Fertility and sterility · 2003
Use of the PROACT System for reduction of postsurgical peritoneal adhesions.
Оценочное исследованиеСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Diamond Michael P, Stecco Kathy, Paulson Amelia J
Аннотация
OBJECTIVE: To assess the efficacy and safety of a new surgical device designed to prevent adhesions.
DESIGN: Prospective, controlled two-phase porcine study.
SETTING: Good Laboratory Practice-certified animal facility.
ANIMAL(S): Phase I: 10 pigs underwent peritoneal treatment with the PROACT System (NTERO Surgical, Inc., Palo Alto, California) at the time of the laparotomy incision, and four had the incision made without treatment. Phase II: 22 animals were randomized to treatment or control groups.
INTERVENTION(S): Animals in both groups underwent laparotomy incision and small bowel resection. The treatment group received treatment to the peritoneum before the peritoneal incision was made. Necropsy and adhesion evaluation were conducted by a blinded reviewer 7-13 days after the initial surgery.
MAIN OUTCOME MEASURE(S): Presence or absence of adhesions.
RESULT(S): Phase I: no treated animal developed adhesions to the incision site; three of four control animals developed adhesions to the incision site. Phase II: 4 of 10 control animals and no treated animals developed midline abdominal wall adhesions. Distal adhesions tended to also be reduced in treated animals. No side effects or increased risks were noted.
CONCLUSION(S): The PROACT System appears to be safe and efficacious in reducing adhesions to the laparotomy incision line in the porcine model.
DESIGN: Prospective, controlled two-phase porcine study.
SETTING: Good Laboratory Practice-certified animal facility.
ANIMAL(S): Phase I: 10 pigs underwent peritoneal treatment with the PROACT System (NTERO Surgical, Inc., Palo Alto, California) at the time of the laparotomy incision, and four had the incision made without treatment. Phase II: 22 animals were randomized to treatment or control groups.
INTERVENTION(S): Animals in both groups underwent laparotomy incision and small bowel resection. The treatment group received treatment to the peritoneum before the peritoneal incision was made. Necropsy and adhesion evaluation were conducted by a blinded reviewer 7-13 days after the initial surgery.
MAIN OUTCOME MEASURE(S): Presence or absence of adhesions.
RESULT(S): Phase I: no treated animal developed adhesions to the incision site; three of four control animals developed adhesions to the incision site. Phase II: 4 of 10 control animals and no treated animals developed midline abdominal wall adhesions. Distal adhesions tended to also be reduced in treated animals. No side effects or increased risks were noted.
CONCLUSION(S): The PROACT System appears to be safe and efficacious in reducing adhesions to the laparotomy incision line in the porcine model.