Colorectal CancerPhase 2NCT06495853
Prospective Phase II Study on Continuous Circumferential Reinforcement of Laparoscopic Rectal Anastomosis to Prevent Complications
A Phase 2 study testing Continuous Circumferential Reinforcement of the Anastomotic in people with Colorectal Cancer and Anastomotic Leakage, run by ZHI-ZHONG PAN at 1 site in China.
Trial summary
Anastomotic leakage (AL) is one of the most severe complications following laparoscopic rectal cancer surgery. According to the International Study Group of Rectal Cancer (ISREC), AL is defined as a defect of intestinal wall integrity at the colorectal or coloanal anastomosis leading to a communication between the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer, Anastomotic Leakage, Operation
- What is being tested?
- Continuous Circumferential Reinforcement of the Anastomotic
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2024to 1 Nov 2025
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological Confirmation:
- Diagnosed with rectal adenocarcinoma confirmed by histology.
- Tumor Location:
- MRI confirms a mid to upper rectal tumor, with the lower margin of the tumor located 6-12 cm from the anal verge.
- Preoperative Staging:
- Preoperative MRI staging indicates the presence or absence of MRF positivity and/or EMVI positivity; the surgical team assesses the tumor as resectable with an estimated R0 resection.
Show all 30Show fewer
- Bowel Obstruction:
- No signs of bowel obstruction.
- Neoadjuvant Chemoradiotherapy:
- For patients who have received neoadjuvant chemoradiotherapy, complete radiotherapy and baseline imaging records must be available at this center.
- Previous Treatments:
- Surgical History:
- No previous colorectal surgery.
- Biological and Immunotherapy:
- No prior treatment with biological drugs (e.g., monoclonal antibodies), immunotherapy (e.g., anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-PD-L2 antibodies, or anti-CTLA-4), or other investigational drugs.
- Endocrine Therapy:
- No restrictions on prior endocrine therapy.
- Patient Characteristics:
- Age:
- Between 18 and 75 years old.
- Performance Status:
- ECOG performance status of 0-1 (see Appendix 3).
- Life Expectancy:
- Greater than 2 years.
- Hematological Parameters:
- WBC > 3×10^9/L; PLT > 80×10^9/L; Hb > 90 g/L.
- Liver Function:
- ALT and AST less than 2 times the upper limit of normal; bilirubin less than 1.5 times the upper limit of normal.
- Renal Function:
- Creatinine less than 1.5 times the upper limit of normal or creatinine clearance (CCr) ≥ 60 ml/min.
Who cannot join
- Patients meeting any of the following conditions will be excluded from the study:
- Need for Multiorgan Resection:
- Patients requiring combined organ resection.
- Preventive or Permanent Stoma:
- Patients requiring preventive or permanent stoma.
- Hartmann or Miles Procedures:
Show all 39Show fewer
- Patients requiring Hartmann's procedure or Miles' surgery.
- Cardiac Conditions:
- Arrhythmias requiring antiarrhythmic treatment (excluding β-blockers or digoxin), symptomatic coronary artery disease, localized myocardial ischemia (myocardial infarction within the last 6 months), or congestive heart failure beyond NYHA Class II.
- Uncontrolled Hypertension:
- Severe hypertension that is not well controlled by medication.
- Infectious Diseases:
- History of HIV infection or active chronic hepatitis B or C with high viral DNA copies.
- Active Tuberculosis (TB):
- Subjects with active pulmonary tuberculosis, currently undergoing anti-tuberculosis treatment, or having received anti-tuberculosis treatment within 1 year prior to screening.
- Severe Infections:
- Other active clinically severe infections (according to NCI-CTC version 5.0).
- Evidence of Distant Metastasis:
- Preoperative evidence of distant metastasis outside the pelvis.
- Cachexia and Organ Failure:
- Cachexia or decompensated organ function.
- Radiotherapy History:
- History of pelvic or abdominal radiotherapy.
- Multiple Primary Colorectal Cancers:
- Presence of multiple primary colorectal cancers.
- Seizure Disorders:
- Patients with seizures requiring treatment (e.g., steroids or antiepileptic therapy).
- History of Other Malignancies:
- History of other malignancies within the past 5 years, except for cured in situ cervical cancer or basal cell carcinoma of the skin.
- Substance Abuse:
- Substance abuse or medical, psychological, or social conditions that could interfere with the patient's participation in the study or the evaluation of study results.
- Allergies:
- Known or suspected allergies to the investigational drug or any drug related to the study.
- Unstable Conditions:
- Any unstable condition or situation that might jeopardize patient safety and compliance.
