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Reparación laparoscópica para la úlcera péptica perforada

Appendices

Appendix 1. MEDLINE search strategy

  1. randomized controlled trial [pt]

  2. controlled clinical trial [pt]

  3. randomized Field: Title/Abstract

  4. placebo Field: Title/Abstract

  5. randomly Field: Title/Abstract

  6. trial Field: Title/Abstract

  7. groups Field: Title/Abstract

  8. 1 OR 2 OR 3 OR 4 OR 4 OR 5 OR 6 OR 7

  9. Limits: Humans

  10. 8 AND 9

  11. ("Peptic Ulcer"[Mesh] OR "Peptic Ulcer Perforation"[Mesh] OR "Peptic Ulcer Hemorrhage"[Mesh])

  12. duoden* NEAR ulcer*

  13. stomach* NEAR ulcer*

  14. bleed* NEAR ulcer*

  15. rebleed* NEAR ulcer*

  16. gastrointestinal NEAR bleed*

  17. gastrointestinal NEAR rebleed*

  18. gastrointestinal NEAR hemorrhag*

  19. gastrointestinal NEAR haemorrhag*

  20. ulcer NEAR haemorrhag*

  21. ulcer NEAR hemorrhag*

  22. ulcer NEAR perforat*

  23. 11 OR 12 OR 13 OR 14 OR 15 OR 16 OR 17 OR 18 OR 19 OR 20 OR 21 OR 22

  24. laparoscop*

  25. "Laparoscopy"[Mesh]

  26. 24 OR 25

  27. 23 AND 26

  28. 10 AND 27

  29. 28 Limits: Publication Date from 2004 to 2009

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
Figuras y tablas -
Figure 1

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

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Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
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Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Comparison 1 Laparoscopic surgery versus open surgery, Outcome 1 Septic abdominal complications (presence or absence).
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Analysis 1.1

Comparison 1 Laparoscopic surgery versus open surgery, Outcome 1 Septic abdominal complications (presence or absence).

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Comparison 1 Laparoscopic surgery versus open surgery, Outcome 2 Pulmonary complications (presence or absence).
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Analysis 1.2

Comparison 1 Laparoscopic surgery versus open surgery, Outcome 2 Pulmonary complications (presence or absence).

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Comparison 1 Laparoscopic surgery versus open surgery, Outcome 3 Number of septic abdominal complications.
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Analysis 1.3

Comparison 1 Laparoscopic surgery versus open surgery, Outcome 3 Number of septic abdominal complications.

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Comparison 1 Laparoscopic surgery versus open surgery, Outcome 4 Surgical site infection.
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Analysis 1.4

Comparison 1 Laparoscopic surgery versus open surgery, Outcome 4 Surgical site infection.

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Comparison 1 Laparoscopic surgery versus open surgery, Outcome 5 Suture dehiscence.
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Analysis 1.5

Comparison 1 Laparoscopic surgery versus open surgery, Outcome 5 Suture dehiscence.

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Comparison 1 Laparoscopic surgery versus open surgery, Outcome 6 Postoperative ileus.
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Analysis 1.6

Comparison 1 Laparoscopic surgery versus open surgery, Outcome 6 Postoperative ileus.

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Comparison 1 Laparoscopic surgery versus open surgery, Outcome 7 Intra‐abdominal abscess.
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Analysis 1.7

Comparison 1 Laparoscopic surgery versus open surgery, Outcome 7 Intra‐abdominal abscess.

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Comparison 1 Laparoscopic surgery versus open surgery, Outcome 8 Incisional hernia.
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Analysis 1.8

Comparison 1 Laparoscopic surgery versus open surgery, Outcome 8 Incisional hernia.

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Comparison 1 Laparoscopic surgery versus open surgery, Outcome 9 Mortality.
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Analysis 1.9

Comparison 1 Laparoscopic surgery versus open surgery, Outcome 9 Mortality.

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Comparison 1 Laparoscopic surgery versus open surgery, Outcome 10 Number of reoperations.
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Analysis 1.10

Comparison 1 Laparoscopic surgery versus open surgery, Outcome 10 Number of reoperations.

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Comparison 1 Laparoscopic surgery versus open surgery, Outcome 11 Operative time.
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Analysis 1.11

Comparison 1 Laparoscopic surgery versus open surgery, Outcome 11 Operative time.

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Summary of findings for the main comparison. Laparoscopic surgery versus open surgery for perforated peptic ulcer disease

Laparoscopic surgery versus open surgery for perforated peptic ulcer disease

Patient or population: patients with perforated peptic ulcer disease
Settings: hospitalized patients from developed countries and availability of laparoscopy equipment
Intervention: laparoscopic surgery versus open surgery

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Control

Laparoscopic surgery versus open surgery

Septic abdominal complications (presence or absence)
Clinical definition
Follow‐up: 30 to 60 days

155 per 1000

108 per 1000
(52 to 213)

OR 0.66
(0.3 to 1.47)

214
(2 studies)

⊕⊕⊝⊝
low1,2

Pulmonary complications (presence or absence)
Follow‐up: 30 to 60 days

86 per 1000

46 per 1000
(7 to 249)

OR 0.52
(0.08 to 3.55)

315
(3 studies)

⊕⊕⊝⊝
low

Surgical site infection
Follow‐up: 30 to 60 days

72 per 1000

21 per 1000
(6 to 72)

OR 0.28
(0.08 to 1)

