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NCT03283540 · ClinicalTrials.gov registry record
Transanal Total Mesorectal Excision for Rectal Cancer on Anal Physiology + Fecal Incontinence
A clinical trial of Rectal Cancer, sponsored by Case Comprehensive Cancer Center.
- Active
- Registry status
- 39
- Enrollment target
- 1
- Study location
NCT03283540: Active study of Rectal Cancer, sponsored by Case Comprehensive Cancer Center.
NCT03283540 is a study of Rectal Cancer that is active but no longer recruiting, run by Case Comprehensive Cancer Center. The registered enrollment target is 39 participants, below the 3,166-participant average among 70 other Rectal Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03283540, a study of Rectal Cancer, is active but no longer recruiting, sponsored by Case Comprehensive Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- 39 participants
- Enrollment target
- 1
- Study location
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
Primary Outcome
anal resting pressure will be estimated by taking measurements prior to operation and at 3-6 months post-operation. The mean change along with its 95% confidence interval will be reported for both groups
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 |
What the registry record for NCT03283540 still lists
NCT03283540 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 3,166-participant average among 70 other Rectal Cancer trials with a reported enrollment target (99% lower).
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.
NCT03283540 reports a single indexed study location in Ohio.
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.
What interventions are being tested in trial NCT03283540?
The interventions under investigation include: TaTME (PROCEDURE), TME (PROCEDURE).
Who is sponsoring clinical trial NCT03283540?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Rectal Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03283540's enrollment target sits among peer trials
39 49th of 70 higher than 21 of 70 other Rectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rectal Cancer 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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