Colon CancerNCT05493033
Intracorporeal Versus Extracorporeal Anastomotic After Laparoscopic Right Colectomy
A study testing Intracorporeal anastomotic after LRC and Extracorporeal anastomotic after LRC in people with Colon Cancer, run by Beijing Friendship Hospital.
Trial summary
Background: Laparoscopic assisted right hemicolectomy is recommended for right colon cancer. As a more minimally invasive procedure, intracorporeal ileocolic anastomosis has potential advantages: reducing torsion and traction on the mesentery, reducing skin incision length and enhancing postoperative recovery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Intracorporeal anastomotic after LRC and Extracorporeal anastomotic after LRC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,158 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 1 Jan 2030
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 ~ 80 years, male or female;
- Histological or cytological diagnosis of right colon cancer (cecum, ascending colon and proximal 1/3 of the transverse colon cancer);
- Stage I-III according to the AJCC-TNM classification including downstaged tumor based on adequate imaging of the thorax and abdomen;
- Intention for right hemicolectomy (including extended right hemicolectomy) with primary anastomosis;
- Informed consent according to local requirements Exclusion criteria
- 1) T4b tumor determined by CT scan; 2) Malignancy other than adenocarcinoma at histological examination ; 3)Other malignancies in medical history, except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri; 4) Previous history of colorectal cancer or synchronous multiple colorectal malignancies; 5) Complications requiring emergency surgery (obstruction, perforation, etc); 6) Planned synchronous abdominal organ resections; 7) Pregnant or lactating women; 8) Familial Adenomatosis Polyposis Coli (FAP), active Crohn's disease or active ulcerative colitis; 9) Absolute contraindication to general anesthesia or laparoscopic surgery.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter Randomized Clinical Trial Comparing Intracorporeal and Extracorporeal Ileocolic Anastomotic After Laparoscopic Right Colectomy for Colon Cancer (COLOR IV)
Background: Laparoscopic assisted right hemicolectomy is recommended for right colon cancer. As a more minimally invasive procedure, intracorporeal ileocolic anastomosis has potential advantages: reducing torsion and traction on the mesentery, reducing skin incision length and enhancing postoperative recovery. However, the longer operative time, greater risk of intra-abdominal infection and steep learning curve for intestinal anastomosis performed under laparoscopic conditions, does this increase the incidence of postoperative complications, especially the incidence of anastomotic leakage, and whether it affects There is no high-level research evidence on the survival of patients.
Study design: COlOR IV study is an international prospective, multicenter, randomized controlled clinical study of intraperitoneal anastomosis versus extraperitoneal anastomosis after laparoscopic right hemicolectomy for colon cancer . The study will include a quality assessment phase before randomisation to ensure required competency level and uniformity of the intracorporeal and extracoporeal techniques.
Read more
Endpoint: Primary outcome is anastomotic leakage within 30 days after surgery. Main secondary endpoint is 3-year disease-free survival rate. Secondary endpoints are mortality and morbidity, postoperative recovery, overall survival, surgical specimen quality, quality of life.
Statistics: The primary endpoint is anastomotic leakage within 30 days after surgery. The anastomotic leakage rate was set to 2% in the both groups, and an increase in the incidence of anastomotic leakage of 2.5% was considered inferior. The one-sided significance level was 0.025, the power was 0.9. The dropout rate was 20%, and taking into account the post-randomization analysis (dropout 5%), the total sample size was 1158. There were 579 cases in the intracorporeal anastomosis group and 579 cases in the extracorporeal anastomosis group.
Main selection: Patients with histologically proven right colon cancer (cecum, ascending colon and proximal 1/3 of the transverse colon malignant tumor), clinically stage I-III, and intention for right hemicolectomy with primary anastomosis.
Hypothesis: The hypothesis is that intracoporeal anastomosis will have comparable anastomotic leak rate and 3-year DFS, but faster postoperative recovery with extracoporeal anastomosis.
- Conditions
- Colon Cancer
- Being tested
- Intracorporeal anastomotic after LRC, Extracorporeal anastomotic after LRC
- Keywords
- laparoscopic, intracorporeal anastomosis, anastomotic leak
- Medical subject headings
- Colonic Neoplasms, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracorporeal anastomotic after LRCProcedure or surgery
Complete laparoscopic dissection of the mesocolon is mandatory. D2 or D3/CME is optional. And the extent of colon resection is based on the location of the tumor while the ileocecal resection is excluded. After fully mobilization of the colon and mesentery, the terminal ileum and transverse colon will be transected by a laparoscopic linear stapler. The side-to-side anastomosis is performed laparoscopically. The enterotomy is closed by a double-layer suture. All the anastomotic procedures are completed laparoscopically. The specimen is then removed through a Pfannenstiel incision within a specimen bag.
