Lateral pararectal versus transrectal stoma placement for prevention of parastomal herniation

Julia Hardt; Joerg J Meerpohl; Maria‐Inti Metzendorf; Peter Kienle; Stefan Post; Florian Herrle

doi:10.1002/14651858.CD009487.pub3

Cochrane Database of Systematic Reviews

Lateral pararectal versus transrectal stoma placement for prevention of parastomal herniation

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DOI:

https://doi.org/10.1002/14651858.CD009487.pub3 Copiar DOI

Base de datos:

Cochrane Database of Systematic Reviews

Versión publicada:

24 abril 2019see what's new

Tipo:

Intervention

Etapa:

Review

Grupo Editorial Cochrane:

Grupo Cochrane de Colorrectal

Copyright:

Copyright © 2019 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Autores

Julia Hardt

Correspondencia a: Department of Surgery, University Medical Centre Mannheim, University of Heidelberg, Mannheim, Germany

[email protected]

[email protected]
Joerg J Meerpohl

Institute for Evidence in Medicine (for Cochrane Germany Foundation), Medical Center ‐ University of Freiburg, Freiburg, Germany
Maria‐Inti Metzendorf

Cochrane Metabolic and Endocrine Disorders Group, Institute of General Practice, Medical Faculty of the Heinrich‐Heine‐University Düsseldorf, Düsseldorf, Germany
Peter Kienle

Department of Surgery, University Medical Centre Mannheim, University of Heidelberg, Mannheim, Germany
Stefan Post

Department of Surgery, University Medical Centre Mannheim, University of Heidelberg, Mannheim, Germany
Florian Herrle

Department of Surgery, University Medical Centre Mannheim, University of Heidelberg, Mannheim, Germany

Contributions of authors

Design, data extraction, analysis, interpretation, and drafting of review: JH, FH, MIM.

Design, resolution of discrepancies, interpretation, drafting, and supervision of review: JM, PK, SP.

Design and execution of search strategies, search documentation: MIM.

Sources of support

Internal sources

University Medicine Mannheim, Germany.

The authors received their regular salaries while they worked on the review update.
Institute for Evidence in Medicine (for Cochrane Germany Foundation), Germany.

The authors received their regular salaries while they worked on the review update.
Cochrane Metabolic and Endocrine Disorders Group, Institute of General Practice, Medical Faculty of the Heinrich‐Heine‐University Düsseldorf, Germany.

The authors received their regular salaries while they worked on the review update.

External sources

There was no external funding available., Other.

Declarations of interest

The PATRASTOM trial was undertaken by some of the authors of this review (JH, FH, PK, SP). In order to prevent confounding and to guarantee transparency and objectivity in regard to the evaluation of the PATRASTOM trial, the data extraction and risk of bias assessment of this trial was checked by an external clinician not involved in the trial.

Acknowledgements

Thanks to:

Gerta Rücker, Institute of Medical Biometry and Medical Informatics of the University Medical Center Freiburg, Freiburg i. Br., Germany, for statistical advice and methodological support;
Lasse T. Krogsbøll, Nordic Cochrane Center, Rigshospitalet, Copenhagen, Denmark, for the translation of Eldrup 1982 and the valuable discussion on how to review observational studies;
the Cochrane Colorectal Cancer Group (CCCG), Copenhagen, Denmark, especially to Henning K. Andersen and Marija Barbateskovic;
Gerd Antes and the team at the German Cochrane Center, Freiburg i. Br., Germany.

Version history

Published

Title

Stage

Authors

Version

2019 Apr 24

Lateral pararectal versus transrectal stoma placement for prevention of parastomal herniation

Review

Julia Hardt, Joerg J Meerpohl, Maria‐Inti Metzendorf, Peter Kienle, Stefan Post, Florian Herrle

https://doi.org/10.1002/14651858.CD009487.pub3

2013 Nov 22

Lateral pararectal versus transrectal stoma placement for prevention of parastomal herniation

Review

Julia Hardt, Joerg J Meerpohl, Maria‐Inti Metzendorf, Peter Kienle, Stefan Post, Florian Herrle

https://doi.org/10.1002/14651858.CD009487.pub2

2011 Dec 07

Lateral pararectal stoma placement versus transrectal stoma siting for prevention of parastomal herniation

Protocol

Julia Hardt, Florian Herrle, Peter Kienle

https://doi.org/10.1002/14651858.CD009487

Differences between protocol and review

We concretised the inclusion criteria for studies. Studies had to compare lateral pararectal versus transrectal enterostomy placement with regard to the incidence of parastomal herniation.

