Mesh fixation with glue versus suture for recurrence and pain in Lichtenstein inguinal hernioplasty

  • Protocol
  • Intervention

Authors

  • Ping Sun,

    1. Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, General Surgery, Wuhan, Hubei Province, China
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  • Xiang Cheng,

    1. Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, General Surgery, Wuhan, Hubei Province, China
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  • Shichang Deng,

    1. Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, General Surgery, Wuhan, Hubei Province, China
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  • Qinggang Hu,

    1. Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, General Surgery, Wuhan, Hubei Province, China
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  • Yi Sun,

    1. Huazhong University of Science and Technology, School of Public Health, Tongji Medical College, Wuhan, Hubei Province, China
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  • Qichang Zheng

    Corresponding author
    1. Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, General Surgery, Wuhan, Hubei Province, China
    • Qichang Zheng, General Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1277 Jiefang Ave., Wuhan, Hubei Province, 430022, China. zqcmd1@163.com.

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Abstract

This is the protocol for a review and there is no abstract. The objectives are as follows:

To determine whether tissue adhesives reduce postoperative complications, especially chronic pain, and reduce recurrence rate, compared with sutures for mesh fixation in Lichtenstein hernia repair.

Background

Description of the condition

Inguinal hernia repair is the most frequent operation in general surgery. Rutkow 2003 reports 800,000 groin hernia repairs in the US in 2003. The Lichtenstein technique, first described in 1986 (Lichtenstein 1986), is the standard open tension-free method of inguinal hernia repair and is used worldwide. In this method, a synthetic mesh is placed over the defect so that the hernia is repaired without the need to pull the tissues together under tension. The advantages of this procedure are that it is technically easy, is associated with lower recurrence rates, has shorter recovery times compared with tension repair (Grant 2002; Nordin 2002), and can be performed using local anaesthetic as a day procedure. However, postoperative chronic pain is frequently reported following mesh-based inguinal hernia repair, from 11.0% to as high as 40.5% (Eklund 2010; MRC Group 1999; Nienhuijs 2007; Nikkolo 2012; Paajanen 2002; Willaert 2012), and has a significant impact on quality of life (van Hanswijck 2008). It is difficult to overcome this problem, as surgery and the use of additional local analgesics haven't shown a clear benefit to the patients (Nienhuijs 2007).

Description of the intervention

Sutures are generally used to secure the prosthetic mesh but may contribute to chronic pain or other problems, such as numbness or groin discomfort, presumably through irritation or nerve compression (Heise 1998). This has prompted the development of less traumatic means of mesh fixation. The original technique for fixation of mesh in Lichtenstein hernioplasty used non-absorbable sutures. Since then, other surgeons have described using absorbable sutures (Paajanen 2002), various tissue glues (Canonico 2005), or novel self-fixing meshes (Kapischke 2010). These methods aim to reduce chronic neuropathic pain and simultaneously speed up the surgical procedure. Because the possibility of trapping nerves with suturing is eliminated, direct nerve irritation is reduced. Therefore, mesh fixation with glue (tissue adhesive) seems an optimal choice to reduce postoperative chronic pain.

How the intervention might work

Fibrin glue and N-butyl-2-cyanoacrylate are two of the most commonly used products for mesh fixation. Fibrin glue is a bio-degradable adhesive that combines human-derived fibrinogen and thrombin. In addition to its haemostatic action, the fibrinogen component gives the product tensile strength and adhesive properties (Katkhouda 2001), as well as promoting fibroblast proliferation (Zieren 1999). N-butyl-2-cyanoacrylate is a new generation of cyanoacrylate that has been used as a surgical tissue adhesive since the 1960s. It polymerises at room temperature and results in lower toxicity and fewer inflammatory reactions compared with cyanoacrylate (Levrier 2003; Montanaro 2001).

