Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06638593
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-27
Brief Title:
MIRRORS-FROZEN - Comparing Open Vs Robotic Surgery in the Management of Women with Complex Pelvic Adnexal Masses 8cm
Sponsor:
None
Organization:
None
Study Overview
Official Title:
MIRRORS-FROZEN - a Pilot Randomised Controlled Trial RCT Comparing Open Vs Robotic Surgery in the Management of Women with Complex Pelvic Adnexal Masses 8cm
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIRRORS-FROZEN
Brief 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 womens 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
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 womens 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 masses or cysts 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 masses 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 cysts or masses will be used The largest diameter of the cysts or masses 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 21 MIRRORS-Frozen vs standard treatment using a simple randomization algorithm carried out by the trial coordinatorPI 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 coordinatorPI 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 masses 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 masses 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 patients 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 tubes and ovaryies based on the patients 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 patients 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
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 masses or cysts 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 masses 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 cysts or masses will be used The largest diameter of the cysts or masses 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 21 MIRRORS-Frozen vs standard treatment using a simple randomization algorithm carried out by the trial coordinatorPI 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 coordinatorPI 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 masses 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 masses 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 patients 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 tubes and ovaryies based on the patients 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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None