Small‐incision versus open cholecystectomy for patients with symptomatic cholecystolithiasis

Frederik Keus; J de Jong; Hein G Gooszen; C JHM Laarhoven

doi:10.1002/14651858.CD004788.pub2

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Figure 1

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.

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Figure 2

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

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Figure 3

Funnel plot on small‐incision versus open cholecystectomy regarding concealment of allocation considering total complications, including 95% confidence interval lines. No arguments for bias.

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Analysis 1.1

Comparison 1 SIC versus OC ‐ high‐quality and low‐quality trials regarding generation of the allocation sequence, Outcome 1 Intra‐operative complications.

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Analysis 1.2

Comparison 1 SIC versus OC ‐ high‐quality and low‐quality trials regarding generation of the allocation sequence, Outcome 2 Minor complications.

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Analysis 1.3

Comparison 1 SIC versus OC ‐ high‐quality and low‐quality trials regarding generation of the allocation sequence, Outcome 3 Severe complications (without bile duct injuries).

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Analysis 1.4

Comparison 1 SIC versus OC ‐ high‐quality and low‐quality trials regarding generation of the allocation sequence, Outcome 4 Bile duct injuries.

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Analysis 1.5

Comparison 1 SIC versus OC ‐ high‐quality and low‐quality trials regarding generation of the allocation sequence, Outcome 5 Total complications.

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Analysis 1.6

Comparison 1 SIC versus OC ‐ high‐quality and low‐quality trials regarding generation of the allocation sequence, Outcome 6 Operative time (minutes).

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Analysis 1.7

Comparison 1 SIC versus OC ‐ high‐quality and low‐quality trials regarding generation of the allocation sequence, Outcome 7 Hospital stay (days).

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Analysis 2.1

Comparison 2 SIC versus OC ‐ high‐quality and low‐quality trials regarding concealment of allocation, Outcome 1 Intra‐operative complications.

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Analysis 2.2

Comparison 2 SIC versus OC ‐ high‐quality and low‐quality trials regarding concealment of allocation, Outcome 2 Minor complications.

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Analysis 2.3

Comparison 2 SIC versus OC ‐ high‐quality and low‐quality trials regarding concealment of allocation, Outcome 3 Severe complications (without bile duct injuries).

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Analysis 2.4

Comparison 2 SIC versus OC ‐ high‐quality and low‐quality trials regarding concealment of allocation, Outcome 4 Bile duct injuries.

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Analysis 2.5

Comparison 2 SIC versus OC ‐ high‐quality and low‐quality trials regarding concealment of allocation, Outcome 5 Total complications.

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Analysis 2.6

Comparison 2 SIC versus OC ‐ high‐quality and low‐quality trials regarding concealment of allocation, Outcome 6 Operative time (minutes).

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Analysis 2.7

Comparison 2 SIC versus OC ‐ high‐quality and low‐quality trials regarding concealment of allocation, Outcome 7 Hospital stay (days).

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Analysis 3.1

Comparison 3 SIC versus OC ‐ high‐quality and low‐quality trials regarding blinding, Outcome 1 Intra‐operative complications.

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Analysis 3.2

Comparison 3 SIC versus OC ‐ high‐quality and low‐quality trials regarding blinding, Outcome 2 Minor complications.

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Analysis 3.3

Comparison 3 SIC versus OC ‐ high‐quality and low‐quality trials regarding blinding, Outcome 3 Severe complications (without bile duct injuries).

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Analysis 3.4

Comparison 3 SIC versus OC ‐ high‐quality and low‐quality trials regarding blinding, Outcome 4 Bile duct injuries.

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Analysis 3.5

Comparison 3 SIC versus OC ‐ high‐quality and low‐quality trials regarding blinding, Outcome 5 Total complications.

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Analysis 3.6

Comparison 3 SIC versus OC ‐ high‐quality and low‐quality trials regarding blinding, Outcome 6 Operative time (minutes).

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Analysis 3.7

Comparison 3 SIC versus OC ‐ high‐quality and low‐quality trials regarding blinding, Outcome 7 Hospital stay (days).

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Analysis 4.1

Comparison 4 SIC versus OC ‐ high‐quality and low‐quality trials regarding follow‐up, Outcome 1 Intra‐operative complications.

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Analysis 4.2

Comparison 4 SIC versus OC ‐ high‐quality and low‐quality trials regarding follow‐up, Outcome 2 Minor complications.

