Last reviewed · How we verify
NCT04801355: FlexLaC
Full-thickness Laparo-endoscopic Excision vs Laparoscopic Colectomy for Colonic Tumors
NA trial testing full-thickness laparo-endoscopic colon adenomas excision in Colorectal Neoplasms, Benign in 100 participants. Status unknown.
1 December 2022
Quick facts
| Lead sponsor | State Scientific Centre of Coloproctology, Russian Federation |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 1 December 2020 |
| Primary completion | 1 December 2022 |
| Estimated completion | 1 April 2023 |
| Sites | 1 location across Russia |
Drugs / interventions tested
- full-thickness laparo-endoscopic colon adenomas excision
- laparoscopic colon resection
Conditions studied
- Colorectal Neoplasms, Benign — all drugs for Colorectal Neoplasms, Benign →
Sponsor
State Scientific Centre of Coloproctology, Russian Federation — full company profile →
Who can join
18 and older, any sex, with Colorectal Neoplasms, Benign. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04801355
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other State Scientific Centre of Coloproctology, Russian Federation trials
Trials by the same sponsor.
- NCT07268261 — Combined Method of Surgical Treatment of Anal Fissure · NA · recruiting
- NCT05598164 — Botulinum Toxin Type A in the Treatment of Chronic Anal Fissure · NA · unknown
- NCT05495776 — Prospective Multicenter Registry Study to Assess the Frequency of Lynch Syndrome Among Patients With Colorectal Cancer · recruiting
- NCT05117697 — Surgical Treatment of a Chronic Anal Fissure · NA · unknown
- NCT05228054 — Treatment of Hemorrhoid With 1940nm Laser Procedure · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04801355 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by State Scientific Centre of Coloproctology, Russian Federation
- Last refreshed: 25 August 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04801355.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing