Clinical trial · Observational
A RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing
Multi Center, Observational, Retrospective Data Collection of Patients Treated With the ColonRing in Routine Clinical Practice. This Study to Continue RETROPRESS Study ID NCT01301417
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The proposed study is a post marketing, observational, retrospective data collection intended to gather and record data on patients treated with the ColonRing device in routine clinical practice at 4-6 centers. The data will assist in future evaluating the performance of the ColonRing device in regards to the creation of a colorectal anastomosis in Low Anterior Resection procedures. Hypothesis: The performance of the ColonRing, determined by the rate of complications, will be within the acceptable range reported in the literature for alternative treatment modalities.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colitis, Ulcerative | — | UNRESOLVED | — |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Colostomy | — | UNRESOLVED | — |
| Crohn Disease | — | UNRESOLVED | — |
| Diverticulum, Colon | — | UNRESOLVED | — |
| Endometriosis | — | UNRESOLVED | — |
| Ileostomy - Stoma | — | UNRESOLVED | — |
| Intestinal Polyposis | — | UNRESOLVED | — |
| Intestinal Volvulus | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- ColonRing
- description
- The ColonRing device is intended to be used for the creation of intestinal anastomoses in colorectal surgery in both open and laparoscopic surgeries. This indication is within the currently cleared indication of the ColonRing device, which has been cleared by the US FDA and carries the CE Mark for use throughout the alimentary trct for the creation of circular end-to-end, side-to-end or side-to-side anastomosis.
Primary outcomes (1)
- measure
- The rate of anastomotic leakage.
- timeFrame
- 6 weeks after the procedure
- description
- Anastomotic leakage is defined as evidence of a defect in the intestinal wall integrity at the anastomotic site leading to a communication between the intra and extra luminal compartments.
Secondary outcomes (1)
- measure
- Rate of other device related complications and measures during hospitalization and post procedure.
- timeFrame
- 6 weeks after the procedure.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient was \> 18 years old at time of procedure 2. Patient underwent a technically successful open or laparoscopic colorectal, Low Anterior Resection procedure with the creation of an anastomosis using the ColonRing™ 3. Patient treated in routine clinical practice 4. Patient underwent his/her first follow-up visit within two months post-surgery Exclusion Criteria: No exclusion criteria have been defined for this data collection.
References
Publications (0)
Data not yet available