Colorectal Neoplasms, BenignFlexLaCNCT04801355
Full-thickness Laparo-endoscopic Excision vs Laparoscopic Colectomy for Colonic Tumors
A study testing full-thickness laparo-endoscopic colon adenomas excision and laparoscopic colon resection in people with Colorectal Neoplasms, Benign, run by State Scientific Centre of Coloproctology, Russian Federation at 1 site in Russia.
Trial summary
Adenoma - carcinoma is a classic pathway of carcinogenesis. On this basis, timely removal of colon adenomas is a prophylactic measure to prevent colon cancer. The standard treatment of colorectal adenomas is endoscopic mucosal resection or submucosal dissection (ESD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms, Benign
- What is being tested?
- full-thickness laparo-endoscopic colon adenomas excision and laparoscopic colon resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- 1 Dec 2020to 1 Apr 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients age is 18 years and older
- Patients with colonic epithelial neoplasms without signs of invasive growth and not removable endoscopically
- Informed agreement
Who cannot join
- Positive regional lymph nodes
- FAP
- The presence of an intestinal stoma
- ASI > III
- Patients with IBD
- Refusal of the patient to participate in the study
Trial locations and contacts
1 site in 1 country.
Evgenii Surovegin contact
Russia1 site, 1 recruiting
- Recruiting
Ryzhikh National Medical Research Center of Coloproctology, Moscow, Russian Federation
Moscow
Achkasov Sergey, professor, +79036710225, achkasovy@mail.ru
About this study
Official title: Single-center, Randomized Trial: Full-thickness Laparo-endoscopic Excision vs Laparoscopic Colectomy for Colonic Tumors
Adenoma - carcinoma is a classic pathway of carcinogenesis. On this basis, timely removal of colon adenomas is a prophylactic measure to prevent colon cancer.
The standard treatment of colorectal adenomas is endoscopic mucosal resection or submucosal dissection (ESD). In 10 - 15% of cases the ESD is impossible, due to the size of the tumor, inconvenient localisation in the area of the diverticulum or appendix, the presence of fibrosis in the submucosal layer (Currie AC framework IDEAL // Colorectal Disease. 2019. No. 9 (21). P. 1004-1016.), (Suzuki S. Short-term results of laparoscopic endoscopic cooperative surgery of colorectal tumors (LECS-CR) in cases of endoscopically inoperable colorectal tumors // Surgery today . 2019. No. 12 (49). S. 1051-1057.). In that cases the segmental colectomy is justified.
Read more
An alternative to colectomy is a hybrid laparo-endoscopic surgery, which reduce postoperative hospital stay, incidence of complications and provide a comparable level of radicality (Lee SW, Garrett KA, Milsom JW Combined endoscopic and laparoscopic surgery (CELS) // Seminars on surgery of the colon and rectum. 2017. No. 1 (28). S. 24-29).
Thus, the planned study will contribute to the introduction into practice of an alternative method of management with tumors of the colon without signs of invasive growth when the endoscopically removal is impossible.
Read the detailed description
During the study we will recruit the patients with colon epithelial tumors without signs of invasive growth which that cannot be removed endoscopically. In case of high risk of conversion endoscopic procedure the patient will be discussed on MD consillium. All of them will be informed about the possibility of resection methods in the absence of using endoscopic technics. Then the patients will be prepared for the operation in accordance with the method adopted in the clinic. At first colonoscopy will be performed in the operating room. Those patients for whom to perform endoscopic removal of the formation is impossible will be randomized intraoperatively using an Internet resource into 2 groups (main and comparison group).
The patients of the main group will undergo to hybrid laparo-endoscopic operation and comparative group - to laparoscopic colon resection.
After surgical procedure a pathomorphological examination of the speciments will performed with assessment of its quality. Postoperative complications in both groups will be recorded in accordance with the Clavien-Dindo classification. The level of postoperative pain will also be registred according to the visual analogue pain scale (VAS). Also we will be study the time of activation of patients, patient self-care scope according to the Bartell scale, postoperative hospital stay will be assessed.