Only one of the planned subgroup analyses could be conducted (see Subgroup analysis and investigation of heterogeneity and Analysis 2.1). None of the planned sensitivity analyses were conducted (see Sensitivity analysis).

Embase was not searched for this update of the review because of the following reasons and based on the following rationale:

1. Embase was no longer available to the author team. Since we still included Web of Science, another large biomedical database, in addition to PubMed and CENTRAL (searches in both databases are mandatory according to MECIR C24, whereas the recommendation to search Embase is facultative), our electronic searches are still in compliance with the MECIR standards (Higgins 2016).

2. RCTs from Embase are now regularly and prospectively included in CENTRAL, approximately four weeks after publication in Embase (see: www.cochranelibrary.com/help/central‐creation‐details.html), so we are confident that we did not miss a RCT that was only indexed in Embase.

3. All of the included studies in the previous and the present review version were indexed in MEDLINE.

Taking these aspects into account, it is very unlikely that searching Embase would have identified further studies for inclusion, especially further RCTs.

Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

Humans;

PICO

Population

Intervention

Comparison

Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Figure 1

Funnel plot of comparison 1. Lateral pararectal versus transrectal enterostomy placement, outcome 1.1. parastomal hernia. Only non‐randomized 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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Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study

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Figure 4

Trial flow diagram

RCT: randomized controlled trial; NRS: non‐randomized study

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Analysis 1.1

Comparison 1 Lateral pararectal versus transrectal enterostomy placement, Outcome 1 parastomal hernia (RCT).

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Analysis 1.2

Comparison 1 Lateral pararectal versus transrectal enterostomy placement, Outcome 2 parastomal hernia (NRS).

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Analysis 1.3

Comparison 1 Lateral pararectal versus transrectal enterostomy placement, Outcome 3 stomal prolapse.

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Analysis 1.4

Comparison 1 Lateral pararectal versus transrectal enterostomy placement, Outcome 4 ileus or stenosis.

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Analysis 1.5

Comparison 1 Lateral pararectal versus transrectal enterostomy placement, Outcome 5 skin irritation.

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Analysis 2.1

Comparison 2 Subgroup analyses ‐ ileostomy versus colostomy, Outcome 1 parastomal hernia.

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Summary of findings for the main comparison. Lateral pararectal versus transrectal enterostomy placement for prevention of parastomal herniation

Lateral pararectal versus transrectal enterostomy placement for prevention of parastomal herniation
Patient or population: people undergoing enterostomy placement for any reason Settings: elective or emergency settings in university and community hospitals Intervention: lateral pararectal enterostomy placement Comparison: transrectal enterostomy placement
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Transrectal enterostomy placement	Lateral pararectal enterostomy placement
parastomal hernia (NRS) clinical examination, CT scan, or both^a Follow‐up: 2 to 240 months	Study population		RR 1.22 (0.84 to 1.75)	864 (10 studies)	⊕⊝⊝⊝ very low^b,c,d,e
	295 per 1000	360 per 1000 (248 to 517)
	Moderate
	348 per 1000	425 per 1000 (292 to 609)
parastomal hernia (RCT) clinical exam, sonography, intraoperatively, or combination, during stoma reversal Follow‐up: 0.5 to 21.4 months (15 to 642 days)	Study population		RR 1.34 (0.4 to 4.48)	56 (1 study)	⊕⊕⊝⊝ low^f
	138 per 1000	185 per 1000 (55 to 618)
	Moderate
	138 per 1000	185 per 1000 (55 to 618)
stomal prolapse clinical exam, documented on a standard pro forma Follow‐up: mean 110.4 months	Study population		RR 1.23 (0.39 to 3.85)	145 (1 study)	⊕⊝⊝⊝ very low^b,d
	78 per 1000	96 per 1000 (30 to 299)
	Moderate
	78 per 1000	96 per 1000 (30 to 300)
ileus or stenosis clinical exam, sonography Follow‐up: 0.5 to 21.4 months (15 to 642 days)	Study population		RR 2 (0.19 to 20.9)	60 (1 study)	⊕⊕⊝⊝ low^f
	33 per 1000	67 per 1000 (6 to 697)
	Moderate
	33 per 1000	66 per 1000 (6 to 690)
skin irritation clinical exam, intraoperative exam, or both, during stoma reversal Follow‐up: 0.5 to 21.4 months (15 to 642 days)	Study population		RR 0.67 (0.21 to 2.13)	60 (1 study)	⊕⊕⊕⊝ moderate^d
	200 per 1000	134 per 1000 (42 to 426)
	Moderate
	200 per 1000	134 per 1000 (42 to 426)
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; RR: Risk 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.
^aIn four studies the presence of parastomal hernia was assessed by clinical examination and CT scan, or CT scan alone. In the remaining studies, participants were clinically examined, e.g. in stoma therapy or outpatient clinic at follow‐up visits, and the findings were documented in the patient chart. ^bWe downgraded by 1 level because of a substantial risk of bias in the included studies. ^cThere are widely differing estimates of the intervention effect (i.e. heterogeneity in results) across studies, but we failed to identify a plausible explanation. Thus, we downgraded by 1 level for inconsistency. ^dWe downgraded by 1 level for imprecision because of small sample sizes and few events (< 300), wide confidence intervals that included both no effect and appreciable benefit or appreciable harm. ^eThe funnel plot test did not suggest asymmetry. Since there was no evidence of publication bias, we did not downgraded further. ^fWe downgraded by 2 levels for substantial imprecision, because very small number of events, and a very wide confidence interval.