- Pregnancy or Lactation:
- Women who are pregnant or breastfeeding, and women of childbearing potential not using adequate contraceptive measures.
- Informed Consent:
- Refusal to sign the informed consent form.
Trial locations and contacts
1 site in 1 country.
China1 site
Colorectal Department,SunYat-sen University Cancer Center
Guangzhou, Guangdong, 510062
About this study
Official title: A Prospective Phase II Clinical Study on Continuous Circumferential Reinforcement of the Anastomotic Site With Laparoscopic Rectal Anastomosis to Prevent Complications.
Anastomotic leakage (AL) is one of the most severe complications following laparoscopic rectal cancer surgery. According to the International Study Group of Rectal Cancer (ISREC), AL is defined as a defect of intestinal wall integrity at the colorectal or coloanal anastomosis leading to a communication between the intra- and extraluminal compartments, including defects of the suture or staple lines of the neorectal reservoir. AL is classified into three grades based on clinical severity: Grade A, identified only radiologically without clinical symptoms; Grade B, presenting with localized or atypical peritonitis requiring antibiotics and local drainage but not surgery; and Grade C, causing severe peritonitis, systemic toxicity symptoms requiring urgent surgical intervention, and potentially leading to life-threatening situations.
AL can prolong hospitalization, necessitate reoperation, delay chemotherapy, increase local recurrence rates, and adversely affect survival and quality of life. Emergency surgical management of AL often requires meticulous peritoneal lavage and ileostomy, aiming for subsequent anastomotic healing or future digestive tract reconstruction. However, some patients face significant challenges due to postoperative adhesions and persistent anastomotic defects despite prolonged lavage.
Read more
Identified risk factors for AL after rectal cancer surgery include male gender, advanced age, hypertension, diabetes, smoking, and advanced TNM staging (III-IV). Additionally, preoperative chemoradiotherapy-induced bowel edema and fibrosis, bowel obstruction, and long-term malnutrition resulting in hypoproteinemia are significant contributors. Mechanical reinforcement of anastomoses using sutures or absorbable barbed sutures has been shown to significantly reduce AL rates in previous studies.
This single-center prospective phase II clinical trial aims to evaluate the efficacy and safety of continuous circumferential reinforcement using absorbable barbed sutures in laparoscopic rectal anastomosis to prevent AL. We will compare the incidence of AL and other postoperative complications between patients undergoing reinforced anastomosis and a control group receiving standard laparoscopic rectal anastomosis.
- Conditions
- Colorectal Cancer, Anastomotic Leakage, Operation
- Being tested
- Continuous Circumferential Reinforcement of the Anastomotic
- Medical subject headings
- Colorectal Neoplasms, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Circumferential Reinforcement of the AnastomoticProcedure or surgery
The reinforcement began on the right side of the anterior wall of the anastomosis, 0.5 cm from the anastomotic line, with continuous full-thickness sutures spaced 1 cm apart. The suture ended with fixation of the suture tail using non-absorbable vascular clips. The decision to perform splenic flexure mobilization depended on the anastomotic tension and the length of the resected bowel segment. The superior mesenteric artery and vein were divided at their roots.
| Study group | Role | What they receive |
|---|---|---|
| GroupA | Experimental | Patients with rectal cancer who did not receive neoadjuvant chemoradiotherapy and underwent rectal anterior resection with anastomotic reinforcement were included in Cohort A. The rectal cancer radical resection was performed in strict accordance with the principles of no-tumor technique and total mesorectal excision (TME) by experienced deputy chief physicians or higher from our research center. The procedure followed standard rectal cancer radical resection protocols. After rectal division using a linear stapler, an end-to-end anastomosis was performed using a circular stapler. For patients in the treatment group, anastomotic reinforcement was performed using absorbable Johnson \& Johnson EB403 barbed sutures laparoscopically.Unless there were clear high-risk factors for anastomotic leakage preoperatively (e.g., diabetes, narrow pelvis, unsatisfactory anastomosis, positive colonic air leak test), ileostomy was not routinely performed in this group of patients. Receives: Procedure: Continuous Circumferential Reinforcement of the Anastomotic |
| Group B | Experimental | Patients who did not receive neoadjuvant chemoradiotherapy and underwent rectal anterior resection with anastomotic reinforcement were included in Cohort B. The rectal cancer radical resection was performed in strict accordance with the principles of no-tumor technique and total mesorectal excision (TME) by experienced deputy chief physicians or higher from our research center. The procedure followed standard rectal cancer radical resection protocols. After rectal division using a linear stapler, an end-to-end anastomosis was performed using a circular stapler. For patients in the treatment group, anastomotic reinforcement was performed using absorbable Johnson \& Johnson EB403 barbed sutures laparoscopically.
