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Transanal Total Mesorectal Excision for Rectal Cancer on Anal Physiology + Fecal Incontinence
NCT03283540 · View on ClinicalTrials.gov ↗
Study Summary
Low Anterior Resection (LAR) surgery can be done using various techniques. The traditional technique for performing the surgery is through one or multiple incision(s) in the muscular wall of the abdomen. This will allow the surgeon to gain access to inside the belly (Abdominal cavity). The surgeon will start from above and go down until reaching the rectum located low in the pelvis. The surgeon will then cut out the rectum along with some of the tissue surrounding it and reconnect the bowel. An alternative new approach to perform Low Anterior Resection is called the Trans-anal approach. In this technique, a tube containing special surgical tools is introduced through the anus (back passage), while the patient is asleep. These tools are used to free the rectum up from its surroundings so that it can be removed. Taking out the rectum via the opening of the anus (Trans-anal) is a relatively new surgical approach. This new technique enables the surgeon to better see deep in the pelvis which makes it easier to remove the rectum and its surrounding outer tissues while protecting other important nerves and organs located in the pelvis. However, it also involves inserting a tube through the opening of the anus to perform the rectal dissection. The alternative traditional way of doing the operation does not involve inserting such a tube because the access to the pelvis and rectum is gained from above through incision(s) in the abdominal wall. The anal sphincter is the medical name for the muscle layers surrounding the opening of the anus. The anal sphincter functions as a seal that can be opened to discharge body waste and allow the passage of stool. A damage to the anal sphincter can result in inability to fully control bowel movements, causing stool (feces) to leak unexpectedly. Because the Trans-anal approach involves inserting a tube through the opening of the anus for the duration of the surgery, this can lead to a certain degree of stretch and damage to the anal sph
Conditions Studied
Interventions
- PROCEDURE TaTME
- PROCEDURE TME
Study Locations (1)
Ohio
- Cleveland Clinic, Case Comprehensive Cancer Center — Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2017-09-25 |
| Est. Completion | 2025-08 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03283540
The ClinicalTrials.gov registry entry for NCT03283540 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Case Comprehensive Cancer Center, which has 276 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Rectal Cancer appearing as the primary indexed condition, and to 2 interventions — of which TaTME is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03283540 reports 1 study location spanning 1 distinct geographic area — top geographies include Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03283540 about?
NCT03283540 is a clinical study titled "Transanal Total Mesorectal Excision for Rectal Cancer on Anal Physiology + Fecal Incontinence". Low Anterior Resection (LAR) surgery can be done using various techniques. The traditional technique for performing the surgery is through one or multiple incision(s) in the muscular wall of the abdomen. This will allow the surgeon to gain access to inside the belly (Abdominal cavity). The surgeon w...
What is the current status of trial NCT03283540?
This trial is currently active not recruiting. The enrollment target is 39 participants. The study started on 2017-09-25. Estimated completion is 2025-08.
What conditions does trial NCT03283540 study?
This clinical trial studies the following conditions: Rectal Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03283540?
The interventions under investigation include: TaTME (PROCEDURE), TME (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03283540?
This trial is sponsored by Case Comprehensive Cancer Center, which has 276 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03283540 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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