Abdominal Wall Defect

Researchers are studying patients with symptomatic rectus diastasis, a condition where the abdominal muscles separate, causing pain and instability. The trial aims to evaluate if laparoscopic abdominal wall reconstruction is a safe treatment option and whether it improves quality of life, trunk stability, and reduces pain. The study also compares two laparoscopic methods: suturing the linea alba alone or with added mesh. Participants will undergo one of two surgical procedures for abdominal wall reconstruction: either narrowing the linea alba using continuous sutures alone or using continuous sutures combined with mesh. Both methods are performed laparoscopically, and the study uses a randomized, double-blind design to compare their outcomes. During the study, participants will be monitored for recurrence of rectus diastasis over one year. Pain levels will be assessed using the Visual Analog Pain Scale, and questionnaires like SF-36 and VHPQ will evaluate quality of life and pain before and after surgery at 1 and 3 years. Abdominal stability will also be measured to understand the surgery's impact. The total duration of participation may extend up to 3 years for follow-up assessments.

Researchers are evaluating the effects of a postoperative rehabilitation program for patients undergoing surgical correction of abdominal rectus diastasis, a condition where the abdominal muscles separate. The study aims to determine if structured abdominal exercises after surgery improve abdominal wall function at three and twelve months and to compare connective tissue components in patients with this condition to healthy individuals. This randomized controlled trial is conducted in Sweden and sponsored by Umeå University. Participants will all undergo surgery to correct the abdominal rectus diastasis by plication of the linea alba. They are randomly assigned to one of two groups: one group follows a postoperative rehabilitation program designed by a physical therapist, while the other group is allowed to exercise freely without a structured program. Blood samples and tissue biopsies from skin, connective tissue, and rectus muscle are collected before and during surgery. Follow-up assessments occur at three and twelve months after surgery. During the study, participants will be evaluated using physical function tests such as the 5 times sit to stand test and repetitions of a 20-kilogram deadlift at three and twelve months post-surgery. They will also complete questionnaires assessing pain, disability, and pelvic floor distress. Safety and progress are monitored through clinical visits and sample collections. The total participation time covers pre-surgery, surgery day procedures, and follow-ups at three and twelve months.

Researchers are evaluating the safety and effectiveness of abdominal wall transplantation to repair abdominal wall defects. This treatment may be done alone or along with another organ transplant. The study involves a small group of participants and aims to assess how well the transplanted abdominal wall restores function. Participants will receive either an isolated abdominal wall transplant or an abdominal wall transplant combined with another solid organ transplant. All participants will be given standard immunosuppression therapy similar to that used in other non-vascularized composite allograft organ transplants. The study will take place over 18 months at Duke University Medical Center. During the 18-month study period, participants will be closely monitored to see if the transplanted abdominal wall remains viable and functional. Researchers will evaluate the success of the transplant and monitor the participants’ health and response to treatment throughout this time. The primary measure is the number of subjects with a viable abdominal wall transplant at 18 months.

This research aims to evaluate whether stone needles therapy can help in the recovery of maternal diastasis rectus abdominis (DRA) based on the Belt channel theory. It also seeks to validate the use of the Chinese version of the Body Attitude Questionnaire (BAQ-C) as a tool to measure body image satisfaction in Chinese women with postpartum DRA. The trial investigates if adding stone needles therapy to neuromuscular electrical stimulation (NMES) and massage therapy improves postpartum DRA recovery. Participants will receive 10 sessions of NMES combined with massage therapy, with the stone needles therapy added after the 3rd, 6th, and 9th massage sessions for those in the stone needles therapy group. Each stone needles therapy session lasts about 30 minutes, with a total of three sessions. The control group will receive NMES and massage therapy without the stone needles treatment. During the study, abdominal circumference and the distance between rectus muscles will be measured after each treatment. After completing all treatments, researchers will assess body image satisfaction, low back pain, dysfunction scores, anxiety, depression, and quality of life. The primary outcomes include changes in the inter-recti distance, abdominal circumference, and body image satisfaction before and after interventions. Participants will be monitored throughout the treatment period to evaluate these effects.

Researchers are investigating the levels of two naturally occurring amino acids, Arginine and Asymmetric Dimethylarginine (ADMA), in newborns undergoing abdominal surgery within the first five days of life due to congenital abdominal malformations. The study aims to understand how the relationship between these amino acids may predict recovery and complications after surgery, based on previous findings in adult patients. This observational, physiological study is conducted across two hospitals within the Liverpool Neonatal Partnership.

This research aims to clinically evaluate the Anovo Surgical System in patients undergoing ventral hernia repair. The study focuses on assessing the safety and performance of this robotic system, which has undergone extensive preclinical testing to ensure its integrity. The system is designed to assist surgeons in accurately controlling robotic arms for tissue manipulation during laparoscopic surgery. Participants will undergo robotic ventral hernia repair using the Anovo Surgical System, which features articulated robotic arms to facilitate access and closure of the fascial defect. The procedure involves endoscopic control of instruments for tasks like grasping, dissection, and electrosurgery. This study includes monitoring both intra-operative and post-operative outcomes, including procedure times, adverse events, wound healing, and hospital stay. During the study, participants will be closely monitored with data collected on operative details such as conversion rates, procedure completion, console and docking times, and adverse events related to the device and procedure. Post-operative assessments will continue for about four weeks to evaluate complications like wound seroma and surgical site infections. The study allows for comprehensive safety and procedural outcome tracking up to hospital discharge and throughout the follow-up period.