Extracorporeal anastomotic after LRCProcedure or surgery
The procedures of the mobilization and vessel ligation are similar. After that, the mobilized colon and terminal ileum are brought out through the upper mid-line incision with the wound protector. The colon and terminal ileum are similarly dissected distally to the specimen with a stapling device. The side-to-side anastomosis is completed and the anastomotic site is reinforced. The anastomotic bowel is returned to the abdominal cavity.
| Study group | Role | What they receive |
|---|---|---|
| Intracorporeal anastomotic after LRC | Experimental | Not described Receives: Procedure: Intracorporeal anastomotic after LRC |
| Extracorporeal anastomotic after LRC | Active comparator | Not described Receives: Procedure: Extracorporeal anastomotic after LRC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomotic leak
Anastomotic leakage is defined as a defect of the intestinal wall at the anastomotic site leading to a communication between intra- and extraluminal compartments.
Diagnosis of anastomotic leakage: The radiological examination (CT abdomen) will be completed if clinically suspected AL. AL is confirmed clinically, radiologically, endoscopically or intraoperatively. The severity of anastomotic leakage was judged with reference to the Clavien-Dindo classification.
Measured: 30 days
Secondary outcomes (17)
Disease-free survival rate
Main secondary outcome
Measured: 3/5 years
Overall survival
Measured: 3/5 years
morbidity
Measured: 5 years
Mortality
Measured: 5 years
Duration of surgery
from incision to suture completion
Measured: Intraoperative
Duration of anastomosis
from the start of dissection of the bowel to the compeletion of the anastomosis
Measured: Intraoperative
Surgical incision length
Measured: Intraoperative
Conversion rate
conversion to open surgery or conversion to extracorporeal anastomosis
Measured: 1 month
Pain score (VAS score)
The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Ask the patient to rate their current level of pain by placing a mark on the line.
Measured: 1-3 days
Time to first flatus passage after surgery
The day of surgery is day 0. The time interval between the day of the first flatus passage after surgery and the day of surgery.
Measured: 1 month
Time to first stool passage after surgery
The day of surgery is day 0. The time interval between the day of the first stool passage after surgery and the day of surgery.
Measured: up to 1 week
Time to first oral intake
The day of surgery is day 0. The time interval between the day of the first oral intake after surgery and the day of surgery.
Measured: up to 1 week
Length of hospital stay after surgery
days from surgery to discharge
Measured: 1 month
Specimen quality
West pathological assessment criteria. Grading of the plane of mesocolic dissection.
- Muscularis propria plane：little bulk to mesocolon with disruptions extending down onto the muscularis propriapropria
- Intramesocolic plane: moderate bulk to mesocolon with irregularity but the incisions do not reach down to the muscularis propria
- Mesocolic plane: intact mesocolon with a smooth peritoneal-lined surface
Measured: 1 month
Health-related quality of life
EORTC QLQ-CR29 and C30: questionnaires to evaluate the overall quality of life of patients with colorectal cancer, including 30 and 29 items, respectively, to score patients' overall quality of life, function, and symptoms. These are coded with four-point scales, namely "Not at all", "A little", "Quite a bit" and "Very much."
Measured: 1 year
health-related quality of life
EQ 5D-5L (Euroqol): This questionnaire is a simple, generic tool for describing and assessing health-related quality of life. It consists of 5 items (mobility, personal care, activities of daily living, pain and anxiety and depression) that answer questions on a 5-point scale ranging from "no problem" (level 1) to "very severe" (level 5).
Measured: 1 year
Incision herniation
The incision herniation is classified by the criteria of the European Hernia Society. The location (Midline/Lateral) and size (length and width) of the herniation will be recorded.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start1 Dec 2023 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhongtao Zhang, Beijing Friendship Hospital
- Investigators
- Zhongtao Zhang, Prof, Principal investigator, Department of General Surgery, Beijing Friendship Hospital, Capital Medical UniversityHendrik J Bonjer, Prof, Principal investigator, Amsterdam UMC, location VUmcHongwei Yao, Prof, Study director, Department of General Surgery, Beijing Friendship Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493033
- Sponsor's protocol ID
- COLOR IV Trial
- Status last verified
- Nov 2023
- First submitted
- 23 May 2022
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are not sharing confidential individual patient data.
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Clinical Trial Comparing Intracorporeal and Extracorporeal Ileocolic Anastomotic After Laparoscopic Right Colectomy for Colon Cancer (COLOR IV)
- ClinicalTrials.gov ID
- NCT05493033
- Acronym / sponsor ID
- COLOR IV Trial
- Conditions
- Colon Cancer
- Keywords
- laparoscopic, intracorporeal anastomosis, anastomotic leak
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,158 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 9 Aug 2022 (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.
Background: Laparoscopic assisted right hemicolectomy is recommended for right colon cancer. As a more minimally invasive procedure, intracorporeal ileocolic anastomosis has potential advantages: reducing torsion and traction on the mesentery, reducing skin incision length and enhancing postoperative recovery. However, the longer operative time, greater risk of intra-abdominal infection and steep learning curve for intestinal anastomosis performed under laparoscopic conditions, does this increase the incidence of postoperative complications, especially the incidence of anastomotic leakage, and whether it affects There is no high-level research evidence on the survival of patients.
Study design: COlOR IV study is an international prospective, multicenter, randomized controlled clinical study of intraperitoneal anastomosis versus extraperitoneal anastomosis after laparoscopic right hemicolectomy for colon cancer . The study will include a quality assessment phase before randomisation to ensure required competency level and uniformity of the intracorporeal and extracoporeal techniques.
