Healing by primary versus secondary intention after surgical treatment for pilonidal sinus

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Iain McCallum; Peter M King; Julie Bruce; Ahmed AL‐Khamis

doi:10.1002/14651858.CD006213.pub2

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Analysis 1.1

Comparison 1 Open vs. closed (all), Outcome 1 SSI rate.

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Analysis 1.2

Comparison 1 Open vs. closed (all), Outcome 2 Recurrence rate.

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Analysis 1.3

Comparison 1 Open vs. closed (all), Outcome 3 Time to return to work (days).

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Analysis 1.4

Comparison 1 Open vs. closed (all), Outcome 4 Other complications & morbidity.

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Analysis 1.5

Comparison 1 Open vs. closed (all), Outcome 5 Patient satisfaction rate.

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Analysis 1.6

Comparison 1 Open vs. closed (all), Outcome 6 Cost.

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Analysis 1.7

Comparison 1 Open vs. closed (all), Outcome 7 Length of stay.

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Analysis 1.8

Comparison 1 Open vs. closed (all), Outcome 8 Pain.

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Analysis 1.9

Comparison 1 Open vs. closed (all), Outcome 9 Wound healing rate.

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Analysis 2.1

Comparison 2 Closed (midline) vs. closed (other), Outcome 1 SSI rate.

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Analysis 2.2

Comparison 2 Closed (midline) vs. closed (other), Outcome 2 Recurrence rate.

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Analysis 2.3

Comparison 2 Closed (midline) vs. closed (other), Outcome 3 Time to return to work.

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Analysis 2.4

Comparison 2 Closed (midline) vs. closed (other), Outcome 4 Other complications & morbidity.

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Analysis 2.5

Comparison 2 Closed (midline) vs. closed (other), Outcome 5 Patient Satisfaction.

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Analysis 2.7

Comparison 2 Closed (midline) vs. closed (other), Outcome 7 Length of stay.

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Analysis 2.8

Comparison 2 Closed (midline) vs. closed (other), Outcome 8 Pain.

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Analysis 2.9

Comparison 2 Closed (midline) vs. closed (other), Outcome 9 Wound healing rate.

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Analysis 3.1

Comparison 3 Closed other vs. closed other, Outcome 1 SSI rate.

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Analysis 3.2

Comparison 3 Closed other vs. closed other, Outcome 2 Recurrence rate.

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Analysis 3.3

Comparison 3 Closed other vs. closed other, Outcome 3 Time to return to work.

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Analysis 3.4

Comparison 3 Closed other vs. closed other, Outcome 4 Other complications & morbidity.

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Analysis 3.7

Comparison 3 Closed other vs. closed other, Outcome 7 Length of stay.

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Table 1. Time to wound healing (median, range) days

Study	Comparison	Experimental group	Control group	Sample Size E	Sample Size C	P value	Results presented as
Gencosmanoglu	Open vs. closed (midline)	79 (21, 112)	14 (14, 63)	73	69	<0.001	Median (range)
Kronborg	Open vs. closed (midline)	64 (17, 157)	13 (7, 203)	32	33	nr	Median (range)
Rao	Open vs. closed (midline)	61 (34, 132)	27 (24, 68)	30	29	<0.001	Median (range)
Khawaja	Open vs. closed (midline)	41 (nr)	14 (nr)	23	23	Median difference (95% CI) ‐23 (‐28 to ‐20)	Median (range)
al‐Hassan	Open vs. closed (midline)	91 (28‐546)	10.3 (10‐15)	40	42	nr	Mean (range)
Hameed	Open vs. closed (midline)	70 (59‐91)	14.5 (12‐21)	20	23	<0.05	Mean (range)
Sondenna (1992)	Open vs. closed (midline)	70 (28‐266)	14 (14‐126)	59	60	<0.001	Median (range)
Ertan	Primary closure vs. rhomboid flap	15.7 (7‐38)	10.3 (5‐22)	50	50	0.001	Mean (range)

Table 1. Time to wound healing (median, range) days

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Table 2. Time to return work (median, range) days

Study	Comparison	Experimental group	Control group	SS E	SS_C	P value
Akca	Closed midline vs. closed (other)	19 (15, 20)	9.5 (8, 12)	100	100	<0.001

Gencosmanoglu	Open vs closed midline	3 (2, 8)	21 (14, 63)	73	69	<0.001
Khawaja	Open vs closed midline	42 nr	19.5 nr	23	23	Median difference (95%CI) ‐22 (‐26, ‐17)

