Adenocarcinoma of the ColonNCT05077358
Intracorporeal Versus Extracorporeal Anastomosis In Laparoscopic Right Colon Resection
A study testing Intracorporeal anastomosis and Extracorporeal anastomosis in people with Adenocarcinoma of the Colon, run by Yonsei University at 1 site in South Korea.
Trial summary
STUDY DESIGN This study is a prospective, randomized, multi-center study comparing intracorporeal versus extracorporeal anastomosis in performing laparoscopic right colectomy. The study subjects will be randomly assigned to 1. intracorporeal anastomosis (experimental group) 2. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Adenocarcinoma of the Colon
- What is being tested?
- Intracorporeal anastomosis and Extracorporeal anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Apr 2021to Oct 2024
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 19 years or older
- Right colon tumor with indication for right colectomy (malignant disease).
- Patients with adequate performance status (Eastern Cooperative Oncology Group Scale score of ≤2)
- Patient has signed and dated the Informed consent before patient inclusion in the study.
Who cannot join
- Patient with a comorbid illness or condition that would preclude the use of surgery.
- Patients with cT4b tumors.
- Patients whose disease condition requires major simultaneous combined resection other than right colectomy (e.g. other intestinal resection, liver resection)
- Patients unwilling to comply with all follow-up study requirements
- Patient undergoing emergency procedures
- Obstructive disease (but, possible to enroll after stent insertion resolving obstruction)
Show all 11Show fewer
- Impossible preoperative bowel preparation
- Metastatic disease
- Pregnant or suspected pregnancy
- Complicated inflammatory bowel disease (Crohn´s Disease, Ulcerative Colitis, Intestinal tuberculosis, Behcet's disease, Undetermined inflammatory bowel disease) that combined with intraabdominal abscess or intestinal fistula
- No Informed consent
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University College of Medicine
Seoul
Byung Soh Min, 82-10-7677-5679, BSMIN@yuhs.ac
About this study
Official title: Intracorporeal Versus Extracorporeal Anastomosis In Laparoscopic Right Colon Resection: A Prospective Randomized Multi-center Clinical Trial
STUDY DESIGN This study is a prospective, randomized, multi-center study comparing intracorporeal versus extracorporeal anastomosis in performing laparoscopic right colectomy. The study subjects will be randomly assigned to 1. intracorporeal anastomosis (experimental group) 2. extracorporeal anastomosis (control group) with 1:1 manner. After surgery the subjects will be followed up at 1month, after then, every 3 month in total 3 years.
STUDY POPULATION
Read more
- Screening A detailed review of the medical records will be performed to assess inclusion/exclusion criteria for all subjects who have been diagnosed with right colon tumor (malignant or benign) or benign disease (complicated diverticulitis and so on) that are subject to a right colectomy procedure.
All patients who are eligible, meet the inclusion and none of the exclusion criteria of this study, will be offered enrollment into the study at each site.
RISK ANALYSIS
- Potential risks All these procedures are in practice today and only surgeons competent in a technique shall be allowed to perform those surgeries. Therefore, there are no anticipated additional risks than would normally be encountered from these surgeries when they are performed for these patients.
- Potential benefits There may be some benefit due to having closer follow-up in the study.
QUALIFICATION OF PARTICIPATING SURGEONS
- Surgical procedure
- Laparoscopic surgery: a surgical technique where operations are performed far from their target anatomy location through small incisions normally less than 15mm.
- Extracorporeal anastomosis: the anastomosis is performed by pulling out the bowel through a laparotomy.
- Intracorporeal anastomosis: the anastomosis is performed inside the abdominal cavity with a laparoscopic technique. Specimen extraction will be done through Pfannenstiel incision or similar incision in lower abdomen.
- Procedure standardization and qualification procedure Participating surgeons should complete the learning curve of the procedure and experience at least 50 laparoscopic right colectomy. They are required to be evaluated by the quality control (QC) committee. They should submit their unedited videos of laparoscopic right colectomy and must be accepted by 2 or more of total 3 QC committee members.
STATISTICAL ANALYSIS Based on attaining a success rate of 85% for the primary endpoint, a total of 106 subjects will be required for each group. Accounting for a 5% loss, a total of 241 subjects will be recruited for this study.
