Anastomotic LeakNCT04985981
The Prediction of Anastomotic Insufficiency Risk After Colorectal Surgery (PANIC) Study
An observational study of Anastomotic Leak and Colorectal Cancer, run by Michel Adamina, MD at 2 sites in Switzerland.
Trial summary
The Prediction of Anastomotic Insufficiency risk after Colorectal surgery (PANIC) study aims to establish a machine-learning-based application that allows for accurate preoperative prediction of patients at risk for anastomotic insufficiency after colon and colorectal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anastomotic Leak, Colorectal Cancer, Diverticulosis
- How many people
- 11,000 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Apr 2021to 31 Dec 2022
- How long will I take part?
- 5 Years
- 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 who underwent colon or colorectal anastomosis for neoplasia, diverticulitis, mesenterial ischemia, iatrogenic or traumatic perforation, or inflammatory bowel disease. Only patients who have reached the age of 18 will be accepted. Only patients who are able to give informed consent to the procedure will be accepted.
Who may be able to join
- Patients who underwent colon or colorectal anastomosis for neoplasia, diverticulitis, mesenterial ischemia, iatrogenic or traumatic perforation, or inflammatory bowel disease
Who cannot join
- age < 18
- recurrent colorectal cancer
- peritoneal carcinomatosis or unresectable metastatic disease at time of bowel resection
- informed consent not obtainable
- follow-up < 6 weeks after surgery
- no reversal of and ostomy
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Clinical Research and Artificial Intelligence in Surgery, Department of Biomedical Engineering, University of Basel, Allschwil, Switzerland
Allschwil, Basel, 4123
Kantonsspital Winterthur
Winterthur, Canton of Zurich, 8401
About this study
Official title: The Prediction of Anastomotic Insufficiency Risk After Colorectal Surgery (PANIC) Study: Development and External Validation of an International, Multicenter Machine Learning Algorithm for Prediction of Anastomotic Insufficiency After Colonic or Colorectal Anastomosis
The Prediction of Anastomotic Insufficiency risk after Colorectal surgery (PANIC) study aims to establish a machine-learning-based application that allows for accurate preoperative prediction of patients at risk for anastomotic insufficiency after colon and colorectal surgery.
Read the detailed description
Anastomotic insufficiency leads to clinical strains for patients, and significantly increases morbidity and mortality. On average, hospital stay is extended by 12 days while healthcare-related expenses are increased by 30,000 USD when patients suffer from an anastomotic leak. In experienced centers, the approximated incidence of anastomotic insufficiency is 3,3% for colon and 8.6% for colorectal procedures. Multiple subgroups of patients with increased risk for anastomotic leaks have been described in previous publications. Meticulous preoperative recognition of patients with increased risk for anastomotic insufficiency is clinically beneficial, as it would permit improved ressource preparation, enhanced patient education and superior surgical decision-making. However, it is often difficult for clinicians to balance the plethora of crucial risk factors for anastomotic leaks for a single patient. Machine learning methods have been exceptionally effective at incorporating various clinical variables into one unified risk prediction model. To the authors' best knowledge, there does not yet exist a credible prediction model or a conclusive prediction score for anastomotic insufficiency after colon and colorectal anastomosis. The aim of the Prediction of Anastomotic Insufficiency risk after Colorectal surgery (PANIC) study is to establish and externally validate an efficient machine-learning-based prediction tool based on multicenter data from a range of international centers.
- Conditions
- Anastomotic Leak, Colorectal Cancer, Diverticulosis, Crohn Disease, Ulcerative Colitis, Mesenteric Ischemia
- Keywords
- Anastomotic Leak
- Medical subject headings
- Anastomotic Leak, Colorectal Neoplasms, Diverticulum, Crohn Disease, Colitis, Ulcerative, Mesenteric Ischemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Anastomotic leak
Occurrence of anastomotic insufficiency/leak is defined as any clinical signs of leakage, confirmed by radiological examination, endoscopy, clinical examination of the anastomosis, or upon reoperation.
