MIRRORS-FROZEN - Comparing Open Vs Robotic Surgery in the Management of Women with Complex Pelvic Adnexal Masses ≤ 8cm.

NCT06638593 | Recruiting

• 1 other identifier: 24SURN279899
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Ovarian Cancer; Ovarian Mass; Ovarian Cysts; Fallopian Tube Neoplasms; Adnexal Carcinoma; Adnexal Cyst; Adnexal Masses

Keywords

Robotic; adnexal masses; Adnexal cysts

Outcome Measures

Primary Outcomes (3)

• 1. Recruitment Rate

  Defined as the percentage of patients who consent to participate out of the total number of patients offered inclusion in the study.

  Through study completion, an average of 24-26 months

• 2. Randomization acceptability

  Defined as the percentage of participants who withdrew consent specifically due to randomization allocation, out of the total number of participants who initially consented.

  Through study completion, an average of 24-26 months

• 3. Response rate to the trial questionnaires

  Defined as the percentage of received responses out of the total number of responses sent at each assessment point defined by the trial protocol.

  Through study completion, an average of 24-26 months

Secondary Outcomes (15)

• Rate of intra-operative cyst rupture with spillage within the peritoneal cavity

  Through study completion, an average of 24-26 months

• Rate of Conversion to open surgery

  Through study completion, an average of 24-26 months

• Blood Loss

  Through study completion, an average of 24-26 months

• Number of units of blood transfused

  Through study completion, an average of 24-26 months

• Intraoperative complications

  Through study completion, an average of 24-26 months

Study Arms (2)

Arm 1: MIRRORS-FROZEN Protocol.

EXPERIMENTAL

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.

Procedure: MIRRORS-FROZEN Protocol.

Arm 2 : Standard open surgery.

ACTIVE COMPARATOR

A midline abdominal incision will be made from the outset, with intraoperative frozen section assessment to determine the extent of the surgery.

Procedure: Standard open surgery

Interventions

MIRRORS-FROZEN Protocol. PROCEDURE

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 1: MIRRORS-FROZEN Protocol.

Standard open surgery PROCEDURE

A midline abdominal incision will be made from the outset, with intraoperative frozen section assessment to determine the extent of the surgery.

Arm 2 : Standard open surgery.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Surrey County Hospital NHS Foundation Trust: lead

Study Sites (1)

The Royal Surrey County Hospital NHS Foundation Trust.

Guildford, GU2 7XX, United Kingdom

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Ovarian Cysts; Fallopian Tube Neoplasms; Carcinoma, Skin Appendage

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Cysts; Fallopian Tube Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Adnexal and Skin Appendage

Central Study Contacts

Radwa Hablase, MBBCh MRCOG PGCert

CONTACT

+441483688660; r.hablase@nhs.net

Laura Gordon

CONTACT

+441483688660; rsc-tr.ResearchAndDevelopment@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 15, 2024
• Study Start: September 23, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Up to 5 years following completion and publication of the study
• Access Criteria: The datasets generated from this current study will be available upon request from Miss Radwa Hablase (r.hablase@nhs.net) as raw anonymised data

Locations

GB (1)