Postoperative ComplicationsNCT05257863
Development of Machine Learning Models for the Prediction of Complications After Colonic, Colorectal and Small Intestine Anastomosis in Psychiatric and Non-psychiatric Patient Collectives (P-Study)
An observational study of Postoperative Complications and Psychosomatic Disorder, run by Dr. Med Anas Taha at 1 site in Switzerland.
Trial summary
Our study aims to lay the basis for a predictive modeling service for postoperative complications and prolonged hospital stay in patients suffering from psychiatric diseases undergoing colorectal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications, Psychosomatic Disorder, Psychiatric Disorder
- How many people
- 10,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 May 2022to 31 Dec 2023
- 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 undergoing colorectal and small intestine surgery.
Who may be able to join
- Colocolic, colorectal and small intestine anastomosis
- Neoplasia,
- Diverticulitis
- Mesenteric ischemia
- Iatrogenic or traumatic perforation
- Inflammatory bowel disease
Who cannot join
- Patients <18 years
- Patients suffering from recurrent colorectal cancer bearing
- Peritoneal carcinomatosis or unresectable metastatic disease at the time of bowel resection and anastomosis will be excluded.
- Patients who cannot be followed up on for more than six weeks after surgery
Trial locations and contacts
1 site in 1 country.
Stephanie Taha-Mehlitz, MD contact
Switzerland1 site, 1 recruiting
- Recruiting
University of Basel
Basel
Anas Taha, MD, 0041 61 207 54 02, anas.taha@unibas.ch
Stephanie Taha-Mehlitz, MD
About this study
Our study aims to lay the basis for a predictive modeling service for postoperative complications and prolonged hospital stay in patients suffering from psychiatric diseases undergoing colorectal surgery.
Furthermore, we aim to investigate the impact of preoperative Risk factors, psychiatric and psychosomatic diseases on the outcomes of colorectal surgery and the complications after colorectal surgeries like anastomosis insufficiency via predictive modeling techniques
The service mentioned above will be publicly available as a web-based application
- Conditions
- Postoperative Complications, Psychosomatic Disorder, Psychiatric Disorder, Cancer, Diverticulitis, Morbus Crohn
- Keywords
- machine learning, clinical prediction modeling, artificial intelligence
- Medical subject headings
- Postoperative Complications, Psychophysiologic Disorders, Mental Disorders, Neoplasms, Diverticulitis, Crohn Disease, Colitis, Ulcerative, Anastomotic Leak
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomotic insufficiency/leakage
Predictive model with an app for the development of anastomosis insufficiency based on the risk factors.
Measured: From index surgery up to six weeks postoperatively
Complication after surgery/ Comprehensive Complication Index/ Clavian Dindo Score
Impact of psychatric and psychosomatic disorders are having higher complication rates
Measured: From index surgery up to six weeks postoperatively
Length of Hospital Stay (in Days)
Impact of psychatric and psychosomatic disorders are having longer hospitalization
Measured: From surgery up to 12 weeks postoperatively
Intraoperative influid manangment
Impact of Intraoperative influid on the development of anastomotic insuffiency
Measured: Time Frame: From index surgery up to six weeks postoperatively
Development of a preoperative score for morbidity/mortality in colorectal surgery
Check the risk for morbidity/mortality in colorectal surgery
Measured: From index surgery up to six weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start1 May 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies 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
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Med Anas Taha
- Sponsor type
- University, hospital or other
- Collaborators
- University of Basel, University of Hamburg-Eppendorf
- Responsible party
- Sponsor-investigator, Dr. Med Anas Taha, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05257863
- Sponsor's protocol ID
- P-Study
- Status last verified
- May 2023
- First submitted
- 21 Jan 2022
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Machine Learning Models for the Prediction of Complications After Colonic, Colorectal and Small Intestine Anastomosis in Psychiatric and Non-psychiatric Patient Collectives (P-Study)
- ClinicalTrials.gov ID
- NCT05257863
- Acronym / sponsor ID
- P-Study
- Conditions
- Postoperative Complications, Psychosomatic Disorder, Psychiatric Disorder, Cancer, Diverticulitis, Morbus Crohn
- Keywords
- machine learning, clinical prediction modeling, artificial intelligence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Dr. Med Anas TahaUniversity, hospital or other
- Collaborators
- University of Basel, University of Hamburg-Eppendorf
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 25 Feb 2022 (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.
Our study aims to lay the basis for a predictive modeling service for postoperative complications and prolonged hospital stay in patients suffering from psychiatric diseases undergoing colorectal surgery.
Furthermore, we aim to investigate the impact of preoperative Risk factors, psychiatric and psychosomatic diseases on the outcomes of colorectal surgery and the complications after colorectal surgeries like anastomosis insufficiency via predictive modeling techniques
The service mentioned above will be publicly available as a web-based application
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing colorectal and small intestine surgery.
Key inclusion criteria (6 listed)
- Colocolic, colorectal and small intestine anastomosis
- Neoplasia,
- Diverticulitis
- Mesenteric ischemia
- Iatrogenic or traumatic perforation
Key exclusion criteria (4 listed)
- Patients <18 years
- Patients suffering from recurrent colorectal cancer bearing
- Peritoneal carcinomatosis or unresectable metastatic disease at the time of bowel resection and anastomosis will be excluded.
- Patients who cannot be followed up on for more than six 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
Anastomotic insufficiency/leakage
Time frame: From index surgery up to six weeks postoperatively
Predictive model with an app for the development of anastomosis insufficiency based on the risk factors.
Complication after surgery/ Comprehensive Complication Index/ Clavian Dindo Score
Time frame: From index surgery up to six weeks postoperatively
Impact of psychatric and psychosomatic disorders are having higher complication rates
Length of Hospital Stay (in Days)
Time frame: From surgery up to 12 weeks postoperatively
Impact of psychatric and psychosomatic disorders are having longer hospitalization
Intraoperative influid manangment
Time frame: Time Frame: From index surgery up to six weeks postoperatively
Impact of Intraoperative influid on the development of anastomotic insuffiency
Development of a preoperative score for morbidity/mortality in colorectal surgery
Time frame: From index surgery up to six weeks postoperatively
Check the risk for morbidity/mortality in colorectal surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- 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.
Stephanie Taha-Mehlitz, MD contact
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 Postoperative Complications and Psychosomatic Disorder, run by Dr. Med Anas Taha 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 6 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 9 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anas Taha, MD (0041612075402, anas.taha@unibas.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastomotic insufficiency/leakage (time frame: From index surgery up to six weeks postoperatively). The study lists 5 primary outcomes in all. 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 9 May 2023.