Colon NeoplasmNCT05034692
Application of Overlap Method to Digestive Tract Reconstruction of Totally Laparoscopic Left Colectomy
A study testing Total laparoscopic with intracorporeal anastomosis by overlap method and Laparoscopic-assisted colectomy with extracorporeal anastomosis in people with Colon Neoplasm, run by Tang-Du Hospital at 1 site in China.
Trial summary
Objective:The comparison between total laparoscopic colectomy with intracorporeal anastomosis by overlap method and laparoscopic-assisted colectomy with extracorporeal anastomosis for colon cancer surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colon Neoplasm
- What is being tested?
- Total laparoscopic with intracorporeal anastomosis by overlap method and Laparoscopic-assisted colectomy with extracorporeal anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 21 Mar 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA<3 classification
- 18kg/m2≤BMI≤30kg/m2
- Neoplasm staging is T1-4a, N0-2, M0
- No previous history of abdominal surgery
- No previous history of neoplasm chemoradiotherapy
- No status of ileus, bowel obstruction and active hemorrhage of the digestive tract
Who cannot join
- Age<18 years or >75 years
- ASA≥3 classification
- BMI<18kg/m2 or BMI>30kg/m2
- Neoplasm staging is T4b or M1 Underwent chemoradiotherapy Appeared status of ileus,bowel perforation or active hemorrhage of digestive tract Patients with pregnant
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
General Surgery Gastrointestinal Department，Tang-Du of Fourth Military Medical University
Xi'an, Shaanxi, 710000
Wang Nan, Doctor, 0086-029-84778829, wangnandoc@163.com
Nan Wang, Master, 0086-029-84717400, 1620544187@qq.com
About this study
Objective:The comparison between total laparoscopic colectomy with intracorporeal anastomosis by overlap method and laparoscopic-assisted colectomy with extracorporeal anastomosis for colon cancer surgery.
Condition or disease：Left colon cancer Intervention/treatment： Procedure:Intracorporeal left colectomy Overlap anastomosis Procedure: Extracorporeal left colectomy convention anastomosis
Read the detailed description
This a simple randomized, single-center, single-blind, randomized controlled trial study.The patients were randomly divided into experimental groups and control groups by computer.The perioperative recovery data, complications and oncology index of total laparoscopic colectomy with intracorporeal anastomosis and laparoscopic-assisted colectomy with extracorporeal anastomosis would be compared.
- Conditions
- Colon Neoplasm
- Being tested
- Total laparoscopic with intracorporeal anastomosis by overlap method, Laparoscopic-assisted colectomy with extracorporeal anastomosis
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total laparoscopic with intracorporeal anastomosis by overlap methodProcedure or surgery
After the intestinal canal was dissociated and vascularized, the intestinal canal was nuded and cut off, and the distal and proximal intestinal canals were overlapped by 6 cm
Laparoscopic-assisted colectomy with extracorporeal anastomosisProcedure or surgery
After the corresponding colon and blood vessels were dissociated and treated, the carbon dioxide pneumoperitoneum was removed. The appropriate length of the incision was cut at the corresponding position of the abdomen, and the incision protector was placed. The tumor was lifted together with the free intestinal canal to the outside of the abdomen. The intestinal canals at the quasi-dismembered sites on both sides of the tumor were nuded, and the colon-colon functional end-to-end anastomosis was performed.
| Study group | Role | What they receive |
|---|---|---|
| Overlap group | Experimental | Total laparoscopic with intracorporeal anastomosis by overlap method Receives: Procedure: Total laparoscopic with intracorporeal anastomosis by overlap method |
| Traditional group | Active comparator | Laparoscopic-assisted colectomy with extracorporeal anastomosis Receives: Procedure: Laparoscopic-assisted colectomy with extracorporeal anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of early complications
According to Clavein Dindo grading standards（The scale is divided into four levels, with the minimum（Ⅰ） and the maximum（Ⅳ） level. The higher the level that more severe symptoms.）, the incidence of complications within one month after surgery, such as incision infection, bleeding, anastomotic leakage, ileus, etc., was counted
Measured: one month after surgery
Secondary outcomes (7)
anastomotic orifice stricture and torsion
According to results of intestinal barium contrast, colonoscopy and clinical symptoms to judgment
Measured: one month after surgery
the time of first flatus
Observation of patients exhaust on days after operation
Measured: one month after surgery
the time of first defecation
Observation of patients bowl movement on days after operation
Measured: one month after surgery
the time of first oral feeding
Observation of patients oral intake on days after operation
Measured: one month after surgery
postoperative hospitalization days
Observation of patients hospitalization duration on days post-surgery
Measured: one month after surgery
the incision length and cosmetic
Comparing length and cosmetic of two groups measuring with metric
Measured: one month after surgery
pain score
Estimate for pain of subject By Visual Analog Scale for Pain (VAS Pain，The scale is divided into four levels, with the minimum（1 score） and the maximum（10 score） level. The higher the level that more severe pain.)
