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Abstract
Objective
To compare the impact of expanded polytetrafluoroethylene (PTFE; Gore-Tex Surgical Membrane; W. L. Gore & Associates, Inc., Flagstaff, AZ) and oxidized regenerated cellulose (Interceed TC7, Johnson & Johnson Medical, Inc., Arlington, TX) on the development of postsurgical adhesions.
Design
A multicenter, nonblinded, randomized clinical trial.
Setting
University medical centers.
Interventions
Each barrier was allocated randomly to the left or right sidewall of every patient.
Patients
Thirty-two women with bilateral pelvic sidewall adhesions undergoing reconstructive surgery and second-look laparoscopy.
Main Outcome Measures
Adhesion score (on a 0- to 11-point scale), the area of adhesion (cm2), and the likelihood of no adhesions.
Results
The use of both barriers was associated with a lower adhesion score and area of adhesion postoperatively. However, those sidewalls covered with PTFE had a significantly lower adhesion score (0.97 +/- 0.30 versus 4.76 +/- 0.61 points, mean +/- SEM) and area of adhesion (0.95 +/- 0.35 versus 3.25 +/- 0.62 cm2). Overall, more sidewalls covered with PTFE had no adhesions (21 versus 7) and, when adhesions were present on the contralateral sidewall, the number of sidewalls covered with PTFE without adhesions was greater than those covered with oxidized regenerated cellulose (16 versus 2).
Conclusion
Expanded polytetrafluoroethylene was associated with fewer postsurgical adhesions to the pelvic sidewall than oxidized regenerated cellulose.
Haney, A. F., Hesla, J., Hurst, B. S., Kettel, L. M., Murphy, A. A., Rock, J. A., Rowe, G., & Schlaff, W. D. (1995). Expanded polytetrafluoroethylene (Gore-Tex Surgical Membrane) is superior to oxidized regenerated cellulose (Interceed TC7+) in preventing adhesions. Fertility and sterility, 63(5), 1021-1026.
Haney AF, Hesla J, Hurst BS, Kettel LM, Murphy AA, Rock JA, et al. Expanded polytetrafluoroethylene (Gore-Tex Surgical Membrane) is superior to oxidized regenerated cellulose (Interceed TC7+) in preventing adhesions. Fertil Steril. 1995;63(5):1021-1026.
Haney, A. F., et al. "Expanded polytetrafluoroethylene (Gore-Tex Surgical Membrane) is superior to oxidized regenerated cellulose (Interceed TC7+) in preventing adhesions." Fertility and sterility, vol. 63, no. 5, 1995, pp. 1021-1026.
To evaluate the ability of the two currently available surgical barriers, oxidized regenerated cellulose and expanded-polytetrafluoroethylene (PTFE), to prevent postsurgical adhesions.
Murine uterine horns were approximated in the midline and the contacting uterine surfaces injured by electrocautery, cutting, and scratching, with and without barriers interposed. Sham-operated and experimental animals had adhesions assessed visually and histologically 7 days postoperatively. In another group, adhesions were created and then lysed 7 days later with barriers interposed. Readhesion formation was assessed 14 days after lysis with the PTFE being removed 7 days after lysis.
Adhesions occurred at 58.5% of the electrocautery sites without barriers, 100% of the readhesion sites with recautery for hemostasis, and 92% of the recautery sites without hemostasis. None of the sham-operated sites developed adhesions. When oxidized regenerated cellulose was interposed, adhesions were observed at 36% of uninjured uterine horn sites, 62% with single and 92% with double electrocautery injuries and 90% of the reformation sites. The PTFE did not cause adhesions in uninjured controls and completely prevented adhesion formation and reformation, regardless of the type of injury or whether hemostasis was achieved. A thin cellular membrane, continuous with the uterine serosa, enveloped the PTFE. Expanded-polytetrafluoroethylene, but not oxidized regenerated cellulose, prevents adhesion formation and reformation in this murine uterine horn model. Additionally, oxidized regenerated cellulose was adhesiogenic even without surgical injury.
To evaluate the effects of Ringer's lactate instillation, Interceed(TC7) (Johnson and Johnson Medical, Inc., New Brunswick NJ), and Gore-Tex Surgical Membrane (W. L. Gore and Associates, Inc., Flagstaff, AZ) in a rat uterine horn model. Rats were in a conventional laboratory setting. Sprague-Dawley white rats, weighing 225 to 250 g. The left uterine horn was subjected to a standardized lesion by serosal denudation and devascularization. The rats were randomly assigned into control group, Interceed(TC7) group, Gore-Tex group, and Ringer's lactate group. Degree of adhesions was evaluated 2 weeks after the initial surgery. Adhesion score after Ringer's lactate instillation was significantly lower than those of control, Interceed(TC7), and Gore-Tex groups. Gore-Tex was associated with less adhesion formation than control. No difference was found in the adhesion formation between the Interceed(TC7) group and the control group. Confirming our previous observations, Ringer's lactate instillation is effective in decreasing adhesion formation. Gore-Tex reduces adhesion formation, but its efficacy is inferior to those of Ringer's lactate. Contrary to previous reports, Interceed(TC7) is ineffective in our animal model.
To evaluate the impact of the materials contained in the available adhesion prevention barriers on the peritoneum. STUDY DESIGN, SETTING, A murine paradigm was used, placing oxidized-regenerated cellulose (Interceed [TC7]) and expanded polytetrafluoroethylene (PTFE; Gore-Tex Surgical Membrane) in the peritoneal cavity for intervals up to 14 days. MAIN The appearance of the peritoneum on scanning and transmission electron microscopy and the presence of de novo adhesions were the end-points used. Oxidized-regenerated cellulose caused localized sloughing of the mesothelial cell layer and leukocyte infiltration of the deeper tissue leading to the formation of adhesions to the bowel and liver in 58% of the animals. The surface of the oxidized-regenerated cellulose-injured peritoneum healed in 5 to 7 days. Neither peritoneal injury nor adhesions were noted in sham-operated animals or animals with PTFE. Oxidized-regenerated cellulose but not PTFE has a localized injurious effect on the peritoneum of the mouse, resulting in de novo adhesions. The impact of the barrier material itself on normal peritoneum may be an important consideration in designing surgical barriers for the prevention of postoperative adhesions.
SurgeryDextran 70 Barrier AgentsTubal and Pelvic SurgerySurgical Interventions
Infertile women of reproductive age requiring an operation for distal tubal disease, endometriosis, or pelvic adhesions were recruited from nine study centers. Prior to closing the peritoneal cavity, 250 ml of 32% dextran 70 (n = 55) or saline (n = 47) was instilled into the dependent portion of the pelvis; 8 to 12 weeks later, laparoscopy was performed on those patients not pregnant. Patients with severe adnexal adhesions at the initial laparotomy had a greater reduction in adhesions if they received 32% dextran 70. Further, patients with a marked reduction in adhesion formation following the initial laparotomy were found to occur more frequently in the 32% dextran 70-treated group (26 of 51 for 32% dextran 70 versus 12 of 40 for saline; P less than 0.05). During second-look laparoscopy, adhesions were found to occur more frequently in control patients than in 32% dextran 70-treated patients at ovary (P less than 0.05); cul-de-sac (P = 0.017); pelvic side wall (P less than 0.001). Thus, in a prospective, randomized, blinded clinical trial, the intraperitoneal high-molecular-weight dextran was found to reduce postoperative adhesion formation effectively.