Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Prepectoral implant (expander or fixed volume) breast reconstruction without mesh

Prepectoral implant (expander or fixed volume) breast reconstruction with mesh (biological or synthetic)

Prepectoral implant based breast reconstruction is an immediate breast reconstruction whereby a fixed volume implant or expander is placed on top of the chest wall muscle (Pectoralis Major) to reconstruct the breast after mastectomy.

Prepectoral implant-based immediate breast reconstruction

Ms Rachel Rolph, MBBS MA FRCS

The goal of this feasibility randomised controlled clinical trial (RCT) is to compare mesh-assisted to no-mesh pre-pectoral implant based immediate breast reconstruction in women undergoing mastectomy for treatment of breast cancer or for risk reduction of an inherited breast cancer risk.

The main questions it aims to answer are:

* To determine the feasibility of a definitive RCT comparing the clinical and cost- effectiveness of no- mesh versus mesh- assisted pre-pectoral breast reconstruction.
* To determine if it is possible to collect data to inform a future economic analysis on the use of mesh in breast reconstruction.

Participants will be randomly allocated to have their breast reconstruction either with the use of mesh or without the use of mesh prior to the start of the operation. Participants will be blinded to their allocation until day 90 post operatively. Participants will be asked to have medical photography and to complete a short quality of life questionnaire before and after surgery at 90 days prior to finding out their allocation.

Trial Design:

Restore-B is a prospective, multicentre parallel 2-armed single-blinded randomised controlled feasibility trial comparing no-mesh to mesh- assisted immediate implant-based prepectoral breast reconstruction surgery.

Patients will be randomised 1:1 to either the intervention surgery (no- mesh) arm or the control arm surgery (mesh-assisted).

Planned Trial Period:

The overall period of the trial is:

12 months recruitment, 3 months follow-up and 6 months data analysis and final reporting of results.

Trial Participants:

Women over 18 years old eligible for elective immediate prepectoral implant-based breast reconstruction with mesh for cancer treatment or risk reduction surgery

Intervention:

Immediate prepectoral implant-based (implant or expander) breast reconstruction without surgical mesh (ADM or synthetic).

Comparator:

Immediate prepectoral implant- based (implant or expander) breast reconstruction with surgical mesh (ADM or synthetic) (standard of care).

Restore-B is a prospective, multicentre parallel 2-armed single-blinded randomised controlled feasibility trial comparing no-mesh to mesh- assisted immediate implant-based prepectoral breast reconstruction surgery.

Patients will be randomised 1:1 to either the intervention surgery (no- mesh) arm or the control arm surgery (mesh-assisted).

Participants will be blinded to their surgical allocation (mesh or no mesh) and will be unblinded after completion of their post-operative questionnaire at day 90.

Restore-B: A Trial Comparing Prepectoral Implant-based Breast Reconstruction With and Without Mesh

Restore-B: A Mixed-methods Trial Evaluating the Feasibility of a Multi-centre Randomised Controlled Trial Comparing No-mesh to Mesh-assisted Immediate Prepectoral Implant-based Breast Reconstruction

The study protocol will be published for reference. Study outcome data will be published at the end of the trial. Data will determine progression to full RCT.

* Number of patients eligible
* Number of patients consented and randomised within 12 months recruitment
* Number of patients lost to follow up/withdrawal
* Completeness of data per participant (%)

- Number of clinical complications in each arm up to 90 days: seroma, infection, re-operation, haematoma, mesh removal, implant removal, revision surgery

Breast Q measures health related QoL and patient satisfaction in the context of breast surgery. The breast reconstruction module will be used in this study and measured pre- and post-operatively in each arm.

All BREAST-Q scales are transformed into scores that range from 0-100, independent of the type and number of modules. The scores are computed by adding the response items together and then converting the raw sum scale score to a score from 0-100. For all BREAST-Q scales, a higher score means greater satisfaction or better QOL (depending on the scale).

Quality of life (QoL) questionnaires pre-and post-operatively at 90 days measured by EuroQol-EQ5D-5L.

This QoL questionnaire comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems (1-5). The patient is asked to indicate her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. A higher score indicates more severe or frequent problems.

National Institute for Health Research, United Kingdom

University of Oxford

TiLOOP Bra

Stefan Paepke, MD

This multicentre, non-randomised, observational clinical device investigation will be performed to obtain postmarketing information on the TiLOOP® Bra and in particular on the improvement of the patients' quality of life as well as on the rate of complications of the device under investigation.

The objective of this clinical investigation is to establish the feasibility, efficacy and safety of the TiLOOP® Bra.

National, Multicenter PMS Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With TiLOOP Bra

National, Multicenter Post-market Surveillance Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With Titaniferously Coated Polypropylene Mesh (TiLOOP Bra)

Measurement of the Patient Reported Outcome (PRO).

Measurement of the Patient Reported Outcome

Complication rate of the first 60 patients in the 6 month follow-up and of all patients after 6, 12 and 24 months.