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Analysis 4.3

Comparison 4 SIC versus OC ‐ high‐quality and low‐quality trials regarding follow‐up, Outcome 3 Severe complications (without bile duct injuries).

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Analysis 4.4

Comparison 4 SIC versus OC ‐ high‐quality and low‐quality trials regarding follow‐up, Outcome 4 Bile duct injuries.

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Analysis 4.5

Comparison 4 SIC versus OC ‐ high‐quality and low‐quality trials regarding follow‐up, Outcome 5 Total complications.

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Analysis 4.6

Comparison 4 SIC versus OC ‐ high‐quality and low‐quality trials regarding follow‐up, Outcome 6 Operative time (minutes).

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Analysis 4.7

Comparison 4 SIC versus OC ‐ high‐quality and low‐quality trials regarding follow‐up, Outcome 7 Hospital stay (days).

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Analysis 5.1

Comparison 5 SIC versus OC ‐ sensitivity analysis imputing medians and standard deviations for missing data, Outcome 1 Sensitivity analysis 1: Operative time (minutes).

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Analysis 5.2

Comparison 5 SIC versus OC ‐ sensitivity analysis imputing medians and standard deviations for missing data, Outcome 2 Sensitivity analysis 2: Hospital stay (days).

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Analysis 5.3

Comparison 5 SIC versus OC ‐ sensitivity analysis imputing medians and standard deviations for missing data, Outcome 3 Sensitivity analysis 3: Omitting outlier Schmitz in total complications.

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Table 1. Randomised, excluded, and included in small‐incision vs open cholecystectomy

Trial	Randomised	Excluded	Included SIC	Included OC	Cholangiography	Antibiotics	Surgical expertise
Assalia 1993	50	0	24	26	N	Y	S
Coelho 1992a	50	0	25	25	Y	U	U
Coelho 1993	45*	0	15	15	U	U	U
O'Dwyer 1992a	30	0	16	14	Y	U	R
Schmitz 1997a	130	0	65	65	U	U	U
Seenu 1994	181	0	97	84	U	U	R
Wani 2002	100	0	50	50	U	U	U
Total	586	0	292	279
* three‐arm trial, patients in the LC group not listed in this table.	N = no	Y = yes	U = unknown	S = one surgeon	R = also registrars

Table 1. Randomised, excluded, and included in small‐incision vs open cholecystectomy

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Table 2. Description of background data (age, sex, BMI, and ASA)

Trial	N	Age	Age	Sex (m/f)	Sex (m/f)	BMI	BMI	ASA (I‐II‐III‐IV)	ASA (I‐II‐III‐IV)
SIC vs OC	randomised	SIC	OC	SIC	OC	SIC	OC	SIC	OC
Assalia 1993	24 / 26	60.3 (12.1)	59.2 (13.4)	5 / 19	7 / 19	‐	‐	‐	‐
Coelho 1992a	25 / 25	46 ( ‐ )	45 ( ‐ )	2 / 23	4 / 21	‐	‐	‐	‐
Coelho 1993	15 / 15	42.5 (25‐66)	45.4 (18‐73)	2 / 13	3 / 12	‐	‐	‐	‐
O'Dwyer 1992a	16 / 14	46 (27‐74)	51 (38‐73)	3 / 13	4 / 10	‐	‐	16 ‐ 0 ‐ 0 ‐ 0	14 ‐ 0 ‐ 0 ‐ 0
Schmitz 1997a	65 / 65	52.6 (14.6)	54.1 (12.2)	20 / 45	23 / 42	‐	‐	‐	‐
Seenu 1994	97 / 84	‐	‐	‐	‐	‐	‐	‐	‐
Wani 2002	50 / 50	34.8 (5.6)	37.4 (6.2)	5 / 45	5 / 45	21.5 (1.9)	21.6 (1.8)	‐	‐
		mean (standard deviation / range)

Table 2. Description of background data (age, sex, BMI, and ASA)

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Table 3. Complications specified per operative technique: small‐incision vs open cholecys

Complications	SIC	OC
INTRA‐OPERATIVE	(0)	(0)

POSTOPERATIVE ‐ MINOR	(25 / 8.6%)	(19 / 6.8%)
wound hematoma	12	4
wound infection	12	15
urinary retention	1	0

POSTOPERATIVE ‐ SEVERE	(4 / 1.4%)	(7 / 2.5%)
stone left in cystic duct (re‐operation)	1	0
pneumonia	1	5
atelectasis	1	0
cardiovascular	1	0
upper GI bleeding (endoscopy / conservative)	0	2

BILE DUCT INJURY	(0)	(0)

TOTAL COMPLICATIONS	29 (9.9%)	26 (9.3%)
RE‐OPERATIONS (all complications)	2 (0.7%)	0
TOTAL NUMBER OF PATIENTS INCLUDED (all trials)	292	279

Table 3. Complications specified per operative technique: small‐incision vs open cholecys

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Table 4. Internal validity assessment of included trials: small‐incision vs open cholecys

Trial	Generation of alloc	Concealment of alloc	Blinding	Follow‐up
Assalia 1993	U	U	N	U
Coelho 1992a	A	U	N	U
Coelho 1993	U	U	N	U
O'Dwyer 1992a	U	A	N	U
Schmitz 1997a	U	A	N	A
Seenu 1994	U	U	N	U
Wani 2002	U	U	N	U
A: Adequate	U: Unclear	I: Inadequate	N: Not performed

Table 4. Internal validity assessment of included trials: small‐incision vs open cholecys

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Table 5. Results of small‐incision vs open cholecystectomy: alloc. concealment (compar.2)

Outcome	RD/WMD	HQ/LQ/AT	Fixed	Random	Discrepancy	Emphasize	HQ‐LQ difference	Significant
Minor complications	RD	HQ	0.12 (0.03, 0.22) *	0.11 (0.02, 0.21) *	no
		LQ	‐0.03 (‐0.07, 0.02)	‐0.01 (‐0.04, 0.02)	no
		AT	0.02 (‐0.03, 0.06)	0.01 (‐0.03, 0.05)	no	random	yes	yes/no
Total complications	RD	HQ	0.15 (0.04, 0.25) *	0.14 (0.04, 0.24) *	no
		LQ	‐0.05 (‐0.10, 0.00)	‐0.03 (‐0.10, 0.03)	no
		AT	0.01 (‐0.04, 0.05)	0.00 (‐0.06, 0.07)	no	random	yes	yes/no
Hospital stay	WMD	HQ	‐3.90 (‐4.57, ‐3.23) *	‐3.90 (‐4.57, ‐3.23) *	no
		LQ	‐1.70 (‐2.05, ‐1.35) *	‐1.70 (‐2.05, ‐1.35) *	no
		AT	‐2.16 (‐2.47, ‐1.85) *	‐2.78 (‐4.94, ‐0.62) *	no	random	no	yes
* significant result	HQ: high‐quality trials	LQ: low‐quality trials	AT: all trials	RD: risk difference	WMD: weighted mean difference	random: random‐effects model

Table 5. Results of small‐incision vs open cholecystectomy: alloc. concealment (compar.2)

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Table 6. Operative time small‐incision vs open cholecystectomy: all available data

Trial	Type of data	SIC ‐ mean/median	SIC ‐ SD/range	OC ‐ mean/median	OC ‐ SD/range	Skewness SIC	Skewness OC
Assalia 1993	A ‐ SD	60	8.7	59	8.5	6.90	6.94
Coelho 1992a	A ‐	86	‐	99	‐	‐	‐
Coelho 1993	A ‐ range	74	40 ‐ 125	86	40 ‐ 140	‐	‐
O'Dwyer 1992a	A ‐ SD	62	22	69	17	2.82	4.06
Schmitz 1997a	A ‐ SD	62	16	58	12	3.88	4.83
Seenu 1994	A ‐ range	60	30 ‐ 100	65	20 ‐ 90	‐	‐
Wani 2002	A ‐ range	74	40 ‐ 125	70	50 ‐ 125	‐	‐
	A: Average / mean	SD: standard deviation

Table 6. Operative time small‐incision vs open cholecystectomy: all available data

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Table 7. Hospital stay small‐incision vs open cholecystectomy: all available data

Trial	Type of data	SIC ‐ mean/median	SIC ‐ SD/range	OC ‐ mean/median	OC ‐ SD/range	Skewness SIC	Skewness OC
Assalia 1993	A ‐ SD	3	0.4	4.7	0.8	7.5	5.88
Coelho 1992a	A ‐	1,7	‐	3,5	‐	‐	‐
Coelho 1993	A ‐ range	1	1 ‐ 1	2	2 ‐ 3	‐	‐
O'Dwyer 1992a	M ‐ range	3	1 ‐ 10	5	3 ‐ 8	‐	‐
Schmitz 1997a	A ‐ SD	11.5	1.2	15.4	2.5	9.58	6.16
Seenu 1994	A ‐ range	2.6	1 ‐ 4	4	3 ‐ 8	‐	‐
Wani 2002	A ‐	3	‐	5	‐	‐	‐
	A: Average / mean	SD: standard deviation	M: median

Table 7. Hospital stay small‐incision vs open cholecystectomy: all available data

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Comparison 1. SIC versus OC ‐ high‐quality and low‐quality trials regarding generation of the allocation sequence

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Intra‐operative complications Show forest plot	7	571	Risk Difference (M‐H, Fixed, 95% CI)	0.0 [‐0.02, 0.02]

1.1 High‐quality trials	1	50	Risk Difference (M‐H, Fixed, 95% CI)	0.0 [‐0.07, 0.07]
1.2 Low‐quality trials	6	521	Risk Difference (M‐H, Fixed, 95% CI)	0.0 [‐0.02, 0.02]
2 Minor complications Show forest plot	7	571	Risk Difference (M‐H, Random, 95% CI)	0.01 [‐0.03, 0.05]

2.1 High‐quality trials	1	50	Risk Difference (M‐H, Random, 95% CI)	‐0.04 [‐0.21, 0.13]
2.2 Low‐quality trials	6	521	Risk Difference (M‐H, Random, 95% CI)	0.02 [‐0.04, 0.07]
3 Severe complications (without bile duct injuries) Show forest plot	7	571	Risk Difference (M‐H, Fixed, 95% CI)	‐0.01 [‐0.04, 0.02]

3.1 High‐quality trials	1	50	Risk Difference (M‐H, Fixed, 95% CI)	‐0.04 [‐0.14, 0.06]
3.2 Low‐quality trials	6	521	Risk Difference (M‐H, Fixed, 95% CI)	‐0.01 [‐0.04, 0.02]
4 Bile duct injuries Show forest plot	7	571	Risk Difference (M‐H, Fixed, 95% CI)	0.0 [‐0.02, 0.02]

4.1 High‐quality trials	1	50	Risk Difference (M‐H, Fixed, 95% CI)	0.0 [‐0.07, 0.07]
4.2 Low‐quality trials	6	521	Risk Difference (M‐H, Fixed, 95% CI)	0.0 [‐0.02, 0.02]
5 Total complications Show forest plot	7	571	Risk Difference (M‐H, Random, 95% CI)	0.00 [‐0.06, 0.07]

5.1 High‐quality trials	1	50	Risk Difference (M‐H, Random, 95% CI)	‐0.08 [‐0.26, 0.10]
5.2 Low‐quality trials	6	521	Risk Difference (M‐H, Random, 95% CI)	0.01 [‐0.06, 0.08]
6 Operative time (minutes) Show forest plot	3	210	Mean Difference (IV, Fixed, 95% CI)	1.94 [‐1.37, 5.25]

6.1 High‐quality trials	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
6.2 Low‐quality trials	3	210	Mean Difference (IV, Fixed, 95% CI)	1.94 [‐1.37, 5.25]
7 Hospital stay (days) Show forest plot	2	180	Mean Difference (IV, Random, 95% CI)	‐2.78 [‐4.94, ‐0.62]

7.1 High‐quality trials	0	0	Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
7.2 Low‐quality trials	2	180	Mean Difference (IV, Random, 95% CI)	‐2.78 [‐4.94, ‐0.62]

Comparison 1. SIC versus OC ‐ high‐quality and low‐quality trials regarding generation of the allocation sequence

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Comparison 2. SIC versus OC ‐ high‐quality and low‐quality trials regarding concealment of allocation

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Intra‐operative complications Show forest plot	7	571	Risk Difference (M‐H, Fixed, 95% CI)	0.0 [‐0.02, 0.02]

1.1 High‐quality trials	2	160	Risk Difference (M‐H, Fixed, 95% CI)	0.0 [‐0.03, 0.03]
1.2 Low‐quality trials	5	411	Risk Difference (M‐H, Fixed, 95% CI)	0.0 [‐0.02, 0.02]
2 Minor complications Show forest plot	7	571	Risk Difference (M‐H, Random, 95% CI)	0.01 [‐0.03, 0.05]

2.1 High‐quality trials	2	160	Risk Difference (M‐H, Random, 95% CI)	0.11 [0.02, 0.21]
2.2 Low‐quality trials	5	411	Risk Difference (M‐H, Random, 95% CI)	‐0.01 [‐0.04, 0.02]
3 Severe complications (without bile duct injuries) Show forest plot	7	571	Risk Difference (M‐H, Fixed, 95% CI)	‐0.01 [‐0.04, 0.02]

