Transanal Total Mesorectal Excision for Rectal Cancer on Anal Physiology + Fecal Incontinence
| Status: | Recruiting |
|---|---|
| Conditions: | Colorectal Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/9/2019 |
| Start Date: | September 25, 2017 |
| End Date: | April 2019 |
| Contact: | Tracy Hull, MD |
| Email: | hullt@ccf.org |
| Phone: | 216-445-6063 |
The Short Term Implications of Transanal Total Mesorectal Excision (TaTME) for Rectal Cancer on Anal Physiology and 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 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.
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.
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 effect of TaTME on fecal incontinence, quality of
life, and LARS utilizing validated questionnaires administered to patients preoperatively and
during postoperative follow-up.
Study Design This is a prospective two-arm cohort study. The study will include patients
already undergoing the standard-of-care, low anterior resection (LAR) for middle to low
rectal cancers. Low anterior resection of the rectum entails a sharp dissection
circumferentially around the mesorectum in an avascular plane between the visceral and
parietal layers of the endopelvic fascia in what is known as Total Mesorectal Excision (TME).
This dissection can be achieved transanally starting down in the pelvis and going up in what
is known as Transanal Total Mesorectal Excision- (TaTME). It can also be done via an
up-to-down approach beginning high in the abdomen and going low in the pelvis to achieve
dissection around the mesorectum. Access in the latter is achieved via laparoscopic or open
abdominal incisions with minimal anal sphincter dilation. In addition, the level of coloanal
anastomosis performed is potentially higher from the anal sphincter in comparison to TaTME.
TaTME on the other hand, involves introducing a special port (gelpoint path) transanally to
perform the TME dissection. In order to better evaluate the effect of TaTME on anal
sphincter, it is quintessential to include a control group with minimal anal sphincter
manipulation, thus the conventional abdominal (open or laparoscopic) TME group will serve as
a control.
studies and anorectal ultrasound administered post- and preoperatively.
Secondary Objective(s) To evaluate the effect of TaTME on fecal incontinence, quality of
life, and LARS utilizing validated questionnaires administered to patients preoperatively and
during postoperative follow-up.
Study Design This is a prospective two-arm cohort study. The study will include patients
already undergoing the standard-of-care, low anterior resection (LAR) for middle to low
rectal cancers. Low anterior resection of the rectum entails a sharp dissection
circumferentially around the mesorectum in an avascular plane between the visceral and
parietal layers of the endopelvic fascia in what is known as Total Mesorectal Excision (TME).
This dissection can be achieved transanally starting down in the pelvis and going up in what
is known as Transanal Total Mesorectal Excision- (TaTME). It can also be done via an
up-to-down approach beginning high in the abdomen and going low in the pelvis to achieve
dissection around the mesorectum. Access in the latter is achieved via laparoscopic or open
abdominal incisions with minimal anal sphincter dilation. In addition, the level of coloanal
anastomosis performed is potentially higher from the anal sphincter in comparison to TaTME.
TaTME on the other hand, involves introducing a special port (gelpoint path) transanally to
perform the TME dissection. In order to better evaluate the effect of TaTME on anal
sphincter, it is quintessential to include a control group with minimal anal sphincter
manipulation, thus the conventional abdominal (open or laparoscopic) TME group will serve as
a control.
Inclusion Criteria:
- 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 Criteria:
- 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.
We found this trial at
1
site
10201 Carnegie Avenue
Cleveland, Ohio 44195
Cleveland, Ohio 44195
Principal Investigator: Tracy Hull, MD
Phone: 216-445-6063
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