- Conditions
- Colorectal Neoplasms, Benign
- Being tested
- full-thickness laparo-endoscopic colon adenomas excision, laparoscopic colon resection
- Keywords
- Full-thickness laparo-endoscopic, Colorectal tumors, Laparoscopic resection
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
full-thickness laparo-endoscopic colon adenomas excisionProcedure or surgery
Full-thickness laparo-endoscopic removal of colon adenomas will be performed as follows: an endoscopist during intraoperative colonoscopy visualize the neoplasm, intra-luminary marks the margins of resection and stop at this in some cases. In another one: endoscopist start full-thickness removal of this lesion then the abdominal team during laparoscopy, with using laparoscopic technique, performe full-thickness resection of intestine wall with the tumor. Speciment extracted intralumenary or via minilaparotomy. Defect of the intestinal wall is sutured intracorporeally using laparoscopic technic. Desuflation, suturing of trocar sites.
laparoscopic colon resectionProcedure or surgery
Standard laparoscopic colon resection
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic resection | Other | patients with colonic adenomas who will undergo to laparoscopic segmental resection Receives: Procedure: laparoscopic colon resection |
| full-thickness laparo-endoscopic colon adenomas excision | Experimental | patients with colonic adenomas who will undergo to laparo-endoscopic full-thickness colon resection Receives: Procedure: full-thickness laparo-endoscopic colon adenomas excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
R1 resection rate
In according to pathological examination
Measured: 30 days
Secondary outcomes (2)
The level of postoperative pain
The level of postoperative pain with using a visual analogue pain scale: The patient assesses the postoperative pain from 0 to 10 points (0 points - no pain, 10 - unbearable pain).
Measured: 10 days
The incidence and structure of postoperative complications
The incidence and structure of postoperative complications according to the Clavien-Dindo scale (I-grade - any deviation from the normal course of the postoperative course without the need for pharmacological, surgical, endoscopic or interventional radiological interventions. drugs that are acceptable include antiemetics, antipyretics, analgesics, diuretics, and electrolytes. In addition, this grade includes a wound infection "stopped at the patient's bedside", V grades - Death of the patient)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start1 Dec 2020
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Neoplasms, BenignStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Laparo-endoscopic full-thickness colon resection
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State Scientific Centre of Coloproctology, Russian Federation
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Achkasov Sergey, State Scientific Centre of Coloproctology, Russian Federation
- Investigators
- Aleksey Kolosov, Study chair, Ryzhikh National Medical Research Center of Coloproctology, Moscow, Russian Federation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801355
- Sponsor's protocol ID
- 201
- Acronym
- FlexLaC
- Status last verified
- Aug 2022
- First submitted
- 8 Mar 2021
- Last updated
- 25 Aug 2022
- 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 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center, Randomized Trial: Full-thickness Laparo-endoscopic Excision vs Laparoscopic Colectomy for Colonic Tumors
- ClinicalTrials.gov ID
- NCT04801355
- Acronym / sponsor ID
- FlexLaC / 201
- Conditions
- Colorectal Neoplasms, Benign
- Keywords
- Full-thickness laparo-endoscopic, Colorectal tumors, Laparoscopic resection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- State Scientific Centre of Coloproctology, Russian FederationOther government
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 17 Mar 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.
Adenoma - carcinoma is a classic pathway of carcinogenesis. On this basis, timely removal of colon adenomas is a prophylactic measure to prevent colon cancer.
The standard treatment of colorectal adenomas is endoscopic mucosal resection or submucosal dissection (ESD). In 10 - 15% of cases the ESD is impossible, due to the size of the tumor, inconvenient localisation in the area of the diverticulum or appendix, the presence of fibrosis in the submucosal layer (Currie AC framework IDEAL // Colorectal Disease. 2019. No. 9 (21). P. 1004-1016.), (Suzuki S. Short-term results of laparoscopic endoscopic cooperative surgery of colorectal tumors (LECS-CR) in cases of endoscopically inoperable colorectal tumors // Surgery today . 2019. No. 12 (49). S. 1051-1057.). In that cases the segmental colectomy is justified.
An alternative to colectomy is a hybrid laparo-endoscopic surgery, which reduce postoperative hospital stay, incidence of complications and provide a comparable level of radicality (Lee SW, Garrett KA, Milsom JW Combined endoscopic and laparoscopic surgery (CELS) // Seminars on surgery of the colon and rectum. 2017. No. 1 (28). S. 24-29).
Thus, the planned study will contribute to the introduction into practice of an alternative method of management with tumors of the colon without signs of invasive growth when the endoscopically removal is impossible.
Detailed description
During the study we will recruit the patients with colon epithelial tumors without signs of invasive growth which that cannot be removed endoscopically. In case of high risk of conversion endoscopic procedure the patient will be discussed on MD consillium. All of them will be informed about the possibility of resection methods in the absence of using endoscopic technics. Then the patients will be prepared for the operation in accordance with the method adopted in the clinic. At first colonoscopy will be performed in the operating room. Those patients for whom to perform endoscopic removal of the formation is impossible will be randomized intraoperatively using an Internet resource into 2 groups (main and comparison group).
The patients of the main group will undergo to hybrid laparo-endoscopic operation and comparative group - to laparoscopic colon resection.
After surgical procedure a pathomorphological examination of the speciments will performed with assessment of its quality. Postoperative complications in both groups will be recorded in accordance with the Clavien-Dindo classification. The level of postoperative pain will also be registred according to the visual analogue pain scale (VAS). Also we will be study the time of activation of patients, patient self-care scope according to the Bartell scale, postoperative hospital stay will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Laparo-endoscopic full-thickness colon resection
| Arm | Type | Receives |
|---|---|---|
| laparoscopic resection | Other | Procedure: laparoscopic colon resectionpatients with colonic adenomas who will undergo to laparoscopic segmental resection |
| full-thickness laparo-endoscopic colon adenomas excision | Experimental | Procedure: full-thickness laparo-endoscopic colon adenomas excisionpatients with colonic adenomas who will undergo to laparo-endoscopic full-thickness colon resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients age is 18 years and older
- Patients with colonic epithelial neoplasms without signs of invasive growth and not removable endoscopically
- Informed agreement
Key exclusion criteria (6 listed)
- Positive regional lymph nodes
- FAP
- The presence of an intestinal stoma
- ASI > III
- Patients with IBD
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 |
|---|---|---|
| full-thickness laparo-endoscopic colon adenomas excisionFull-thickness laparo-endoscopic removal of colon adenomas will be performed as follows: an endoscopist during intraoperative colonoscopy visualize the neoplasm, intra-luminary marks the margins of resection and stop at this in some cases. In another one: endoscopist start full-thickness removal of this lesion then the abdominal team during laparoscopy, with using laparoscopic technique, performe full-thickness resection of intestine wall with the tumor. Speciment extracted intralumenary or via minilaparotomy. Defect of the intestinal wall is sutured intracorporeally using laparoscopic technic. Desuflation, suturing of trocar sites. | Procedure or surgery | full-thickness laparo-endoscopic colon adenomas excision |
| laparoscopic colon resectionStandard laparoscopic colon resection | Procedure or surgery | laparoscopic resection |
Primary outcome
R1 resection rate
Time frame: 30 days
In according to pathological examination
2 secondary outcomes
The level of postoperative pain
Time frame: 10 days
The incidence and structure of postoperative complications
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Colorectal Neoplasms, Benign
Active, not recruiting
da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures
Colorectal Cancer, Benign or Malignant Rectal or Colon Tumors
Not yet recruitingObservational study
COLOFLOW: Laser Speckle Contrast Imaging Versus Near-infrared Fluorescence Imaging With Indocyanine Green
Leakage, Anastomotic, Colon Cancer
RecruitingPhase 4
Fluid Challenge and Plasma Volume, During Surgery
Colorectal Cancer, Urologic Cancer
Not yet recruitingObservational study
Outcomes After Liver and Biliary Resection at a High-Volume Center
Liver Neoplasms, Hepatobiliary Diseases
Active, not recruiting
Optimization and Standardization of Single-Port Robotic Transanal Minimally Invasive Surgery for Rectal Tumor Excision
Rectal Neoplasms, Rectal Cancer Patients
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.
Evgenii Surovegin contact
Aleksey Kolosov study chair
Ryzhikh National Medical Research Center of Coloproctology, Moscow, Russian Federation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing full-thickness laparo-endoscopic colon adenomas excision and laparoscopic colon resection in people with Colorectal Neoplasms, Benign, run by State Scientific Centre of Coloproctology, Russian Federation at 1 site in Russia.
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 3 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: status not confirmed, as of the sponsor's last update on 25 Aug 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 Russia. 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 Sergey Achkasov, professor (+79036710225, achkasovy@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R1 resection rate (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 25 Aug 2022.