Computer Navigation-assisted Surgery for Locally Advanced and Recurrent Rectal Cancer

NCT04512937 | Active Not Recruiting

• 1 other identifier: 2020/123753
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate feasibility of computer navigation-assisted surgery in particularly difficult cases of locally advanced (LARC) and recurrent (LRRC) rectal cancer where the standard surgical strategy is expected to result in incomplete tumour removal. The investigators hypothesize that computer navigation-assisted surgery can facilitate improved anatomic orientation in the pelvis enabling tumour removal with free margins in these cases.

Conditions

Rectal Cancer

Keywords

Surgery, Computer-Assisted; Feasibility study

Outcome Measures

Primary Outcomes (1)

• Rate of patients with R0 resection

  Resection status will be determined by histopathological examination of specimen

  2 years

Secondary Outcomes (8)

• Assessment of whether pre-procedural plan was executed during surgery by comparing pre- and post-operative magnetic resonance imaging (MRI).

  2 years

• Assessment of whether pre-procedural plan was executed by comparing volume of intended resection with volume of resected specimen.

  2 years

• Assessment of surgeons' opinion on benefit of computer navigation through qualitative interviews.

  2 years

• Occurrence of 30 day morbidity and mortality assessed with the Accordion severity grading system of surgical complications

  30 days after surgery

• Assessment of patients quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

  3 years

Study Arms (1)

All patients

EXPERIMENTAL

All patients will be subjects to the intervention of computer navigation-assisted surgery

Device: Computer-assisted navigation surgery

Interventions

Computer-assisted navigation surgery DEVICE

Computer navigation-assisted surgery has two main elements; the pre-procedural planning to create accurate 3D images of the pelvis allowing the surgical team to achieve an accurate perception of the operative field, and intraoperative navigation where these images are used for anatomical guidance to enhance surgical precision. Accordingly, computer software is used in this study to outline the tumour and other pelvic organs on pre-operative images which are subsequently used for intraoperative navigation.

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with LARC or LRRC (either biopsy verified, or demonstrated on MRI and confirmed by the MDT decision)
• The MDT must deem standard surgical strategy at high risk of resulting in R1/R2 resection and computer-assisted navigation likely to improve the chances of obtaining R0 resection.
• Written informed consent

You may not qualify if:

• Non-adenocarcinoma malignancies.
• Unresectable distant metastatic disease or unresectable synchronous other malignancy
• Patients deemed unfit to participation according to the MDT.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital- The Norwegian Radium Hospital

Oslo, 0424, Norway

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Kjersti Flatmark, Professor

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: August 14, 2020
• Study Start: September 1, 2020
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)