Rectal CancerTEDRMARSNCT04023448
The Effect of Different Reconstruction Methods on Anterior Resection Syndrome
A study testing transverse coloplasty pouch in people with Rectal Cancer and Low Anterior Resection Syndrome, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
The incidence of prerectal resection syndrome (LARS) after middle and low rectal cancer surgery is as high as 70%, which seriously affects the quality of life of patients. Studies have shown that colon pouch can reduce and alleviate LARS symptoms. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Rectal Cancer, Low Anterior Resection Syndrome
- What is being tested?
- transverse coloplasty pouch
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20 years old ≤80 years old, regardless of gender, signed informed consent,
- BMI≤kg/m^2,
- Primary rectal lesions are pathologically diagnosed as rectal adenocarcinoma by endoscopic biopsy,
- The distance between the tumor and the anal margin is 5cm to 12cm,
- Preoperative tumor stage is T1-4N0-3M0,(according to AJCC-8th TNM tumor staging),
- Normal anorectal function and LARS score ≤20.
Who cannot join
- Patients with inflammatory bowel disease, chronic constipation, irritable bowel syndrome and other intestinal diseases that may affect bowel function,
- Patients with large tumors or extensive invasion of surrounding tissues and organs, TME is not applicable,
- Long-term use of drugs (such as morphine) that may affect bowel function,
- Patients with a history of abdominal, pelvic and anorectal surgery,
- Patients with severe mental illness or who cannot be evaluated due to cultural or psychological reasons.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Third Affiliated Hospital of Sun Yat-Sen university
Guanzhou, Guangdong, 510000
Bo Wei, M.D, (86)20-85252228, sanpi2013@163.com
About this study
Official title: The Effect of Different Reconstruction Methods in Laparoscopic Anterior Rectal Resection on Postoperative Anterior Resection Syndrome：a Randomized Controlled Trial
The incidence of prerectal resection syndrome (LARS) after middle and low rectal cancer surgery is as high as 70%, which seriously affects the quality of life of patients. Studies have shown that colon pouch can reduce and alleviate LARS symptoms. However, most previous studies focused on open surgery, and the evaluation index lacked objectivity. Therefore, in the context of minimally invasive rectal cancer surgery, it is necessary to re-evaluate the value of improved surgical methods for the prevention of LARS, so as to improve the quality of life of patients.
Read the detailed description
The incidence of prerectal resection syndrome (LARS) after middle and low rectal cancer surgery is as high as 70%, which seriously affects the quality of life of patients. LARS may be related to the injury of anal internal sphincter, anal sensory nerve injury, defecation reflex pathway injury, changes in anorectal Angle and rectum sigmoid Angle, changes in new rectal sensory function and compliance, and changes in dynamics,etc. After AR surgery, the rectum loses its good compliance and the storage capacity is reduced, which is one of the important reasons for the increased frequency and urgency of defecation.Therefore, on the basis of traditional colon-rectum (or anal canal) end-to-end anastomosis, "J" shaped pouch anastomosis, end-to-end anastomosis, coloplasty and other special anastomosis methods were performed. Meanwhile, for the lack of objective evaluation index, the results were not credible. The LARS score was first published in 2012,and has been validated, evaluated, or used as an outcome measure in more than 30 published scientific papers. Further more,laparoscopic surgery is widely used in gastrointestinal surgery. Herein, current randomized controlled trial comparing coloplasty with straight colorectal anastomosis in LARS in order to guide clinical practise was conducted.
- Conditions
- Rectal Cancer, Low Anterior Resection Syndrome
- Being tested
- transverse coloplasty pouch
- Keywords
- rectal cancer
- Medical subject headings
- Rectal Neoplasms, Low Anterior Resection Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transverse coloplasty pouchProcedure or surgery
a transverse coloplasty pouch was performed before end to end colon-rectum (or anal canal) anastomosis
| Study group | Role | What they receive |
|---|---|---|
| coloplasty(CP) | Experimental | After purse-string suture and ligation of the head of the stapler at the colonic end, 5cm away from the colonic end, 5cm longitudinal incision was made to the proximal end of the teniae coli in the anterior wall of the colon, transverse suture was performed, and the plasmomuscular layer was embedded, then end to end colon-rectum (or anal canal) anastomosis was performed Receives: Procedure: transverse coloplasty pouch |
| straight colorectal anastomosis (SCA) | No intervention | End to end colon-rectum (or anal canal) anastomosis was performed routinely |
What is being measured
The primary outcome is the main question the study is designed to answer.