Endpoint: Primary outcome is anastomotic leakage within 30 days after surgery. Main secondary endpoint is 3-year disease-free survival rate. Secondary endpoints are mortality and morbidity, postoperative recovery, overall survival, surgical specimen quality, quality of life.
Statistics: The primary endpoint is anastomotic leakage within 30 days after surgery. The anastomotic leakage rate was set to 2% in the both groups, and an increase in the incidence of anastomotic leakage of 2.5% was considered inferior. The one-sided significance level was 0.025, the power was 0.9. The dropout rate was 20%, and taking into account the post-randomization analysis (dropout 5%), the total sample size was 1158. There were 579 cases in the intracorporeal anastomosis group and 579 cases in the extracorporeal anastomosis group.
Main selection: Patients with histologically proven right colon cancer (cecum, ascending colon and proximal 1/3 of the transverse colon malignant tumor), clinically stage I-III, and intention for right hemicolectomy with primary anastomosis.
Hypothesis: The hypothesis is that intracoporeal anastomosis will have comparable anastomotic leak rate and 3-year DFS, but faster postoperative recovery with extracoporeal anastomosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intracorporeal anastomotic after LRC | Experimental | Procedure: Intracorporeal anastomotic after LRC |
| Extracorporeal anastomotic after LRC | Active comparator | Procedure: Extracorporeal anastomotic after LRC |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: 18 ~ 80 years, male or female;
- Histological or cytological diagnosis of right colon cancer (cecum, ascending colon and proximal 1/3 of the transverse colon cancer);
- Stage I-III according to the AJCC-TNM classification including downstaged tumor based on adequate imaging of the thorax and abdomen;
- Intention for right hemicolectomy (including extended right hemicolectomy) with primary anastomosis;
- Informed consent according to local requirements Exclusion criteria
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Intracorporeal anastomotic after LRCComplete laparoscopic dissection of the mesocolon is mandatory. D2 or D3/CME is optional. And the extent of colon resection is based on the location of the tumor while the ileocecal resection is excluded. After fully mobilization of the colon and mesentery, the terminal ileum and transverse colon will be transected by a laparoscopic linear stapler. The side-to-side anastomosis is performed laparoscopically. The enterotomy is closed by a double-layer suture. All the anastomotic procedures are completed laparoscopically. The specimen is then removed through a Pfannenstiel incision within a specimen bag. | Procedure or surgery | Intracorporeal anastomotic after LRC |
| Extracorporeal anastomotic after LRCThe procedures of the mobilization and vessel ligation are similar. After that, the mobilized colon and terminal ileum are brought out through the upper mid-line incision with the wound protector. The colon and terminal ileum are similarly dissected distally to the specimen with a stapling device. The side-to-side anastomosis is completed and the anastomotic site is reinforced. The anastomotic bowel is returned to the abdominal cavity. | Procedure or surgery | Extracorporeal anastomotic after LRC |
Primary outcome
Anastomotic leak
Time frame: 30 days
Anastomotic leakage is defined as a defect of the intestinal wall at the anastomotic site leading to a communication between intra- and extraluminal compartments. Diagnosis of anastomotic leakage: The radiological examination (CT abdomen) will be completed if clinically suspected AL. AL is confirmed clinically, radiologically, endoscopically or intraoperatively. The severity of anastomotic leakage was judged with reference to the Clavien-Dindo classification.
17 secondary outcomes
Disease-free survival rate
Time frame: 3/5 years
Overall survival
Time frame: 3/5 years
morbidity
Time frame: 5 years
Mortality
Time frame: 5 years
Duration of surgery
Time frame: Intraoperative
Duration of anastomosis
Time frame: Intraoperative
Surgical incision length
Time frame: Intraoperative
Conversion rate
Time frame: 1 month
Pain score (VAS score)
Time frame: 1-3 days
Time to first flatus passage after surgery
Time frame: 1 month
Time to first stool passage after surgery
Time frame: up to 1 week
Time to first oral intake
Time frame: up to 1 week
Length of hospital stay after surgery
Time frame: 1 month
Specimen quality
Time frame: 1 month
Health-related quality of life
Time frame: 1 year
health-related quality of life
Time frame: 1 year
Incision herniation
Time frame: 1 year
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 1 Dec 2023.
- Individual participant dataSharing planned: No. We are not sharing confidential individual patient data.
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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.
Zhongtao Zhang, Prof principal investigator
Department of General Surgery, Beijing Friendship Hospital, Capital Medical University
Hendrik J Bonjer, Prof principal investigator
Amsterdam UMC, location VUmc
Hongwei Yao, Prof study director
Department of General Surgery, Beijing Friendship Hospital, Capital Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Intracorporeal anastomotic after LRC and Extracorporeal anastomotic after LRC in people with Colon Cancer, run by Beijing Friendship Hospital.
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 0 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: opening soon, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Hongwei Yao, Prof (+8613611015609, yaohongwei@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastomotic leak (time frame: 30 days). 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 1 Dec 2023.