Measured: postoperative 6 hours, the first day and the third day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start21 Mar 2022
- Primary completion20 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon NeoplasmStudies of the same condition, open and under way.
- More trials run by Tang-Du 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wang Nan, Doctor, Study chair, General surgery ,Tang Du of Fourth Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034692
- Sponsor's protocol ID
- K202012-10
- Status last verified
- Oct 2022
- First submitted
- 6 Feb 2021
- Last updated
- 24 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Overlap Method to Digestive Tract Reconstruction of Totally Laparoscopic Left Colectomy
- ClinicalTrials.gov ID
- NCT05034692
- Acronym / sponsor ID
- K202012-10
- Conditions
- Colon Neoplasm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 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.
Objective:The comparison between total laparoscopic colectomy with intracorporeal anastomosis by overlap method and laparoscopic-assisted colectomy with extracorporeal anastomosis for colon cancer surgery.
Condition or disease：Left colon cancer Intervention/treatment： Procedure:Intracorporeal left colectomy Overlap anastomosis Procedure: Extracorporeal left colectomy convention anastomosis
Detailed description
This a simple randomized, single-center, single-blind, randomized controlled trial study.The patients were randomly divided into experimental groups and control groups by computer.The perioperative recovery data, complications and oncology index of total laparoscopic colectomy with intracorporeal anastomosis and laparoscopic-assisted colectomy with extracorporeal anastomosis would be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Overlap group | Experimental | Procedure: Total laparoscopic with intracorporeal anastomosis by overlap methodTotal laparoscopic with intracorporeal anastomosis by overlap method |
| Traditional group | Active comparator | Procedure: Laparoscopic-assisted colectomy with extracorporeal anastomosisLaparoscopic-assisted colectomy with extracorporeal anastomosis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ASA<3 classification
- 18kg/m2≤BMI≤30kg/m2
- Neoplasm staging is T1-4a, N0-2, M0
- No previous history of abdominal surgery
- No previous history of neoplasm chemoradiotherapy
Key exclusion criteria (4 listed)
- Age<18 years or >75 years
- ASA≥3 classification
- BMI<18kg/m2 or BMI>30kg/m2
- Neoplasm staging is T4b or M1 Underwent chemoradiotherapy Appeared status of ileus,bowel perforation or active hemorrhage of digestive tract Patients with pregnant
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 |
|---|---|---|
| Total laparoscopic with intracorporeal anastomosis by overlap methodAfter the intestinal canal was dissociated and vascularized, the intestinal canal was nuded and cut off, and the distal and proximal intestinal canals were overlapped by 6 cm | Procedure or surgery | Overlap group |
| Laparoscopic-assisted colectomy with extracorporeal anastomosisAfter the corresponding colon and blood vessels were dissociated and treated, the carbon dioxide pneumoperitoneum was removed. The appropriate length of the incision was cut at the corresponding position of the abdomen, and the incision protector was placed. The tumor was lifted together with the free intestinal canal to the outside of the abdomen. The intestinal canals at the quasi-dismembered sites on both sides of the tumor were nuded, and the colon-colon functional end-to-end anastomosis was performed. | Procedure or surgery | Traditional group |
Primary outcome
The incidence of early complications
Time frame: one month after surgery
According to Clavein Dindo grading standards（The scale is divided into four levels, with the minimum（Ⅰ） and the maximum（Ⅳ） level. The higher the level that more severe symptoms.）, the incidence of complications within one month after surgery, such as incision infection, bleeding, anastomotic leakage, ileus, etc., was counted
7 secondary outcomes
anastomotic orifice stricture and torsion
Time frame: one month after surgery
the time of first flatus
Time frame: one month after surgery
the time of first defecation
Time frame: one month after surgery
the time of first oral feeding
Time frame: one month after surgery
postoperative hospitalization days
Time frame: one month after surgery
the incision length and cosmetic
Time frame: one month after surgery
pain score
Time frame: postoperative 6 hours, the first day and the third day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
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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.
Wang Nan, Doctor study chair
General surgery ,Tang Du of Fourth Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total laparoscopic with intracorporeal anastomosis by overlap method and Laparoscopic-assisted colectomy with extracorporeal anastomosis in people with Colon Neoplasm, run by Tang-Du Hospital 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 6 inclusion and 4 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 24 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nan Wang, Doctor (0086-029-84778829, wangnandoc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of early complications (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?
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 24 Oct 2022.