Trial Title:
MIRRORS-FROZEN - Comparing Open Vs Robotic Surgery in the Management of Women with Complex Pelvic Adnexal Masses ≤ 8cm.
NCT ID:
NCT06638593
Condition:
Ovarian Cancer
Ovarian Mass
Ovarian Cysts
Fallopian Tube Neoplasms
Adnexal Carcinoma
Adnexal Cyst
Adnexal Masses
Conditions: Official terms:
Cysts
Ovarian Cysts
Fallopian Tube Neoplasms
Carcinoma, Skin Appendage
Conditions: Keywords:
Robotic
adnexal masses
Adnexal cysts
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
MIRRORS-FROZEN Protocol.
Description:
Initial laparoscopic phase and thorough inspection of the abdomino-pelvic cavity to
determine the feasibility of proceeding robotically, followed by robotic excision of the
mass(es) and its retrieval in a bag if deemed suitable to proceed robotically. The mass
or cyst will be sent for frozen section to determine the extent of the surgery. The
surgery will continue robotically, with conversion to laparotomy considered at any point
at the discretion of the individual surgeon.
Arm group label:
Arm 1: MIRRORS-FROZEN Protocol.
Intervention type:
Procedure
Intervention name:
Standard open surgery
Description:
A midline abdominal incision will be made from the outset, with intraoperative frozen
section assessment to determine the extent of the surgery.
Arm group label:
Arm 2 : Standard open surgery.
Summary:
Adnexal masses are growths that can form in the ovaries or fallopian tubes for different
reasons, such as hormonal changes, infection, or cancer. These masses may cause pelvic
discomfort, pain, constipation, or no symptoms at all. When adnexal masses are found on
scans, they are described in a certain way to indicate if they could represent
early-stage cancer, and the word "complex" is used to refer to these masses. Surgery is
often recommended, where the mass is removed and examined under the microscope during
surgery in a process called (frozen section analysis); to determine its true nature.
It is still difficult to confirm cancer before surgery, and many of these masses turn out
to be benign (not cancerous) or borderline (slow-growing tumours). Currently, doctors use
open surgery with a cut from at least the belly button to the pubic bone to remove these
masses. Patients with a cancer diagnosis will then have more surgical steps including
assessment and sampling of various areas inside the abdomen (known as staging surgery) to
see how far the cancer has spread.
Recovery after open surgery can be long and painful, with a slow return to normal daily
activities. The trial investigators know from practice that robotic surgery has replaced
open surgery for most benign adnexal diseases and other types of women's cancers, such as
womb cancer. Recovery is quicker, with less pain and blood loss, allowing for a faster
return to daily activities.
This study, MIRRORS-FROZEN (pilot), compares robotic versus the standard open surgery in
managing women with complex adnexal masses of eight centimetres or less. The hope is to
decrease the need for open surgery in patients with benign or borderline disease and to
assess if robotic surgery has similar, worse, or better outcomes for patients with
cancer.
MIRRORS-FROZEN is funded by Intuitive Foundation and GRACE Charity. The investigators
will establish the feasibility of conducting a large multicentre randomized controlled
trial in the future comparing certain cancer outcomes between robotic and open surgery.
Detailed description:
Open surgical staging is the current standard practice in managing women with complex
adnexal masses suspicious of cancer. The diagnostic dilemma of early-stage ovarian cancer
often leads to overtreatment by laparotomy in a number of patients with benign or
borderline pathology.
MIRRORS-FROZEN (pilot) is a feasibility study that aims to establish whether the
MIRRORS-FROZEN protocol can operate successfully and whether patients are willing to be
recruited and randomized to either of the trial arms. The pilot trial also examines the
feasibility and appropriateness of collecting a number of surgical, oncological, and
patient-reported outcomes. The aim is to provide proof of concept that a larger,
adequately powered multi-centre RCT is feasible.
Patients referred to the MDT with complex adnexal pelvic mass(es) or cyst(s) will be
identified through the MDT meeting and screened against the eligibility criteria. Complex
adnexal pelvic masses are defined as O-RADS-3 and deemed high risk of cancer as per
subjective expert opinion, or O-RADS-4, O-RADS-5, and masses with an IOTA ADNEX score of
≥ 10%. As per standard practice, all patients referred with suspicious pelvic mass(es)
will undergo a staging CT scan, serving as the primary screening tool to determine
suitability for MIRRORS-FROZEN (pilot). In situations where MRI has been performed as
staging imaging, the diameter of the cyst(s) or mass(es) will be used. The largest
diameter of the cyst(s) or mass(es) should be ≤ 8 cm. In cases of bilateral masses or
cysts, the larger cyst will be used to determine suitability for inclusion in the trial.
Potential participants will then be contacted by the trial coordinator or an
appropriately trained member of the trial team to introduce the trial and provide the
participant information leaflet and study consent form, along with the contact details of
the trial team, at least 24 hours before the standard preoperative clinic appointment.
Those who express interest in participating will undergo a comprehensive consent process
conducted by an adequately trained member of the trial team. Following the consent
process, baseline data collection will take place along with the baseline trial
questionnaires.
