Rectal CancerISRECLeakNCT06059924
Does the Management of Anastomotic Leakage After Low Rectal Resection Affect Survival
An observational study of Rectal Cancer and Anastomotic Leak, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
Trial summary
The aim of this retrospective cohort-study is to assess the effects of AL and its severity divided according the ISREC-classification on the long-term oncological outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Anastomotic Leak
- What is being tested?
- Anastomotic leakage
- How many people
- 941 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 1991to 31 Dec 2020
- 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 operated at the Cantonal Hospital of St. Gallen
Who may be able to join
- Patients receiving elective low anterior resection (LAR) between February 1991 and December 2020 at the Cantonal Hospital of St. Gallen
Who cannot join
- Other diagnosis than rectal cancer
- Discontinuity resection (no anastomosis)
- Emergency situation
- R1-resection
- Incomplete staging
- Metastatic cancer
Show all 10Show fewer
- 30-day mortality
- Decline of a retrospective data analysis
- Secondary malignancy
- Age under 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does the Management of Anastomotic Leakage After Low Rectal Resection Affect the Long-term Oncological Outcome: A Retrospective Propensity Score Adjusted Cohort Study
The aim of this retrospective cohort-study is to assess the effects of AL and its severity divided according the ISREC-classification on the long-term oncological outcome.
Read the detailed description
Rectal cancer is one of the most common malignancies in the world. Its costs and cancer-related mortality are increasing worldwide. The surgical treatment was revolutionized in recent years by the total mesorectal excision (TME) technique as well as the laparoscopic, robotic, and transanal approach. But anastomotic leakage (AL) remains one of the most feared complications after low rectal resection regarding postoperative morbidity and mortality as well as functional outcome. Several risk factors causing AL like low level of anastomosis, large tumor mass, male gender, smoking, perioperative bleeding, and preoperative radio-chemotherapy are known. Protective ileo- or colostomy formation and transanal tube placement may decrease the risk of AL and reduces the rate of reoperation due to AL. Diverting results of the association between AL and the long-term oncological outcome (local recurrence, systemic recurrence, survival) are described in the current literature.
The International Study Group of Rectal Cancer (ISREC) provides a classification of AL according to its clinical management:
- Grade A results in no change in patient's management
- Grade B requires active therapeutic intervention without re-laparotomy
- Grade C requires re-laparotomy
This classification allows a good stratification regarding postoperative morbidity and mortality. However, the association between the ISREC-classification of AL and the long-term oncological outcome is not yet clear.
- Conditions
- Rectal Cancer, Anastomotic Leak
- Being tested
- Anastomotic leakage
- Keywords
- Rectal cancer, Low rectal resection, Anastomotic leakage, ISREC-classification, Cancer-specific survival, Propensity score
- Medical subject headings
- Rectal Neoplasms, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anastomotic leakageOther
Anastomotic leakage was defined as a defect of the intestinal wall at the anastomotic site leading to a communication between the intra- and extraluminal compartments. It was diagnosed by clinical, laboratory, radiological (ultrasound, endosonography, computed tomography), endoscopic, and/or surgical findings.
| Study group | Role | What they receive |
|---|---|---|
| leak | Patients with diagnosed anastomotic leakage after low rectal resection for rectal cancer UICC stage I to III Receives: Other: Anastomotic leakage | |
| noleak | Patients without anastomotic leakage after low rectal resection for rectal cancer UICC stage I to III |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer-specific survival
Measured: 30 days postoperative to 5 years postoperative
Secondary outcomes (3)
Overall survival
Measured: 30 days postoperative to 5 years postoperative
Disease-free survival
Measured: 30 days postoperative to 5 years postoperative
Recurrence-free survival
Measured: 30 days postoperative to 5 years postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start1 Feb 1991
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies 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
- 941 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital of St. Gallen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ignazio Tarantino, Cantonal Hospital of St. Gallen
- Investigators
- Ignazio Tarantino, PD Dr. med., Principal investigator, Klinik für Chirurgie, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059924
- Sponsor's protocol ID
- ISREC leakage rectal resection
- Acronym
- ISRECLeak
- Status last verified
- Sep 2023
- First submitted
- 15 Sep 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rahbari NN, Weitz J, Hohenberger W, Heald RJ, Moran B, Ulrich A, Holm T, Wong WD, Tiret E, Moriya Y, Laurberg S, den Dulk M, van de Velde C, Buchler MW. Definition and grading of anastomotic leakage following anterior resection of the rectum: a proposal by the International Study Group of Rectal Cancer. Surgery. 2010 Mar;147(3):339-51. doi: 10.1016/j.surg.2009.10.012. Epub 2009 Dec 11.
PubMed 20004450Ammann Y, Marti L, Warschkow R, Bischofberger S, Reissfelder C, Schmied B, Brunner W, Tarantino I. Does the management of anastomotic leakage after rectal cancer resection affect long-term oncological survival? A retrospective propensity score-adjusted cohort study. Tech Coloproctol. 2026 Mar 6;30(1):40. doi: 10.1007/s10151-026-03289-6.
