Endonasal versus external dacryocystorhinostomy for nasolacrimal duct obstruction

Lona Jawaheer; Caroline J MacEwen; Deepa Anijeet

doi:10.1002/14651858.CD007097.pub3

Dacriocistorrinostomía endonasal versus externa para la obstrucción del conducto nasolagrimal

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Hartikainen J, Grenman R, Puukka P, Seppä H. Prospective randomized comparison of external dacryocystorhinostomy and endonasal laser dacryocystorhinostomy. Ophthalmology 1998;105(6):1106‐13.

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Referencias de los estudios excluidos de esta revisión

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Referencias de los estudios en espera de evaluación

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Cui W, Jiang L, Jiang YH, Xi J. Effects analysis of three kinds of operation methods in treatment of dacryocystitis. International Eye Science 2013;13(7):1510‐1.

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Referencias adicionales

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Referencias de otras versiones publicadas de esta revisión

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estudios excluidos
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otras referencias

Anijeet D, Dolan L, MacEwen CJ. Endonasal versus external dacryocystorhinostomy for nasolacrimal duct obstruction. Cochrane Database of Systematic Reviews 2011, Issue 1. [DOI: 10.1002/14651858.CD007097.pub2]

Anijeet D, Dolan L, MacEwen CJ. Endonasal versus external dacryocystorhinostomy for nasolacrimal duct obstruction. Cochrane Database of Systematic Reviews 2008, Issue 2. [DOI: 10.1002/14651858.CD007097]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

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Hartikainen 1998

Methods	Randomised controlled trial; simple parallel group design with participants individually randomised to one of two intervention groups
Participants	Country: Finland 64 eyes (63 participants) Age: range 23 to 89 years Mean age: 65 years
Interventions	Intervention 1: endonasal laser‐assisted dacryocystorhinostomy Intervention 2: external dacryocystorhinostomy
Outcomes	Patent lacrimal passage on irrigation at one year
Notes	Operations performed between January and December 1994, manuscript received May 1997. Study supported in part by a grant from the Turku University Foundation, Turku, Finland. The authors did not have any proprietary interest in any of the equipment mentioned in the article.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No description of sequence generation is provided in the trial report.
Allocation concealment (selection bias)	Unclear risk	No description of allocation concealment is provided in the trial report.
Blinding (performance bias and detection bias) All outcomes	Unclear risk	No description of masking either the participants or outcome assessors is provided in the trial report.
Incomplete outcome data (attrition bias) All outcomes	Low risk	At 12 months follow‐up all participants in both groups were assessed for success. Complication rates were also determined for the whole study group. Therefore there was no incomplete data.

Moras 2011

Methods	Randomised controlled trial; simple parallel group design with participants individually randomised to one of two intervention groups
Participants	Country: India 40 eyes (40 participants) Age: 16‐68 Mean age: not specified
Interventions	Intervention 1: endonasal mechanical dacryocystorhinostomy using punch forceps Intervention 2: external dacryocystorhinostomy
Outcomes	Patent lacrimal drainage system on sac syringing at the end of 6 months
Notes	Date of submission: December 2010 (date of study not available from article). No competing interests declared by authors.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	'They were randomised into two groups' with no further description.
Allocation concealment (selection bias)	Unclear risk	No description of allocation concealment is provided in the trial report.
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Masking of surgeons not possible. No description of masking either the participants or outcome assessors is provided in the trial report.
Incomplete outcome data (attrition bias) All outcomes	Low risk	At 6 months there were no participants lost to follow‐up.

Characteristics of excluded studies [ordered by study ID]

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Study	Reason for exclusion
Ajalloueyan 2007	Even though the authors describe their surgery as endonasal, the technique described in the full‐text of the trial is that of transcanalicular rather than endonasal DCR.
Balikoglu‐Yilmaz 2015	Prospective study comparing outcomes of external DCR, mechanical endonasal DCR and transcanalicular DCR using multidiode laser. Study excluded as it was non‐randomised, the procedure being chosen according to participant preference.
Derya 2013	The endoscopic procedure involved a transcanalicular approach with the diode laser probe instead of an endonasal one.
Hartikainen 1998b	The same group conducted the two studies: Hartikainen 1998 and Hartikainen 1998b. The external DCR group in these two studies appear to be the same. We were unsuccessful in our attempts to contact the authors to clarify this matter.
Javate 2010	This trial uses a lacrimal microendoscope with a trephine to remove fibrous obstruction along the lacrimal sac and nasolacrimal sac. It does not create an alternative drainage pathway using an endonasal technique which is what our review evaluates.
Tang 2015	This study used a transcanalicular approach using a fifth generation lacrimal endoscope with a microdrill, instead of an endonasal technique.
Taskin 2011	Alternate allocation used, therefore this study does not qualify as a randomised controlled trial.
Yigit 2007	The full‐text article revealed that the study was not a randomised trial.