Table 2. Time to return work (median, range) days

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Table 3. Length of stay (median, range) days

Study name	Comparison	Experimental group	Control group	S size exp	S size control	P value
Berkem	Closed midline vs. closed offmidline	3 (2, 6)	3 (2,7)	16	18	0.62
Khawaja	Open vs. closed midline	3 nr	1 nr	23	23	nr

Table 3. Length of stay (median, range) days

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Table 4. Ertan trial: SF‐36 Quality of life scores

Item	Midline closure N=50	Offmidline N=50	P value
General health perception	71.1 (11.7)	78.2 (14.1)	0.008
Physical functioning	74.8 (12.9)	77.6 (14.8)	ns
Social functioning	87.3 (32.8)	110.4 (33.8)	0.001
Role limitation physical	42.5 (29.1)	49.5 (41.1)	ns
Role limitation emotional	57.3 (33.0)	54.6 (44.5)	ns
Pain	54.5 (14.0)	67.5 (18.4)	0.001
Energy & vitality	77.5 (16.8)	72.9 (17.2)	ns
Mental health	79.5 (12.3)	77.6 (13.1)	ns

Table 4. Ertan trial: SF‐36 Quality of life scores

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Table 5. Quality assessment for included trials

Study	Sample size	Randomization	Allocation	Baseline comparable	Follow‐up >80%	Quality
Abu Galala 1999	Yes	Yes	Adequate	Yes	Yes	High
Akca 2005	Yes	Yes	Adequate	Yes	Yes	High
Al‐Hassan 1990	No	No	Adequate	Yes	No	Low
Berkem 2005	No	No	Unclear	No	Yes	Low
Cihan 2006	No	No	Inadequate	Yes	Unclear	Low
Ertan 2005	No	Yes	Unclear	Yes	No	Medium
Fuzun 1994	No	No	Inadequate	Unclear	No	Low
Gencosmanoglu 2005	Yes	No	Inadequate	Yes	No	Low
Hameed 2001	No	Unclear	Inadequate	Yes	Yes	Medium
Khawaja 1992	No	Yes	Adequate	Yes	Unclear	Medium
Kronborg 1985	No	Yes	Unclear	Yes	No	Medium
Miocinovic 1999	No	Unclear	Inadequate	Unclear	Yes	Poor
Mohamed 2005	No	Yes	Adequate	Yes	Unclear	Medium
Rao 2001	No	Unclear	Unclear	Unclear	Unclear	Poor
Sondenaa 1992	No	Yes	Inadequate	Unclear	Yes	Medium
Testini 2001	No	Yes	Unclear	Yes	Unclear	Medium
Wright 2001	No	Yes	Unclear	Yes	Unclear	Medium
Fazelli 2006	Yes	Yes	Inadequate	Yes	Yes	Medium

Table 5. Quality assessment for included trials

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Table 6. Pain score (median, range)

Table 6. Pain score (median, range)

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Comparison 1. Open vs. closed (all)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 SSI rate Show forest plot	5	559	Risk Ratio (M‐H, Random, 95% CI)	1.20 [0.55, 2.63]

1.1 open vs closed (midline)	4	415	Risk Ratio (M‐H, Random, 95% CI)	0.78 [0.20, 3.09]
1.2 open vs closed (other)	1	144	Risk Ratio (M‐H, Random, 95% CI)	1.43 [0.58, 3.55]
2 Recurrence rate Show forest plot	11	994	Risk Ratio (M‐H, Fixed, 95% CI)	0.42 [0.26, 0.66]

2.1 Open vs closed (midline)	9	756	Risk Ratio (M‐H, Fixed, 95% CI)	0.38 [0.23, 0.63]
2.2 Open vs closed (other)	2	238	Risk Ratio (M‐H, Fixed, 95% CI)	0.70 [0.20, 2.42]
3 Time to return to work (days) Show forest plot	5	563	Mean Difference (IV, Fixed, 95% CI)	10.48 [5.75, 15.21]

3.1 Open vs closed (midline)	3	319	Mean Difference (IV, Fixed, 95% CI)	8.56 [2.97, 14.15]
3.2 Open vs closed (other)	2	244	Mean Difference (IV, Fixed, 95% CI)	15.30 [6.44, 24.16]
4 Other complications & morbidity Show forest plot	7	677	Risk Ratio (M‐H, Random, 95% CI)	0.67 [0.27, 1.70]

