Clinical trial · Interventional
Safety Study of Totally Laparoscopic Resection With Natural Orifice Specimen Extraction (NOSE) for Rectosigmoid Cancer
A Prospective Randomized Controlled Trial Comparing Totally Laparoscopic Resection With Natural Orifice Specimen Extraction (NOSE) Versus Conventional Laparoscopic Surgery for Sigmoid Colon or Rectal Cancer
NCT02635503CI-TRIAL-00023759unknownPhase 3ClinicalTrials.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 compare the safety and efficacy of laparoscopic resection with natural orifice specimen extraction versus conventional laparoscopic surgery for sigmoid colon or 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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional laparoscopic surgery | Procedure | — | UNRESOLVED |
| transrectal specimen extraction | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- transrectal specimen extraction
- description
- Laparoscopic colorectal resection with natural orifice specimen extraction will be performed for patients in this group.
- interventionNames
- Procedure: transrectal specimen extraction
- type
- ACTIVE_COMPARATOR
- label
- Conventional laparoscopic surgery
- description
- Conventional laparoscopic surgery for colorectal cancer will be performed for patients in this group.
- interventionNames
- Procedure: Conventional laparoscopic surgery
Primary outcomes (1)
- measure
- Early morbidity rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years \< age \< 80 years * Tumor located in rectosigmoid (defined as 8- to 30-cm from the anal verge) * Pathological rectosigmoid adenocarcinoma * Preoperative T stage ranging from T1 to T4a according to the 7th Edition of American Joint Committee on Cancer (AJCC) Staging Manual * Tumor size of 6 cm or less; * Eastern Cooperative Oncology Group (ECOG) score is 0-1 * American Society of Anesthesiology (ASA) score is Ⅰ-Ⅲ * Informed consent Exclusion Criteria: * Body mass index (BMI) \>30 kg/m2 * Pregnant woman or lactating woman * Severe mental disease * Previous abdominal surgery * Emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer * Requirement of simultaneous surgery for other disease
References
Publications (0)
Data not yet available
No reference posted for this study.