315
(3 studies)

⊕⊕⊕⊝
moderate3

Suture dehiscence
Follow‐up: 30 to 60 days

13 per 1000

20 per 1000
(4 to 96)

OR 1.52
(0.29 to 7.98)

315
(3 studies)

⊕⊕⊝⊝
low3

Postoperative ileus
Follow‐up: 30 to 60 days

Study population

OR 0.54
(0.16 to 1.8)

315
(3 studies)

⊕⊕⊝⊝
low4,5

46 per 1000

25 per 1000
(8 to 80)

Moderate

35 per 1000

19 per 1000
(6 to 61)

Intra‐abdominal abscess
Follow‐up: 30 to 60 days

20 per 1000

23 per 1000
(7 to 75)

OR 1.15
(0.33 to 4.03)

315
(3 studies)

⊕⊝⊝⊝
very low5,6,7

Operative time
Follow‐up: 30 to 60 days

The mean operative time in the control groups was
minutes

The mean operative time in the intervention groups was
14.62 higher
(35.25 lower to 64.49 higher)

214
(2 studies)

⊕⊝⊝⊝
very low7,8

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; OR: Odds ratio;

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 Imprecision is probably because the small sample size of the studies and the lack of reporting form the largest one.
2 There are only three RCTs, all with positive results. Two were from the same city in China. There are no reports from other developed or undeveloped countries where other types of laparoscopic procedures are currently undertaken.
3 For suture dehiscence there are too few events to consider the results precise.
4 The measurement of postoperative ileus is subjective and heterogeneous between groups.
5 The multicenter trial showed no intra‐abdominal abscesses. This can be explained because it is the last one published, where the training curve could be already reached.
6 Former trials showed an increase in intra‐abdominal abscesses in comparison with the last one. Data are very different between trials.
7 There are only three RCT, all with positive results. Two were from the same city in China. There is no report from other developed or undeveloped countries where other types of laparoscopic procedures are currently undertaken.
8 The operative time has a very large confidence interval that could be explained by the lack of completion of the training curve in the former trials.

Figuras y tablas -
Summary of findings for the main comparison. Laparoscopic surgery versus open surgery for perforated peptic ulcer disease
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Table 1. Measures reported in non‐parametric form

Variable

Study

Laparoscopic group

Open surgery group

P value

Nasogastric aspiration time (median and range)

Bertleff 2009

2 (3.0) IQR

3 (1.3) IQR

0.33

Siu 2002

3 (2‐33)

3(1‐8)

0.28

Lau 1996

2 (1‐4)/ 3 (2‐1)

2 (1‐13)/ 3(1‐17)

No significant (P value not reported)

Time to return to oral diet

Siu 2002

4 (3‐35)

5 (3‐24)

0.06

Lau 1996

4 (3‐7)/ 4 (2‐11)

4 (3‐16)/ 4 (3‐19)

No significant (P value not reported)

Length of stay

Bertleff 2009

6.5 (9.3) IQR

8 (7.3) IQR

0.23

Siu 2002

6 (4‐35)

7 (4‐39)

0.004

Lau 1996

5 (3‐20)/ 6 (3‐11)

5 (3‐19)/ 5 (2‐21)

No significant (P value not reported)

Analgesic doses

Siu 2002

0 (0‐11)

6 (1‐30)

<0.001

Lau 1996

1 (0‐12)/ 2 (0‐17)

3 (0‐10)/ 4 (1‐9)

0.03

Bertleff 2009

1 (1.25) median days of analgesics

1 (1.0) median days of analgesics

0.007
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Table 1. Measures reported in non‐parametric form
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Comparison 1. Laparoscopic surgery versus open surgery

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Septic abdominal complications (presence or absence) Show forest plot

2

214

Odds Ratio (M‐H, Fixed, 95% CI)

0.66 [0.30, 1.47]

2 Pulmonary complications (presence or absence) Show forest plot

3

315

Odds Ratio (M‐H, Random, 95% CI)

0.52 [0.08, 3.55]

3 Number of septic abdominal complications Show forest plot

3

315

Odds Ratio (M‐H, Fixed, 95% CI)

0.60 [0.32, 1.15]

4 Surgical site infection Show forest plot

3

315

Odds Ratio (M‐H, Random, 95% CI)

0.28 [0.08, 1.00]

5 Suture dehiscence Show forest plot

3

315

Odds Ratio (M‐H, Random, 95% CI)

1.52 [0.29, 7.98]

6 Postoperative ileus Show forest plot

3

315

Odds Ratio (M‐H, Fixed, 95% CI)

0.54 [0.16, 1.80]

7 Intra‐abdominal abscess Show forest plot

3

315

Odds Ratio (M‐H, Fixed, 95% CI)

1.15 [0.33, 4.03]

8 Incisional hernia Show forest plot

3

315

Odds Ratio (M‐H, Fixed, 95% CI)

0.93 [0.21, 4.15]

9 Mortality Show forest plot

3

315

Odds Ratio (M‐H, Fixed, 95% CI)

0.57 [0.18, 1.78]

10 Number of reoperations Show forest plot

2

214

Odds Ratio (M‐H, Fixed, 95% CI)

1.89 [0.46, 7.71]

11 Operative time Show forest plot

2

214

Mean Difference (IV, Random, 95% CI)

14.62 [‐35.25, 64.49]
Figuras y tablas -
Comparison 1. Laparoscopic surgery versus open surgery
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