Transverse Colon CancerNCT05061199
Resection Margin of Transverse Colon Cancer With Extracorporeal Versus Intracorporeal Anastomosis
An observational study of Transverse Colon Cancer, run by Shanghai Minimally Invasive Surgery Center at 1 site in China.
Trial summary
The approach of anastomosis in laparoscopic resection of transverse colon cancer (TCC) has rarely been discussed. This study aims to compare the resection margin of TCC with extracorporeal anastomosis (ECA) versus intracorporeal anastomosis (ICA). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Transverse Colon Cancer
- What is being tested?
- approach of anastomosis
- Type of treatment
- Surgery or procedure
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 31 Jul 2023
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: transverse colon cancer
Who may be able to join
- 1. pathologically confirmed adenocarcinoma of colon
- 2. The tumor is located in the transverse colon (including hepatic or splenic flexure);
- 3. One of the following procedures was performed: transverse colectomy, right hemicolectomy, enlarged right hemicolectomy, left colectomy, enlarged left colectomy;
- 4. Laparoscopic surgery (laparoscopy-assisted surgery or complete laparoscopic surgery) from August 2019 to July 2021;
- 5. Radical resection (R0) was accomplished;
Who cannot join
- 1. Simultaneous multiple colorectal cancer;
- 2. history of colorectal surgery (except endoscopic surgery);
- 3. robot-assisted surgery;
- 4. palliative resection (non-R0 resection) or palliative bypass;
- 5. the approach of anastomosis could not be determined from the documents;
- 6. the length of resection margin was not recorded in pathological report;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Intracorporeal Anastomosis on Resection Margin During Laparoscopic Radical Resection of Transverse Colon Cancer: a Retrospective Multi-center Study
The approach of anastomosis in laparoscopic resection of transverse colon cancer (TCC) has rarely been discussed. This study aims to compare the resection margin of TCC with extracorporeal anastomosis (ECA) versus intracorporeal anastomosis (ICA).
Patients who underwent laparoscopic resection of TCC from August 2019 to July 2021 in 13 participating centers are included in this study. According to the approach of anastomosis, patients are divided into two groups, ECA group and ICA group respectively. The clinical characteristics, the perioperative outcomes and the pathological results (especially the length of resection margin) are compared between the two groups. The length of two-sided resection margins (long margin, short margin) are measured on formalin-fixed specimens and those with short margin less than 4.0 cm are defined as unqualified specimens.
Read the detailed description
13 participating centers are as follows: Ruijin Hospital, Shanghai Jiaotong University School of Medicine；Zhejiang University Medical College Affiliated Sir Run Shaw Hospital；Zhongshan Hospital Affiliated to Fudan University；Renji Hospital Affiliated to Medical College of Shanghai Jiaotong University; Jiangsu Provincial People's Hospital; Xiangya Hospital of Central South University; The First Affiliated Hospital of Chongqing Medical University; The first hospital of Jilin University; Beijing Friendship Hospital Affiliated to Capital Medical University; Tangdu Hospital; Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology; Cancer Hospital of Chinese Academy of Medical Sciences; Henan Provincial People's Hospital
- Conditions
- Transverse Colon Cancer
- Being tested
- approach of anastomosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
approach of anastomosisProcedure or surgery
The approach of anastomosis
| Study group | Role | What they receive |
|---|---|---|
| ECA group | TCC with extracorporeal anastomosis (ECA) Receives: Procedure: approach of anastomosis | |
| ICA group | TCC with intracorporeal anastomosis (ICA). Receives: Procedure: approach of anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of the resection margin
length of the two -sided resection margins measured on formalin-fixed specimen (CM)
Measured: one month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start1 Aug 2022
- Primary completion31 Dec 2022
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transverse Colon 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Minimally Invasive Surgery Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05061199
- Sponsor's protocol ID
- MISC-TCC-ECA-ICA
- Status last verified
- Mar 2024
- First submitted
- 18 Sep 2021
- Last updated
- 7 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhong H, Cai Z, Lu J, Yang Y, Xu Q, Wang N, He L, Hu X, Fingerhut A, Zheng M, Lu A, Liu Z, Xiao Y, Feng B. Pathological and perioperative outcomes of extracorporeal versus intracorporeal anastomosis in laparoscopic transverse colon cancer resection: retrospective multicentre study. BJS Open. 2023 May 5;7(3):zrad045. doi: 10.1093/bjsopen/zrad045.