3.1 High‐quality trials	2	160	Risk Difference (M‐H, Fixed, 95% CI)	0.02 [‐0.03, 0.08]
3.2 Low‐quality trials	5	411	Risk Difference (M‐H, Fixed, 95% CI)	‐0.02 [‐0.06, 0.01]
4 Bile duct injuries Show forest plot	7	571	Risk Difference (M‐H, Fixed, 95% CI)	0.0 [‐0.02, 0.02]

4.1 High‐quality trials	2	160	Risk Difference (M‐H, Fixed, 95% CI)	0.0 [‐0.03, 0.03]
4.2 Low‐quality trials	5	411	Risk Difference (M‐H, Fixed, 95% CI)	0.0 [‐0.02, 0.02]
5 Total complications Show forest plot	7	571	Risk Difference (M‐H, Random, 95% CI)	0.00 [‐0.06, 0.07]

5.1 High‐quality trials	2	160	Risk Difference (M‐H, Random, 95% CI)	0.14 [0.04, 0.24]
5.2 Low‐quality trials	5	411	Risk Difference (M‐H, Random, 95% CI)	‐0.03 [‐0.10, 0.03]
6 Operative time (minutes) Show forest plot	3	210	Mean Difference (IV, Fixed, 95% CI)	1.94 [‐1.37, 5.25]

6.1 High‐quality trials	2	160	Mean Difference (IV, Fixed, 95% CI)	2.81 [‐1.78, 7.41]
6.2 Low‐quality trials	1	50	Mean Difference (IV, Fixed, 95% CI)	1.0 [‐3.77, 5.77]
7 Hospital stay (days) Show forest plot	2	180	Mean Difference (IV, Random, 95% CI)	‐2.78 [‐4.94, ‐0.62]

7.1 High‐quality trials	1	130	Mean Difference (IV, Random, 95% CI)	‐3.9 [‐4.57, ‐3.23]
7.2 Low‐quality trials	1	50	Mean Difference (IV, Random, 95% CI)	‐1.70 [‐2.05, ‐1.35]

Comparison 2. SIC versus OC ‐ high‐quality and low‐quality trials regarding concealment of allocation

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Comparison 3. SIC versus OC ‐ high‐quality and low‐quality trials regarding blinding

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Intra‐operative complications Show forest plot	7	571	Risk Difference (M‐H, Fixed, 95% CI)	0.0 [‐0.02, 0.02]

1.1 High‐quality trials	0	0	Risk Difference (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
1.2 Low‐quality trials	7	571	Risk Difference (M‐H, Fixed, 95% CI)	0.0 [‐0.02, 0.02]
2 Minor complications Show forest plot	7	571	Risk Difference (M‐H, Random, 95% CI)	0.01 [‐0.03, 0.05]

2.1 High‐quality trials	0	0	Risk Difference (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.2 Low‐quality trials	7	571	Risk Difference (M‐H, Random, 95% CI)	0.01 [‐0.03, 0.05]
3 Severe complications (without bile duct injuries) Show forest plot	7	571	Risk Difference (M‐H, Fixed, 95% CI)	‐0.01 [‐0.04, 0.02]

3.1 High‐quality trials	0	0	Risk Difference (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.2 Low‐quality trials	7	571	Risk Difference (M‐H, Fixed, 95% CI)	‐0.01 [‐0.04, 0.02]
4 Bile duct injuries Show forest plot	7	571	Risk Difference (M‐H, Fixed, 95% CI)	0.0 [‐0.02, 0.02]

4.1 High‐quality trials	0	0	Risk Difference (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.2 Low‐quality trials	7	571	Risk Difference (M‐H, Fixed, 95% CI)	0.0 [‐0.02, 0.02]
5 Total complications Show forest plot	7	571	Risk Difference (M‐H, Random, 95% CI)	0.00 [‐0.06, 0.07]

5.1 High‐quality trials	0	0	Risk Difference (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
5.2 Low‐quality trials	7	571	Risk Difference (M‐H, Random, 95% CI)	0.00 [‐0.06, 0.07]
6 Operative time (minutes) Show forest plot	3	210	Mean Difference (IV, Fixed, 95% CI)	1.94 [‐1.37, 5.25]

6.1 High‐quality trials	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
6.2 Low‐quality trials	3	210	Mean Difference (IV, Fixed, 95% CI)	1.94 [‐1.37, 5.25]
7 Hospital stay (days) Show forest plot	2	180	Mean Difference (IV, Random, 95% CI)	‐2.78 [‐4.94, ‐0.62]

