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Aim of the study is to evaluate long-term success rate of Biodesign® anal fistula plug for treatment of complex trans-sphincteric anal fistulas.
A prospective series of 95 consecutive patients (30 with inflammatory bowel disease) treated with Biodesign® plug in May 2006 - October 2009. All patients were preoperatively assessed by physical examination and 3D endoanal ultrasound, and treated with a loose seton. The patients were assessed by physical examination and 3D endoanal ultrasound at 2 weeks, 3 months, and 6 to 12 months after surgery. Long-term follow-up was carried out using a questionnaire, and, when indicated, physical examination and 3D endoanal ultrasound.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Complex anal fistula | Patients with complex transsphincteric anal fistulas were treated with Biodesign® plug. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biodesign® anal fistula plug | Procedure | Patient in general anesthesia and lithotomy position. Mucosa excision of the internal fistula opening is performed. The plug was prepared in 0.9% sodium chloride, and secured to the endoluminal brush by a suture with a 2-0 vicryl tie. The narrow end of the of the plug was then pulled through the internal opening into the fistula tract. The plug was pulled until it covered the whole length of the fistula and blocked the internal opening, the excess plug material coming out through the external opening. The plug was fixed at the internal opening by reabsorbable 3-0 sutures. Special attention was paid to ensuring that the plug was covered by mucosa when closing the internal opening. The excess plug material was trimmed by the external opening that was left open for drainage. |
| Measure | Description | Time Frame |
|---|---|---|
| Fistula recurrence; Technical failure | Plug fallen out | Week 2 |
| Fistula recurrence; Infection | Surgical site infection | Week 2 |
| Fistula recurrence; Infection | Surgical site infection | Month 3 |
| Fistula recurrence; Infection | Surgical site infection | Month 6-12 |
| Fistula recurrence; Infection | Surgical site infection | Through study completion, an average of 8 years |
| Fistula recurrence; New opening | Faeces coming through external opening | Week 2 |
| Fistula recurrence; New opening | Faeces coming through external opening | Month 3 |
| Fistula recurrence; New opening | Faeces coming through external opening | Month 6-12 |
| Fistula recurrence; New opening | Faeces coming through external opening |
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Inclusion Criteria:
Exclusion Criteria:
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All patients with anal fistulas not treatable with a simple fistulotomy offered to participate.
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| Name | Affiliation | Role |
|---|---|---|
| Marianne Starck, MD, PhD | Region Skane | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skåne University Hospital | Malmö | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37203207 | Derived | Aho Falt U, Zawadzki A, Starck M, Bohe M, Regner S, Johnson LB. Postoperative three-dimensional endoanal ultrasound findings and relation to anal fistula plug failure. Scand J Gastroenterol. 2023 Jul-Dec;58(10):1200-1206. doi: 10.1080/00365521.2023.2212310. Epub 2023 May 18. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 22, 2021 | |
| Reset | Nov 22, 2021 | |
| Release | Feb 9, 2023 | |
| Reset | Nov 22, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 22, 2021 | Nov 22, 2021 | |||
| Feb 9, 2023 |
| ID | Term |
|---|---|
| D012003 | Rectal Fistula |
| ID | Term |
|---|---|
| D007412 | Intestinal Fistula |
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D000070635 | Punctal Plugs |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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|
|
| Through study completion, an average of 8 years |
| Nov 22, 2023 |
| D005767 | Gastrointestinal Diseases |
| D012002 | Rectal Diseases |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |