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TerminatedNCT07490080Updated Mar 24, 2026

Study With Dehisgel Used in Adult Patients Undergoing Colorectal Anastomosis

An observational study in Anastomosis, Leaking, sponsored by Contipro Pharma a.s.. Terminated at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-24.

Sponsored by Contipro Pharma a.s. · Observational

Why this study was terminated
safety was ok, but efficacy was considered too low - it was decided not to continue woth this study design
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study summary

A two-phase, multicenter, open-label, "first-in-human" prospective study evaluating the product's safety and efficacy in a pivotal phase.

02

Conditions studied

  • Anastomosis, Leaking
03

In context

Lead sponsor

Contipro Pharma a.s. is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The patients included in the study underwent elective rectal resection with colorectal anastomosis due to rectal cancer.

Inclusion criteria

  • Age ≥ 18 years
  • Patients with histologically confirmed rectal adenocarcinoma (\< 15 cm from the anal margin) following rectal resection with colorectal anastomosis
  • Patients with or without neoadjuvant therapy
  • Patients willing and able to provide written informed consent
  • Patients able to communicate effectively with the investigator in the local language and to understand and comply with the study requirements.

Exclusion criteria

Exclusion criteria

  • Age \< 18 years
  • Pregnant or breastfeeding women
  • Patients in the terminal stage of life
  • Subjects with known hypersensitivity or allergy to any component of the investigational product or to the administered antibiotics
  • Acute surgery
  • Preventive ostomy
  • Other malignancies
  • Incomplete data
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
20 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Incidence of anastomotic leak

    (Grade B, C according to the International Study Group of Rectal Cancer)

    Time frame: 30 days

07

Study locations

1 site
  • FN HK
    Hradec Králové, Czechia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07490080
Lead sponsor
Contipro Pharma a.s.
Responsible party
Sponsor
First posted
Mar 24, 2026
Start date
Oct 23, 2024
Primary completion
Dec 30, 2025
Completion
Dec 30, 2025
Last update
Mar 24, 2026

Oversight

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

Not currently enrolling

This study is terminated, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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