Clinical trials: Abdominal Surgery Complications
Postoperative Pain
Phase 3 Herniorrhaphy Study for Postoperative Analgesia (EPOCH 2)
This is a Phase 3, randomized, double-blind, saline placebo- and active-controlled, multicenter study to evaluate the analgesic efficacy and safety of HTX 011 administered via local administration into the surgical site in…
- Trial name
- NCT03237481
- Testing
- HTX-011, Bupivacaine HCl, Luer-lock applicator
- Where
- 24 sites in United States, Belgium
- Volunteers
- 418 people
- Sponsor
- Heron Therapeutics
Post Surgical Pain
Dose Escalation of Dexamethasone to Increase Duration of Transversus Abdominal Plane Block Following Cesarean Section
The study aims to improve the care of the obstetric population after cesarean section and improve total patient satisfaction by improving post-surgical pain control with the use of dexamethasone in combination with bilateral TAP…
- Trial name
- NCT03098420
- Testing
- 2mg Dexamethasone, 4mg Dexamethasone, Ropivacaine (TAP blocks)
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Myomectomy; Surgical Blood Loss
Rectal Misoprostol as a Hemostatic Agent During Abdominal Myomectomy
Purpose is to identify if misoprostol in addition to local vasopressin decreases blood loss when compared to vasopressin alone, which is our current practice at this time.
- Trial name
- NCT03064568
- Testing
- Misoprostol 200Mcg Tab
- Where
- 3 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- The University of Texas Health Science Center at San Antonio
Wound Complication
Tissue Reinforcement of Incisional Closure Among High Risk Patients
Half of all individuals will undergo abdominal surgery in their lifetime. Following abdominal surgery, 30% of patients will suffer a major chronic complication with their wound closure in the first post-operative year.
- Trial name
- NCT03148496
- Testing
- Biologic Mesh, Small Bites, Large Bites
- Where
- 2 sites in United States
- Volunteers
- 163 people
- Sponsor
- The University of Texas Health Science Center, Houston
Surgical Site Infection, Colon Surgery
D-PLEX 311: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection
Phase III, Prospective, Multinational, Multicenter, Randomized, Controlled, Two-arm, Double Blind Study to assess Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SoC), compared to a SoC treated…
- Conditions
- Surgical Site Infection, Colon Surgery, Abdominal Surgery, Post-Op Infection
- Trial name
- NCT04233424
- Testing
- D-PLEX, Standard of Care (SoC)
- Where
- 62 sites in United States, Bulgaria and 8 more
- Volunteers
- 977 people
- Sponsor
- PolyPid Ltd.
High Risk Abdominal Wounds
Use of Negative Pressure Wound Therapy in High Risk Surgical Closed Incisions
The purpose of this study is to investigate the use of Negative Pressure Wound Therapy in high risk surgical wounds to evaluate the rate of surgical site infections (SSIs).
- Trial name
- NCT02137447
- Testing
- Negative Pressure treatment
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Massachusetts General Hospital
Postoperative Pain, Abdominal Surgery
Bupivacaine Effectiveness and Safety in SABER® Trial
This is a research study testing SABER-Bupivacaine (an experimental pain-relieving medication). SABER-Bupivacaine is designed to continuously deliver bupivacaine, a common local anesthetic, for a few days in order to treat local…
- Trial name
- BESST (NCT01052012)
- Testing
- SABER-Bupivacaine, Bupivacaine HCl
- Where
- 26 sites in United States, Australia and 1 more
- Volunteers
- 331 people
- Sponsor
- Durect
Hernia, Ventral Hernia
Prospective Clinical Evaluation of High-Purity Type I Collagen in Select High-Risk Hernia Repair Scenarios
This prospective, single-arm clinical study evaluates the safety, feasibility, and early clinical outcomes of High-Purity Type I Collagen (HPTC; Surgicoll-Mesh®) when used as a biologic reinforcement in selected hernia repair…
- Conditions
- Hernia, Ventral Hernia, Incisional Hernia, İnguinal Hernia
- Trial name
- NCT07360691
- Testing
- High-Purity Type I Collagen Mesh
- Where
- India
- Volunteers
- 30 people
- Sponsor
- Adichunchanagiri Institute of Medical Sciences, B G Nagara
Ventral Hernia
A Comparison of the Outcomes in Fortiva and Strattice Mesh
A comparison of ventral hernia repair with Strattice and Fortiva mesh.Primary The study team aims to determine the hernia recurrence rates for RTI Surgical biologic mesh (Fortiva) compared to Strattice.
- Trial name
- NCT05572021
- Testing
- Prospective Ventral Hernia Repair with Fortiva, RetroSpective Ventral Hernia Repair with Strattice
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Wake Forest University Health Sciences
Post-Operative Pain
A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™)to Intravenous Patient-Controlled Analgesia With Morphine for the Treatment of Acute Post-Operative Pain
The study is intended to show that the Sufentanil NanoTab PCA System is as effective as morphine intravenous patient-controlled analgesia (IV PCA) for treating pain after surgery.
- Trial name
- NCT01539538
- Testing
- Sufentanil NanoTab PCA System/15 mcg, morphine IV PCA
- Where
- 16 sites in United States
- Volunteers
- 357 people
- Sponsor
- Talphera, Inc
Surgical Wound Dehiscence, Wound Infection
Prevention of Wound Complications After Cesarean Delivery in Obese Women Utilizing Negative Pressure Wound Therapy
Wound complications after Cesarean section (C-section) are common in obese women. Approximately 25% of obese women having a C-section will have a wound complication.
