Laparotomy Clinical Trial
Official title:
A Prospective, Multi-Center, Single Arm, Feasibility Study Using REBUILD Bioabsorbableā¢ for Closure of the Abdominal Wall After Oncologic Laparotomy
The REBUILD Study is a first-in-human evaluation of the safety and performance of REBUILD Bioabsorbable.
REBUILD is an investigational medical device designed to be used with third-party suture to distribute suture tension in abdominal wall closures. In this study, REBUILD will be used in oncology patients undergoing an open, elective, intent-to-cure, laparotomy procedure. The study is a prospective, non-randomized, multi-center study designed to generate descriptive data about the use of REBUILD. The primary safety outcome is reported device-related adverse events. The primary performance outcome is the integrity of the abdominal wall over one year assessed by clinical examination of the abdomen. If available, CT studies performed within 12 months post-procedure will be used to confirm apposition of the medial border of the rectus muscles and integrity of the abdominal wall. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT03234543 -
Remote Ischemic Conditioning in Abdominal Surgery
|
N/A | |
Completed |
NCT03827291 -
QL Block With Exparel in Colectomy
|
Phase 4 | |
Recruiting |
NCT01719796 -
Effect of TAP Block on Ventilatory Function Following Abdominal Surgery
|
Phase 2 | |
Completed |
NCT02596269 -
Nefopam/Fentanyl Postoperative Intravenous Patient-Controlled-Analgesia
|
Phase 2/Phase 3 | |
Completed |
NCT01723280 -
Supplemental Oxygen - Effect on Occurrence of Subsequent Cancer After Abdominal Surgery (Follow-up of the PROXI Trial)
|
N/A | |
Completed |
NCT00364741 -
Supplemental Oxygen and Complications After Abdominal Surgery (The PROXI-trial)
|
Phase 4 | |
Terminated |
NCT00514566 -
PDS vs Polyamide for Midline Abdominal Closure
|
N/A | |
Recruiting |
NCT06089551 -
Early vs Postponed Parenteral Nutrition After Emergency Abdominal Surgery
|
Phase 4 | |
Withdrawn |
NCT03966768 -
DuraMesh Laparotomy Study
|
N/A | |
Recruiting |
NCT04985695 -
Influence of Analgesic Technique on Post Operative Rehabilitation After Median Laparotomy
|
N/A | |
Recruiting |
NCT03739944 -
Different Surgical Approaches in Patients of Early-stage Cervical Cancer
|
Phase 3 | |
Terminated |
NCT01890408 -
Continuous Preperitoneal Infusion of Ropivacaine After Open Liver Resection: Effect on Post-operative Recovery and Morbidity.
|
Phase 2 | |
Recruiting |
NCT00544583 -
Continuous Versus Interrupted Abdominal Wall Closure After Emergency Midline Laparotomy
|
Phase 2/Phase 3 | |
Recruiting |
NCT04256798 -
Perioperative Respiratory Care and Outcomes for Patients Undergoing High Risk Abdominal Surgery
|
Phase 3 | |
Recruiting |
NCT03738969 -
Longitudinal Study of Different Surgical Approaches in Chinese Patients of Uterine Cervical Cancer
|
||
Completed |
NCT03989570 -
Transversus Abdominis Plane Block Versus Erector Spinae Plane Block
|
N/A | |
Not yet recruiting |
NCT04266535 -
TCI vs Manually Controlled Infusion of Propofol
|
||
Completed |
NCT04065607 -
Indications and Outcome of Laparostomy
|
||
Completed |
NCT00637936 -
Respiratory Effects of Perioperative Oxygen During General Anaesthesia
|
Phase 4 | |
Completed |
NCT01040013 -
Gut Oxygenation and Laparoscopy
|
Phase 2 |