Why it is important to do this review

As inguinal hernia repair is performed so frequently and often associated with postoperative chronic pain, even relatively modest improvements in clinical outcomes would have a significant medical and economic impact. Comparison between mesh fixation with sutures and fixation with glue may support change in current surgical practice, if reduced postoperative chronic pain is demonstrated with fixation with glue.
However, there is concern of increased recurrence associated with glue fixation because fibrin glue is fully absorbed within 2 weeks of application (Petersen 2004). Several randomised trials and observational studies compare the two methods (Campanelli 2012; Helbling 2003; Negro 2011; Paajanen 2011), but consensus regarding which method is better has not been reached.
Thus, an evaluation of the use of mesh fixation with glue would be very useful.

Objectives

To determine whether tissue adhesives reduce postoperative complications, especially chronic pain, and reduce recurrence rate, compared with sutures for mesh fixation in Lichtenstein hernia repair.

Methods

Criteria for considering studies for this review

Types of studies

We will consider randomised and quasi-randomised controlled trials comparing glue versus sutures for mesh fixation in Lichtenstein hernia repair for inclusion. We will include trials in any language. We will also consider studies including both primary and recurrent inguinal hernia when the report allows the separate extraction of data on the primary repair.

Types of participants

Adults (more than 18 years old) undergoing Lichtenstein hernia repair for primary groin hernia (direct and indirect). We will exclude people with femoral hernias.

Types of interventions

Lichtenstein hernia repair with mesh fixation by:

  1. glue (tissue adhesive);

  2. sutures.

Types of outcome measures

Primary outcomes
  1. Chronic pain: pain persisting beyond three months postoperatively.

  2. Hernia recurrence: clinically or radiologically diagnosed.

Secondary outcomes
  1. Duration of operation (minutes).

  2. Wound/mesh infection.

  3. Haematoma/seroma.

  4. Persistent numbness: numbness in the groin or testicle persisting beyond three months postoperatively.

  5. Postoperative length of stay (days).

  6. Recovery time to daily activities (walking, driving, manual work) (days).

We will identify differences between glue and sutures for mesh fixation using primary/secondary outcome measures.

Search methods for identification of studies

Electronic searches

The Lichtenstein technique was first described in 1986, thus searches will be limited to publications from 1986 to present. We will search the following electronic databases:

  1. The Cochrane Colorectal Cancer Group Controlled Trials Register;

  2. The Cochrane Central Register of Controlled Trials (CENTRAL, latest Issue);

  3. MEDLINE Ovid (The National Library of Medicine);

  4. EMBASE Ovid (The Intelligent Gateway to Biomedical & Pharmacological Information);

  5. Science Citation Index (Web of Science);

  6. CBM (Chinese Biomedical Database);

  7. CNKI (China National Knowledge Infrastructure);

  8. VIP (a full-text database of China);

  9. Wanfang databases.

For comprehensive search strategies, see Appendix 1 (CENTRAL), Appendix 2 (MEDLINE), Appendix 3 (EMBASE), Appendix 4 (Science Citation Index), Appendix 5 (CBM), Appendix 6 (CNKI), Appendix 7 (VIP) and Appendix 8 (Wanfang).

Searching other resources

We will contact experts in the field for information about any further completed and ongoing trials. Relevant web sites will be searched and reference lists of the all included studies will be checked for additional studies suitable for inclusion.

We will search the following trial registers:

  1. ClinicalTrials.gov (ClinicalTrials.gov);

  2. World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/en/).

Data collection and analysis

Selection of studies

Two review authors (Sun P and Cheng X) will independently assess all abstracts identified by the search strategies to exclude studies that are clearly not relevant. We will obtain the full-text publications of all possibly relevant abstracts and formally assess them for inclusion. Review authors will not be blinded to the names of the authors, their institutions, the journal of publication or the results. We will resolve any disagreements by discussion or a third review author (Sun Y) will act as arbiter. We will also list the excluded trials and the reasons for their exclusion.

