Bowel; Functional SyndromeNCT03669237
Postoperative Bowel Function After SPS by Different Reconstruction Methods
A study testing different reconstruction methods in people with Bowel; Functional Syndrome, run by YE Yingjiang at 1 site in China.
Trial summary
Colorectal cancer is one of the most common malignant tumors in the world. Surgery is still the main treatment for rectal cancer. With the popularization of stapler technology and the application of preoperative neoadjuvant therapy, more and more patients with rectal cancer have treated sphincter preservation surgery… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Bowel; Functional Syndrome
- What is being tested?
- different reconstruction methods
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 12 Oct 2018to 31 Jul 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The rectal adenocarcinoma is proved by pathology before surgery
- The lower margin of the tumor is less than 12cm higher from the anal verge under no anesthesia measured
- The tumor can be excised discussed by MDT
- Anus preserving operation can be performed
- ECOG score ranges between 0 and 2
- The estimate life is supposed to be more than 12 months
- The informed consent should be signed
Who cannot join
- The patient can not follow the experimental scheme
- The case is an emergency
- The patient is in pregnant or breast-feeding
- TME surgery can not be performed
- One-stage anastomosis can not be performed
- The patient has a history of anus surgery or rectal surgery
Show all 11Show fewer
- The patient has a history of left hemicolectomy
- The patient has a long history of bowel dysfunction,such as diarrhea or dysporia before surgery
- The patient has cognitive disorder or communication disorder
- The patient has repeat infection or other disorders poorly controlled
- The patient joins other clinical trail that may disturb the bowel function
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: A Randomized Study From Single Institutions on Postoperative Bowel Function Following Sphincter Preservation Surgery in Patients With Rectal Cancer by Different Reconstruction Methods
Colorectal cancer is one of the most common malignant tumors in the world. Surgery is still the main treatment for rectal cancer. With the popularization of stapler technology and the application of preoperative neoadjuvant therapy, more and more patients with rectal cancer have treated sphincter preservation surgery for rectal cancer. postoperative observation found that some patients with rectal cancer anus-preserving surgery had different degrees of defecation dysfunction after surgery, such as incontinence, tightness, increased frequency of bowel movements, and constipation. These clinical symptoms have been classified as "Low anterior resection syndrome (LARS)" in recent years.Now there is no treatment for LARS.Meanwhile,J-pouch and side-to-end anastomosis can help the patients,but there is few trials can prove this.This trial means to prove weather side-to-end anastomosis can improve bowel of rectal patients afer surgery.
Read the detailed description
Colorectal cancer is one of the most common malignant tumors in the world. There are more than 1.7 million new cases worldwide each year, accounting for 9.7% of all cancers. Among them, 840,000 deaths, accounting for 8.5% of all cancer deaths, mortality Second only to lung cancer, liver cancer and gastric cancer. China is a country with high incidence of colorectal cancer, and its morbidity and mortality are the fifth highest in malignant tumors. Rectal cancer is the most common type of colorectal cancer. The incidence of rectal cancer in China is 14.0/100,000, which is the 7th cancer incidence rate in China.
Surgery is still the main treatment for rectal cancer. With the popularization of stapler technology and the application of preoperative neoadjuvant therapy, more and more patients with rectal cancer have treated sphincter preservation surgery for rectal cancer. The proportion of permanent ostomy has dropped to 16.9% to 29% . With the popularity of TME principles worldwide, the standardized treatment of rectal cancer is becoming more and more stable, and the postoperative survival rate of patients is steadily increasing. However, postoperative observation found that some patients with rectal cancer anus-preserving surgery had different degrees of defecation dysfunction after surgery, such as incontinence, tightness, increased frequency of bowel movements, and constipation. These clinical symptoms have been classified as "Low anterior resection syndrome (LARS)" in recent years. The research on LARS is still in its infancy, and its pathogenesis, influencing factors, pathophysiology and other explorations are not deep enough. Behind the various symptoms of low anterior resection syndrome is a complex pathophysiological basis. The symptoms and severity are affected by many changes in intestinal anatomy, nerve injury, postoperative healing process, diet structure and psychological status. The risk factors associated with the onset of defecation dysfunction after rectal cancer anal sphincter preservation include radiotherapy, total mesorectal excision, and tumor location. The role of various risk factors in the pathogenesis of defecation dysfunction after rectal cancer anal sphincter preservation is still controversial. At present, the diagnosis, grading and treatment of LARS are still in the exploration stage, and there is still no effective treatment.