Read the detailed description
STUDY METHODS
- Ethical committee approval The study protocol, patient informed consent form and other required study documentation will be reviewed and approved by an institutional review board or any other authority body, prior to study start-up.
- Study duration and enrollment The total study duration will be approximately 5 years. Study enrollment will take approximately 24 months. The study subjects will have a short-term follow-up at 30 and 3 months post procedure, with long term follow-up upto 3 years after surgery. Surveillance will be performed according to standard follow-up guideline after colorectal cancer surgery.
- Randomization All the enrolled subject will be randomly assigned to one of the study group (intracorporeal or extracorporeal). The randomization will be performed upon the enrollment at the central institution stratifying center on 1:1 manner by a coordinator who is not aware of any clinical information
- Data collection Data will be collected at baseline, operative procedure, discharge, 1 month, 3 months and 1 year. A screening log will be maintained at each site during the enrollment period, in which all patients eligible for the trial shall be identified. This will be maintained to ensure no patient selection bias occurs within a center or by a surgeon.
- Informed Consent Using the study-specific, IRB approved, informed consent form, information pertinent to this study will be provided to the subjects in writing and in their native, non-technical, language. The consent form will include a description of the study and its purpose, potential benefits, potential risks, site contact information, and all other elements required of an informed consent. Subjects are required to voluntarily sign the informed consent form before any study-specific procedure is performed. The Investigator and/or his/her authorized designee, trained on the protocol and performing a consent, will conduct the informed consent process and will answer questions the subjects may have. If the subject agrees to participate, the informed consent form must be signed and dated by the subject or his/her legally authorized representative prior to enrollment in the study and separately signed and dated by the person taking consent. Only subjects who have signed the study informed consent will be included in the study.
- Withdrawal and discontinuation The subject's participation in any clinical trial is voluntary. The subject has the right to withdraw at any time without penalty or loss of benefit. Study withdrawal means the subject is no longer participating in the study and no further follow-ups will be performed. All subjects that withdraw after informed consent is signed will be evaluated at the time of withdrawal. Every effort will be made to document the subject outcome at the time of withdrawal. The investigator has the right to discontinue subjects from the study at their discretion to ensure wellbeing of the subject. The reasons for withdrawal shall be documented.
- Conditions
- Adenocarcinoma of the Colon
- Being tested
- Intracorporeal anastomosis, Extracorporeal anastomosis
- Keywords
- Intracorporeal anastomosis, Laparoscopic colectomy, Complete mesocolic excision with central vessel ligation, Surgical site infection
- Medical subject headings
- Colonic Neoplasms, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracorporeal anastomosisProcedure or surgery
In this group, the anastomosis is performed inside the abdominal cavity with a laparoscopic technique. Specimen extraction will be done through Pfannenstiel incision or similar incision in lower abdomen.
Extracorporeal anastomosisProcedure or surgery
In this group, the anastomosis is performed by pulling out the bowel through a laparotomy.
| Study group | Role | What they receive |
|---|---|---|
| Intracorporeal anastomosis | Experimental | In this group, the anastomosis is performed inside the abdominal cavity with a laparoscopic technique. Specimen extraction will be done through Pfannenstiel incision or similar incision in lower abdomen. Receives: Procedure: Intracorporeal anastomosis |
| Extracorporeal anastomosis | Active comparator | In this group, the anastomosis is performed by pulling out the bowel through a laparotomy. Receives: Procedure: Extracorporeal anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
surgical site infection
The efficacy of the anastomosis technique is defined as a lack of surgical site infection within 30 postoperative days.
