Minimally Invasive Robotic Surgery, Role in Optimal Debulking Ovarian Cancer, Recovery & Survival
NCT ID: NCT04402333
Last Updated: 2020-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
40 participants
OBSERVATIONAL
2020-06-26
2021-10-03
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Robotic surgery is unlikely to be suitable in all cases of ovarian cancer, particularly those with large pelvic masses or extensive disease around the upper part of the abdomen, however, it has the potential to provide significant recovery and quality of life benefits to a selected group of patients.
MIRRORS - ICG "Peritoneal angiography / perfusion assessment using Indocyanine green (ICG) in patients with advanced ovarian cancers" is a ancillary study within MIRRORS. Using ICG dye, the investigators aim to observe whether there are any changes in the blood vessel pattern associated with the tumour deposits the investigators remove that makes them distinctive. The ICG will not be used to guide where biopsies are taken or tissue is removed. Participation in this ancillary research is not required for participation in the trial.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
MIRRORS-RCT Pilot: Role of Robotic Interval Cytoreductive Surgery for Advanced Ovarian Cancer
NCT05960630
Feasibility of Frailty Assessment and Implementation of Interventions in Women Over 70 With Epithelial Ovarian Cancer
NCT04300699
Debulking Surgery in Ovarian Cancer
NCT03378128
Laparoscopic Interval Cytoreductive Surgery in Advance Ovarian Cancer
NCT06883409
MicroFluO: FLUorescence-guided Surgery for Ovarian Cancer
NCT05633836
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Null Hypothesis: Robotic surgery is not suitable for the treatment of ovarian cancer following neoadjuvant chemotherapy. It is not possible to achieve maximal debulking surgery and patient outcomes are not improved.
To assess the feasibility of obtaining consent from women and acceptability of Robotic interval debulking surgery for advanced ovarian cancer. Women deemed suitable for interval debulking surgery will be identified through the Gynaecological Oncology multidisciplinary team meeting. The aim is to recruit women over a period of 1 year aiming for a total of 20 women who undergo Minimally Invasive Robotic Interval debulking surgery for advanced ovarian cancer. The main outcomes are feasibility of the recruitment process and acceptability of the questionnaires and numeric rating pain scale (NRS11) as assessed by completion rate and patient interviews.
In order to be able to offer MIRRORS to as many patients as possible the investigators have kept the inclusion criteria wide, not restricting by Body Mass Index (BMI), patient comorbidities or Ca125 level.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Robotic interval debulking surgery
Surgery will commence with an initial assessment with a camera inserted though the belly button. This visual assessment will be used to determine whether it is feasible to proceed with surgery robotically or whether full debulking surgery to zero macroscopic residual disease would be best carried out through an open surgical approach. If an open surgical approach is considered the optimum treatment for the patient and they have consented for this, then this will be done. If there is disease that cannot be removed Robotically after starting by this route, but can be removed via an open incision the surgery will be converted to an open procedure if it is safe to do so. If there are any complications, we may also need to convert to open surgery. The aim of the surgery whether by robotic or open is to remove all visible disease safely.
Robotic Interval Debulking Surgery
Interval debulking surgery carried out in a minimally invasive manner using the Da Vinci Robot.
Open interval debulking surgery
Standard Care. Following initial laparoscopic assessment patients not deemed suitable for minimally invasive robotic surgery will proceed with standard open interval debulking surgery through an extended midline incision. These patients will also be followed up to assess recovery, complication rate and quality of life.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Robotic Interval Debulking Surgery
Interval debulking surgery carried out in a minimally invasive manner using the Da Vinci Robot.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Considered suitable for Interval debulking surgery
≤8cm pelvic mass
Exclusion Criteria
Severe renal insufficiency estimated Glomerular filtration rate (GFR)\< 55ml/min, known allergy to iodine or Indocyanine green (ICG) and hyperthyroidism.
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Royal Surrey County Hospital NHS Foundation Trust
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Simon Butler-Manuel, MD
Role: PRINCIPAL_INVESTIGATOR
Royal Surrey NHS Foundation Trust
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Royal Surrey NHS Foundation Trust
Guildford, Surrey, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MIRRORS
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.