7.1 High‐quality trials	0	0	Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
7.2 Low‐quality trials	2	180	Mean Difference (IV, Random, 95% CI)	‐2.78 [‐4.94, ‐0.62]

Comparison 3. SIC versus OC ‐ high‐quality and low‐quality trials regarding blinding

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Comparison 4. SIC versus OC ‐ high‐quality and low‐quality trials regarding follow‐up

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Intra‐operative complications Show forest plot	7	571	Risk Difference (M‐H, Fixed, 95% CI)	0.0 [‐0.02, 0.02]

1.1 High‐quality trials	1	130	Risk Difference (M‐H, Fixed, 95% CI)	0.0 [‐0.03, 0.03]
1.2 Low‐quality trials	6	441	Risk Difference (M‐H, Fixed, 95% CI)	0.0 [‐0.02, 0.02]
2 Minor complications Show forest plot	7	571	Risk Difference (M‐H, Random, 95% CI)	0.01 [‐0.03, 0.05]

2.1 High‐quality trials	1	130	Risk Difference (M‐H, Random, 95% CI)	0.14 [0.03, 0.25]
2.2 Low‐quality trials	6	441	Risk Difference (M‐H, Random, 95% CI)	‐0.01 [‐0.04, 0.03]
3 Severe complications (without bile duct injuries) Show forest plot	7	571	Risk Difference (M‐H, Fixed, 95% CI)	‐0.01 [‐0.04, 0.02]

3.1 High‐quality trials	1	130	Risk Difference (M‐H, Fixed, 95% CI)	0.03 [‐0.02, 0.08]
3.2 Low‐quality trials	6	441	Risk Difference (M‐H, Fixed, 95% CI)	‐0.02 [‐0.05, 0.01]
4 Bile duct injuries Show forest plot	7	571	Risk Difference (M‐H, Fixed, 95% CI)	0.0 [‐0.02, 0.02]

4.1 High‐quality trials	1	130	Risk Difference (M‐H, Fixed, 95% CI)	0.0 [‐0.03, 0.03]
4.2 Low‐quality trials	6	441	Risk Difference (M‐H, Fixed, 95% CI)	0.0 [‐0.02, 0.02]
5 Total complications Show forest plot	7	571	Risk Difference (M‐H, Random, 95% CI)	0.00 [‐0.06, 0.07]

5.1 High‐quality trials	1	130	Risk Difference (M‐H, Random, 95% CI)	0.17 [0.05, 0.29]
5.2 Low‐quality trials	6	441	Risk Difference (M‐H, Random, 95% CI)	‐0.02 [‐0.07, 0.03]
6 Operative time (minutes) Show forest plot	3	210	Mean Difference (IV, Fixed, 95% CI)	1.94 [‐1.37, 5.25]

6.1 High‐quality trials	1	130	Mean Difference (IV, Fixed, 95% CI)	4.0 [‐0.86, 8.86]
6.2 Low‐quality trials	2	80	Mean Difference (IV, Fixed, 95% CI)	0.16 [‐4.35, 4.68]
7 Hospital stay (days) Show forest plot	2	180	Mean Difference (IV, Random, 95% CI)	‐2.78 [‐4.94, ‐0.62]

7.1 High‐quality trials	1	130	Mean Difference (IV, Random, 95% CI)	‐3.9 [‐4.57, ‐3.23]
7.2 Low‐quality trials	1	50	Mean Difference (IV, Random, 95% CI)	‐1.70 [‐2.05, ‐1.35]

Comparison 4. SIC versus OC ‐ high‐quality and low‐quality trials regarding follow‐up

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Comparison 5. SIC versus OC ‐ sensitivity analysis imputing medians and standard deviations for missing data

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Sensitivity analysis 1: Operative time (minutes) Show forest plot	7	571	Mean Difference (IV, Random, 95% CI)	‐2.98 [‐7.86, 1.90]

2 Sensitivity analysis 2: Hospital stay (days) Show forest plot	7	571	Mean Difference (IV, Random, 95% CI)	‐1.97 [‐2.56, ‐1.39]

3 Sensitivity analysis 3: Omitting outlier Schmitz in total complications Show forest plot	6	441	Risk Difference (M‐H, Fixed, 95% CI)	‐0.04 [‐0.09, 0.01]

Comparison 5. SIC versus OC ‐ sensitivity analysis imputing medians and standard deviations for missing data

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