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RecruitingNCT05257863Updated May 9, 2023

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 in Postoperative Complications, Psychosomatic Disorder and Psychiatric Disorder, sponsored by Dr. Med Anas Taha. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-09.

Primary conditionAnastomotic LeakRegistry: Postoperative ComplicationsReclassifiedWhy we changed it
Registry
Postoperative Complications — the first condition term the registry derived for this study.
ClinicalTrials.gg
Anastomotic Leak
Why
  1. The study's listed conditions name Anastomotic Leak, a narrower term within Postoperative Complications.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Dr. Med Anas Taha · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 10 months ago, but the record still lists the study as recruiting.
  • Started May 2022; still recruiting 4 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
10,000
Ages
18 Years and older
Sex
All
01

Study 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.

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

02

Conditions studied

  • Postoperative Complications
  • Psychosomatic Disorder
  • Psychiatric Disorder
  • Cancer
  • Diverticulitis
  • Morbus Crohn
  • Colitis Ulcerosa
  • Anastomotic Leak
  • Anastomotic Complication
  • Small Intestine Anastomotic Leak

Keywords

  • machine learning
  • clinical prediction modeling
  • artificial intelligence
03

In context

Anastomotic Leak Reclassified

240 studies on the registry are indexed under Anastomotic Leak; 72 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 166 across 111 observational studies indexed under Anastomotic Leak.

Browse Anastomotic Leak studies →

Lead sponsor

Dr. Med Anas Taha is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Compared within Anastomotic Leak, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Postoperative Complications. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients undergoing colorectal and small intestine surgery.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Colocolic, colorectal and small intestine anastomosis
  • Neoplasia,
  • Diverticulitis
  • Mesenteric ischemia
  • Iatrogenic or traumatic perforation
  • Inflammatory bowel disease

Exclusion criteria

Exclusion Criteria:

  • Patients \<18 years
  • Patients suffering from recurrent colorectal cancer bearing
  • Peritoneal carcinomatosis or unresectable 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
10,000 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Anastomotic insufficiency/leakage

    Predictive model with an app for the development of anastomosis insufficiency based on the risk factors.

    Time frame: From index surgery up to six weeks postoperatively

  2. Complication after surgery/ Comprehensive Complication Index/ Clavian Dindo Score

    Impact of psychatric and psychosomatic disorders are having higher complication rates

    Time frame: From index surgery up to six weeks postoperatively

  3. Length of Hospital Stay (in Days)

    Impact of psychatric and psychosomatic disorders are having longer hospitalization

    Time frame: From surgery up to 12 weeks postoperatively

  4. Intraoperative influid manangment

    Impact of Intraoperative influid on the development of anastomotic insuffiency

    Time frame: Time Frame: From index surgery up to six weeks postoperatively

  5. Development of a preoperative score for morbidity/mortality in colorectal surgery

    Check the risk for morbidity/mortality in colorectal surgery

    Time frame: From index surgery up to six weeks postoperatively

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2022 (actual). Primary completion is estimated for Dec 2023, 19 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 21, 2022
First posted
Feb 25, 2022
StartActual
May 1, 2022
Primary completionEst.
Dec 31, 2023
CompletionEst.
Dec 31, 2023
Last update
May 9, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05257863
Lead sponsor
Dr. Med Anas Taha
Collaborators
University of Basel, University of Hamburg-Eppendorf
Responsible party
Dr. Med Anas Taha (Research Fellow, University of Basel) — Sponsor-investigator
First posted
Feb 25, 2022
Start date
May 1, 2022
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
May 9, 2023

Study contacts

Anas Taha, MD
Contact
anas.taha@unibas.ch
0041612075402
Stephanie Taha-Mehlitz, MD
Contact
Stephanie.taha@clarunis.ch

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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