NCT03283540Active, not recruiting
Transanal Total Mesorectal Excision for Rectal Cancer on Anal Physiology + Fecal Incontinence
The Short Term Implications of Transanal Total Mesorectal Excision (TaTME) for Rectal Cancer on Anal Physiology and Fecal Incontinence
Source: ClinicalTrials.gov · Last updated 17 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 39 (actual)
- First submitted
- 12 Sept 2017
- Start date
- 25 Sept 2017
- Primary completion date
- 31 Aug 2025
- Lead sponsor
- Case Comprehensive Cancer Center
- Diseases
- Colorectal cancer
- NCT number
- NCT03283540
What you commit to
- Study type: Observational
- Participants enrolled: 39
- From 25 Sept 2017 to the primary completion date, 31 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects requiring a multivisceral resection or an abdominoperineal resection.
- Subjects with history of fecal incontinence. Fecal incontinence (FI) will be defined based on Rome IV Criteria for Colorectal Disorders 31 as the uncontrolled passage of solid or liquid stool, occurring at least two times in a 4-week period.
- Very low rectal cancers can cause a feeling of tenesmus associated with mucus leakage. As a result, patients will be asked if they had a bowel incontinence problem that dates back to a year ago (i.e. prior to the manifestation of current rectal cancer symptoms).
Other illness
- Intestinal obstruction or perforation.
- Subjects with rectal cancer arising in the background of inflammatory bowel disease.
- Subjects with ultra-low rectal cancer where low anterior resection is converted to abdominoperineal resection intraoperatively due to sphincter involvement.
Other
- Specific contraindications to laparoscopy.
- Histology other than adenocarcinoma.
- Subjects treated through local excision (ie, endoscopic, anorectal, or TEM approach).
- Subjects with synchronous metastases, except those with resectability criteria for the rectum.
- Subjects converted to open technique.
Who the study is looking for
- Subjects must have histologically confirmed Rectal Adenocarcinoma.
- Subjects must have Rectal Adenocarcinoma located up to 10 cm from the anal verge measured by preoperative MRI, proctoscopy, or digital rectal examination.
- Subjects must have treated with Transanal total mesorectal excision (TaTME) or abdominal transanal endoscopic microsurgery (TME) resections.
- Subjects must be Patients treated with curative intention.
- Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cleveland Clinic, Case Comprehensive Cancer Center Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.