Journal of the American College of Surgeons
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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.
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Randomized Controlled Trial Comparative Study Clinical Trial
A prospective randomized comparison of the metabolic and stress hormonal responses of laparoscopic and open cholecystectomy.
In a relatively short period of time, therapeutic laparoscopy has become an everyday part of the general surgeon's life. Although laparoscopy provides distinct clinical advantages, it is not yet clear that it lessens the stress response typical of elective surgical procedures, and as such, the morbidity of surgery. The hypothesis that laparoscopic cholecystectomy produces less of a metabolic and stress hormonal response than open cholecystectomy was tested in a prospective randomized trial. ⋯ Elective laparoscopic and open cholecystectomy for uncomplicated cholelithiasis result in similar degrees of perioperative hormonal stimulation. The different hormonal responses in the immediate and later postoperative periods after laparoscopic and open cholecystectomy suggest differential stressful stimuli between the two procedures.
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Randomized Controlled Trial Clinical Trial
A prospective randomized study of end points of resuscitation after major trauma: global oxygen transport indices versus organ-specific gastric mucosal pH.
Gastric tonometry, as a method of organ-specific monitoring of the status of the splanchnic circulation, has demonstrated prognostic and therapeutic implications in critically ill patients. The experience with this method in patients with trauma has been limited. ⋯ Gastric mucosal pH may be an important marker to assess the adequacy of resuscitation. Monitoring of pHi may provide early warning for systemic complications in the postresuscitation period.
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Randomized Controlled Trial Comparative Study Clinical Trial
The Pittsburgh randomized trial of tacrolimus compared to cyclosporine for hepatic transplantation.
Tacrolimus (formerly FK506) was first used clinically in 1989 to successfully replace cyclosporine in hepatic transplant recipients who were experiencing intractable rejection or as the baseline drug from the time of operation. After extensive pilot experience, an institutional review board-mandated clinical trial comparing cyclosporine with tacrolimus was performed. ⋯ Seventy-nine patients were randomized to the tacrolimus arm and 75 to the cyclosporine arm during 1990 and 1991. All patients were available for follow-up throughout the trial, which terminated on May 30, 1995. The mean duration of follow-up was four years. Patients randomized to the tacrolimus arm were less likely to experience acute rejection than were those receiving cyclosporine, with 36.2 percent of the patients receiving tacrolimus and 16.8 percent of the patients receiving cyclosporine showing freedom from rejection at one year (p = 0.003, likelihood ratio test). Survival of patients over the course of the study was virtually the same in the two groups.
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Randomized Controlled Trial Clinical Trial
Infectious morbidity, operative blood loss, and length of the operative procedure after cesarean delivery by method of placental removal and site of uterine repair.
This study was done to determine the impact of the method of placental removal and the site of uterine repair on postcesarean infectious morbidity rates in women receiving prophylactic antibiotics at cesarean delivery. ⋯ Manual placental removal and exteriorization of the uterus for repair of the surgical incision increases the infectious morbidity rate in women receiving prophylactic antibiotics at the time of cesarean delivery and increases the length of hospitalization.