All eligible participants who have consented to participate in the trial will be
randomized using an online randomization service, Sealed Envelope™. Randomization will be
at a ratio of 2:1 (MIRRORS-Frozen vs. standard treatment), using a simple randomization
algorithm carried out by the trial coordinator/PI or a designated member of the trial
team. After randomization and theatre allocation, participants will be contacted by a
member of the trial team to inform participants of their allocation. No blinding or
masking of allocation will occur, as both the participant and surgeon need to be aware of
the allocation. The trial coordinator/PI and statistician will not be blinded to the
groups.
Participants randomized to the MIRRORS-FROZEN protocol will undergo an initial
laparoscopic phase. A thorough inspection of the abdomino-pelvic cavity will be performed
to determine the feasibility of proceeding robotically. In patients randomized to the
robotic arm and deemed suitable to proceed, peritoneal fluid or washings will be
retrieved, followed by robotic excision of the mass(es) and its retrieval in a bag. The
choice of specimen retrieval method, whether through a wound protector ring or vaginally,
is left to the discretion of the individual surgeon. Following retrieval of the mass(es),
it will be sent for frozen section analysis as per standard pathology department practice
to determine the extent of the surgery.
The surgery continues robotically; however, conversion to laparotomy can be considered at
any point at the discretion of the individual surgeon, in the event of surgical
difficulty where it is felt to be in the patient's best interest. For example, in
situations of complex adhesions or to achieve intact removal of the cyst.
Participants randomized to the open arm will start with a midline abdominal incision from
the outset, with intraoperative frozen section assessment.
Frozen section results will determine the extent of surgery in both the trial arms and
the following surgical steps to be performed in both trial arms: For participants with
benign pathology, the surgery may either end or proceed to completion hysterectomy and
removal of the remaining tube(s) and ovary(ies), based on the patient's preference and
agreed consent. For participants with borderline pathology, surgical staging will be
performed and includes: peritoneal biopsies of normal surfaces, including from the
undersurface of the right hemidiaphragm, bladder reflection, Pouch of Douglas, right and
left paracolic gutters, and both pelvic sidewalls; infracolic omentectomy; hysterectomy
and contralateral salpingo-oophorectomy unless preservation of fertility is desired; and
appendicectomy for mucinous tumours.
If the mass is malignant, surgical staging should include: peritoneal biopsies of normal
surfaces, including from the undersurface of the right hemidiaphragm, bladder reflection,
Pouch of Douglas, right and left paracolic gutters, and both pelvic sidewalls (4-6
biopsies); supracolic omentectomy; retroperitoneal lymph node assessment of pelvic and
para-aortic nodes, with removal of enlarged lymph nodes as a minimum (may be omitted in
mucinous tumours); hysterectomy and contralateral salpingo-oophorectomy apart from cases
of apparent Stage 1A disease where fertility preservation is desired; and appendicectomy
if abnormal.
The trial participants will be followed up for six weeks, and patient-reported outcome
questionnaires will be collected at trial-specified points. The trial questionnaires
include The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30
and the ovarian cancer module (EORTC QLQ-OV28) complementing the EORTC QLQ-C30. The
Hospital Anxiety and Depression Scale (HADS), consisting of 14 items, scored on a Likert
scale and 11-point pain scale (0-10), will be used. The EQ5D-5L questionnaire will also
be used to collect health economic data.
All the required trial data will be recorded directly on an e-Case Record Form (eCRF)
using The Research Electronic Data Capture (REDCap). The collection of Patient Reported
Outcomes (PROMs) will be carried out via emails, containing a link sent to the trial
participants at specific trial points. All trial appointments will be tailored around the
patient's routine hospital visits, negating the need for extra visits.
Anticipating a small standardized difference and aiming to achieve 80% power for the main
trial, the investigators aim to recruit 40 women within a 24-month recruitment window.
This sample size is pragmatically set to provide precision in estimating predefined
feasibility criteria, such as the consent rate, ensuring timely recruitment. The key
feasibility parameters will be assessed, offering foundational insights for the main
trial.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Complex adnexal Pelvic mass/es ≤8 cm with no malignant disease outside the adnexae
on CT or MRI.
- Women aged ≥18 & ≤100 years old.
- Patients who had given their signed and written informed consent
Exclusion Criteria:
- Adnexal pelvic mass > 8 cm.
- Radiological or histological or cytological evidence of stage III or IV disease.
- Lack of capacity to understand and give informed consent.
- Patients not suitable for laparoscopic surgery, such as but not limited to those
with severe aortic stenosis.
- Any patient randomized to either of the study arms and found to have disease which
appears greater than stage 1 will be withdrawn from the trial and treated according
to the national guidelines
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Royal Surrey County Hospital NHS Foundation Trust.
Address:
City:
Guildford
Zip:
GU2 7XX
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Radwa Hablase, MBBCh MRCOG PGCert
Phone:
(0044)01483 571122
Phone ext:
4115
Email:
r.hablase@nhs.net
Contact backup:
Last name:
Laura Gordon
Email:
rsc-tr.ResearchAndDevelopment@nhs.net
Contact backup:
Last name:
Simon Butler-Manuel, MD
Start date:
September 23, 2024
Completion date:
February 1, 2027
Lead sponsor:
Agency:
Royal Surrey County Hospital NHS Foundation Trust
Agency class:
Other
Source:
Royal Surrey County Hospital NHS Foundation Trust
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06638593
