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Diagnostic value of water-soluble contrast computerized tomography fistulography in detecting anastomotic leakage following low rectal cancer resection

Diagnostic value of water-soluble contrast computerized tomography fistulography in detecting anastomotic leakage following low rectal cancer resection

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600116291
Enrollment
Unknown
Registered
2026-01-07
Start date
2022-01-20
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

low rectal anastomotic leakage

Interventions

Gold Standard:Enhanced computed tomography (CT) scan combined with oral or rectal administration of a water-soluble contrast agent (such as iopamidol) to observe for contrast extravasation.
Index test:Pelvic double-lumen catheterisation with water-soluble contrast medium for sinusography CT

Sponsors

Fuzhou University Affiliated Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 82 Years

Inclusion criteria

Inclusion criteria: 1.Age >=18 years. 2. Rectal adenocarcinoma confirmed by pathology following endoscopic biopsy. 3.The tumor distal margin is located <= 7 cm from the anal verge, as demonstrated by abdominal enhanced CT or rectal MRI. 4.Successful completion of laparoscopic/robotic low anterior resection (LAR) with a colorectal or coloanal end-to-end anastomosis. 5.Routine placement of a pelvic double-lumen catheter near the rectal anastomosis during surgery. 6.Postoperative patients with a clinical suspicion of low rectal anastomotic leakage were evaluated using water-soluble contrast fistulography and water-soluble contrast computerized tomography fistulography.

Exclusion criteria

Exclusion criteria: 1.Underwent Abdominoperineal Resection (APR) for Rectal Cancer or Hartmann's procedure. 2. Other postoperative complications involving "leakage" or fistula formation, such as intestinal perforation, bowel ischemia/necrosis, or rectovaginal fistula.

Design outcomes

Primary

MeasureTime frame
diagnostic sensitivity;

Secondary

MeasureTime frame
Diagnostic specificity;Diagnostic positive predictive value;diagnostic negative predictive value;Diameter of anastomotic leakage;Leakage location at anastomotic site;

Countries

China

Contacts

Public ContactWang Yuanzhao

Fuzhou University Affiliated Provincial Hospital

wangyuanzhao5409@163.com+86 591 88618709

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026