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Bioresorbable Hyaluronate-Carboxymethylcellulose Membrane (Seprafilm) in Surgery for Rectal Carcinoma: A Prospective Randomized Clinical Trial

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Abstract

Purpose

To evaluate the effectiveness of Seprafilm in preventing abdominal adhesions after radical resection of rectal carcinoma, and to observe whether Seprafilm had any adverse effects in patients treated with radiotherapy and chemotherapy.

Methods

A total of 62 patients participated in this prospective randomized clinical study, which was conducted to compare the outcomes of patients operated on with Seprafilm (SEPRA+) with those operated on without Seprafilm (SEPRA−). All patients received preoperative radiotherapy, followed by a two-stage operation, and 5-fluorouracil (5-FU)-based systemic chemotherapy. The primary endpoint of severity and extent of adhesions were evaluated at the time of ileostomy closure. The secondary endpoint included the recurrence of tumors, late complications, and outcome.

Results

Seprafilm significantly reduced the adhesions in both the midline incision area and peristomal area. This in turn reduced the operation time, blood loss, and extent of the incision at ileostomy closure. Seprafilm was not associated with any postoperative complications or chemoradiation-related toxicity, nor did it affect recurrence or survival rates.

Conclusion

Seprafilm effectively reduced abdominal adhesions in chemoradiated patients, and had no adverse effects on the oncologic results of fully introduced adjuvant therapy. Thus, Seprafilm is a safe and effective tool for use in rectal carcinoma surgery.

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Authors and Affiliations

  1. Second Department of Surgery, Mie University School of Medicine, 2-174 Edobashi, Tsu, 514-8507, Japan

    Masato Kusunoki, Hitoshi Tonouchi, Yasuhiko Mohri, Keiichi Uchida, Yasuhiro Inoue, Minako Kobayashi & Chikao Miki

  2. Second Department of Surgery, Hyogo College of Medicine, Nishinomiya, Japan

    Hiroki Ikeuchi, Hidenori Yanagi, Masafumi Noda & Takehira Yamamura

Authors
  1. Masato Kusunoki
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  2. Hiroki Ikeuchi
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  3. Hidenori Yanagi
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  4. Masafumi Noda
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  5. Hitoshi Tonouchi
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  6. Yasuhiko Mohri
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  7. Keiichi Uchida
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  8. Yasuhiro Inoue
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  9. Minako Kobayashi
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  10. Chikao Miki
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  11. Takehira Yamamura
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Kusunoki, M., Ikeuchi, H., Yanagi, H. et al. Bioresorbable Hyaluronate-Carboxymethylcellulose Membrane (Seprafilm) in Surgery for Rectal Carcinoma: A Prospective Randomized Clinical Trial. Surg Today 35, 940–945 (2005). https://doi.org/10.1007/s00595-005-3061-0

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  • DOI: https://doi.org/10.1007/s00595-005-3061-0

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