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A Real-World Evidence Study of Different Surgical Procedures for Rectal cancer

A Retrospective Multicenter Real-World Evidence Study of Open, Laparoscopic and Robotic-assisted Rectal Resections for Rectal cancer - ISI-dVLAR-001

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/03/050448
Enrollment
2500
Registered
2023-03-07
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C20- Malignant neoplasm of rectum

Interventions

None listed

Sponsors

Intuitive Surgical Pvt. Ltd. India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subject who was 18 years of age or older at the time of surgery 2. Subject who has undergone any of open, laparoscopic and robotic assisted rectal resection for non-metastatic rectal cancer (Stage I-IIIb). The intent of the surgery should have been curative.

Exclusion criteria

Exclusion criteria: 1. Subject who has undergone any of open, laparoscopic and robotic assisted rectal resection for rectal cancer with a palliative intent 2. Subject who has undergone any of open, laparoscopic and robotic assisted rectal resection for metastatic rectal cancer 3. Subject who has undergone an emergency procedure for primary treatment of rectal cancer (ie, radical rectal resection)

Design outcomes

Primary

MeasureTime frame
The primary outcome of this study is to retrospectively assess the perioperative outcomes through discharge and the short-term clinical outcomes from discharge to 90 days after open, laparoscopic or robotic-assisted rectal resections for rectal cancerTimepoint: From discharge to 90 days after surgery

Secondary

MeasureTime frame
The secondary outcome of this study is to retrospectively assess the oncological outcomes, progression-free survival, and overall survival from postoperative day 91 and beyond up to 5 years after open, laparoscopic, or robotic-assisted rectal resections for rectal cancerTimepoint: From postoperative, day 91 and beyond, up to 5 years after surgery

Countries

India

Contacts

Public ContactDr Akhil Dahiya

Intuitive Surgical Pvt. Ltd. India

akhil.dahiya@intusurg.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026