DCR: dacryocystorhinostomy

Characteristics of studies awaiting assessment [ordered by study ID]

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Cui 2013

Methods	Participants randomly divided into 3 treatment groups; details of randomisation process not available
Participants	182 cases (202 eyes)
Interventions	External dacryocystorhinostomy Endonasal endoscopic dacryocystorhinostomy Nd:YAG laser dacryoplasty
Outcomes	Criteria for success not defined in abstract
Notes	Only Chinese version of article available. Chinese translator asked by CEV Information Specialist to contact study authors on June 4th 2015 for additional information about study (methods of randomisation etc). No response from study authors.

Zhou 2015

Methods	Participants randomly divided into 2 treatment groups. Translation of methods section in full‐text Chinese article is as follows 'The sample is a collection of cases of people with chronic dacryocystitis from November 2010 to January 2011 within the author’s hospital ‐ Songjiang District Central Hospital. There are 2 males and 35 females, aged from 25 to 63 years of age (average 44.03±7.13)'. Unable to ascertain method of randomisation from this description.
Participants	37 cases (37 eyes) with chronic dacryocystitis
Interventions	External dacryocystorhinostomy Endonasal endoscopic dacryocystorhinostomy combined with intubation of lacrimal ducts
Outcomes	Criteria of 'success' not defined in abstract
Notes	Study authors emailed by Chinese translator on 12 Oct 2015 ‐ no response from study authors to date

Data and analyses

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Comparison 1. Endonasal versus external DCR

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Anatomic success Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.1 Comparison 1 Endonasal versus external DCR, Outcome 1 Anatomic success.
1.1 Laser‐assisted	1	64	Risk Ratio (M‐H, Fixed, 95% CI)	0.69 [0.52, 0.92]
1.2 Mechanical	1	40	Risk Ratio (M‐H, Fixed, 95% CI)	1.0 [0.81, 1.23]
2 Subjective success Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
Open in figure viewer Analysis 1.2 Comparison 1 Endonasal versus external DCR, Outcome 2 Subjective success.
3 Intraoperative bleeding Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
Open in figure viewer Analysis 1.3 Comparison 1 Endonasal versus external DCR, Outcome 3 Intraoperative bleeding.
3.1 Laser‐assisted	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.2 Mechanical	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Postoperative bleeding Show forest plot	2	104	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.04, 3.10]
Open in figure viewer Analysis 1.4 Comparison 1 Endonasal versus external DCR, Outcome 4 Postoperative bleeding.
4.1 Laser‐assisted	1	64	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.01, 7.89]
4.2 Mechanical	1	40	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.01, 7.72]
5 Wound infection/gaping Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
Open in figure viewer Analysis 1.5 Comparison 1 Endonasal versus external DCR, Outcome 5 Wound infection/gaping.
5.1 Laser‐assisted	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
5.2 Mechanical	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Figure 1

Study flow diagram.

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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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Analysis 1.1

Comparison 1 Endonasal versus external DCR, Outcome 1 Anatomic success.

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Analysis 1.2

Comparison 1 Endonasal versus external DCR, Outcome 2 Subjective success.

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Analysis 1.3

Comparison 1 Endonasal versus external DCR, Outcome 3 Intraoperative bleeding.

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Analysis 1.4

Comparison 1 Endonasal versus external DCR, Outcome 4 Postoperative bleeding.

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Analysis 1.5

Comparison 1 Endonasal versus external DCR, Outcome 5 Wound infection/gaping.