- Superficial surgical site infection
- Deep surgical site infection
Measured: within 30 postoperative days
Secondary outcomes (8)
3 year disease-free survival
Measured: 3 years
Tissue morphometry
- The distance from the tumour and the closest bowel wall to the high vascular tie (mm)
- The length of colon and ileum (mm)
- The area of mesocolon (mm2)
- Macroscopic quality of specimen (3 grades) G1 : intact mesocolon G2 : significant mesocolic disruptions away from the muscularis G3 : significant disruptions extending down to the muscularis
Measured: within 30 postoperative days
Incidence of incisional hernia within 1 year after surgery
Measured: 1 year
Postoperative pain score in visual analogue scale
Measured: within 7 postoperative days
Length of postoperative hospital stay
Measured: within 7 postoperative days
Number of patient with Clavien-Dindo grade IIIb-IV at 30 days postop as an operation-related morbidity
Measured: within 30 postoperative days
Operative time (min)
Measured: within the day of operation
Incidence of conversion
Measured: within 30 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start5 Apr 2021
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Adenocarcinoma of the ColonStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Model description
- This study is a prospective, randomized, multi-center study comparing intracorporeal versus extracorporeal anastomosis in performing laparoscopic right colectomy. The study subjects will be randomly assigned to: 1. Intracorporeal anastomosis 2. Extracorporeal anastomosis
- Masking
- None (open label)
- Enrolment
- 241 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05077358
- Sponsor's protocol ID
- 4-2020-1037
- Status last verified
- Sep 2021
- First submitted
- 23 Aug 2021
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hellan M, Anderson C, Pigazzi A. Extracorporeal versus intracorporeal anastomosis for laparoscopic right hemicolectomy. JSLS. 2009 Jul-Sep;13(3):312-7.
PubMed 19793468van Oostendorp S, Elfrink A, Borstlap W, Schoonmade L, Sietses C, Meijerink J, Tuynman J. Intracorporeal versus extracorporeal anastomosis in right hemicolectomy: a systematic review and meta-analysis. Surg Endosc. 2017 Jan;31(1):64-77. doi: 10.1007/s00464-016-4982-y. Epub 2016 Jun 10.
PubMed 27287905Shapiro R, Keler U, Segev L, Sarna S, Hatib K, Hazzan D. Laparoscopic right hemicolectomy with intracorporeal anastomosis: short- and long-term benefits in comparison with extracorporeal anastomosis. Surg Endosc. 2016 Sep;30(9):3823-9. doi: 10.1007/s00464-015-4684-x. Epub 2015 Dec 10.
PubMed 26659237Wu Q, Jin C, Hu T, Wei M, Wang Z. Intracorporeal Versus Extracorporeal Anastomosis in Laparoscopic Right Colectomy: A Systematic Review and Meta-Analysis. J Laparoendosc Adv Surg Tech A. 2017 Apr;27(4):348-357. doi: 10.1089/lap.2016.0485. Epub 2016 Oct 21.
PubMed 27768552Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
PubMed 15273542Xu H, Li J, Sun Y, Li Z, Zhen Y, Wang B, Xu Z. Robotic versus laparoscopic right colectomy: a meta-analysis. World J Surg Oncol. 2014 Aug 28;12:274. doi: 10.1186/1477-7819-12-274.
PubMed 25169141
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracorporeal Versus Extracorporeal Anastomosis In Laparoscopic Right Colon Resection: A Prospective Randomized Multi-center Clinical Trial
- ClinicalTrials.gov ID
- NCT05077358
- Acronym / sponsor ID
- 4-2020-1037
- Conditions
- Adenocarcinoma of the Colon
- Keywords
- Intracorporeal anastomosis, Laparoscopic colectomy, Complete mesocolic excision with central vessel ligation, Surgical site infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 241 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 5 Apr 2021 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 14 Oct 2021 (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.
STUDY DESIGN This study is a prospective, randomized, multi-center study comparing intracorporeal versus extracorporeal anastomosis in performing laparoscopic right colectomy. The study subjects will be randomly assigned to 1. intracorporeal anastomosis (experimental group) 2. extracorporeal anastomosis (control group) with 1:1 manner. After surgery the subjects will be followed up at 1month, after then, every 3 month in total 3 years.
STUDY POPULATION
- Screening A detailed review of the medical records will be performed to assess inclusion/exclusion criteria for all subjects who have been diagnosed with right colon tumor (malignant or benign) or benign disease (complicated diverticulitis and so on) that are subject to a right colectomy procedure.
All patients who are eligible, meet the inclusion and none of the exclusion criteria of this study, will be offered enrollment into the study at each site.
RISK ANALYSIS
- Potential risks All these procedures are in practice today and only surgeons competent in a technique shall be allowed to perform those surgeries. Therefore, there are no anticipated additional risks than would normally be encountered from these surgeries when they are performed for these patients.
- Potential benefits There may be some benefit due to having closer follow-up in the study.
