Clinical trial · Interventional
Phase II Trial to Evaluate Laparoscopic Surgery for Stage 0/I Rectal Carcinoma
NCT00635466CI-TRIAL-00005028Lap RCunknownPhase 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)
The purpose of this study is to examine the technical and oncological feasibility of laparoscopic surgery for rectal carcinoma
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laparoscopic surgery for rectal carcinoma | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lap, 1
- description
- Patients undergoing laparoscopic surgery for rectal carcinoma
- interventionNames
- Procedure: laparoscopic surgery for rectal carcinoma
Primary outcomes (1)
- measure
- overall survival
- timeFrame
- 5 year
Secondary outcomes (1)
- measure
- anastomotic leakage rate
- timeFrame
- 1 month
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically proven rectal carcinoma. 2. Tumor located in the rectum. 3. Clinical Tis, T1, T2 N0 M0 4. Without multiple lesions other than carcinoma in situ 5. Tumor size \<8 cm. 6. Sufficient organ function. 7. No bowel obstruction. 8. No history of major colorectal surgery. 9. No history of chemotherapy or radiotherapy. 10. Provide written informed consent. Exclusion Criteria: 1. Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ. 2. Pregnant or lactating women. 3. Severe mental disease. 4. Severe pulmonary emphysema, interstitial pneumonitis or ischemic heart disease. 5. Continuous systemic steroid therapy.
References
Publications (3)
- BACKGROUNDYamamoto S, Yoshimura K, Konishi F, Watanabe M. Phase II trial to evaluate laparoscopic surgery for Stage 0/I rectal carcinoma. Jpn J Clin Oncol. 2008 Jul;38(7):497-500. doi: 10.1093/jjco/hyn054. Epub 2008 Jun 26. PMID 18586667
- DERIVEDIto M, Yamamoto S, Okuda J, Fujii S, Yamaguchi S, Otsuka K, Yoshimura K, Watanabe M; Japan Society of Laparoscopic Colorectal Surgery. Long-term survival outcomes following laparoscopic surgery for clinical stage 0/I rectal carcinoma. Ann Gastroenterol Surg. 2020 May 20;4(3):294-300. doi: 10.1002/ags3.12333. eCollection 2020 May. PMID 32490343
- DERIVEDYamamoto S, Ito M, Okuda J, Fujii S, Yamaguchi S, Yoshimura K, Sugihara K, Watanabe M; Japan Society of Laparoscopic Colorectal Surgery. Laparoscopic surgery for stage 0/I rectal carcinoma: short-term outcomes of a single-arm phase II trial. Ann Surg. 2013 Aug;258(2):283-8. doi: 10.1097/SLA.0b013e318283669c. PMID 23426337