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Endonasal dacryocystorhinostomy (DCR) compared with external DCR for nasolacrimal duct obstruction
Patient or population: People with nasolacrimal duct obstruction Settings: Hospital Intervention: Endonasal DCR Comparison: External DCR
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No. of Participants (studies)	Certainty of the evidence (GRADE)	Comments
	Assumed risk¹	Corresponding risk
	External DCR	Endonasal DCR
Anatomic success (i.e. patent lacrimal passage after a period of at least six months after operation)	900 per 1000	Laser‐assisted endonasal DCR			⊕⊝⊝⊝ VERY LOW^2,3,4
		621 per 1000 (468 to 828)	RR 0.69 (0.52 to 0.92)	64 (1)
		Mechanical endonasal DCR
		900 per 1000 (729 to 1000)	RR 1.00 (0.81 to 1.23)	40 (1)
Subjective success (i.e. resolution of symptoms of watering following surgery)	840 per 1000	Laser‐assisted endonasal DCR⁵			⊕⊕⊝⊝ LOW^2,3
		588 per 1000 (428 to 815)	RR 0.70 (0.51 to 0.97)	64 (1)
Intraoperative bleeding	170 per 1000	Laser‐assisted endonasal DCR			⊕⊝⊝⊝ VERY LOW^2,3,6	No cases of intraoperative bleeding reported in trial of laser‐assisted endonasal DCR
		Not estimable	Not estimable	64 (1)
		Mechanical endonasal DCR
		170 per 1000 (85 to 337)	RR 1.00 (0.50 to 1.98)	40 (1)
Postoperative bleeding	40 per 1000	13 per 1000 (2 to 124)	RR 0.33 (0.04 to 3.10)	104 (2)	⊕⊝⊝⊝ VERY LOW^2,7
Wound infection/gaping	40 per 1000	Laser‐assisted endonasal DCR			⊕⊝⊝⊝ VERY LOW^2,7	No cases of wound infection/gaping reported in trial of laser‐assisted endonasal DCR
		Not estimable	Not estimable	64 (1)
		Mechanical endonasal DCR
		8 per 1000 (0 to 157)	RR 0.20 (0.01 to 3.92)	40 (1)
CI: confidence interval; DCR: dacryocystorhinostomy; RR: risk ratio
GRADE Working Group grades of evidence High‐certainty: Further research is very unlikely to change our confidence in the estimate of effect. Moderate‐certainty: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low‐certainty: 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‐certainty: We are very uncertain about the estimate.
¹The assumed control risk was estimated from the control group in the included studies. ²We downgraded one level for study limitations because the methods used for random sequence generation, allocation concealment and masking were not clearly described. ³We downgraded one level for imprecision because the number of participants enrolled in these trials was low and the estimate of effect was imprecise. ⁴We downgraded one level for inconsistency as there was clinical and statistical heterogeneity in the two trials (test for interaction P = 0.04). ⁵Subjective success was not reported in the trial of mechanical endonasal DCR (Moras 2011). ⁶We downgraded one level for inconsistency as there was clinical heterogeneity in the two trials. There were no cases of intraoperative haemorrhage in the trial of laser‐assisted endonasal DCR. ⁷We downgraded two levels for imprecision as there were only two events recorded, both in the external DCR group.

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Comparison 1. Endonasal versus external DCR

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Anatomic success Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.1 Laser‐assisted	1	64	Risk Ratio (M‐H, Fixed, 95% CI)	0.69 [0.52, 0.92]
1.2 Mechanical	1	40	Risk Ratio (M‐H, Fixed, 95% CI)	1.0 [0.81, 1.23]
2 Subjective success Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

3 Intraoperative bleeding Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

3.1 Laser‐assisted	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.2 Mechanical	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Postoperative bleeding Show forest plot	2	104	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.04, 3.10]

4.1 Laser‐assisted	1	64	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.01, 7.89]
4.2 Mechanical	1	40	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.01, 7.72]
5 Wound infection/gaping Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

5.1 Laser‐assisted	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
5.2 Mechanical	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 1. Endonasal versus external DCR

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Referencias

Referencias de los estudios incluidos en esta revisión

Hartikainen 1998 {published data only (unpublished sought but not used)}

Moras 2011 {published data only}

Referencias de los estudios excluidos de esta revisión

Ajalloueyan 2007 {published data only}

Balikoglu‐Yilmaz 2015 {published data only}

Derya 2013 {published data only}

Hartikainen 1998b {published data only}

Javate 2010 {published data only}

Tang 2015 {published data only}

Taskin 2011 {published data only}

Yigit 2007 {published data only}

Referencias de los estudios en espera de evaluación

Cui 2013 {published data only}

Zhou 2015 {published data only}

Referencias adicionales

Atkins 2004

Bakri 1999

Ben Simon 2005

Boush 1994

Caldwell 1893

Chen 2009

Cokkeser 2000

Dolman 2003

Dupuy‐Dutemps 1921

Fayers 2009

Glanville 2006

GRADEpro GDT 2014 [Computer program]

Halle 1914

Henson 2007

Higgins 2011

Hii 2012

Huang 2014

Ibrahim 2001

Kennedy 1985

Kong 1994

Maini 2007

Mathew 2004

McDonogh 1989

Metson 1994

Moore 2002

Muellner 2000

Ng 2015

Pearlman 1997

Qin 2010

Reifler 1993

RevMan 2014 [Computer program]

Roozitalab 2004

Saiju 2009

Seppa 1994

Sham 2000

Smirnov 2006

Stammberger 1986

Tarbet 1995

Toti 1904

Tsirbas 2004

Unlu 2009

Verma 2006

Watts 2001

West 1910

Woog 1993

Yuce 2013

Referencias de otras versiones publicadas de esta revisión

Anijeet 2011

Anijeet 2008

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Characteristics of excluded studies [ordered by study ID]

Characteristics of studies awaiting assessment [ordered by study ID]

Data and analyses

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