Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Hernia

Incisional Hernia

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Pathological Conditions, Anatomical

Postoperative Complications

Biologic mesh placed in retromuscular position

Synthetic mesh placed in retromuscular position

Biologic mesh placed in retromuscular position during ileostoma closure

Biologic Mesh

synthetic mesh placed in retromuscular position during ileostoma closure

Synthetic Mesh

Leon Maggiori, MD

This study aim to assess long-term results of an incisional hernia-prophylactic mesh placement during stoma reversal after total mesorectal excision (TME) for rectal cancer

This study aim to assess long-term results of an incisional hernia-prophylactic mesh placement during stoma reversal after TME for rectal cancer.

Patients are randomized in 3 groups : no mesh, synthetic mesh (Parietex, Covidien), biologic mesh (Cellis, Meccelis). Meshes are placed in retromuscular position after diverting ileostomy closure.

Primary endpoint is radiological incisional hernia rate, assessed on CT-scan, at the end of follow-up Secondary endpoints include postoperative morbidity, postoperative pain, postoperative quality of life, long-term clinical incisional hernia rate.

Mesh Reinforcement During Temporary Stoma Closure After Sphincter-Saving Rectal Cancer Surgery

Mesh Reinforcement During Temporary Stoma Closure After Sphincter-Saving Rectal Cancer Surgery: A Randomized-controlled Trial

Primary endpoint is radiological incisional hernia rate, assessed on CT-scan, at the end of follow-up.

Statistical analysis will be performed as soon as follow-up reach 12 months for last included patient

Clinical incisional hernia rate : Statistical analysis will be performed as soon as follow-up reach 12 months for last included patient

Assistance Publique - Hôpitaux de Paris

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

The tissue expander-implant reconstruction with TiLoop Bra mesh.

The tissue expander-implant reconstruction without TiLoop Bra mesh. The tissue expander is placed sub-pectoral and covered by muscle/fascia.

The tissue expander is inserted with TiLoop Bra mesh in the first stage of reconstruction immediately after nipple/skin-sparing mastectomy. The tissue expander is placed sub-pectoral.

TiLoop Bra mesh in expander-implant breast reconstrution

The tissue expander is inserted without TiLoop Bra mesh in the first stage of reconstruction immediately after nipple/skin-sparing mastectomy. The tissue expander is placed sub-pectoral and covered by muscle/fascia.

sub-pectoral expander-implant breast reconstruction

Jian Yin

Bowen Ding

Edward Chang

Suisheng Yang

Guiying Xu

Xuli Meng

Stefan Paepke

This is the first prospective randomized and controlled study on the efficacy and safety of TiLOOP® Bra mesh in patients with expander-implant breast reconstruction. The investigators hypothesize that incoporating TiLOOP Bra mesh with tissue expanders will reduce the rates of capsular contraction, improve the efficiency of expansion and provide better aesthetic result.

Breast Mesh Used in Two-staged Breast Reconstruction

A Prospective Randomized and Controlled Study of Efficacy and Safety of TiLOOP® Bra Mesh in Patients With Expander-Implant Breast Reconstruction.

complications related to the reconstructed breast, including flap complications, capsular contracture, surgical site infection, prosthetic malposition/extrusion, reconstruction failure, etc.

percentage of average injected saline volume to total volume (E=average volume/ total volume）through study completion, an average of 1 year

To record the rate of surgical revision events on the breast including but not limited to fat tranplantation, reduction mammoplasty/mastompexy, contralateral augmentation,

Harris evaluation score was used to evaluate the aesthetic outcome of patients' reconstructed breasts, which was scored as "excellent," "good," "fair," "poor".

Breast-Q questionaire was also used to evaluate the aesthetic outcome of patients' reconstructed breast.

We use the Breast-Q questionnaire to evaluate patients' satisfaction via the reconstruction module of BREAST-Q.

post-operative occurrence of deep venous thrombosis

post-operative occurrence of non-surgical site infection including but not limited pneumonia, urinary tract infection, etc.

Tianjin Medical University Cancer Institute and Hospital

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Mesh Reinforcement During Temporary Stoma Closure After Sphincter-Saving Rectal Cancer Surgery	NCT02576184	Incisional Hern...	Biologic Mesh Synthetic Mesh	18 Years -	Assistance Publique - Hôpitaux de Paris
Breast Mesh Used in Two-staged Breast Reconstruction	NCT04967976	Breast Cancer Radiation Breast Reconstr... Synthetic Mesh	TiLoop Bra mesh... sub-pectoral ex...	18 Years - 70 Years	Tianjin Medical University Cancer Institute and Hospital
Mesh Reinforcement During Temporary Stoma Closure After Sphincter-Saving Rectal Cancer Surgery	NCT02576184	Incisional Hern...	Biologic Mesh Synthetic Mesh	18 Years -	Assistance Publique - Hôpitaux de Paris
Biological Matrices Versus Synthetic Meshes	NCT05449691	Breast Cancer	One-stage immed...	18 Years -	University Hospitals of Derby and Burton NHS Foundation Trust

Spots Global Cancer Trial Database for synthetic mesh