Clinical trial · Interventional
Full-thickness Laparo-endoscopic Excision vs Laparoscopic Colectomy for Colonic Tumors
Single-center, Randomized Trial: Full-thickness Laparo-endoscopic Excision vs Laparoscopic Colectomy for Colonic Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms, Benign | Benign Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| full-thickness laparo-endoscopic colon adenomas excision | Procedure | — | UNRESOLVED |
| laparoscopic colon resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- laparoscopic resection
- description
- patients with colonic adenomas who will undergo to laparoscopic segmental resection
- interventionNames
- Procedure: laparoscopic colon resection
- type
- EXPERIMENTAL
- label
- full-thickness laparo-endoscopic colon adenomas excision
- description
- patients with colonic adenomas who will undergo to laparo-endoscopic full-thickness colon resection
- interventionNames
- Procedure: full-thickness laparo-endoscopic colon adenomas excision
Primary outcomes (1)
- measure
- R1 resection rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients age is 18 years and older 2. Patients with colonic epithelial neoplasms without signs of invasive growth and not removable endoscopically 3. Informed agreement Exclusion Criteria: 1. Positive regional lymph nodes 2. FAP 3. The presence of an intestinal stoma 4. ASI \> III 5. Patients with IBD 6. Refusal of the patient to participate in the study
References
Publications (0)
Data not yet available