- Trial name
- NCT00654641
- Testing
- Negative pressure wound closure, Standard wound closure
- Where
- 2 sites in United States
- Volunteers
- 54 people
- Sponsor
- West Virginia University
Analgesia
Study of Post-Herniorrhaphy Non-opioid MMA Regimens
This is a Phase 3b, open-label study to assess postoperative opioid use in subjects undergoing unilateral open inguinal herniorrhaphy with intraoperative administration of HTX-011 and a postoperative non-opioid multimodal…
- Trial name
- NCT03907176
- Testing
- HTX-011, Luer lock applicator, Ibuprofen
- Where
- 30 sites in United States
- Volunteers
- 209 people
- Sponsor
- Heron Therapeutics
Post-Operative Pain
A Trial Evaluating the Efficacy and Safety of the Sublingual Sufentanil Tablet 30 mcg for Post-Operative Pain After Abdominal Surgery
The purpose of this study is to compare the efficacy and safety of the sublingual Sufentanil Tablet (ST) 30 mcg to the sublingual Placebo Tablet (PT) for the short-term management of moderate-to-severe acute post-operative pain…
- Trial name
- NCT02356588
- Testing
- Sufentanil Tablet 30 mcg
- Where
- 4 sites in United States
- Volunteers
- 161 people
- Sponsor
- Talphera, Inc
Postoperative Pain
An International Trial to Evaluate the Efficacy and Safety of SABER®-Bupivacaine for Postoperative Pain Control in Patients Undergoing Hysterectomy
The objective is to identify the optimal dose of SABER-Bupivacaine for postoperative pain control in patients undergoing hysterectomy on the basis of pharmacokinetics, efficacy and safety evaluations.
- Trial name
- NCT00993226
- Testing
- SABER-Bupivacaine Treatment 1a, Bupivacaine HCl Treatment 1c, SABER-Bupivacaine Treatment 2a
- Where
- 14 sites in France, Germany and 4 more
- Volunteers
- 115 people
- Sponsor
- Durect
Peritoneal Surface Malignancy, Postoperative Adhesion
SurgiPerito Trial: High-Purity Type-I Collagen for Peritoneal Reconstruction After Cytoreductive Surgery
This dual-centre, randomized controlled trial evaluates the safety and efficacy of high-purity Type-I collagen-based biomaterial, as a peritoneal substitute following peritonectomy in patients undergoing cytoreductive surgery…
- Conditions
- Peritoneal Surface Malignancy, Postoperative Adhesion, Bowel Obstruction, Wound Complications
- Trial name
- NCT07241091
- Testing
- High-Purity Type-I Collagen Scaffold, Standard Peritonectomy Closure
- Where
- 2 sites in India
- Volunteers
- 60 people
- Sponsor
- Adichunchanagiri Institute of Medical Sciences, B G Nagara
Gynecologic Cancer, Gynecologic Neoplasms
Intravenous and Intraperitoneal Paclitaxel and Oral Nilotinib for Peritoneal Carcinomatosis
Background: Tumors that have spread to the lining of the abdomen from other cancers, such as cancer of the appendix, colon, or ovary, are called peritoneal carcinomatosis. In most cases, outcomes are poor.
- Conditions
- Gynecologic Cancer, Gynecologic Neoplasms, Peritoneal Carcinomatosis, Peritoneal Neoplasms
- Trial name
- NCT05185947
- Testing
- Paclitaxel, Nilotinib, ECG
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- National Cancer Institute (NCI)
Bladder Cancer
FITBIT Study on Mobility and Readmissions After Radical Cystectomy
This is a two-arm randomized, controlled trial during the postoperative period after major abdominal surgery for cancer, including for example radical cystectomy, nephrectomy, colectomy, comparing a control group that uses a…
- Trial name
- FITBIT (NCT04314778)
- Testing
- social incentive-based gamification
- Where
- 2 sites in United States
- Volunteers
- 64 people
- Sponsor
- University of Pennsylvania
Pelvic Organ Prolapse, Abdominal Surgery
The Effect of Abdominal Binder Use on Postoperative Pain and Mobility in Patients Undergoing Pelvic Surgery
To determine the effect of post-operative abdominal binder usage on total narcotic usage after undergoing surgery. To determine if abdominal binder usage results in decreased visual analog scale (VAS) pain scores and shorter time…
- Conditions
- Pelvic Organ Prolapse, Abdominal Surgery, Laparoscopic Surgery, Post Operative Pain
- Trial name
- NCT03684304
- Testing
- Abdominal binder
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- University Hospitals Cleveland Medical Center
Surgical Site Infection, Colon Surgery
D-PLEX 312 - Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection (SHIELD II)
Phase III, Prospective, Multinational, Multicenter, Randomized, Controlled, Two-arm, Double Blind Study to Assess Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SoC), Compared to a SoC Treated…
- Conditions
- Surgical Site Infection, Colon Surgery, Abdominal Surgery, Post-Op Infection
- Trial name
- D-PLEX312 (NCT04411199)
- Testing
- D-PLEX, Standard of Care (SoC)
- Where
- 58 sites in United States, Bosnia and Herzegovina and 11 more
- Volunteers
- 975 people
- Sponsor
- PolyPid Ltd.
Peritoneal Carcinomatosis
Role of Intraperitoneal Intraoperative Chemotherapy With Paclitaxel in the Surgical Treatment of Peritoneal Carcinomatosis From Ovarian Cancer. Hyperthermia Versus Normothermia
A randomized controlled single-blind clinical trial was performed, in 32 patients diagnosed with peritoneal carcinomatosis from epithelial ovarian cancer, who underwent radical surgery-peritonectomy, achieving an optimal R0-R1…
- Trial name
- NCT02739698
- Testing
- Paclitaxel, Radical surgery-peritonectomy
- Volunteers
- 32 people
- Sponsor
- Maimónides Biomedical Research Institute of Córdoba