Journal of the American College of Surgeons
-
Randomized Controlled Trial Multicenter Study Clinical Trial
Fibrin sealant reduces the duration and amount of fluid drainage after axillary dissection: a randomized prospective clinical trial.
Patients who have axillary dissections during lumpectomy or modified radical mastectomy for breast carcinoma accumulate serosanguinous fluid, potentially resulting in a seroma. Currently accepted practice includes insertion of one or more drains for fluid evacuation. This multicenter, randomized, controlled, phase II study was undertaken to evaluate whether a virally inactivated, investigational fibrin sealant is safe and effective when used as a sealing agent to reduce the duration and volume of serosanguinous fluid drainage and to determine the dose response of this effect. ⋯ Application of fibrin sealant following axillary dissection at the time of lumpectomy or modified radical mastectomy can significantly decrease the duration and quantity of serosanguinous drainage. The viral safety of the product was also supported.
-
Randomized Controlled Trial Comparative Study Clinical Trial
Comparison of pulmonary function and postoperative pain after laparoscopic versus open gastric bypass: a randomized trial.
Impairment of pulmonary function is common after upper abdominal operations. The purpose of this study was to compare postoperative pulmonary function and analgesic requirements in patients undergoing either laparoscopic or open Roux-en-Y gastric bypass (GBP). ⋯ Laparoscopic gastric bypass resulted in less postoperative suppression of pulmonary function, decreased pain, improved oxygenation, and less atelectasis than open gastric bypass.
-
Randomized Controlled Trial Comparative Study Clinical Trial
Wound closure technique and acute wound complications in gastric surgery for morbid obesity: a prospective randomized trial.
During the past 10 years, numerous clinical studies have supported the use of continuous monofilament fascial closure after laparotomy. Because of the increased incidence of surgical-site infections and other acute wound complications in the morbidly obese, these patients are well suited for a study of technical factors that may affect the frequency of these wound complications. ⋯ Continuous fascial closure reduces major acute wound complications in morbidly obese patients undergoing gastric operations for obesity.
-
Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
The first randomized trial of human polymerized hemoglobin as a blood substitute in acute trauma and emergent surgery.
Human polymerized hemoglobin (PolyHeme) is a universally compatible, disease-free, oxygen-carrying resuscitative fluid. This is the first prospective, randomized trial to compare directly the therapeutic benefit of PolyHeme with that of allogeneic red blood cells (RBCs) in the treatment of acute blood loss. ⋯ PolyHeme is safe in acute blood loss, maintains total [Hb] in lieu of red cells despite the marked fall in RBC [Hb], and reduces the use of allogeneic blood. PolyHeme appears to be a clinically useful blood substitute.
-
Randomized Controlled Trial Multicenter Study Clinical Trial
Prevention of postoperative abdominal adhesions by a sodium hyaluronate-based bioresorbable membrane: a prospective, randomized, double-blind multicenter study.
Postoperative abdominal adhesions are associated with numerous complications, including small bowel obstruction, difficult and dangerous reoperations, and infertility. A sodium hyaluronate and carboxymethylcellulose bioresorbable membrane (HA membrane) was developed to reduce formation of postoperative adhesions. The objectives of our prospective study were to assess the incidence of adhesions that recurred after a standardized major abdominal operation using direct laparoscopic peritoneal imaging and to determine the safety and effectiveness of HA membrane in preventing postoperative adhesions. ⋯ This study represents the first controlled, prospective evaluation of postoperative abdominal adhesion formation and prevention after general abdominal surgery using standardized, direct peritoneal visualization. In this study, HA membrane was safe and significantly reduced the incidence, extent, and severity of postoperative abdominal adhesions.