Rectal CancerNCT03283540
Transanal Total Mesorectal Excision for Rectal Cancer on Anal Physiology + Fecal Incontinence
An observational study of Rectal Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- TaTME and TME
- Type of treatment
- Surgery or procedure
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2017to Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Men, women and members of all races and ethnic groups are eligible for this trial. Patients will be identified prospectively by the treating Co-Investigator surgeon according to the inclusion/exclusion criteria. The outpatient clinic schedule will be regularly screened ahead of time to identify potential candidates that fit the enrollment criteria.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
Official title: 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.
Read more
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.
Read the 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 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.
- Conditions
- Rectal Cancer
- Being tested
- TaTME, TME
- Keywords
- Low Anterior Resection
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TaTMEProcedure or surgery
Also called Trans-anal Total Mesorectal Excision
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. This dissection can be achieved transanally starting down in the pelvis and going up in what is known as Transanal Total Mesorectal Excision
TMEProcedure or surgery
Also called Total Mesorectal Excision
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. This surgery 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.
| Study group | Role | What they receive |
|---|---|---|
| TaTME | Trans-anal Total Mesorectal Excision (TaTME) is the visualization and dissection of the rectum located deep in the pelvis. In it, a trans-anal port is inserted for the duration of the surgery. Multiple surgical tools are then introduced through the port and the rectum is resected from down-to-up under direct visualization. Receives: Procedure: TaTME | |
| abdominal TME | Total Mesorectal Excision involves resecting the rectum along with its surrounding Mesorectal plane. If the anal sphincter is spared, this surgery is named Low Anterior resection (LAR) for rectal cancer. Traditionally, TME dissection in LAR is performed through open or laparoscopic incisions(s) made in the abdominal wall. Mobilization of the splenic flexure along with sigmoid dissection follows. Lastly, the rectum is dissected in accordance with TME principles from above. This "up-to-down" approach is known as abdominal TME. Receives: Procedure: TME |
What is being measured
The primary outcome is the main question the study is designed to answer.
average change in anal resting pressure
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
Measured: Up to 6 months post-operation
maximum squeeze pressure
maximum squeeze 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
Measured: Up to 6 months post-operation
Average intra-balloon pressure
Average intra-balloon 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
Measured: Up to 6 months post-operation
Secondary outcomes (4)
Change in Fecal Incontinence Severity Index Score (FISI)
Self-Reported, 4-question survey describing frequency of incontinence
Measured: From before operation up to 12 weeks after operation
Change in Cleveland Clinic Florida Fecal Incontinence (Wexner) score (CCF-FI)
Self-Reported, 5-question survey scored 0-4 were higher scores indicate greater incontinence
Measured: From before operation up to 12 weeks after operation
Cleveland Clinic Global Quality of Life score (CGQL)
Self-Reported, 4-question survey scored 1-10 where higher scores indicate greater quality of life
Measured: From before operation up to 12 weeks after operation
Low Anterior Resection Syndrome score (LARS)
Self-Reported, 5-question survey with total scores ranging from 0-42 where higher scores indicating less bowel function
Measured: From before operation up to 12 weeks after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start25 Sep 2017
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tracy Hull, MD, Principal investigator, Cleveland Clinic, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03283540
- Sponsor's protocol ID
- CASE6217
- Status last verified
- Aug 2025
- First submitted
- 12 Sep 2017
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Short Term Implications of Transanal Total Mesorectal Excision (TaTME) for Rectal Cancer on Anal Physiology and Fecal Incontinence
- ClinicalTrials.gov ID
- NCT03283540
- Acronym / sponsor ID
- CASE6217
- Conditions
- Rectal Cancer
- Keywords
- Low Anterior Resection
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 14 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TaTME | – | Procedure: TaTMETrans-anal Total Mesorectal Excision (TaTME) is the visualization and dissection of the rectum located deep in the pelvis. In it, a trans-anal port is inserted for the duration of the surgery. Multiple surgical tools are then introduced through the port and the rectum is resected from down-to-up under direct visualization. |
| abdominal TME | – | Procedure: TMETotal Mesorectal Excision involves resecting the rectum along with its surrounding Mesorectal plane. If the anal sphincter is spared, this surgery is named Low Anterior resection (LAR) for rectal cancer. Traditionally, TME dissection in LAR is performed through open or laparoscopic incisions(s) made in the abdominal wall. Mobilization of the splenic flexure along with sigmoid dissection follows. Lastly, the rectum is dissected in accordance with TME principles from above. This "up-to-down" approach is known as abdominal TME. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men, women and members of all races and ethnic groups are eligible for this trial. Patients will be identified prospectively by the treating Co-Investigator surgeon according to the inclusion/exclusion criteria. The outpatient clinic schedule will be regularly screened ahead of time to identify potential candidates that fit the enrollment criteria.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TaTMEAlso: Trans-anal Total Mesorectal ExcisionLow 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. This dissection can be achieved transanally starting down in the pelvis and going up in what is known as Transanal Total Mesorectal Excision | Procedure or surgery | TaTME |
| TMEAlso: Total Mesorectal ExcisionLow 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. This surgery 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. | Procedure or surgery | abdominal TME |
Primary outcome
average change in anal resting pressure
Time frame: Up to 6 months post-operation
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
maximum squeeze pressure
Time frame: Up to 6 months post-operation
maximum squeeze 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
Average intra-balloon pressure
Time frame: Up to 6 months post-operation
Average intra-balloon 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
4 secondary outcomes
Change in Fecal Incontinence Severity Index Score (FISI)
Time frame: From before operation up to 12 weeks after operation
Change in Cleveland Clinic Florida Fecal Incontinence (Wexner) score (CCF-FI)
Time frame: From before operation up to 12 weeks after operation
Cleveland Clinic Global Quality of Life score (CGQL)
Time frame: From before operation up to 12 weeks after operation
Low Anterior Resection Syndrome score (LARS)
Time frame: From before operation up to 12 weeks after operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tracy Hull, MD principal investigator
Cleveland Clinic, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
average change in anal resting pressure (time frame: Up to 6 months post-operation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.