Clinical trial · Observational
Laparoscopic Assisted Transanal Total Mesorectal Excision for Rectal Cancer in Low Site
Laparoscopic Assisted transAnal Total Mesorectal Excision for Rectal cAncer in Low Site :A Prospective,Multi-center, Patients Registry Trial in China (LATERAL Trial)
- 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)
At present, surgical resection is still the main treatment for the potential cure of rectal cancer. Total mesorectal excision (TME) is the gold standard. The traditional laparoscopic or open surgery for some special patients is really difficult, especially for male, prostate hypertrophy, obesity, low tumor and pelvic stenosis patients to expose the gap around the mesorectum and separate to the pelvic floor. While transanal total mesorectal excision (TaTME) approach could be more directly separate the low mesorectum and relatively simple to complete distal rectal transection, which would bring some considerable advantages. Although active learning from abroad, laparoscopic assisted TaTME surgery is now in its infancy in China. It is urgent for clinical studies to obtain the results in China. This multicenter, observational study will help to encourage research in this field and to obtain data on the safety and efficacy of this procedure in Chinese patients with rectal cancer.
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 |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Positive rate of circumferential resection margin (CRM) of the specimens
- timeFrame
- 10 days after surgery
- description
- Circumferential resection margin (CRM) is the distance between the deepest point of tumor in the primary cancer and the margin of resection in the retroperitoneum or mesentery by pathological examination. CRM 0-1mm is defined as positive, while \>1mm is negative.
Secondary outcomes (9)
- measure
- The grade score of the specimens integrity
- timeFrame
- 10 days after surgery
- description
- shows the quality of the specimens: grade 1 is bad gross specimen which means incomplete mesorectum and pelvic fascia, and muscle layer can be see \>5mm; grade 3 is high quality gross specimen, which means the specimen is cylindrical, mesorectum and pelvic fascia are complete; grade 2 is between 1and 3.
- measure
- The distance between lower tumor margin and the lower reaction margin
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * adenocarcinoma of the rectum by biopsy * the lower edge of the tumor from the anal margin less than 10cm according to MRI or rigid endoscopy * tumor diameter less than 4cm * baseline clinical stage I-III: cT1-3 N0-2 M0 (AJCC v7) * tolerable to surgery * be able to understand and willing to participate in this trial with signature Exclusion Criteria: * history of malignant colorectal neoplasia * recent diagnosis with other malignancies * patients requiring emergency surgery such as obstruction，perforation and bleeding * tumor involving adjacent organs, anal sphincter, or levator ani muscle * muti-focal colorectal cancer * preoperative poor anal function, anal stenosis, anal injury, or fecal incontinence * history of inflammatory bowel disease or familial adenomatous polyposis * participating in other clinical trails * can not tolerate the surgery * history of serious mental illness * pregnancy or lactating women * preoperative uncontrolled infection * the researchers believe the patients should not enrolled in
References
Publications (0)
Data not yet available