Since the 1980s, a variety of colon-rectal anastomosis methods have been used in clinical practice to improve the dysfunction of rectal cancer after anal sphincter preservation, including J-pouch anastomosis, Colon transverse anastomosis, and end-to-side anastomosis. Each of the above three methods has its advantages and disadvantages: J-type storage bag improves the postoperative bowel movement anastomosis effect, but the technique is complicated and has more anastomotic symptoms; the colon transverse of the colon has a wide application range but the effect of improving the defecation function is poor; It has the longest history, but the time to apply to functional protection is the shortest, and there are few studies. Huttner et al published a meta-analysis published in 2015 (including 1636 cases from 21 clinical trials reports. Compared with end-to-end anastomosis, J-pouch can reduce the frequency of defecation and antidiarrheal drugs after 1 year after surgery. Similar results have been achieved with end-to-side anastomosis and colonic angioplasty; a review published by Brown et al also suggests that J-pouch can reduce the frequency of defecation and urgency of bowel movements during early (0-8 months) and mid-term (8-18 Months) .The end-to-side anastomosis achieved similar effects in each stage of the J-pouch, so it can be inferred that the end-to-side anastomosis (relative to end-to-end anastomosis) can improve postoperative defecation function. A retrospective study of end-to-end anastomosis and end-to-end anastomosis published in China also found that end-to-side anastomosis can reduce bowel movements and improve postoperative defecation function at 6 months after surgery. However, there is still no prospective clinical trial comparing the end-to-side anastomosis and end-to-end anastomosis for postoperative intestinal function. The ideal anastomosis should meet the characteristics of exact effect, simple operation and low complications. The end-to-side anastomosis is one of the potential choices, but its validity and safety lack relevant research evidence and need further study.
- Conditions
- Bowel; Functional Syndrome
- Being tested
- different reconstruction methods
- Keywords
- Bowel Function, Sphincter Preservation Surgery, Reconstruction Method
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
different reconstruction methodsProcedure or surgery
Different reconstruction methods should be performed after sphincter preservation surgery in two groups.The methods include end-to-end anastomosis or end-to-side anastomosis
| Study group | Role | What they receive |
|---|---|---|
| end-to-side anastomosis | Experimental | All surgeries during the study were performed by the same experienced surgical team and were performed following TME principles. End-to-side anastomosis was used to perform colorectal anastomosis after primary tumor resection. Receives: Procedure: different reconstruction methods |
| end-to-end anastomosis | No intervention | All surgeries during the study were performed by the same experienced surgical team and were performed following TME principles. After resection of the primary tumor, end-to-end anastomosis was used for colorectal anastomosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative bowel function of 1 year after surgery
Each patients will be interviewed by telephone and asked to answer a copy of LARS score questionnaire.
Designed for LARS patients only, the LARS score is a total score questionnaire containing five single choice questions with a corresponding score for each option. Each of the five questions tested a single symptom of the bowel function, including incontinence for flatus(score value from 0 to 7), incontinence for liquid stool (score value from 0 to 3), frequency of bowel movement (score value from 0 to 5), clustering of stools (score value from 0 to 11) and urgency (score value from 0 to 16). According to the total score of each patient, the questionnaire can evaluate the defecation function of the subject, which is divided into three categories from best to worst: no LARS (0 to 20), miner LARS (21 to 29) and major LARS (30 to 42).
Measured: 1 year after surgery
Secondary outcomes (3)
Operation safety
surgery time, blood loss, quality of surgical specimen, etc. will be record to assess safety of each reconstruction method.
The incidence of key post-operative complication like anastomosis leakage, post-operative bleeding, server bowel obstruction, intra-abdominal abscess and surgical site infection, etc. will be record.
Measured: Data will be assess during operation and at the last visit before check-off.
Postoperative bowel function within the first year
Each patients will be interviewed by telephone and asked to answer a copy of LARS score questionnaire.
Designed for LARS patients only, the LARS score is a total score questionnaire containing five single choice questions with a corresponding score for each option. Each of the five questions tested a single symptom of the bowel function, including incontinence for flatus(score value from 0 to 7), incontinence for liquid stool (score value from 0 to 3), frequency of bowel movement (score value from 0 to 5), clustering of stools (score value from 0 to 11) and urgency (score value from 0 to 16). According to the total score of each patient, the questionnaire can evaluate the defecation function of the subject, which is divided into three categories from best to worst: no LARS (0 to 20), miner LARS (21 to 29) and major LARS (30 to 42).
Measured: from the first month to the 11th month
Postoperative bowel function of the long stable result
Each patients will be interviewed by telephone and asked to answer a copy of LARS score questionnaire after one year of operation.
Measured: 16 months after the primary surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start12 Oct 2018
- Primary completion31 Dec 2021
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel; Functional SyndromeStudies 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
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- YE Yingjiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, YE Yingjiang, Peking University People's Hospital
- Investigators
- Yingjiang Ye, M.D. & PhD., Study chair, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03669237
- Sponsor's protocol ID
- Bas-1904
- Status last verified
- Dec 2022
- First submitted
- 11 Sep 2018
- Last updated
- 29 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study From Single Institutions on Postoperative Bowel Function Following Sphincter Preservation Surgery in Patients With Rectal Cancer by Different Reconstruction Methods
- ClinicalTrials.gov ID
- NCT03669237
- Acronym / sponsor ID
- Bas-1904
- Conditions
- Bowel; Functional Syndrome
- Keywords
- Bowel Function, Sphincter Preservation Surgery, Reconstruction Method
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- YE YingjiangUniversity, hospital or other
- Study start
- 12 Oct 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 13 Sep 2018 (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.
Colorectal cancer is one of the most common malignant tumors in the world. Surgery is still the main treatment for rectal cancer. With the popularization of stapler technology and the application of preoperative neoadjuvant therapy, more and more patients with rectal cancer have treated sphincter preservation surgery for rectal cancer. postoperative observation found that some patients with rectal cancer anus-preserving surgery had different degrees of defecation dysfunction after surgery, such as incontinence, tightness, increased frequency of bowel movements, and constipation. These clinical symptoms have been classified as "Low anterior resection syndrome (LARS)" in recent years.Now there is no treatment for LARS.Meanwhile,J-pouch and side-to-end anastomosis can help the patients,but there is few trials can prove this.This trial means to prove weather side-to-end anastomosis can improve bowel of rectal patients afer surgery.
Detailed description
Colorectal cancer is one of the most common malignant tumors in the world. There are more than 1.7 million new cases worldwide each year, accounting for 9.7% of all cancers. Among them, 840,000 deaths, accounting for 8.5% of all cancer deaths, mortality Second only to lung cancer, liver cancer and gastric cancer. China is a country with high incidence of colorectal cancer, and its morbidity and mortality are the fifth highest in malignant tumors. Rectal cancer is the most common type of colorectal cancer. The incidence of rectal cancer in China is 14.0/100,000, which is the 7th cancer incidence rate in China.
Surgery is still the main treatment for rectal cancer. With the popularization of stapler technology and the application of preoperative neoadjuvant therapy, more and more patients with rectal cancer have treated sphincter preservation surgery for rectal cancer. The proportion of permanent ostomy has dropped to 16.9% to 29% . With the popularity of TME principles worldwide, the standardized treatment of rectal cancer is becoming more and more stable, and the postoperative survival rate of patients is steadily increasing. However, postoperative observation found that some patients with rectal cancer anus-preserving surgery had different degrees of defecation dysfunction after surgery, such as incontinence, tightness, increased frequency of bowel movements, and constipation. These clinical symptoms have been classified as "Low anterior resection syndrome (LARS)" in recent years. The research on LARS is still in its infancy, and its pathogenesis, influencing factors, pathophysiology and other explorations are not deep enough. Behind the various symptoms of low anterior resection syndrome is a complex pathophysiological basis. The symptoms and severity are affected by many changes in intestinal anatomy, nerve injury, postoperative healing process, diet structure and psychological status. The risk factors associated with the onset of defecation dysfunction after rectal cancer anal sphincter preservation include radiotherapy, total mesorectal excision, and tumor location. The role of various risk factors in the pathogenesis of defecation dysfunction after rectal cancer anal sphincter preservation is still controversial. At present, the diagnosis, grading and treatment of LARS are still in the exploration stage, and there is still no effective treatment.
