.12558.
PubMed 244283302015 European Society of Coloproctology Collaborating Group. Predictors for Anastomotic Leak, Postoperative Complications, and Mortality After Right Colectomy for Cancer: Results From an International Snapshot Audit. Dis Colon Rectum. 2020 May;63(5):606-618. doi: 10.1097/DCR.0000000000001590.
PubMed 32032201Platell C, Mackay J, Woods R. A multivariate analysis of risk factors associated with recurrence following surgery for Crohn's disease. Colorectal Dis. 2001 Mar;3(2):100-6. doi: 10.1046/j.1463-1318.2001.00213.x.
PubMed 12791002Nakamura T, Pikarsky AJ, Potenti FM, Lau CW, Weiss EG, Nogueras JJ, Wexner SD. Are complications of subtotal colectomy with ileorectal anastomosis related to the original disease? Am Surg. 2001 May;67(5):417-20.
PubMed 11379639Pastore RL, Wolff BG, Hodge D. Total abdominal colectomy and ileorectal anastomosis for inflammatory bowel disease. Dis Colon Rectum. 1997 Dec;40(12):1455-64. doi: 10.1007/BF02070712.
PubMed 9407985Loftus EV Jr, Delgado DJ, Friedman HS, Sandborn WJ. Colectomy and the incidence of postsurgical complications among ulcerative colitis patients with private health insurance in the United States. Am J Gastroenterol. 2008 Jul;103(7):1737-45. doi: 10.1111/j.1572-0241.2008.01867.x. Epub 2008 Jun 28.
PubMed 18564126Bjork J, Akerbrant H, Iselius L, Svenberg T, Oresland T, Pahlman L, Hultcrantz R. Outcome of primary and secondary ileal pouch-anal anastomosis and ileorectal anastomosis in patients with familial adenomatous polyposis. Dis Colon Rectum. 2001 Jul;44(7):984-92. doi: 10.1007/BF02235487.
PubMed 11496079Segelman J, Mattsson I, Jung B, Nilsson PJ, Palmer G, Buchli C. Risk factors for anastomotic leakage following ileosigmoid or ileorectal anastomosis. Colorectal Dis. 2018 Apr;20(4):304-311. doi: 10.1111/codi.13938.
PubMed 29059489
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RISK FACTORS FOR ANASTOMOTIC LEAKAGE FOLLOWING TOTAL OR SUBTOTAL COLECTOMY (RIALTCOT)
- ClinicalTrials.gov ID
- NCT04512326
- Acronym / sponsor ID
- RIALTCOT / 212/20
- Conditions
- Total Colectomy, Subtotal Colectomy
- Keywords
- Total colectomy, Subtotal colectomy, Ileorectal anastomosis, Ileosigmoid anastomosis, Anastomotic leakage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 13 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total or subtotal colectomy | – | Procedure: Total or Subtotal colectomyTotal or subtotal colectomy with ileorectal or ileosigmoid anastomosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients underwent total or subtotal colectomy with primary anastomosis
Key inclusion criteria (4 listed)
- (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
Key exclusion criteria (4 listed)
- (1) non-restorative TSC
- (2) previous colorectal resection
- (3) deferred anastomosis in trauma surgery and
- (4) other surgical resection in the same procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total or Subtotal colectomyTotal or subtotal colectomy (emergent or elective) with primary anastomosis (ileorectal or ileosigmoid) | Procedure or surgery | Total or subtotal colectomy |
Primary outcome
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
3 secondary outcomes
Risk factors associated to postoperative morbidity
Time frame: 90 days postoperatively
Risk factors associated to mortality
Time frame: 90 days postoperatively
Risk factors associated to re-admissions.
Time frame: 90 days postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Background: PubMed 12520576Elton C, Makin G, Hitos K, Cohen CR. Mortality, morbidity and functional outcome after ileorectal anastomosis. Br J Surg. 2003 Jan;90(1):59-65. doi: 10.1002/bjs.4005.
- Results publication: PubMed 23433833Moszkowicz D, Mariani A, Tresallet C, Menegaux F. Ischemic colitis: the ABCs of diagnosis and surgical management. J Visc Surg. 2013 Feb;150(1):19-28. doi: 10.1016/j.jviscsurg.2013.01.002. Epub 2013 Feb 20.
- Results publication: PubMed 24294125Washington C, Carmichael JC. Management of ischemic colitis. Clin Colon Rectal Surg. 2012 Dec;25(4):228-35. doi: 10.1055/s-0032-1329534.
- Results publication: PubMed 24536013Bakker IS, Grossmann I, Henneman D, Havenga K, Wiggers T. Risk factors for anastomotic leakage and leak-related mortality after colonic cancer surgery in a nationwide audit. Br J Surg. 2014 Mar;101(4):424-32; discussion 432. doi: 10.1002/bjs.9395.
- Results publication: PubMed 21394013Mirnezami A, Mirnezami R, Chandrakumaran K, Sasapu K, Sagar P, Finan P. Increased local recurrence and reduced survival from colorectal cancer following anastomotic leak: systematic review and meta-analysis. Ann Surg. 2011 May;253(5):890-9. doi: 10.1097/SLA.0b013e3182128929.
- Results publication: PubMed 17390180Law WL, Choi HK, Lee YM, Ho JW, Seto CL. Anastomotic leakage is associated with poor long-term outcome in patients after curative colorectal resection for malignancy. J Gastrointest Surg. 2007 Jan;11(1):8-15. doi: 10.1007/s11605-006-0049-z.
- Results publication: PubMed 26855399Lu ZR, Rajendran N, Lynch AC, Heriot AG, Warrier SK. Anastomotic Leaks After Restorative Resections for Rectal Cancer Compromise Cancer Outcomes and Survival. Dis Colon Rectum. 2016 Mar;59(3):236-44. doi: 10.1097/DCR.0000000000000554.
- Results publication: PubMed 24428330Duclos J, Lefevre JH, Lefrancois M, Lupinacci R, Shields C, Chafai N, Tiret E, Parc Y. Immediate outcome, long-term function and quality of life after extended colectomy with ileorectal or ileosigmoid anastomosis. Colorectal Dis. 2014 Aug;16(8):O288-96. doi: 10.1111/codi.12558.
- Results publication: PubMed 320322012015 European Society of Coloproctology Collaborating Group. Predictors for Anastomotic Leak, Postoperative Complications, and Mortality After Right Colectomy for Cancer: Results From an International Snapshot Audit. Dis Colon Rectum. 2020 May;63(5):606-618. doi: 10.1097/DCR.0000000000001590.
- Results publication: PubMed 12791002Platell C, Mackay J, Woods R. A multivariate analysis of risk factors associated with recurrence following surgery for Crohn's disease. Colorectal Dis. 2001 Mar;3(2):100-6. doi: 10.1046/j.1463-1318.2001.00213.x.
- Results publication: PubMed 11379639Nakamura T, Pikarsky AJ, Potenti FM, Lau CW, Weiss EG, Nogueras JJ, Wexner SD. Are complications of subtotal colectomy with ileorectal anastomosis related to the original disease? Am Surg. 2001 May;67(5):417-20.
- Results publication: PubMed 9407985Pastore RL, Wolff BG, Hodge D. Total abdominal colectomy and ileorectal anastomosis for inflammatory bowel disease. Dis Colon Rectum. 1997 Dec;40(12):1455-64. doi: 10.1007/BF02070712.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Ocaña, MD principal investigator
H.U Ramon y Cajal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Colectomy and Subtotal Colectomy, run by Hospital Universitario Ramon y Cajal at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastomotic Leakage (time frame: 90 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04512326, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2020.