Cosmetic success confirming the reinforcement will be assessed by the patient and an independent professional at a photo. The questions posed are part of the validated Breast Q questionnaire.

Measurement of the Patient Reported Outcome and complication rate of all patients

pfm medical gmbh

Pfm Medical Mepro Gmbh

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Diseases and Abnormalities at or Before Birth

Rare Diseases

Syndrome

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Hereditary Breast and Ovarian Cancer Syndrome

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplastic Syndromes, Hereditary

Genetic Diseases, Inborn

Breast Diseases

Skin Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

immediate breast reconstruction with an implant and TiLoop Bra

immediate breast reconstruction with an implant and Protexa

TiLoop Bra

Protexa

Daphne Gschwantler-Kaulich, Ass.Prof.Dr.

Randomized controlled trial to look at early complications, cosmetic outcome, patient satisfaction and thickness of the tissue overlying the implant at the lower pole in immediate implant based breast reconstruction after Skin or Nipple Sparing Mastectomy with either a mesh (TiLOOP Bra) or an ADM (Protexa). Multicenter austrian trial with four breast cancer centers, 50 patients randomized 1:1 in the TiLoop or Protexa group.

Protexa® Versus TiLoopBra® in Immediate Breast Reconstruction- A Pilot Study

hematoma, seroma, infection, skin necrosis, capsular contracture, implant loss

four point Harris Scale (1=poor, 4=excellent)

The thickness of the tissue covering the implant in the lower pole im mm measured by ultrasound

Medical University of Vienna

Ass.Prof.Dr.

Participants will undergo immediate breast reconstruction using biological matrix and implant

Participants will undergo immediate breast reconstruction using synthetic mesh and implant

One-stage mesh assisted implant breast reconstruction

One-stage immediate breast reconstruction

Amit Goyal, MS, MD, FRCS

Emanuele Garreffa

Kartikae Grover

Monika Kaushik

In this feasibility study, 60 women undergoing reconstruction will be randomly allocated to receive biological or synthetic mesh and followed for 6 months. The findings will tell us if patients and surgeons are comfortable with not being able to choose which mesh is used for the operation. In the larger surgical study, the investigators plan to measure patients' satisfaction with the reconstruction, patients' quality of life, complications from the operation and costs over 5 years.

Immediate breast reconstruction in women undergoing removal of the whole breast for cancer or risk reduction is most commonly done using breast implants. Surgeons often use a sheet of mesh to cover the implant as standard treatment. It acts like an internal bra and supports the implant and re-creates a natural looking breast.

Natural(biological) or man-made (synthetic) meshes are used routinely in the NHS. Biological ones are made from animal tissue (pig, cow) that have been made safe to use in people and are costly. Synthetic meshes are made from net-like fabric and cost less. The choice about which mesh to use depends on surgeons' personal experience and how much money the hospital has for these operations. The two meshes may have different acceptability issues for patients because of their personal values, religious beliefs, ethnic background or views on animal welfare.

A large UK review of breast reconstruction with implants gathered information up to 3 months after surgery on the use and outcomes of the two meshes. This suggests that both may be equally safe in the short-term. However, this information can be improved by comparing the meshes side-by-side and looking at how safe they are long-term. This is important as some side-effects only appear later after surgery. Clinicians do not know how outcomes impact on patients' health and well-being.

The best proof would come from a randomised surgical study, where a computer allocates patients to receive either the biological or synthetic mesh. Investigators will measure how patients feel, how their health is, and record if they have any side-effects from the reconstructive surgery. This type of study would tell us how good each mesh is and if they are safe long-term.

Before starting such a study, investigators will run a smaller one that will help us understand if patients and surgeons would be comfortable taking part.

Biological Matrices Versus Synthetic Meshes

BIOSYM - A Feasibility Randomised Controlled Trial Comparing Biological Matrices With Synthetic Meshes in Women Undergoing One Stage Implant Based Breast Reconstruction

Proportion of eligible women offered the trial

Proportion of women offered the trial who participate in the trial

Number of patient recruited per year per site

Number of patients not complying with randomisation allocation

University Hospitals of Derby and Burton NHS Foundation Trust

Chief Investigator

Infections

Wounds and Injuries

Digestive System Diseases

Communicable Diseases

Surgical Wound Infection

Hernia

Emergencies

Surgical Wound

Wound Infection

Incisional Hernia

Colorectal Neoplasms

Disease Attributes

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Pathological Conditions, Anatomical

Postoperative Complications

All Drugs and Chemicals

Fluorides

Protective Agents

In all patients, surgery will be performed according to their individual pathology. Once midline laparotomy closure is initiated, randomization will be conducted, and patients will be assigned to one of the two groups.

PVDF Group (Polyvinylidene Fluoride Mesh): Midline laparotomy closure using the "small bites" technique associated with a prophylactic suprafascial polyvinylidene fluoride mesh

In all patients, surgery will be performed according to their individual pathology. Once midline laparotomy closure is initiated, randomization will be conducted, and patients will be assigned to one of the two groups.