PubMed 41790293
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Management of Anastomotic Leakage After Low Rectal Resection Affect the Long-term Oncological Outcome: A Retrospective Propensity Score Adjusted Cohort Study
- ClinicalTrials.gov ID
- NCT06059924
- Acronym / sponsor ID
- ISRECLeak / ISREC leakage rectal resection
- Conditions
- Rectal Cancer, Anastomotic Leak
- Keywords
- Rectal cancer, Low rectal resection, Anastomotic leakage, ISREC-classification, Cancer-specific survival, Propensity score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 941 participants (actual)
- Lead sponsor
- Cantonal Hospital of St. GallenUniversity, hospital or other
- Study start
- 1 Feb 1991 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 29 Sep 2023 (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.
The aim of this retrospective cohort-study is to assess the effects of AL and its severity divided according the ISREC-classification on the long-term oncological outcome.
Detailed description
Rectal cancer is one of the most common malignancies in the world. Its costs and cancer-related mortality are increasing worldwide. The surgical treatment was revolutionized in recent years by the total mesorectal excision (TME) technique as well as the laparoscopic, robotic, and transanal approach. But anastomotic leakage (AL) remains one of the most feared complications after low rectal resection regarding postoperative morbidity and mortality as well as functional outcome. Several risk factors causing AL like low level of anastomosis, large tumor mass, male gender, smoking, perioperative bleeding, and preoperative radio-chemotherapy are known. Protective ileo- or colostomy formation and transanal tube placement may decrease the risk of AL and reduces the rate of reoperation due to AL. Diverting results of the association between AL and the long-term oncological outcome (local recurrence, systemic recurrence, survival) are described in the current literature.
The International Study Group of Rectal Cancer (ISREC) provides a classification of AL according to its clinical management:
- Grade A results in no change in patient's management
- Grade B requires active therapeutic intervention without re-laparotomy
- Grade C requires re-laparotomy
This classification allows a good stratification regarding postoperative morbidity and mortality. However, the association between the ISREC-classification of AL and the long-term oncological outcome is not yet clear.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| leak | – | Other: Anastomotic leakagePatients with diagnosed anastomotic leakage after low rectal resection for rectal cancer UICC stage I to III |
| noleak | – | –Patients without anastomotic leakage after low rectal resection for rectal cancer UICC stage I to III |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients operated at the Cantonal Hospital of St. Gallen
Key inclusion criteria (1 listed)
- Patients receiving elective low anterior resection (LAR) between February 1991 and December 2020 at the Cantonal Hospital of St. Gallen
Key exclusion criteria (10 listed)
- Other diagnosis than rectal cancer
- Discontinuity resection (no anastomosis)
- Emergency situation
- R1-resection
- Incomplete staging
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 |
|---|---|---|
| Anastomotic leakageAnastomotic leakage was defined as a defect of the intestinal wall at the anastomotic site leading to a communication between the intra- and extraluminal compartments. It was diagnosed by clinical, laboratory, radiological (ultrasound, endosonography, computed tomography), endoscopic, and/or surgical findings. | Other | leak |
Primary outcome
Cancer-specific survival
Time frame: 30 days postoperative to 5 years postoperative
3 secondary outcomes
Overall survival
Time frame: 30 days postoperative to 5 years postoperative
Disease-free survival
Time frame: 30 days postoperative to 5 years postoperative
Recurrence-free survival
Time frame: 30 days postoperative to 5 years postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Background: PubMed 20004450Rahbari NN, Weitz J, Hohenberger W, Heald RJ, Moran B, Ulrich A, Holm T, Wong WD, Tiret E, Moriya Y, Laurberg S, den Dulk M, van de Velde C, Buchler MW. Definition and grading of anastomotic leakage following anterior resection of the rectum: a proposal by the International Study Group of Rectal Cancer. Surgery. 2010 Mar;147(3):339-51. doi: 10.1016/j.surg.2009.10.012. Epub 2009 Dec 11.
- Derived from this study: PubMed 41790293Ammann Y, Marti L, Warschkow R, Bischofberger S, Reissfelder C, Schmied B, Brunner W, Tarantino I. Does the management of anastomotic leakage after rectal cancer resection affect long-term oncological survival? A retrospective propensity score-adjusted cohort study. Tech Coloproctol. 2026 Mar 6;30(1):40. doi: 10.1007/s10151-026-03289-6.
- Individual participant dataSharing planned: No
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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.
Ignazio Tarantino, PD Dr. med. principal investigator
Klinik für Chirurgie, Cantonal Hospital of St. Gallen
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 Rectal Cancer and Anastomotic Leak, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
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 1 inclusion and 10 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: finished, as of the sponsor's last update on 29 Sep 2023. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cancer-specific survival (time frame: 30 days postoperative to 5 years postoperative). 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 NCT06059924, which also lists 2 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 29 Sep 2023.