4.1 Open vs closed (midline)	5	433	Risk Ratio (M‐H, Random, 95% CI)	0.56 [0.12, 2.51]
4.2 Open vs closed (other)	2	244	Risk Ratio (M‐H, Random, 95% CI)	0.87 [0.36, 2.10]
5 Patient satisfaction rate Show forest plot	1	83	Risk Ratio (M‐H, Random, 95% CI)	0.75 [0.57, 0.99]

6 Cost Show forest plot	1	43	Mean Difference (IV, Fixed, 95% CI)	23.94 [0.73, 47.15]

7 Length of stay Show forest plot	5	533	Mean Difference (IV, Random, 95% CI)	‐1.26 [‐2.77, 0.24]

7.1 Open vs closed (midline)	3	289	Mean Difference (IV, Random, 95% CI)	‐1.87 [‐2.16, ‐1.57]
7.2 Open vs closed (other)	2	244	Mean Difference (IV, Random, 95% CI)	‐0.13 [‐0.26, 0.00]
8 Pain Show forest plot	2	220	Risk Ratio (M‐H, Fixed, 95% CI)	1.13 [0.45, 2.80]

9 Wound healing rate Show forest plot	5	474	Risk Ratio (M‐H, Random, 95% CI)	0.94 [0.85, 1.04]

9.1 Open vs closed (midline) > 6 months	3	278	Risk Ratio (M‐H, Random, 95% CI)	0.96 [0.90, 1.01]
9.2 Open vs closed (other) > 6 months	1	100	Risk Ratio (M‐H, Random, 95% CI)	1.02 [0.97, 1.08]
9.3 Open vs closed (midline) < 6 months	1	96	Risk Ratio (M‐H, Random, 95% CI)	0.74 [0.62, 0.88]

Comparison 1. Open vs. closed (all)

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Comparison 2. Closed (midline) vs. closed (other)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 SSI rate Show forest plot	4	380	Risk Ratio (M‐H, Fixed, 95% CI)	4.70 [1.93, 11.45]

2 Recurrence rate Show forest plot	5	413	Peto Odds Ratio (Peto, Fixed, 95% CI)	4.95 [2.18, 11.24]

2.1 Follow‐up more than one year (>80%)	2	246	Peto Odds Ratio (Peto, Fixed, 95% CI)	8.26 [2.71, 25.13]
2.2 Follow‐up less than one year (>80%)	1	33	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.13 [0.01, 2.26]
2.3 Follow‐up more than one year (<80%)	2	134	Peto Odds Ratio (Peto, Fixed, 95% CI)	5.33 [1.39, 20.43]
3 Time to return to work Show forest plot	2		Mean Difference (IV, Random, 95% CI)	Totals not selected

4 Other complications & morbidity Show forest plot	2	300	Risk Ratio (M‐H, Random, 95% CI)	8.94 [2.10, 38.02]

5 Patient Satisfaction Show forest plot	1	100	Mean Difference (IV, Fixed, 95% CI)	‐0.90 [‐1.51, ‐0.29]

7 Length of stay Show forest plot	2	146	Mean Difference (IV, Random, 95% CI)	1.95 [0.21, 3.69]

8 Pain Show forest plot	2	133	Mean Difference (IV, Fixed, 95% CI)	‐13.0 [‐19.41, ‐6.59]

9 Wound healing rate Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

9.1 > 6 months	1	46	Risk Ratio (M‐H, Fixed, 95% CI)	0.78 [0.61, 0.98]

Comparison 2. Closed (midline) vs. closed (other)

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Comparison 3. Closed other vs. closed other

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 SSI rate Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

2 Recurrence rate Show forest plot	1		Peto Odds Ratio (Peto, Fixed, 95% CI)	Subtotals only

2.1 Follow‐up more than one year (>80%)	1	68	Peto Odds Ratio (Peto, Fixed, 95% CI)	7.19 [0.44, 117.48]
3 Time to return to work Show forest plot	1	68	Mean Difference (IV, Random, 95% CI)	2.40 [2.21, 2.59]

4 Other complications & morbidity Show forest plot	1	68	Risk Ratio (M‐H, Random, 95% CI)	7.54 [1.00, 57.07]

7 Length of stay Show forest plot	1	68	Mean Difference (IV, Random, 95% CI)	2.1 [1.89, 2.31]

Comparison 3. Closed other vs. closed other

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Comparison

Experimental group

Control group

P value

Rao pain score day 4

Open vs. closed midline