anterior resection syndrome incidence
LARS score≥21
Measured: 1 year after surgery
Secondary outcomes (4)
Early postoperative complication incidence
Anastomotic fistula, Hemorrhage, Pulmonary infection，Death
Measured: 30 days after surgery
Length of hospital stay after surgery
Length of hospital stay
Measured: 30 days after surgery
Bowel recovery time
Time interval from surgery to flatus and defecation
Measured: 7 days after surgery
Long-term postoperative complication incidence
Anastomotic fistula, Hemorrhage，Intestinal obstruction
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start1 Sep 2019 (estimated)
- Primary completion1 May 2022 (estimated)
- Study completion1 Sep 2022 (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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongbo Wei, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Hongbo Wei, Ph.D, Study director, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023448
- Sponsor's protocol ID
- CPSCA-01
- Acronym
- TEDRMARS
- Status last verified
- Jul 2019
- First submitted
- 13 Jul 2019
- Last updated
- 17 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Reconstruction Methods in Laparoscopic Anterior Rectal Resection on Postoperative Anterior Resection Syndrome：a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04023448
- Acronym / sponsor ID
- TEDRMARS / CPSCA-01
- Conditions
- Rectal Cancer, Low Anterior Resection Syndrome
- Keywords
- rectal cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 17 Jul 2019 (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.
The incidence of prerectal resection syndrome (LARS) after middle and low rectal cancer surgery is as high as 70%, which seriously affects the quality of life of patients. Studies have shown that colon pouch can reduce and alleviate LARS symptoms. However, most previous studies focused on open surgery, and the evaluation index lacked objectivity. Therefore, in the context of minimally invasive rectal cancer surgery, it is necessary to re-evaluate the value of improved surgical methods for the prevention of LARS, so as to improve the quality of life of patients.
Detailed description
The incidence of prerectal resection syndrome (LARS) after middle and low rectal cancer surgery is as high as 70%, which seriously affects the quality of life of patients. LARS may be related to the injury of anal internal sphincter, anal sensory nerve injury, defecation reflex pathway injury, changes in anorectal Angle and rectum sigmoid Angle, changes in new rectal sensory function and compliance, and changes in dynamics,etc. After AR surgery, the rectum loses its good compliance and the storage capacity is reduced, which is one of the important reasons for the increased frequency and urgency of defecation.Therefore, on the basis of traditional colon-rectum (or anal canal) end-to-end anastomosis, "J" shaped pouch anastomosis, end-to-end anastomosis, coloplasty and other special anastomosis methods were performed. Meanwhile, for the lack of objective evaluation index, the results were not credible. The LARS score was first published in 2012,and has been validated, evaluated, or used as an outcome measure in more than 30 published scientific papers. Further more,laparoscopic surgery is widely used in gastrointestinal surgery. Herein, current randomized controlled trial comparing coloplasty with straight colorectal anastomosis in LARS in order to guide clinical practise was conducted.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| coloplasty(CP) | Experimental | Procedure: transverse coloplasty pouchAfter purse-string suture and ligation of the head of the stapler at the colonic end, 5cm away from the colonic end, 5cm longitudinal incision was made to the proximal end of the teniae coli in the anterior wall of the colon, transverse suture was performed, and the plasmomuscular layer was embedded, then end to end colon-rectum (or anal canal) anastomosis was performed |
| straight colorectal anastomosis (SCA) | No intervention | –End to end colon-rectum (or anal canal) anastomosis was performed routinely |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 20 years old ≤80 years old, regardless of gender, signed informed consent,
- BMI≤kg/m^2,
- Primary rectal lesions are pathologically diagnosed as rectal adenocarcinoma by endoscopic biopsy,
- The distance between the tumor and the anal margin is 5cm to 12cm,
- Preoperative tumor stage is T1-4N0-3M0,(according to AJCC-8th TNM tumor staging),
Key exclusion criteria (5 listed)
- Patients with inflammatory bowel disease, chronic constipation, irritable bowel syndrome and other intestinal diseases that may affect bowel function,
- Patients with large tumors or extensive invasion of surrounding tissues and organs, TME is not applicable,
- Long-term use of drugs (such as morphine) that may affect bowel function,
- Patients with a history of abdominal, pelvic and anorectal surgery,
- Patients with severe mental illness or who cannot be evaluated due to cultural or psychological reasons.
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 |
|---|---|---|
| transverse coloplasty poucha transverse coloplasty pouch was performed before end to end colon-rectum (or anal canal) anastomosis | Procedure or surgery | coloplasty(CP) |
Primary outcome
anterior resection syndrome incidence
Time frame: 1 year after surgery
LARS score≥21
4 secondary outcomes
Early postoperative complication incidence
Time frame: 30 days after surgery
Length of hospital stay after surgery
Time frame: 30 days after surgery
Bowel recovery time
Time frame: 7 days after surgery
Long-term postoperative complication incidence
Time frame: 1 year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
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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.
Hongbo Wei, Ph.D study director
Third Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transverse coloplasty pouch in people with Rectal Cancer and Low Anterior Resection Syndrome, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 17 Jul 2019. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bo Wei, M.D ((86)20-85252228, sanpi2013@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anterior resection syndrome incidence (time frame: 1 year after surgery). 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 Jul 2019.