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NCT04916067 · ClinicalTrials.gov registry record · NA
Stoma Closure and Reinforcement Trial ll
A NA study, sponsored by Dartmouth-Hitchcock Medical Center.
- Terminated
- Registry status
- NA
- Development phase
- 8
- Enrollment target
NCT04916067: Clinical Trial NA study, sponsored by Dartmouth-Hitchcock Medical Center.
NCT04916067 is a NA study that was terminated before completion, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 8 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04916067, a NA study, was terminated before completion, sponsored by Dartmouth-Hitchcock Medical Center.
- TERMINATED
- Registry status
- NA
- Development phase
- 8 participants
- Enrollment target
Study Summary
Hernia formation at sites of ostomy closure is a common complication. The investigator believes that using evidence based hernia repair techniques as a preventive measure during closure of ostomies will reduce the incidence of hernia formation. In this trial, the investigator will pilot a novel technique of monofilament bioresorbable mesh reinforcement of the abdominal wall defects that remain after closure of an ileostomy to evaluate for safety and begin to evaluate the effectiveness compared to standard techniques.
Primary Outcome
Number of wound occurrences (defined as superficial surgical site infection \[s-SSI\], deep surgical site infection \[d-SSI\], organ space surgical site infection \[O-SSI\], dehiscence, and seroma formation) at 30 days, with particular attention to wound occurrences requiring procedural intervention, including but not limited to, operative debridement, radiographically guided drain placement, or excision of the mesh will be assessed.
Interventions
- DEVICE Mesh Implantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2021-12-01 |
| Est. Completion | 2024-08-05 |
| Phase | NA |
Why NCT04916067 stopped before completion
NCT04916067 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Mesh Implantation is the first listed.
NCT04916067 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04916067 about?
NCT04916067 is a clinical study titled "Stoma Closure and Reinforcement Trial ll". Hernia formation at sites of ostomy closure is a common complication. The investigator believes that using evidence based hernia repair techniques as a preventive measure during closure of ostomies will reduce the incidence of hernia formation. In this trial, the investigator will pilot a novel tech...
What is the current status of trial NCT04916067?
This trial is currently terminated. It is a NA study. The enrollment target is 8 participants. The study started on 2021-12-01. Estimated completion is 2024-08-05.
What interventions are being tested in trial NCT04916067?
The interventions under investigation include: Mesh Implantation (DEVICE).
Who is sponsoring clinical trial NCT04916067?
This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04916067's enrollment target sits among peer trials
8 1976th of 2000 higher than 19 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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