Clinical trial · Interventional
Safety & Efficacy of a Novel Asymmetrical Linear Stapler (NALS) for Securing Distal Resection Margin in Laparoscopic Rectal Cancer Surgery: Pilot Study
NCT06709170CI-TRIAL-00083113not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
Through the use of a novel asymmetrical linear stapler (NALS, Meditulip co. Ltd.), we aim to prove that true distal margins greater than 1cm may be harvested more readily and easily compared to the conventional staplers. The study is designed as a pilot RCT of 30 patients in each group, with the primary outcome of distal margin length \>1cm. Secondary outcomes include anastomosis dehiscence and time taken to harvest the distal margin.
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 |
|---|---|---|---|
| Colo-rectal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Novel asymmetrical linear stapler | Device | — | UNRESOLVED |
| Signia™ | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Novel asymmetrical linear stapler
- description
- Rectal cancer patients randomized to this group will use the novel asymmetrical linear stapler for distal rectum transection, and with 2 rows of stapler lines instead of 3, sufficient tissue is left on the specimen side to harvest the true distal margin for accurate pathological evaluation.
- interventionNames
- Device: Novel asymmetrical linear stapler
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- Rectal cancer patients in the control group will use the conventional Signia™ stapler (Medtronic co.) as routinely used in the centers involved with the study, which has triple stapling technology (3 rows of stapler lines on both sides of transection)
- interventionNames
- Device: Signia™
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: * Rectal cancer patients between the age of 19\~79, who require anus preserving laparoscopic rectum resection surgery Exclusion Criteria: * Advanced rectal cancer that invades surrounding structures or has known distant metastasis * Uncontrolled comorbidities * Patients otherwise considered unsuitable for the study
References
Publications (0)
Data not yet available
No reference posted for this study.