Researchers are evaluating natural orifice specimen extraction (NOSE), a minimally invasive surgical technique for colorectal surgery where the specimen is removed through natural openings like the anus or vagina instead of an abdominal incision. This prospective multicenter observational registry compares outcomes of NOSE with traditional transabdominal specimen extraction, focusing on long-term results such as incisional hernia risk and patient-reported experiences. The study aims to provide comprehensive data on wound complications, bowel, urinary and sexual function, and cancer outcomes across several centers in the Asia-Pacific region. The study includes two groups: patients planned for NOSE extraction and those planned for transabdominal extraction, both undergoing elective minimally invasive colorectal surgery. Surgical methods, perioperative care, and follow-up remain according to each center’s usual practice without mandated changes. Data on surgical details, complications, and oncologic outcomes are collected prospectively, with patient-reported quality-of-life and functional assessments at multiple time points up to two years after surgery. Participants will be followed for up to 24 months after their surgery to evaluate the time to incisional hernia and other complications. Researchers will collect clinical data, patient questionnaires on quality of life, body image, bowel and sexual function, as well as cancer recurrence outcomes. The study uses validated tools such as EQ-5D-5L, Body Image Scale, and Low Anterior Resection Syndrome score. Data are securely stored and no changes to routine care are required, ensuring participant safety and standard treatment continuity.

This research aims to evaluate the safety and performance of the ECLIPSIUM device in securing mesh during ventral hernia repair. It compares ECLIPSIUM, a bioresorbable polymer-based fixation device, to bioresorbable tacks to determine if it can reduce the risk of hernia recurrence. The study is a prospective, multi-center, randomized, single-blind trial designed to assess whether ECLIPSIUM offers clinical benefits in laparoscopic intraperitoneal onlay mesh ventral hernia repair procedures. Participants will receive one of two treatments: the ECLIPSIUM System, which applies a biodegradable polymer coating to the mesh and secures it with photoactivation using a special curing light, or resorbable tacks that fasten the mesh and are absorbed by the body over time. Each participant undergoes laparoscopic ventral hernia repair with mesh fixation using either method. The study will monitor outcomes over 12 months, including hernia recurrence and complications. During the study, participants will have assessments at 6 and 12 months to check for hernia recurrence and any complications. The trial includes follow-up visits and evaluations to monitor safety and effectiveness. Participants will be observed for the cumulative incidence of complications up to 12 months, and the primary outcome measurement is hernia recurrence at 6 months. The total duration of participation will vary depending on individual follow-up schedules.

This research aims to assess the effectiveness of using non absorbable mesh versus suture repair for ventral hernia (VH) during bariatric surgery (BS) in adults aged 18 to 60 years with morbid obesity. The main goal is to see if mesh repair lowers the chance of hernia returning within two years after surgery compared to suture repair. The study also evaluates other outcomes such as hernia recurrence at one year, need for reoperation, surgical complications, chronic pain, quality of life, weight loss, and cost-effectiveness. Participants will be randomly assigned to one of two groups: one receiving VH repair with non absorbable mesh placed during BS (either sleeve gastrectomy or bypass), and the other having suture repair of the hernia during BS. The mesh repair technique and mesh type depend on each surgical center's choice. The suture repair involves removing the hernia sac and closing the defect with slowly absorbable sutures through an open approach. Both groups undergo the bariatric procedure as decided before surgery. Throughout the study, patients will be monitored according to clinical guidelines with follow-up visits at 1, 3, 6, 9, 12, 18, and 24 months after surgery. Researchers will assess hernia recurrence rates, complications like infection or hernia strangulation, chronic pain levels, quality of life, weight loss progress, and costs. Safety and postoperative morbidity and mortality will be tracked up to 90 days after surgery. The study includes 29 surgical centers aiming to enroll 354 patients, with statistical analyses planned after follow-up completion and an interim analysis halfway through.

Researchers are evaluating the use of TiLOOP4 Bra mesh in patients undergoing expander-implant breast reconstruction after breast cancer surgery. This is the first prospective randomized and controlled study designed to assess the safety and effectiveness of incorporating TiLOOP Bra mesh with tissue expanders. The goal is to see if this mesh can reduce capsular contracture rates, improve the efficiency of tissue expansion, and provide better aesthetic results compared to reconstruction without mesh. Participants will be randomly assigned to one of two groups: one receiving tissue expander-implant reconstruction with TiLOOP Bra mesh placed sub-pectorally immediately after nipple or skin-sparing mastectomy, and the other receiving tissue expander-implant reconstruction without the mesh, where the expander is placed sub-pectorally and covered by muscle or fascia. The study includes a triple masking design to reduce bias. During the study, participants will be monitored for complications up to 24 months post-surgery and for expansion efficiency over about one year. Additional assessments include the number of revision surgeries, aesthetic outcomes evaluated by the Harris score and Breast-Q questionnaire, psychological evaluations, total treatment cost, and occurrences of deep venous thrombosis or infections. The study spans from tissue expander implantation through expander exchange and follow-up, with careful safety and outcome monitoring throughout.