Clinical trials: Abdominal Surgery Complications
SURGICAL SITE INFECTION
Early Short-term Antibiotic Therapy in Penetrating Abdominal Trauma, 3 vs 7 Days
Abdominal penetrating trauma represents a frequent cause of consult into emergency rooms in Venezuela. Accidents and violence at Hospital "Miguel Perez Carreño" along april 2009 were represented by gunshots and stabbing wounds…
- Trial name
- NCT01203046
- Testing
- Ertapenem
- Volunteers
- 56 people
- Sponsor
- Silvia M. Pinango L.
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
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.
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
Pain, Postoperative, Major Abdominal Surgery
Bilateral Transversus Abdominis Plane Block With Exparel Verus Continuous Epidural Analgesia With Bupivacaine
Comparison of Bilateral Transversus Abdominis Plane Block with Exparel versus Continuous Epidural Analgesia With Bupivacaine
- Trial name
- NCT02996227
- Testing
- TAP block, Epidural analgesia, EXPAREL
- Where
- 2 sites in United States
- Volunteers
- 514 people
- Sponsor
- The Cleveland Clinic
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)
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 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
Pain, Postoperative, Hernia, Inguinal
Surgical Pain After Inguinal Hernia Repair (SPAIHR)
The purpose of this study is to test whether pregabalin added to the standard of care with dosing starting preoperatively and continuing for 1 week post surgery will decrease the intensity of acute post-operative pain following…
- Trial name
- NCT00551135
- Testing
- Pregabalin
- Where
- 42 sites in United States, Australia and 4 more
- Volunteers
- 425 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Abdominal Surgery, Respiratory Failure
Metabolites of Tramadol in the Postoperative Surgical Patients
Tramadol is opioid analgesic widely used to treat moderate to severe pain. It is metabolized by cytochrome CYP2D6 into two major metabolites: pharmacologically active metabolite O-desmethyltramadol (M1) and inactive…
- Conditions
- Abdominal Surgery, Respiratory Failure, Renal Failure, Liver Dysfunction
- Trial name
- METRAS (NCT04004481)
- Testing
- Postoperative analgesia using tramadol
- Where
- Croatia
- Volunteers
- 50 people
- Sponsor
- Osijek University Hospital
PONV
Efficacy of IV Palo With IV Dexamethasone vs IV Palo for Prevention of Immediate & Delayed PONV
The purpose of this study is to determine if subjects who receive Palonosetron plus Dexamethasone have less post-operative nausea and vomiting (PONV) than those who receive Palonosetron alone.
- Trial name
- PONV (NCT00952133)
- Testing
- Palonosetron only, Palonosetron with Dexamethasone
- Where
- United States
- Volunteers
- 118 people
- Sponsor
- NYU Langone Health
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
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
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
Prolapse, Urinary Incontinence
Long-term Effectiveness of Abdominal Sacrocolpopexy for the Treatment of Pelvic Organ Prolapse
The Colpopexy and Urinary Reduction Effort (CARE) trial is a research study designed to evaluate whether the addition of a second surgical procedure in addition to a procedure for female pelvic organ prolapse (POP) affects the…
- Trial name
- E-CARE (NCT00099372)
- Where
- 8 sites in United States
- Volunteers
- 215 people
- Sponsor
- NICHD Pelvic Floor Disorders Network
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
Abdominal Surgery, Colon Surgery
D-PLEX 310: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection
Subjects who are planned to undergo an abdominal (colon) surgery and who will meet the study entry criteria will be randomly divided into 2 groups: for half D-PLEX will be administered concomitantly with the standard of care…
- Conditions
- Abdominal Surgery, Colon Surgery, Post-Op Infection
- Trial name
- NCT03633123
- Testing
- D-PLEX, Standard of Care (SoC)
- Where
- 8 sites in Israel
- Volunteers
- 202 people
- Sponsor
- PolyPid Ltd.
Post-Operative Pain
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™) for the Treatment of Post-Operative Pain in Patients After Open Abdominal Surgery
The purpose of this study is to compare the efficacy and safety of the Sufentanil NanoTab PCA System/15 mcg to the Placebo Sufentanil NanoTab PCA System for the management of acute moderate to severe post-operative pain after…
- Trial name
- NCT01539642
- Testing
- Sufentanil NanoTab PCA System/15 mcg
- Where
- 12 sites in United States
- Volunteers
- 172 people
- Sponsor
- Talphera, Inc
Pain, Postoperative
An Efficacy and Safety Study to Compare Fentanyl Ionsys and Routine Care With Intravenous (IV) Morphine Patient-controlled Analgesia (PCA) in Participants Who Have Undergone Elective Major Abdominal or Orthopedic Surgery
The purpose of this study is to evaluate the mobilization characteristics, clinical use, safety and Ease of Care (EOC) of a fentanyl Iontophoretic Transdermal Patient Controlled Analgesia (PCA) system (Ionsys) and morphine…
- Trial name
- NCT00766506
- Testing
- Fentanyl IONSYS, Morphine IV PCA
- Where
- 7 sites in United Kingdom
- Volunteers
- 108 people
- Sponsor
- Janssen-Cilag Ltd.
Hernia, Surgical Wound Dehiscence
Repair of Challenging Abdominal Wall Defects: Strattice(TM) TM in Abdominal Wall Repair (StAR)
The objective of this study is to compare the incidence of post-repair wound related complications, including hernia occurrence/recurrence, between challenging abdominal wall defects repaired with Strattice(TM) Reconstructive…
- Trial name
- StAR (NCT01083472)
- Testing
- Strattice(TM) Reconstructive Tissue Matrix, Suture/suture with absorbable mesh
- Where
- 29 sites in France, Germany and 4 more
- Volunteers
- 37 people
- Sponsor
- LifeCell