QUALIFICATION OF PARTICIPATING SURGEONS
- Surgical procedure
- Laparoscopic surgery: a surgical technique where operations are performed far from their target anatomy location through small incisions normally less than 15mm.
- Extracorporeal anastomosis: the anastomosis is performed by pulling out the bowel through a laparotomy.
- Intracorporeal anastomosis: the anastomosis is performed inside the abdominal cavity with a laparoscopic technique. Specimen extraction will be done through Pfannenstiel incision or similar incision in lower abdomen.
- Procedure standardization and qualification procedure Participating surgeons should complete the learning curve of the procedure and experience at least 50 laparoscopic right colectomy. They are required to be evaluated by the quality control (QC) committee. They should submit their unedited videos of laparoscopic right colectomy and must be accepted by 2 or more of total 3 QC committee members.
STATISTICAL ANALYSIS Based on attaining a success rate of 85% for the primary endpoint, a total of 106 subjects will be required for each group. Accounting for a 5% loss, a total of 241 subjects will be recruited for this study.
Detailed description
STUDY METHODS
- Ethical committee approval The study protocol, patient informed consent form and other required study documentation will be reviewed and approved by an institutional review board or any other authority body, prior to study start-up.
- Study duration and enrollment The total study duration will be approximately 5 years. Study enrollment will take approximately 24 months. The study subjects will have a short-term follow-up at 30 and 3 months post procedure, with long term follow-up upto 3 years after surgery. Surveillance will be performed according to standard follow-up guideline after colorectal cancer surgery.
- Randomization All the enrolled subject will be randomly assigned to one of the study group (intracorporeal or extracorporeal). The randomization will be performed upon the enrollment at the central institution stratifying center on 1:1 manner by a coordinator who is not aware of any clinical information
- Data collection Data will be collected at baseline, operative procedure, discharge, 1 month, 3 months and 1 year. A screening log will be maintained at each site during the enrollment period, in which all patients eligible for the trial shall be identified. This will be maintained to ensure no patient selection bias occurs within a center or by a surgeon.
- Informed Consent Using the study-specific, IRB approved, informed consent form, information pertinent to this study will be provided to the subjects in writing and in their native, non-technical, language. The consent form will include a description of the study and its purpose, potential benefits, potential risks, site contact information, and all other elements required of an informed consent. Subjects are required to voluntarily sign the informed consent form before any study-specific procedure is performed. The Investigator and/or his/her authorized designee, trained on the protocol and performing a consent, will conduct the informed consent process and will answer questions the subjects may have. If the subject agrees to participate, the informed consent form must be signed and dated by the subject or his/her legally authorized representative prior to enrollment in the study and separately signed and dated by the person taking consent. Only subjects who have signed the study informed consent will be included in the study.
- Withdrawal and discontinuation The subject's participation in any clinical trial is voluntary. The subject has the right to withdraw at any time without penalty or loss of benefit. Study withdrawal means the subject is no longer participating in the study and no further follow-ups will be performed. All subjects that withdraw after informed consent is signed will be evaluated at the time of withdrawal. Every effort will be made to document the subject outcome at the time of withdrawal. The investigator has the right to discontinue subjects from the study at their discretion to ensure wellbeing of the subject. The reasons for withdrawal shall be documented.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a prospective, randomized, multi-center study comparing intracorporeal versus extracorporeal anastomosis in performing laparoscopic right colectomy. The study subjects will be randomly assigned to: 1. Intracorporeal anastomosis 2. Extracorporeal anastomosis
| Arm | Type | Receives |
|---|---|---|
| Intracorporeal anastomosis | Experimental | Procedure: Intracorporeal anastomosisIn this group, the anastomosis is performed inside the abdominal cavity with a laparoscopic technique. Specimen extraction will be done through Pfannenstiel incision or similar incision in lower abdomen. |
| Extracorporeal anastomosis | Active comparator | Procedure: Extracorporeal anastomosisIn this group, the anastomosis is performed by pulling out the bowel through a laparotomy. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 19 years or older
- Right colon tumor with indication for right colectomy (malignant disease).
- Patients with adequate performance status (Eastern Cooperative Oncology Group Scale score of ≤2)
- Patient has signed and dated the Informed consent before patient inclusion in the study.