Data extraction and management

A data extraction form will be developed and two review authors (Sun P and Deng S) will independently extract data and complete these forms. Data on the following will be extracted:

  1. study Information: study identification, first author, country of author, year of publication;

  2. methods of the study: study design, method of randomisation, allocation concealment, blinding;

  3. participants: setting, country, enrolment dates, inclusion criteria, exclusion criteria, age, sex, body mass index (where documented), activities (i.e. job, sport, hobbies), health status (i.e. chronic obstructive pulmonary disease, constipation, prostatism), details of hernia (type and size, unilateral/bilateral), total number of participants originally assigned to each intervention group;

  4. intervention: material for fixation;

  5. duration of follow-up;

  6. outcomes: chronic pain, recurrence, length of operation, haematoma/seroma, wound infection, mesh infection, persistent numbness, postoperative hospital length of stay (days), recovery time to achieving normal daily activities (walking, driving, manual work) (days), quality of life;

  7. routine prophylactic use of perioperative antibiotics;

  8. economic aspects;

  9. other technical details: type of mesh, overlap to the pubic tubercle, fixation locations, handling of nerves.

Where a difference of opinion arises between authors, they will resolve it through discussion with a third review author (Hu Q). We will contact study authors to request missing or updated information.

Assessment of risk of bias in included studies

We will assess all studies that meet the inclusion criteria for methodological quality, as recommended by the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). Two review authors (Sun P and Cheng X) will assess the risk of bias of included studies and a third review author (Sun Y) will resolve disagreements where necessary. If sufficient studies exist, we will construct funnel plots to investigate the presence of publication bias.

Measures of treatment effect

We will analyse the data using Review Manager 5 (RevMan 2012), following the Cochrane Handbook for Systematic Reviews of Interventions recommendations (Higgins 2011). Dichotomous outcomes will be expressed as odds ratio (OR) with 95% confidence intervals (CI). Continuous outcomes will be expressed as standardised mean differences (SMD), with 95% CI.

Unit of analysis issues

People with bilateral hernias:

If people are randomised who have bilateral hernias and receive the same intervention, the number of participants will be used as the denominator in the analysis. If hernias are randomised, bilateral hernias may receive different interventions, and a separate outcome judgement will be made for each hernia using the number of hernias as the denominator in the analysis.

Dealing with missing data

We will search for the protocols of studies included in the review using electronic databases, or by contacting the authors of the respective studies. If there is suspicion of selective reporting, we will contact the study authors for clarification. If essential data for assessment and analysis are insufficient or are unclear in the included studies, we will try to contact the authors of the publications for further information. If data are missing due to participants dropping out of studies, we will conduct an intention-to-treat analysis and treat dropouts as failures when they occur.

Assessment of heterogeneity

First, we will assess the clinical diversity among the included studies. We will focus on the participants, interventions, and measurement of outcomes. Second, we will judge variability in study design and risk of bias. We will assess heterogeneity using the Q (Chi2) test (significance set at P value < 0.1) and I2 statistic. The interpretation of the I2 value will be guided by the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2002; Higgins 2011).

Data synthesis

Where appropriate, for dichotomous outcomes, we will pool data in meta-analyses using the Mantel-Haenszel approach (fixed-effect model), and for continuous outcomes, using the inverse variance method (fixed-effect model). The RevMan software (RevMan 2012) will be used to analyse the data.

Subgroup analysis and investigation of heterogeneity

We intend to perform subgroup analyses by type of glue:

  1. synthetic glue versus sutures,

  2. biological glue versus sutures, and

  3. synthetic glue versus biological glue.

Sensitivity analysis

We will perform sensitivity analyses to explore the influence of the following factors on effect size:

  1. repeating the analysis excluding unpublished studies (if there are any);

  2. repeating the analysis taking into account risk of bias of the studies, such as excluding studies with moderate or high risk of bias as described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011);

  3. repeating the analysis excluding studies using heavyweight meshes.

Acknowledgements

None.