PP Group (Polypropylene Mesh): Midline laparotomy closure using the "small bites" technique associated with a prophylactic suprafascial polypropylene mesh.

Midline laparotomy closure using the "small bites" technique associated with a prophylactic suprafascial polyvinylidene fluoride mesh.

Polyvinylidene fluoride mesh

Midline laparotomy closure using the "small bites" technique associated with a prophylactic suprafascial polypropylene mesh.

Prophylactic polypropylene mesh

Frank Fernández, Dr.

Frank Fernández

Pere Planellas, Dr.

Ramon Farrés, Dr.

Jorge García-Adámez, Dr.

Lidia Cornejo, MsC

In the latest guidelines for abdominal wall closure in emergency surgery published in the World Journal of Emergency Surgery (WJES) in 2023, no specific recommendations are made in this regard.

Current literature does not provide any articles comparing these two types of mesh materials (PP vs PVDF) in emergency colorectal surgery. It is necessary to conduct a study comparing these two types of mesh materials, specifically in high-risk patients for incisional hernia and emergency colorectal surgery. This study aims to contribute to generating evidence regarding differences in wound infection incidence and potential subsequent complications, such as chronic pain.

It is essential to conduct a study comparing different methods of laparotomy closure, specifically in emergency colorectal surgery, to contribute valuable evidence regarding the incidence of incisional hernia and potential subsequent complications.

Patients meeting the inclusion criteria for the study will be randomized 1:1 using random number generation functions with SPSS v.21 software into either the PP or PVDF group. This randomization will be carried out using sealed opaque envelopes at the time immediately preceding the onset of the surgical intervention within the operating room. The envelope will be opened within the operating room once the closure of the midline laparotomy is initiated.

Comparing PP and PVDF Meshes in Midline Laparotomy Closure for High-risk Colorectal Surgery. Impact on Incisional Hernia and Surgical Wound Infection.

Comparison Between the Use of a Polypropylene (PP) Prophylactic Mesh and a Polyvinylidene Fluoride (PVDF) Mesh in the Closure of Midline Laparotomy in Emergency Colorectal Surgery for High-risk Patients of Incisional Hernia. Impact on Surgical Wound Infection.

Compare the incidence of surgical wound infection between the two groups: Closure of midline laparotomy using the "small bites" technique associated with a suprafascial polypropylene mesh versus closure of midline laparotomy using the "small bites" technique associated with a suprafascial polyvinylidene fluoride mesh.

Compare the rate of incisional hernia at one year post-surgery, postoperative complications, and abdominal pain at 6 and 12 months in both groups. Also, compare the rates of parastomal hernias.

Comparison between the two groups on various aspects related to postoperative morbidity and mortality. Other aspects to be evaluated include the time of initiation of tolerance to solid oral diet, onset of ambulation, presence of anastomotic dehiscence, need for reinterventions, and occurrence of complications according to the Clavien-Dindo classification at 30 and 90 days, as well as the mortality rate at 90 days. Additionally, the aim is to compare the rate of initiation of adjuvant treatment within the first 6 weeks post-surgery, if indicated.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Restore-B: A Trial Comparing Prepectoral Implant-based Breast Reconstruction With and Without Mesh	NCT06112977	Breast Cancer Risk Reduction	Prepectoral imp...	18 Years -	University of Oxford
National, Multicenter PMS Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With TiLOOP Bra	NCT01885572	Breast Reconstr...	TiLOOP Bra	18 Years - 70 Years	Pfm Medical Mepro Gmbh
Protexa® Versus TiLoopBra® in Immediate Breast Reconstruction- A Pilot Study	NCT02562170	Breast Cancer Hereditary Brea...	TiLoop Bra Protexa	18 Years - 75 Years	Medical University of Vienna
Biological Matrices Versus Synthetic Meshes	NCT05449691	Breast Cancer	One-stage immed...	18 Years -	University Hospitals of Derby and Burton NHS Foundation Trust
Protexa® Versus TiLoopBra® in Immediate Breast Reconstruction- A Pilot Study	NCT02562170	Breast Cancer Hereditary Brea...	TiLoop Bra Protexa	18 Years - 75 Years	Medical University of Vienna
National, Multicenter PMS Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With TiLOOP Bra	NCT01885572	Breast Reconstr...	TiLOOP Bra	18 Years - 70 Years	Pfm Medical Mepro Gmbh
Comparing PP and PVDF Meshes in Midline Laparotomy Closure for High-risk Colorectal Surgery. Impact on Incisional Hernia and Surgical Wound Infection.	NCT06220045	Colorectal Canc... Wound Infection Hernia Incision...	Polyvinylidene ... Prophylactic po...	18 Years -	Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Spots Global Cancer Trial Database for mesh

Every month we try and update this database with for mesh cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for mesh

Every month we try and update this database with for mesh cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for mesh cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.