Measured: 5 years
Secondary outcomes (2)
Occurrence of Death
Measured: 90 days
Time to diagnosis of anastomotic leak
Time to diagnosis of a leakage will be calculated as days between the index operation and diagnosis of the leakage by imaging with extraluminal contrast, endoscopy, re-operation, or when fecal containing fluid is objectified in a drainage.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start1 Apr 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Why it stopped: Change in core study organization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anastomotic LeakStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 11,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Michel Adamina, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Cantonal Hospital of St. Gallen, University Hospital, Geneva, Clarunis - Universitäres Bauchzentrum Basel, University Hospital, Basel, Switzerland, University of Zurich
- Responsible party
- Sponsor-investigator, Michel Adamina, MD, Kantonsspital Winterthur KSW
- Investigators
- Michel Adamina, Prof. Dr. med., Study chair, Clinical Research and Artificial Intelligence in Surgery, Department of Biomedical Engineering, University of Basel, Allschwil, SwitzerlandAnas Taha, Dr. med., Principal investigator, None currentlyThomas Steffen, Principal investigator, Cantonal Hospital of St. GallenStephanie Taha-Mehlitz, Dr. med., Principal investigator, Department of Visceral Surgery, Clarunis, University Hospital Basel, Basel, SwitzerlandFrédéric Ris, Prof. Dr. med., Principal investigator, Department of Surgery, Hôpitaux Universitaires de Genève
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04985981
- Sponsor's protocol ID
- PANIC
- Status last verified
- Nov 2021
- First submitted
- 22 Jul 2021
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prediction of Anastomotic Insufficiency Risk After Colorectal Surgery (PANIC) Study: Development and External Validation of an International, Multicenter Machine Learning Algorithm for Prediction of Anastomotic Insufficiency After Colonic or Colorectal Anastomosis
- ClinicalTrials.gov ID
- NCT04985981
- Acronym / sponsor ID
- PANIC
- Conditions
- Anastomotic Leak, Colorectal Cancer, Diverticulosis, Crohn Disease, Ulcerative Colitis, Mesenteric Ischemia
- Keywords
- Anastomotic Leak
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Change in core study organization
- Enrolment
- 11,000 participants (estimated)
- Lead sponsor
- Michel Adamina, MDUniversity, hospital or other
- Collaborators
- Cantonal Hospital of St. Gallen, University Hospital, Geneva, Clarunis - Universitäres Bauchzentrum Basel, University Hospital, Basel, Switzerland, University of Zurich
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 2 Aug 2021 (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 Prediction of Anastomotic Insufficiency risk after Colorectal surgery (PANIC) study aims to establish a machine-learning-based application that allows for accurate preoperative prediction of patients at risk for anastomotic insufficiency after colon and colorectal surgery.
Detailed description
Anastomotic insufficiency leads to clinical strains for patients, and significantly increases morbidity and mortality. On average, hospital stay is extended by 12 days while healthcare-related expenses are increased by 30,000 USD when patients suffer from an anastomotic leak. In experienced centers, the approximated incidence of anastomotic insufficiency is 3,3% for colon and 8.6% for colorectal procedures. Multiple subgroups of patients with increased risk for anastomotic leaks have been described in previous publications. Meticulous preoperative recognition of patients with increased risk for anastomotic insufficiency is clinically beneficial, as it would permit improved ressource preparation, enhanced patient education and superior surgical decision-making. However, it is often difficult for clinicians to balance the plethora of crucial risk factors for anastomotic leaks for a single patient. Machine learning methods have been exceptionally effective at incorporating various clinical variables into one unified risk prediction model. To the authors' best knowledge, there does not yet exist a credible prediction model or a conclusive prediction score for anastomotic insufficiency after colon and colorectal anastomosis. The aim of the Prediction of Anastomotic Insufficiency risk after Colorectal surgery (PANIC) study is to establish and externally validate an efficient machine-learning-based prediction tool based on multicenter data from a range of international centers.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent colon or colorectal anastomosis for neoplasia, diverticulitis, mesenterial ischemia, iatrogenic or traumatic perforation, or inflammatory bowel disease. Only patients who have reached the age of 18 will be accepted. Only patients who are able to give informed consent to the procedure will be accepted.
Key inclusion criteria (1 listed)
- Patients who underwent colon or colorectal anastomosis for neoplasia, diverticulitis, mesenterial ischemia, iatrogenic or traumatic perforation, or inflammatory bowel disease
Key exclusion criteria (6 listed)
- age < 18
- recurrent colorectal cancer
- peritoneal carcinomatosis or unresectable metastatic disease at time of bowel resection
- informed consent not obtainable
- follow-up < 6 weeks after surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurrence of Anastomotic leak
Time frame: 5 years
Occurrence of anastomotic insufficiency/leak is defined as any clinical signs of leakage, confirmed by radiological examination, endoscopy, clinical examination of the anastomosis, or upon reoperation.
2 secondary outcomes
Occurrence of Death
Time frame: 90 days
Time to diagnosis of anastomotic leak
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Anastomotic Leak
Recruiting
Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
Anastomotic Leaks, Hartmanns Stump Leakage
Recruiting
Prospective, Multicenter, Randomized Controlled Phase III Trial of Biological Mesh for Alimentary Tract Reconstruction in Digestive Surgery
Digestive System Surgical Procedures, Anastomosis, Surgical
Recruiting
Pre-emptive Endoscopic Vacuum Therapy Reduces the Incidence of Anastomotic Leakage After Colorectal Cancer Surgery
Colorectal Cancer, Colorectal Surgery
Not yet recruiting
FLuorescent Angiography in REduction of Anastomotic Leak in Rectal Cancer Surgery
Rectal Cancer Patients, Rectal Cancer Surgery
RecruitingObservational study
Surgical Intuition in Anastomotic Leakage After Colorectal Surgery
Anastomotic Leaks
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.
Michel Adamina, Prof. Dr. med. study chair
Clinical Research and Artificial Intelligence in Surgery, Department of Biomedical Engineering, University of Basel, Allschwil, Switzerland
Anas Taha, Dr. med. principal investigator
None currently
Thomas Steffen principal investigator
Cantonal Hospital of St. Gallen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anastomotic Leak and Colorectal Cancer, run by Michel Adamina, MD at 2 sites 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 6 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: paused, as of the sponsor's last update on 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Occurrence of Anastomotic leak (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Dec 2021.