Since the 1980s, a variety of colon-rectal anastomosis methods have been used in clinical practice to improve the dysfunction of rectal cancer after anal sphincter preservation, including J-pouch anastomosis, Colon transverse anastomosis, and end-to-side anastomosis. Each of the above three methods has its advantages and disadvantages: J-type storage bag improves the postoperative bowel movement anastomosis effect, but the technique is complicated and has more anastomotic symptoms; the colon transverse of the colon has a wide application range but the effect of improving the defecation function is poor; It has the longest history, but the time to apply to functional protection is the shortest, and there are few studies. Huttner et al published a meta-analysis published in 2015 (including 1636 cases from 21 clinical trials reports. Compared with end-to-end anastomosis, J-pouch can reduce the frequency of defecation and antidiarrheal drugs after 1 year after surgery. Similar results have been achieved with end-to-side anastomosis and colonic angioplasty; a review published by Brown et al also suggests that J-pouch can reduce the frequency of defecation and urgency of bowel movements during early (0-8 months) and mid-term (8-18 Months) .The end-to-side anastomosis achieved similar effects in each stage of the J-pouch, so it can be inferred that the end-to-side anastomosis (relative to end-to-end anastomosis) can improve postoperative defecation function. A retrospective study of end-to-end anastomosis and end-to-end anastomosis published in China also found that end-to-side anastomosis can reduce bowel movements and improve postoperative defecation function at 6 months after surgery. However, there is still no prospective clinical trial comparing the end-to-side anastomosis and end-to-end anastomosis for postoperative intestinal function. The ideal anastomosis should meet the characteristics of exact effect, simple operation and low complications. The end-to-side anastomosis is one of the potential choices, but its validity and safety lack relevant research evidence and need further study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| end-to-side anastomosis | Experimental | Procedure: different reconstruction methodsAll surgeries during the study were performed by the same experienced surgical team and were performed following TME principles. End-to-side anastomosis was used to perform colorectal anastomosis after primary tumor resection. |
| end-to-end anastomosis | No intervention | –All surgeries during the study were performed by the same experienced surgical team and were performed following TME principles. After resection of the primary tumor, end-to-end anastomosis was used for colorectal anastomosis. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The rectal adenocarcinoma is proved by pathology before surgery
- The lower margin of the tumor is less than 12cm higher from the anal verge under no anesthesia measured
- The tumor can be excised discussed by MDT
- Anus preserving operation can be performed
- ECOG score ranges between 0 and 2
Key exclusion criteria (11 listed)
- The patient can not follow the experimental scheme
- The case is an emergency
- The patient is in pregnant or breast-feeding
- TME surgery can not be performed
- One-stage anastomosis can not be performed
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 |
|---|---|---|
| different reconstruction methodsDifferent reconstruction methods should be performed after sphincter preservation surgery in two groups.The methods include end-to-end anastomosis or end-to-side anastomosis | Procedure or surgery | end-to-side anastomosis |
Primary outcome
Postoperative bowel function of 1 year after surgery
Time frame: 1 year after surgery
Each patients will be interviewed by telephone and asked to answer a copy of LARS score questionnaire. Designed for LARS patients only, the LARS score is a total score questionnaire containing five single choice questions with a corresponding score for each option. Each of the five questions tested a single symptom of the bowel function, including incontinence for flatus(score value from 0 to 7), incontinence for liquid stool (score value from 0 to 3), frequency of bowel movement (score value from 0 to 5), clustering of stools (score value from 0 to 11) and urgency (score value from 0 to 16). According to the total score of each patient, the questionnaire can evaluate the defecation function of the subject, which is divided into three categories from best to worst: no LARS (0 to 20), miner LARS (21 to 29) and major LARS (30 to 42).
3 secondary outcomes
Operation safety
Time frame: Data will be assess during operation and at the last visit before check-off.
Postoperative bowel function within the first year
Time frame: from the first month to the 11th month
Postoperative bowel function of the long stable result
Time frame: 16 months after the primary surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
- Individual participant dataSharing planned: Undecided
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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.
Yingjiang Ye, M.D. & PhD. study chair
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing different reconstruction methods in people with Bowel; Functional Syndrome, run by YE Yingjiang 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 7 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: finished, as of the sponsor's last update on 29 Dec 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postoperative bowel function of 1 year after surgery (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 29 Dec 2022.