Since neoadjuvant chemoradiotherapy is a high-risk factor for postoperative anastomotic leakage, ileostomy was routinely performed in this group of patients to prevent severe intra-abdominal infections caused by anastomotic leakage. Receives: Procedure: Continuous Circumferential Reinforcement of the Anastomotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Clinically and Radiologically Confirmed Anastomotic Leakage within 30 Days Postoperatively
Clinical and radiological assessment of anastomotic leakage within 30 days postoperatively, including Grade A and B leaks detected through imaging without clinical symptoms, as well as Grade C leaks with clear clinical manifestations.
Measured: 30-days after surgery
Secondary outcomes (5)
Time to First Postoperative Flatus
Time to First Postoperative Flatus
Measured: 3-days after surgery
Time to First Postoperative Oral Intake
This refers to the duration from the end of surgery until the patient is able to tolerate oral intake of food or liquids.
Measured: 3-days after surgery
Incidence of Postoperative Intra-abdominal Hemorrhage
This refers to the frequency at which patients experience bleeding within the abdominal cavity following surgery. It is typically assessed through clinical signs, imaging studies, and the need for interventions such as transfusions or reoperations.
Measured: 14-days after surgery
Incidence of Postoperative Anastomotic Hemorrhage
This refers to the frequency at which patients experience bleeding at the site of the anastomosis following surgery. It is typically evaluated based on clinical symptoms, endoscopic findings, or imaging studies, and may require interventions such as endoscopic hemostasis, transfusions, or reoperation.
Measured: 14-days after surgery
Incidence of Postoperative Anastomotic Stricture
This refers to the frequency at which patients develop a narrowing at the anastomotic site following surgery. This condition can be identified through symptoms such as difficulty in passing stool, abdominal pain, or diagnosed via endoscopy or imaging studies. It may require interventions such as balloon dilation, stenting, or surgical revision.
Measured: 60-days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start20 Jul 2024 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ZHI-ZHONG PAN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ZHI-ZHONG PAN, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495853
- Sponsor's protocol ID
- 2023-FXY-182
- Status last verified
- Jul 2024
- First submitted
- 3 Jul 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase II Clinical Study on Continuous Circumferential Reinforcement of the Anastomotic Site With Laparoscopic Rectal Anastomosis to Prevent Complications.
- ClinicalTrials.gov ID
- NCT06495853
- Acronym / sponsor ID
- 2023-FXY-182
- Conditions
- Colorectal Cancer, Anastomotic Leakage, Operation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- ZHI-ZHONG PANUniversity, hospital or other
- Study start
- 20 Jul 2024 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 11 Jul 2024 (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.
Anastomotic leakage (AL) is one of the most severe complications following laparoscopic rectal cancer surgery. According to the International Study Group of Rectal Cancer (ISREC), AL is defined as a defect of intestinal wall integrity at the colorectal or coloanal anastomosis leading to a communication between the intra- and extraluminal compartments, including defects of the suture or staple lines of the neorectal reservoir. AL is classified into three grades based on clinical severity: Grade A, identified only radiologically without clinical symptoms; Grade B, presenting with localized or atypical peritonitis requiring antibiotics and local drainage but not surgery; and Grade C, causing severe peritonitis, systemic toxicity symptoms requiring urgent surgical intervention, and potentially leading to life-threatening situations.
AL can prolong hospitalization, necessitate reoperation, delay chemotherapy, increase local recurrence rates, and adversely affect survival and quality of life. Emergency surgical management of AL often requires meticulous peritoneal lavage and ileostomy, aiming for subsequent anastomotic healing or future digestive tract reconstruction. However, some patients face significant challenges due to postoperative adhesions and persistent anastomotic defects despite prolonged lavage.
Identified risk factors for AL after rectal cancer surgery include male gender, advanced age, hypertension, diabetes, smoking, and advanced TNM staging (III-IV). Additionally, preoperative chemoradiotherapy-induced bowel edema and fibrosis, bowel obstruction, and long-term malnutrition resulting in hypoproteinemia are significant contributors. Mechanical reinforcement of anastomoses using sutures or absorbable barbed sutures has been shown to significantly reduce AL rates in previous studies.
