Advertisement

Surgery Today

, Volume 35, Issue 11, pp 940–945 | Cite as

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

  • Masato Kusunoki
  • Hiroki Ikeuchi
  • Hidenori Yanagi
  • Masafumi Noda
  • Hitoshi Tonouchi
  • Yasuhiko Mohri
  • Keiichi Uchida
  • Yasuhiro Inoue
  • Minako Kobayashi
  • Chikao Miki
  • Takehira Yamamura
Article

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.

Key words

Seprafilm Rectal carcinoma Chemoradiotherapy 

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. 1.
    Burns, JW, Colt, MJ, Burgees, LS, Skinner, KC 1997Preclinical evaluation of Seprafilm bioresorbable membrane (Review)Eur J Surg Suppl577408PubMedGoogle Scholar
  2. 2.
    Becker, JM, Dayton, MT, Fazio, VW, Beck, DE, Stryker, SJ, Wexner, SD,  et al. 1996Prevention of postoperative abdominal adhesions by a sodium hyaluronate-based bioresorbable membrane: a prospective, randomized, double-blind multicenter studyJ Am Coll Surg183297306PubMedGoogle Scholar
  3. 3.
    Underwood, RA, Wu, JS, Wright, MP, Ruiz, MB, Pfister, SM, Connett, JM,  et al. 1999Sodium hyaluronate carboxymethylcellulose-based bioresorbable membrane (Seprafilm)—does it affect tumor implantation at abdominal wound sites?Dis Colon Rectum426149PubMedGoogle Scholar
  4. 4.
    Hubbard, SC, Burns, JW 2002Effects of a hyaluronan-based membrane (Seprafilm) on intraperitoneally disseminated human colon cancer cell growth in a nude mouse modelDis Colon Rectum4533444CrossRefPubMedGoogle Scholar
  5. 5.
    Kusunoki, M, Yanagi, H, Shoji, Y, Yamamura, T, Utsunomiya, J 1997Anoabdominal rectal resection and colonic J pouch-anal anastomosis: 10 years' experienceBr J Surg84127780CrossRefPubMedGoogle Scholar
  6. 6.
    Kusunoki, M, Yanagi, H, Kotera, H, Noda, M, Yamamura, T 1998Effects of pharmacokinetic modulating chemotherapy using oral UFT and continuous venous 5FU infusion on the prognosis of irradiated rectal carcinomas with p53 overexpressionInt J Oncol136537PubMedGoogle Scholar
  7. 7.
    Yoshikawa, R, Kusunoki, M, Yanagi, H, Noda, M, Furuyama, JI, Yamamura, T,  et al. 2001Dual antitumor effects of 5-fluorouracil on the cell cycle in colorectal carcinoma cells: a novel target mechanism concept for pharmacokinetic modulating chemotherapyCancer Res61102937PubMedGoogle Scholar
  8. 8.
    Kusunoki, M, Yanagi, H, Shoji, Y, Yamamura, T 1996Modification of the stapled functional end-to-end anastomosis for ileostomy closureSurg Today2610335CrossRefPubMedGoogle Scholar
  9. 9.
    NCI. Clinical announcement. Adjuvant therapy for rectal cancer. 1991; 14 MarchGoogle Scholar
  10. 10.
    Collaborative Group, Colorectal Cancer 2001Adjuvant radiotherapy for rectal cancer: a systematic overview of 8,507 patients from 22 randomized trialsLancet3581291304CrossRefPubMedGoogle Scholar
  11. 11.
    Camma, C, Giunta, M, Fiorica, F, Pagliaro, L, Craxi, A, Cottone, M 2000Preoperative radiotherapy for respectable rectal cancer: a meta-analysisJAMA284100815CrossRefPubMedGoogle Scholar
  12. 12.
    Vrijland, WW, Tseng, LN, Eijkman, HJ, Hop, WC, Jakimowicz, JJ, Leguit, P,  et al. 2002Fewer intraperitoneal adhesions with use of hyaluronic acid-carboxymethylcellulose membrane: a randomized clinical trialAnn Surg2351939CrossRefPubMedGoogle Scholar
  13. 13.
    Oikonomakis, I, Wexner, SD, Gervaz, P, You, SY, Secic, M, P. Seprafilm, Giamundo 2002a retrospective preliminary evaluation of the impact on short-term oncologic outcome in colorectal cancerDis Colon Rectum45137680CrossRefPubMedGoogle Scholar

Copyright information

© Springer-Verlag Tokyo 2005

Authors and Affiliations

  • Masato Kusunoki
    • 1
  • Hiroki Ikeuchi
    • 2
  • Hidenori Yanagi
    • 2
  • Masafumi Noda
    • 2
  • Hitoshi Tonouchi
    • 1
  • Yasuhiko Mohri
    • 1
  • Keiichi Uchida
    • 1
  • Yasuhiro Inoue
    • 1
  • Minako Kobayashi
    • 1
  • Chikao Miki
    • 1
  • Takehira Yamamura
    • 2
  1. 1.Second Department of SurgeryMie University School of MedicineTsuJapan
  2. 2.Second Department of SurgeryHyogo College of MedicineNishinomiyaJapan

Personalised recommendations