Seprafilm® adhesion barrier: (2) a review of the clinical literature on intraabdominal use

Diamond, Michael P.; Burns, Ellen L.; Accomando, Beverly; Mian, Sadiqa; Holmdahl, Lena

doi:10.1007/s10397-012-0742-8

Table 1 Clinical publications and calculated effect size

From: Seprafilm^® adhesion barrier: (2) a review of the clinical literature on intraabdominal use

Reference	N	Therapeutic area	Favorable seprafilm outcome	Effect size^a	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
Tang et al. [27]	181	Abdominal	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
Mohri et al. [16]	367	Abdominal	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
Fazio et al. [8]	1791	Abdominal	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
Fujii et al. [9]	27	Abdominal	Incidence of adhesions	11.6	0.0004
Van der Wal et al. [31]	35	Abdominal	Incidence of chronic abdominal complaints	4.7	0.018
Van der Wal et al. [31]	35	Abdominal	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
Park et al. [38]	427	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
Kawamura et al. [29]	36	Abdominal laparoscopy	Seprafilm vs. no treatment	—no SD or SEM reported	0.023
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
Bristow et al. [33]	21	Gynecologic Oncologic	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
Tabata et al. [18]	371	Gynecologic Oncologic	Incidence of surgical site infection	2.0	NS

^aFor continuous outcomes, effect size is the (control group mean − the Seprafilm mean) divided by the pooled standard deviation for the 2 groups [ES = (M1 − M2)/pooled SD], and for binomial outcomes, effect size is the odds ratio or the ratio of the odds of a success for the Seprafilm group to the odds of a success for the control group [ES = (ad)/(bc)]

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