This single-center prospective phase II clinical trial aims to evaluate the efficacy and safety of continuous circumferential reinforcement using absorbable barbed sutures in laparoscopic rectal anastomosis to prevent AL. We will compare the incidence of AL and other postoperative complications between patients undergoing reinforced anastomosis and a control group receiving standard laparoscopic rectal anastomosis.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GroupA | Experimental | Procedure: Continuous Circumferential Reinforcement of the AnastomoticPatients with rectal cancer who did not receive neoadjuvant chemoradiotherapy and underwent rectal anterior resection with anastomotic reinforcement were included in Cohort A. The rectal cancer radical resection was performed in strict accordance with the principles of no-tumor technique and total mesorectal excision (TME) by experienced deputy chief physicians or higher from our research center. The procedure followed standard rectal cancer radical resection protocols. After rectal division using a linear stapler, an end-to-end anastomosis was performed using a circular stapler. For patients in the treatment group, anastomotic reinforcement was performed using absorbable Johnson \& Johnson EB403 barbed sutures laparoscopically.Unless there were clear high-risk factors for anastomotic leakage preoperatively (e.g., diabetes, narrow pelvis, unsatisfactory anastomosis, positive colonic air leak test), ileostomy was not routinely performed in this group of patients. |
| Group B | Experimental | Procedure: Continuous Circumferential Reinforcement of the AnastomoticPatients who did not receive neoadjuvant chemoradiotherapy and underwent rectal anterior resection with anastomotic reinforcement were included in Cohort B. The rectal cancer radical resection was performed in strict accordance with the principles of no-tumor technique and total mesorectal excision (TME) by experienced deputy chief physicians or higher from our research center. The procedure followed standard rectal cancer radical resection protocols. After rectal division using a linear stapler, an end-to-end anastomosis was performed using a circular stapler. For patients in the treatment group, anastomotic reinforcement was performed using absorbable Johnson \& Johnson EB403 barbed sutures laparoscopically. Since neoadjuvant chemoradiotherapy is a high-risk factor for postoperative anastomotic leakage, ileostomy was routinely performed in this group of patients to prevent severe intra-abdominal infections caused by anastomotic leakage. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Diagnosed with rectal adenocarcinoma confirmed by histology.
- MRI confirms a mid to upper rectal tumor, with the lower margin of the tumor located 6-12 cm from the anal verge.
- Preoperative MRI staging indicates the presence or absence of MRF positivity and/or EMVI positivity; the surgical team assesses the tumor as resectable with an estimated R0 resection.
- No signs of bowel obstruction.
- For patients who have received neoadjuvant chemoradiotherapy, complete radiotherapy and baseline imaging records must be available at this center.
Key exclusion criteria (39 listed)
- Patients requiring combined organ resection.
- Patients requiring preventive or permanent stoma.
- Patients requiring Hartmann's procedure or Miles' surgery.
- Arrhythmias requiring antiarrhythmic treatment (excluding β-blockers or digoxin), symptomatic coronary artery disease, localized myocardial ischemia (myocardial infarction within the last 6 months), or congestive heart failure beyond NYHA Class II.
- Severe hypertension that is not well controlled by medication.
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 |
|---|---|---|
| Continuous Circumferential Reinforcement of the AnastomoticThe reinforcement began on the right side of the anterior wall of the anastomosis, 0.5 cm from the anastomotic line, with continuous full-thickness sutures spaced 1 cm apart. The suture ended with fixation of the suture tail using non-absorbable vascular clips. The decision to perform splenic flexure mobilization depended on the anastomotic tension and the length of the resected bowel segment. The superior mesenteric artery and vein were divided at their roots. | Procedure or surgery | Group B, GroupA |
Primary outcome
Incidence of Clinically and Radiologically Confirmed Anastomotic Leakage within 30 Days Postoperatively
Time frame: 30-days after surgery
Clinical and radiological assessment of anastomotic leakage within 30 days postoperatively, including Grade A and B leaks detected through imaging without clinical symptoms, as well as Grade C leaks with clear clinical manifestations.
5 secondary outcomes
Time to First Postoperative Flatus
Time frame: 3-days after surgery
Time to First Postoperative Oral Intake
Time frame: 3-days after surgery
Incidence of Postoperative Intra-abdominal Hemorrhage
Time frame: 14-days after surgery
Incidence of Postoperative Anastomotic Hemorrhage
Time frame: 14-days after surgery
Incidence of Postoperative Anastomotic Stricture
Time frame: 60-days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Continuous Circumferential Reinforcement of the Anastomotic in people with Colorectal Cancer and Anastomotic Leakage, run by ZHI-ZHONG PAN 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 30 inclusion and 39 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 11 Jul 2024. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Incidence of Clinically and Radiologically Confirmed Anastomotic Leakage within 30 Days Postoperatively (time frame: 30-days 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 11 Jul 2024.