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Active, not recruiting No phase listed Observational

Transanal Total Mesorectal Excision for Rectal Cancer on Anal Physiology + Fecal Incontinence

ClinicalTrials.gov ID: NCT03283540

Public ClinicalTrials.gov record NCT03283540. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 11:15 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

The Short Term Implications of Transanal Total Mesorectal Excision (TaTME) for Rectal Cancer on Anal Physiology and Fecal Incontinence

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 sphincter muscles. The main aim of this study is to compare the effect of the these two possible approaches to perform "Low Anterior Resection" operation on the muscles of the anal sphincter and whether they are associated with stool seepage from the anus after the operation. Whether the patient is receiving the traditional or trans-anal approach is not related to the subject's participation in the study and is decided by the treating surgeon based on medical and surgical reasoning.

Study identification

NCT ID
NCT03283540
Recruitment status
Active, not recruiting
Study type
Observational
Phase
Not listed
Enrollment
39 participants

Conditions and interventions

Conditions

Interventions

Procedure

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 24, 2017
Primary completion
Jul 31, 2025
Completion
Jul 31, 2025
Last update posted
Aug 16, 2025

2017 – 2025

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Cleveland Clinic, Case Comprehensive Cancer Center Cleveland Ohio 44195

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03283540, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 16, 2025 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03283540 live on ClinicalTrials.gov.

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