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

NCT03283540 | Active Not Recruiting DMC

• 1 other identifier: CASE6217
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Rectal Cancer

Keywords

Low Anterior Resection

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  Up to 6 months post-operation

Secondary Outcomes (4)

• Change in Fecal Incontinence Severity Index Score (FISI)

  From before operation up to 12 weeks after operation

• Change in Cleveland Clinic Florida Fecal Incontinence (Wexner) score (CCF-FI)

  From before operation up to 12 weeks after operation

• Cleveland Clinic Global Quality of Life score (CGQL)

  From before operation up to 12 weeks after operation

• Low Anterior Resection Syndrome score (LARS)

  From before operation up to 12 weeks after operation

Study Arms (2)

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.

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.

Procedure: TME

Interventions

TaTME PROCEDURE

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

Also known as: Trans-anal Total Mesorectal Excision

TaTME

TME PROCEDURE

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.

Also known as: Total Mesorectal Excision

abdominal TME

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Surgical specimen will be evaluated by a pathologist as part of the standard of care for the quality of resection and TME plane assessment. Resections will be categorized as follows: R0-all gross disease resected by enblocresection with margins histologically free of disease; R1-all gross disease resected byenblocresection with margins histologically positive for disease; and R2-residual gross disease remains unresected

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Tracy Hull, MD

  Cleveland Clinic, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: September 14, 2017
• Study Start: September 25, 2017
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 17, 2025

Record last verified: 2025-08

Locations

US (1)