From: Seprafilm® adhesion barrier: (2) a review of the clinical literature on intraabdominal use
Reference | N | Therapeutic area | Favorable seprafilm outcome | Effect sizea | Reported p value |
---|---|---|---|---|---|
Becker et al. [3] | 183 | Abdominal | Incidence | 17.4 | <0.00000000001 |
Incidence of fewer dense adhesions | 7.6 | <0.0001 | |||
Incidence of fewer moderate adhesions | 16.5 | ||||
Incidence of greater mild adhesions | 8.5 | ||||
Extent | 1.2 | <0.001 | |||
Fukushima et al. [5] | 30 | Abdominal | Comparison to untreated control site | ||
Incidence of adhesions | 3.0 | 0.05 | |||
Incidence of more grade 1 | 3.3 | 0.05 | |||
Incidence of fewer grade 3 | 2.1 | ||||
Comparison to pts with previous laparotomy | |||||
Incidence of adhesions | 3.6 | 0.05 | |||
Incidence of more grade 1 | 9.0 | 0.01 | |||
Incidence of fewer grade 3 | 3.5 | ||||
Salum et al. [14] | 538 | Abdominal | Incidence of intestinal obstruction | 1.5 | NS |
Incidence of enterolysis | 2.6 | NS | |||
Successful conservative management of bowel obstruction | 1.1 | NS | |||
Vriland et al. [30] | 71 | Abdominal | Incidence of adhesions entire incision | Cannot be calculated—0 events in control group | 0.48 |
Incidence of pelvic adhesions | 3.0 | 0.41 | |||
Incidence of adhesions superior segment | 2.1 | 0.48 | |||
Incidence of adhesions middle segment | 8.0 | 0.09 | |||
Incidence of adhesions inferior segment | 3.0 | 0.28 | |||
Median severity score entire incision | Cannot be calculated—only range reported | 0.002 | |||
Tang et al. [27] | 181 | Abdominal | Overall mean 4 quadrant adhesion score Phase I | −0.06 | NS |
Overall mean 4 quadrant adhesion score Phase II | 0.8 | 0.02 | |||
Kudo et al. [15] | 51 | Abdominal | Incidence of early postoperative bowel obstruction | Cannot be calculated—0 events in Seprafilm group | <0.05 |
Resumed liquid diet sooner | 0.6 | NS | |||
Resumed solid diet sooner | 0.5 | NS | |||
Mohri et al. [16] | 367 | Abdominal | Incidence of early postoperative small bowel obstruction | 2.4 | 0.02 |
Reoperation for early postoperative small bowel obstruction | 2.7 | NS | |||
Fazio et al. [8] | 1791 | Abdominal | Incidence of operative adhesive small bowel obstruction | 1.9 | 0.044 |
Incidence of all cause bowel obstruction | 1.0 | NS | |||
Salum et al. [28] | 191 | Abdominal | Incidence of grade 0 adhesions midline and stoma | 4.3 | 0.021 |
Incidence of grade 0 adhesions midline | 3.1 | ||||
Incidence of greater grade 1 adhesions midline and stoma | 2.0 | 0.096 | |||
Incidence of greater grade 1 adhesions midline | 1.1 | ||||
Incidence of fewer grade 3 adhesions midline and stoma | 2.56 | ||||
Incidence of fewer grade 3 adhesions midline | 1.2 | ||||
Incidence of enterotomy/myotomy midline and stoma | 0.7 | ||||
Incidence of enterotomy/myotomy midline | 0.8 | ||||
Fujii et al. [9] | 115 | Abdominal | Incidence of adhesion related post-op ileus | 1.0 | NS |
27 | Incidence of adhesions | 11.6 | 0.0004 | ||
Van der Wal et al. [31] | 35 | Abdominal | Incidence of chronic abdominal complaints | 4.7 | 0.018 |
Incidence of small bowel obstruction | Cannot be calculated—0 events in treatment group | NS | |||
Oikonomokis et al. [35] | 156 | Abdominal Oncologic | Recurrence rate | 1.8 | NS |
1 year survival | 1.2 | NS | |||
2 year survival | 2.3 | NS | |||
Kusonoki et al. [36] | 62 | Abdominal Oncologic | Incidence of intestinal obstruction prior to ileostomy closure | 2.2 | 0.60 |
Incidence of intestinal obstruction following ileostomy closure | 2.9 | 0.22 | |||
Incidence of grade 0 adhesions midline | 40.6 | ||||
Incidence of grade 0 adhesions stoma | Cannot be calculated—0 events in control group | ||||
5 year survival | 1.6 | ||||
Uchida et al. [32] | 278 | Abdominal Oncologic | No control group | n/a | n/a |
Hayashi et al. [37] | 144 | Abdominal Oncologic | Incidence of small bowel obstruction | 1.7 | NS |
Park et al. [38] | 427 | Abdominal | Incidence of early postoperative bowel obstruction | 2.7 | NS |
Oncologic | Incidence of readmission for early postoperative bowel obstruction | 1.7 | NS | ||
