Bioresorbable hyaluronate-carboxymethylcellulose membrane (Seprafilm) in surgery for rectal carcinoma: a prospective randomized clinical trial.
OBJECTIVE
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.


CONCLUSIONS
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.
Kusunoki
Masato
M
Second Department of Surgery, Mie University School of Medicine, Tsu, Japan.
Ikeuchi
Hiroki
H
Yanagi
Hidenori
H
Noda
Masafumi
M
Tonouchi
Hitoshi
H
Mohri
Yasuhiko
Y
Uchida
Keiichi
K
Inoue
Yasuhiro
Y
Kobayashi
Minako
M
Miki
Chikao
C
Yamamura
Takehira
T
D020341:Absorbable Implants; D000328:Adult; D000368:Aged; D002277:Carcinoma / Q000601:surgery*; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage*; D010535:Laparoscopy; D008297:Male; D008567:Membranes, Artificial; D008875:Middle Aged; D011183:Postoperative Complications / Q000517:prevention & control; D012004:Rectal Neoplasms / Q000601:surgery*; D000267:Tissue Adhesions / Q000175:diagnosis / Q000517:prevention & control; D014945:Wound Healing
D008567:Membranes, Artificial; C118198:Seprafilm; D006820:Hyaluronic Acid