Clinical trial · Interventional
Anal Sphincter Prosthesis in Treating Patients Who Are Undergoing Surgery for Anal or Rectal Cancer
Total Anorectal Reconstruction With The American Medical Systems, Inc. Acticon Neosphincter Prosthesis After Abdominoperineal Resection
- 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)
RATIONALE: An anal sphincter prosthesis may replace the need for a permanent colostomy and may improve the quality of life of patients who are undergoing surgery for anal or rectal cancer. PURPOSE: Clinical trial to study the effectiveness of an anal sphincter prosthesis in treating patients who have anal or rectal cancer and are undergoing surgery to remove the anus and rectum.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Cancer | Malignant Anal Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Perioperative/Postoperative Complications | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| management of therapy complications | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Anal Sphincter Prosthesis
- description
- All patients will follow a common treatment algorithm. Anorectal reconstruction with the ABS neosphincter device will be a staged surgical approach. Routine postoperative testing will then be performed at 6 months (+/- 8 weeks) and 12 months (+/- 8 weeks), following ileostomy reversal which we have designated as time zero. Postoperative testing will include completion of a series of questionnaires.
- interventionNames
- Procedure: conventional surgery
- Procedure: management of therapy complications
Primary outcomes (1)
- measure
- Determine the risk of complications and feasibility of total anorectal reconstruction using the Acticon Neosphincter prosthesis after abdominoperineal resection in patients with anal or rectal cancer.
- timeFrame
- 2 years
Secondary outcomes (1)
- measure
- Determine continence, bowel function, and quality of life of patients treated with this surgery.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Subject Inclusion Criteria: * Histologically proven cancer of distal rectum or anus * Not candidates for sphincter preservation * \> or = 18 years of age * an acceptable risk for surgery and general anesthesia * sufficient dexterity and mental capacity to operate the device * willing and able to give valid Informed Consent Subject Exclusion Criteria: * Patients with recurrent anorectal cancer * Patients with metastatic anorectal cancer * Patients at high risk for local recurrence * Patients with active pelvic sepsis * Patients currently enrolled in another study involving an investigational product
References
Publications (0)
Data not yet available