Khaitan et al. [20] | 19 | Abdominal laparoscopy | No control group | n/a | n/a |
Shinohara et al. [23] | 8 | Abdominal laparoscopy | Feasibility study | n/a | n/a |
Ortiz and Awad [25] | n/a | Abdominal laparoscopy | Feasibility study | n/a | n/a |
Kawamura et al. [29] | 36 | Abdominal laparoscopy | Ileostomy take down time | Cannot be calculated | 0.023 |
Seprafilm vs. no treatment | —no SD or SEM reported | ||||
Kawamura et al. [6] | 282 | Abdominal laparoscopy | Incidence of 2-year adhesive postoperative bowel obstruction | 7.8 | 0.021 |
Klinger et al. [45] | 1 | Abdominal | Case report | n/a | n/a |
Trickett et al. [46] | 4 | Abdominal | Case report | n/a | n/a |
Remzi et al. [47] | 3 | Abdominal | Case report | n/a | n/a |
David et al. [48] | 1 | Abdominal | Case report | n/a | n/a |
Tyler et al. [49] | 3 | Abdominal | Case report | n/a | n/a |
Mizuno et al. [39] | 9 | Pediatrics abdominal | No control group | n/a | n/a |
Ong et al. [40] | 3 | Pediatrics abdominal | No control group | n/a | n/a |
Inoue et al. [41] | 122 | Pediatrics abdominal | Incidence of adhesions | 6.7 | 0.007 |
Incidence of greater grade 1 adhesions | 12.8 | 0.0009 | |||
Reoperative time | 1.1 | 0.04 | |||
Blood loss ≥ 3 g/kg | Cannot be calculated | 0.09 | |||
Blood loss < 3 g/kg | —no SD or SEM reported | ||||
Winfield et al. [42] | 18 | Pediatric abdominal | No control group | n/a | n/a |
Fushiki et al. [43] | 52 | Obstetrics | Incidence of adhesions | 11.5 | 0.001 |
Operative time to delivery | Cannot be calculated—only range reported | 0.014 | |||
Operative time total | Cannot be calculated—only range reported | 0.009 | |||
Blood loss | Cannot be calculated—only range reported | 0.134 | |||
Severity of adhesions | Cannot be calculated—only range reported | 0.001 | |||
Diamond et al. [4] | 127 | Gynecologic | Mean number of sites adherent to the uterus | 0.8 | <0.0001 |
Severity | 0.5 | <0.01 | |||
Extent | 0.4 | <0.01 | |||
Tsuji et al. [44] | 63 | Gynecologic | Incidence of uterine adhesions compared o no treatment control | 20 | 0.0003 |
Incidence of uterine adhesions compared to Dextran 40 | 14.4 | 0.0004 | |||
Incidence of uterine adhesions compared to Beriplast | 18 | 0.0005 | |||
Incidence of peritoneal adhesions compared to no treatment control | 13.5 | 0.001 | |||
Incidence of peritoneal adhesions compared to Dextran 40 | 2.5 | 0.2557 | |||
Incidence of peritoneal adhesions compared to Beriplast | 4.3 | 0.0818 | |||
Incidence of adnexal adhesions compared to no treatment control | 72 | <0.0001 | |||
Incidence of adnexal adhesions compared to Dextran 40 | 6.8 | 0.0098 | |||
Incidence of adnexal adhesions compared to Beriplast | 1.2 | 0.855 | |||
AFS Score compared to no treatment control | 1.5 | <0.0001 | |||
AFS Score compared to Dextran 40 | 0.9 | 0.0223 | |||
AFS Score compared to Beriplast | 0.3 | 0.8208 | |||
Takeuchi et al. [21] | 114 | Gynecologic laparoscopy | No control group | n/a | n/a |
Chuang et al. [22] | 127 | Gynecologic laparoscopy | No control group | n/a | n/a |
Fenton and Fanning [24] | 15 | Gynecologic laparoscopy | Feasibility study | n/a | n/a |
Lipetskaia et al. [26] | 171 | Gynecologic laparoscopy | Feasibility study | n/a | n/a |
Bristow et al. [33] | 21 | Gynecologic Oncologic | Mean pelvic adhesion score versus mean abdominal adhesion score (internal control) | 1.9 | 0.002 |
Mean pelvic adhesion score versus mean pelvic adhesion score (historical control) | 1.7 | 0.004 | |||
Bristow et al. [50] | n/a | Gynecologic Oncologic | No control group—cost effectiveness | n/a | n/a |
Tan et al. [34] | 202 | Gynecologic Oncologic | 5 year disease free survival | 0.6 | NS |
5 year overall survival | 0.6 | ||||
30 day bowel obstruction | 3.4 | ||||
Leitao et al. [17] | 423 | Gynecologic Oncologic | Incidence of intraabdominal collections | 0.3 | 0.0009 |
Tabata et al. [18] | 371 | Gynecologic Oncologic | Incidence of early postoperative small bowel obstruction | 5.0 | <0.05 |
Incidence of surgical site infection | 2.0 | NS |