Status:
ACTIVE_NOT_RECRUITING
Transanal Total Mesorectal Excision for Rectal Cancer on Anal Physiology + Fecal Incontinence
Lead Sponsor:
Case Comprehensive Cancer Center
Conditions:
Rectal Cancer
Eligibility:
All Genders
18+ years
Brief 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 abdom...
Detailed Description
Primary Objective To evaluate effect of TaTME on anal sphincter via anorectal functional studies and anorectal ultrasound administered post- and preoperatively. Secondary Objective(s) To evaluate the...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Specific contraindications to laparoscopy.
- Intestinal obstruction or perforation.
- Histology other than adenocarcinoma.
- Subjects with rectal cancer arising in the background of inflammatory bowel disease.
- Subjects treated through local excision (ie, endoscopic, anorectal, or TEM approach).
- Subjects with synchronous metastases, except those with resectability criteria for the rectum.
- Subjects requiring a multivisceral resection or an abdominoperineal resection.
- Subjects converted to open technique.
- 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).
- Subjects with ultra-low rectal cancer where low anterior resection is converted to abdominoperineal resection intraoperatively due to sphincter involvement.
Key Trial Info
Start Date :
September 25 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2025
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT03283540
Start Date
September 25 2017
End Date
August 1 2025
Last Update
August 17 2025
Active Locations (1)
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1
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195