Clinical trial · Observational
Robotic Top-down Intersphincteric Resection
A Feasibility Study of Robotic Transabdominal Top-down Intersphincteric Resection With Double-stapling Coloanal Anastomosis for Distal Rectal Cancer
NCT05961969CI-TRIAL-00080923recruitingClinicalTrials.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 present study is to develop the novel robotic surgical technique and enhance the surgery quality for the treatment of distal 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Robotic surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients undergoing robotic Transabdominal Top-down Intersphincteric Resection
- description
- Patients undergoing robotic Transabdominal Top-down Intersphincteric Resection with Double-stapling Coloanal Anastomosis
- interventionNames
- Procedure: Robotic surgery
Primary outcomes (1)
- measure
- Completion of transabdominal ISR
- timeFrame
- About one week
- description
- 1. The total mobilization and transection of anorectum was performed in the transabdominal down sequence, followed by the double-stapling technique for the coloanal anastomosis; 2. the proximal and distal stapled tissue doughnuts recovered from EEA device were intact; 3. A variable length of muscular cuff of proximal internal anal sphincter was removed with a TME specimen; 4. To define a successful transabdominal total ISR, besides the above-mentioned three criteria, the anastomotic site should be checked by immediate anoscopy to confirm the stapling line is approximately at the level of anal intersphincteric groove.
Secondary outcomes (12)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * cT1-3 or yT 1-3 rectal adenocarcinoma whose low border was located below the anorectal sling (4 cm from anal verge), in which the required surgery meets the definition of ISR; * Clinically Tumor-Node-Metastasis (TNM) stage I-III rectal adenocarcinoma; * Curative and elective surgery; * American Society of Anesthesiology (ASA) class Ⅰ to Ⅲ patients; * Age between 20 and 75 years. Exclusion Criteria: * cT4 adenocarcinoma, i.e., the rectal cancer invaded to external sphincter or adjacent pelvic organs; * Evidence of distant metastasis; * Primary tumor mass≧8 cm in diameter; * Morbidly obese patients, i.e., body mass index (BMI) ≧ 40 kg/m2 ; * Previous major surgery of low upper abdomen; * The adenocarcinoma has invaded to lateral pelvic side wall requiring a lateral pelvic lymph node dissection. (7) Patients with poor anorectal function (Wexner incontinence Score≧ 10)
References
Publications (0)
Data not yet available
No reference posted for this study.