Key exclusion criteria (11 listed)
- Patient with a comorbid illness or condition that would preclude the use of surgery.
- Patients with cT4b tumors.
- Patients whose disease condition requires major simultaneous combined resection other than right colectomy (e.g. other intestinal resection, liver resection)
- Patients unwilling to comply with all follow-up study requirements
- Patient undergoing emergency procedures
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 anastomosisIn this group, the anastomosis is performed inside the abdominal cavity with a laparoscopic technique. Specimen extraction will be done through Pfannenstiel incision or similar incision in lower abdomen. | Procedure or surgery | Intracorporeal anastomosis |
| Extracorporeal anastomosisIn this group, the anastomosis is performed by pulling out the bowel through a laparotomy. | Procedure or surgery | Extracorporeal anastomosis |
Primary outcome
surgical site infection
Time frame: within 30 postoperative days
The efficacy of the anastomosis technique is defined as a lack of surgical site infection within 30 postoperative days. 1. Superficial surgical site infection 2. Deep surgical site infection
8 secondary outcomes
3 year disease-free survival
Time frame: 3 years
Tissue morphometry
Time frame: within 30 postoperative days
Incidence of incisional hernia within 1 year after surgery
Time frame: 1 year
Postoperative pain score in visual analogue scale
Time frame: within 7 postoperative days
Length of postoperative hospital stay
Time frame: within 7 postoperative days
Number of patient with Clavien-Dindo grade IIIb-IV at 30 days postop as an operation-related morbidity
Time frame: within 30 postoperative days
Operative time (min)
Time frame: within the day of operation
Incidence of conversion
Time frame: within 30 postoperative days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Background: PubMed 19793468Hellan M, Anderson C, Pigazzi A. Extracorporeal versus intracorporeal anastomosis for laparoscopic right hemicolectomy. JSLS. 2009 Jul-Sep;13(3):312-7.
- Background: PubMed 27287905van Oostendorp S, Elfrink A, Borstlap W, Schoonmade L, Sietses C, Meijerink J, Tuynman J. Intracorporeal versus extracorporeal anastomosis in right hemicolectomy: a systematic review and meta-analysis. Surg Endosc. 2017 Jan;31(1):64-77. doi: 10.1007/s00464-016-4982-y. Epub 2016 Jun 10.
- Background: PubMed 26659237Shapiro R, Keler U, Segev L, Sarna S, Hatib K, Hazzan D. Laparoscopic right hemicolectomy with intracorporeal anastomosis: short- and long-term benefits in comparison with extracorporeal anastomosis. Surg Endosc. 2016 Sep;30(9):3823-9. doi: 10.1007/s00464-015-4684-x. Epub 2015 Dec 10.
- Background: PubMed 27768552Wu Q, Jin C, Hu T, Wei M, Wang Z. Intracorporeal Versus Extracorporeal Anastomosis in Laparoscopic Right Colectomy: A Systematic Review and Meta-Analysis. J Laparoendosc Adv Surg Tech A. 2017 Apr;27(4):348-357. doi: 10.1089/lap.2016.0485. Epub 2016 Oct 21.
- Background: PubMed 15273542Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
- Background: PubMed 25169141Xu H, Li J, Sun Y, Li Z, Zhen Y, Wang B, Xu Z. Robotic versus laparoscopic right colectomy: a meta-analysis. World J Surg Oncol. 2014 Aug 28;12:274. doi: 10.1186/1477-7819-12-274.
- Individual participant dataSharing planned: No
Related trials for Adenocarcinoma of the Colon
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
Active, not recruitingPhase 2
Perioperative Cadonilimab (AK104) in Locally Advanced MSI-H/dMMR Gastric or Gastroesophageal Junction and Colorectal Adenocarcinoma
MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
RecruitingPhase 1/2
Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread
Metastatic Breast Cancer, Metastatic Gastric Adenocarcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracorporeal anastomosis and Extracorporeal anastomosis in people with Adenocarcinoma of the Colon, run by Yonsei University at 1 site in South Korea.
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 4 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: status not confirmed, as of the sponsor's last update on 14 Oct 2021. 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 South Korea. 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 Byung Soh Min (82-10-7677-5679, BSMIN@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
surgical site infection (time frame: within 30 postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05077358, which also lists 6 linked publications.
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 14 Oct 2021.