Clinical trial · Interventional
Long Term Outcomes After Laparoscopic Intersphincteric Resection With Total Mesorectal Excision for Low Rectal Cancer.
Long Term Outcomes After Laparoscopic Intersphincteric Resection With Total Mesorectal Excision for Low Rectal Cancer: a Double Blind Randomized Clinical Trial
NCT02468362CI-TRIAL-00018222ISR-TMEunknownPhase 2ClinicalTrials.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 a double blinded study, patients with low rectal cancer will be randomized into two equal groups to compare between the 5 year disease free survival as a primary outcome measure.
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 |
|---|---|---|---|
| Low Rectal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laparoscopic intersphincteric resection | Procedure | — | UNRESOLVED |
| open intersphincteric resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Laparoscopic group
- interventionNames
- Procedure: laparoscopic intersphincteric resection
- type
- ACTIVE_COMPARATOR
- label
- Open group
- interventionNames
- Procedure: open intersphincteric resection
Primary outcomes (1)
- measure
- Disease Free survival
- timeFrame
- 5 years
Secondary outcomes (3)
- measure
- Local recurrence
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Low rectal cancer below 5 cm from the anal verge * Fit for laparoscopic total mesorectal excsion * T2, T3 rectal cancer * No distant metstasis Exclusion Criteria: * T1, AND T4 * Distant metastasis * Tumor infiltrating the dentate line * unwilling to participate
References
Publications (0)
Data not yet available
No reference posted for this study.