PubMed 37161672
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Intracorporeal Anastomosis on Resection Margin During Laparoscopic Radical Resection of Transverse Colon Cancer: a Retrospective Multi-center Study
- ClinicalTrials.gov ID
- NCT05061199
- Acronym / sponsor ID
- MISC-TCC-ECA-ICA
- Conditions
- Transverse Colon Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Shanghai Minimally Invasive Surgery CenterUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 29 Sep 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.
The approach of anastomosis in laparoscopic resection of transverse colon cancer (TCC) has rarely been discussed. This study aims to compare the resection margin of TCC with extracorporeal anastomosis (ECA) versus intracorporeal anastomosis (ICA).
Patients who underwent laparoscopic resection of TCC from August 2019 to July 2021 in 13 participating centers are included in this study. According to the approach of anastomosis, patients are divided into two groups, ECA group and ICA group respectively. The clinical characteristics, the perioperative outcomes and the pathological results (especially the length of resection margin) are compared between the two groups. The length of two-sided resection margins (long margin, short margin) are measured on formalin-fixed specimens and those with short margin less than 4.0 cm are defined as unqualified specimens.
Detailed description
13 participating centers are as follows: Ruijin Hospital, Shanghai Jiaotong University School of Medicine；Zhejiang University Medical College Affiliated Sir Run Shaw Hospital；Zhongshan Hospital Affiliated to Fudan University；Renji Hospital Affiliated to Medical College of Shanghai Jiaotong University; Jiangsu Provincial People's Hospital; Xiangya Hospital of Central South University; The First Affiliated Hospital of Chongqing Medical University; The first hospital of Jilin University; Beijing Friendship Hospital Affiliated to Capital Medical University; Tangdu Hospital; Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology; Cancer Hospital of Chinese Academy of Medical Sciences; Henan Provincial People's Hospital
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECA group | – | Procedure: approach of anastomosisTCC with extracorporeal anastomosis (ECA) |
| ICA group | – | Procedure: approach of anastomosisTCC with intracorporeal anastomosis (ICA). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- transverse colon cancer
Key inclusion criteria (5 listed)
- 1. pathologically confirmed adenocarcinoma of colon
- 2. The tumor is located in the transverse colon (including hepatic or splenic flexure);
- 3. One of the following procedures was performed: transverse colectomy, right hemicolectomy, enlarged right hemicolectomy, left colectomy, enlarged left colectomy;
- 4. Laparoscopic surgery (laparoscopy-assisted surgery or complete laparoscopic surgery) from August 2019 to July 2021;
- 5. Radical resection (R0) was accomplished;
Key exclusion criteria (6 listed)
- 1. Simultaneous multiple colorectal cancer;
- 2. history of colorectal surgery (except endoscopic surgery);
- 3. robot-assisted surgery;
- 4. palliative resection (non-R0 resection) or palliative bypass;
- 5. the approach of anastomosis could not be determined from the documents;
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 |
|---|---|---|
| approach of anastomosisThe approach of anastomosis | Procedure or surgery | ECA group, ICA group |
Primary outcome
length of the resection margin
Time frame: one month after surgery
length of the two -sided resection margins measured on formalin-fixed specimen (CM)
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 7 Mar 2024.
- Derived from this study: PubMed 37161672Zhong H, Cai Z, Lu J, Yang Y, Xu Q, Wang N, He L, Hu X, Fingerhut A, Zheng M, Lu A, Liu Z, Xiao Y, Feng B. Pathological and perioperative outcomes of extracorporeal versus intracorporeal anastomosis in laparoscopic transverse colon cancer resection: retrospective multicentre study. BJS Open. 2023 May 5;7(3):zrad045. doi: 10.1093/bjsopen/zrad045.
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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?
An observational study of Transverse Colon Cancer, run by Shanghai Minimally Invasive Surgery Center 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 5 inclusion and 6 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 7 Mar 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.
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?
length of the resection margin (time frame: one month after surgery). 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 NCT05061199, which also lists 1 linked publication.
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 7 Mar 2024.