Summary of findings for the main comparison. Lateral pararectal versus transrectal enterostomy placement for prevention of parastomal herniation

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Table 1. Risk of bias summary: review authors' judgements about each quality item using the NOS criteria

	Representativeness of the experimental intervention cohort	Selection of the control cohort	Ascertainment of intervention	Demonstration that outcome of interest was not present at start of study	Comparability of cohorts on the basis of the design or analysis	Assessment of outcome	Was follow‐up long enough for outcomes to occur	Adequacy of follow‐up of cohorts
Cingi 2006			★	★		★
Eldrup 1982		★	★	★		★
Ho 2018		★	★	★		★	★	★
Leong 1994		★	★	★		★	★
Londono‐Schimmer 1994		★	★	★		★	★
Ortiz 1994		★	★	★		★	★
Pilgrim 2010			★	★		★
Sjodahl 1988		★	★	★		★	★
von Smitten 1986		★	★	★		★
Williams 1990		★	★	★		★	★
A study can be awarded a maximum of one star for each numbered item within the Selection and Outcome categories. A maximum of two stars can be given for Comparability. A maximum of nine stars can be awarded overall.

Table 1. Risk of bias summary: review authors' judgements about each quality item using the NOS criteria

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Comparison 1. Lateral pararectal versus transrectal enterostomy placement

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 parastomal hernia (RCT) Show forest plot	1	56	Risk Ratio (M‐H, Random, 95% CI)	1.34 [0.40, 4.48]

2 parastomal hernia (NRS) Show forest plot	10	864	Risk Ratio (M‐H, Random, 95% CI)	1.22 [0.84, 1.75]

3 stomal prolapse Show forest plot	1	145	Risk Ratio (M‐H, Random, 95% CI)	1.23 [0.39, 3.85]

4 ileus or stenosis Show forest plot	1	60	Risk Ratio (M‐H, Random, 95% CI)	2.0 [0.19, 20.90]

5 skin irritation Show forest plot	1	60	Risk Ratio (M‐H, Random, 95% CI)	0.67 [0.21, 2.13]

Comparison 1. Lateral pararectal versus transrectal enterostomy placement

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Comparison 2. Subgroup analyses ‐ ileostomy versus colostomy

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 parastomal hernia Show forest plot	7	624	Risk Ratio (M‐H, Random, 95% CI)	1.16 [0.81, 1.65]

1.1 ileostomy	2	173	Risk Ratio (M‐H, Random, 95% CI)	0.70 [0.21, 2.29]
1.2 colostomy	5	451	Risk Ratio (M‐H, Random, 95% CI)	1.30 [0.80, 2.11]

Comparison 2. Subgroup analyses ‐ ileostomy versus colostomy

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Lateral pararectal versus transrectal stoma placement for prevention of parastomal herniation

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