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NCT Number: NCT04512937

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital- The Norwegian Radium Hospital

Oslo, 0424, Norway

About this study

Curative treatment of rectal cancer requires surgical removal of the tumour. The key challenge in this surgery is to remove the tumour with free margins - R0 resection. Failure to achieve R0 resection often leads to recurrence, which is associated with risk of long-term suffering, poor quality of life and death for the patients. Achieving R0 resection is most difficult in advanced rectal cancer cases, where the tumour is threatening - and sometimes even growing into - neighbouring organs.

Computer navigation-assisted surgery has typically been implemented where extreme surgical precision is necessary or in surgical fields with high anatomic complexity. In such settings, it contributes to preservation of vital anatomic structures close to the tumour, and ensures completeness of resection in cases of malignant disease.

With this in mind, feasibility of navigation in surgically challenging rectal cancer cases will be investigated in this study. If found feasible, navigation could improve surgical management for patients who otherwise would not have the possibility of cure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Rate of patients with R0 resection

    Time frame: 2 years

    Resection status will be determined by histopathological examination of specimen

Secondary outcomes

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

    Time frame: 2 years

    Postoperative MRI of the pelvis will be examined and compared to preoperative MRI to evaluate what structures were removed at surgery.

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

    Time frame: 2 years

    Volume of intended resection (measured in millilitres) based on pre-procedural MRI will be comparted with volume of resected specimen (measured in millilitres).

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

    Time frame: 2 years

    Interviews with the surgeons will be semi-structured based on an interview guide. They will be recorded and transcribed, and analyzed using thematic analysis.

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

    Time frame: 30 days after surgery

    The Accordion severity grading system of surgical complications classifies surgical complications in 6 Levels ranging from mild complications (1) to Death (6)

  5. 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)

    Time frame: 3 years

    The EORTC QLQ-C30 comprises 30 items (i.e. single questions) registering five functioning scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea/vomiting) and one global health status scale. EORTC QLQ C30 will be completed prior to surgery, and at one and three years after surgery. Changes over time will be analysed.

  6. Overall survival (OS)

    Time frame: 5 years

    OS is defined as time from surgery until death from any cause

  7. Rate of local (re-)recurrence after surgery

    Time frame: 5 years

    Local (re)-recurrence will be determined by routine follow-up

  8. Progression-free survivial (PFS)

    Time frame: 5 years

    PFS is defined as time from surgery until disease progression or death from any cause

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Acronym: NAVI-LARRC

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Aug 14, 2020
Registry last updated
Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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