Comparing CT scans and endoscopy for detecting leaks after colon surgery
Computed Tomography with Rectal Contrast and Early Endoscopy for the Detection of Anastomotic Leaks After Left Sided Colorectal Resection. a Single Center, Prospective Trial.
Spital Limmattal Schlieren · NCT03148054
This study is testing whether CT scans or endoscopy is better at finding leaks after colon surgery in patients who have just had the procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Spital Limmattal Schlieren (other) |
| Locations | 1 site (Schlieren, ZH) |
| Trial ID | NCT03148054 on ClinicalTrials.gov |
What this trial studies
This observational study involves patients undergoing elective left-sided colon resection who will receive both a CT scan and an endoscopy on days 3, 4, or 5 post-surgery. The aim is to evaluate the accuracy of these two procedures in detecting anastomotic leaks, which can lead to serious complications. Patients will be monitored for up to 42 days postoperatively to assess outcomes. Informed consent is obtained prior to surgery, and the study will analyze data from approximately 400 participants.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 undergoing elective left-sided colorectal resection with primary anastomosis.
Not a fit: Patients who have a stoma formed during the initial operation or those with significant renal impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve early detection of anastomotic leaks, potentially reducing complications and improving patient outcomes.
How similar studies have performed: While similar studies have been conducted, this specific comparison of CT scans and endoscopy for anastomotic leak detection is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Laparoscopic or open left sided colorectal resection with primary anastomosis (left hemicolectomy, sigmoid resection, anterior resection, segmental resection) and subtotal colectomy with anastomosis * Male and Female patients \>18 years of age * Signed Informed Consent after being informed * Elective surgery Exclusion Criteria: * Formation of a stoma during the initial operation * For i.v. contrast CT scan: creatinine \> 110 umol/l and/or glomerular filtration rate GFR \< 45 ml/min, measured in the standard blood test on postoperative day 2 * Women who are pregnant. Women of childbearing age are regularly tested for possible pregnancy. Pregnancy tests are performed in the hospital at no charge * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant * Participation in another study with an investigational drug within the 30 days preceding and during the present study * Emergency intervention
Where this trial is running
Schlieren, ZH
- Spital Limmattal — Schlieren, ZH, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Urs Zingg, Prof. Dr. med. — Head of department (surgery)
- Study coordinator: Urs Zingg, Prof. Dr. med.
- Email: urs.zingg@spital-limmattal.ch
- Phone: +41 44 733 21 26
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anastomosis, Complications, Colon Disease, Leak, Anastomotic, Colon, CT, Endoscopy, Enema