Appendices

Appendix 1. The Cochrane Central Register of Controlled Trials (CENTRAL) search strategy

#1 MeSH descriptor: [Sutures] explode all trees
#2 MeSH descriptor: [Adhesives] explode all trees
#3 MeSH descriptor: [Fibrin Tissue Adhesive] explode all trees
#4 MeSH descriptor: [Tissue Adhesives] explode all trees
#5 MeSH descriptor: [Suture Techniques] explode all trees
#6 MeSH descriptor: [Cyanoacrylates] explode all trees
#7 MeSH descriptor: [Polyglycolic Acid] explode all trees
#8 glue or suture* or tissue adhesiv* or fibrin or N-butyl-2-cyanoacrylate or Tisseel or Tissucol or cyanoacrylate* or polyglycolic* acid* or adhesiv*:ti,ab,kw
#9 (#1 or #2 or #3 or #4 or #5 or #6 or #7 or #8)
#10 MeSH descriptor: [Surgical Mesh] explode all trees
#11 mesh:ti,ab,kw
#12 (#10 or #11)
#13 MeSH descriptor: [Herniorrhaphy] explode all trees
#14 lichtenstein or open or repair or tension-free or hernio*:ti,ab,kw
#15 (#13 or #14)
#16 MeSH descriptor: [Hernia, Inguinal] explode all trees
#17 ((inguina* or groin*) near/3 hernia*):ti,ab,kw
#18 (#16 or #17)
#19 (#9 and #12 and #15 and #18) from 1986 to 2013

Appendix 2. MEDLINE search strategy

1. exp Sutures/
2. exp Adhesives/
3. exp Fibrin Tissue Adhesive/
4. exp Tissue Adhesives/
5. exp Suture Techniques/
6. exp Cyanoacrylates/
7. exp Polyglycolic Acid/
8. (glue or suture* or tissue adhesiv* or fibrin or N-butyl-2-cyanoacrylate or Tisseel or Tissucol or cyanoacrylate* or polyglycolic* acid* or adhesiv*).mp.
9. 1 or 2 or 3 or 4 or 5 or 6 or 7 or 8
10. exp Surgical Mesh/
11. mesh.mp.
12. 10 or 11
13. exp Herniorrhaphy/
14. (lichtenstein or open or repair or tension-free or hernio*).mp.
15. 13 or 14
16. exp Hernia, Inguinal/
17. ((inguina* or groin*) adj3 hernia*).mp.
18. 16 or 17
19. 9 and 12 and 15 and 18
20. randomised controlled trial.pt.
21. controlled clinical trial.pt.
22. randomized.ab.
23. placebo.ab.
24. clinical trial.sh.
25. randomly.ab.
26. trial.ti.
27. 20 or 21 or 22 or 23 or 24 or 25 or 26
28. humans.sh.
29. 27 and 28
30. 19 and 29
31. limit 30 to yr="1986 -Current"

Appendix 3. EMBASE search strategy

1. exp suture/
2. exp adhesive agent/
3. exp suturing method/
4. exp cyanoacrylate derivative/
5. exp polyglycolic acid/
6. (glue or suture* or tissue adhesiv* or fibrin or N-butyl-2-cyanoacrylate or Tisseel or Tissucol or cyanoacrylate* or polyglycolic* acid* or adhesiv*).mp.
7. 1 or 2 or 3 or 4 or 5 or 6
8. exp surgical mesh/
9. exp mesh sling/
10. mesh.mp.
11. 8 or 9 or 10
12. exp hernioplasty/
13. exp herniorrhaphy/
14. exp herniotomy/
15. (lichtenstein or open or repair or tension-free or hernio*).mp.
16. 12 or 13 or 14 or 15
17. exp inguinal hernia/
18. ((inguina* or groin*) adj3 hernia*).mp.
19. 17 or 18
20. 7 and 11 and 16 and 19
21. CROSSOVER PROCEDURE.sh.
22. DOUBLE-BLIND PROCEDURE.sh.
23. SINGLE-BLIND PROCEDURE.sh.
24. (crossover* or cross over*).ti,ab.
25. placebo*.ti,ab.
26. (doubl* adj blind*).ti,ab.
27. allocat*.ti,ab.
28. trial.ti.
29. RANDOMIZED CONTROLLED TRIAL.sh.
30. random*.ti,ab.
31. 21 or 22 or 23 or 24 or 25 or 26 or 27 or 28 or 29 or 30
32. (exp animal/ or exp invertebrate/ or animal.hw. or nonhuman/) not (exp human/ or human cell/ or (human or humans or man or men or wom?n).ti.)
33. 31 not 32
34. 20 and 33
35. limit 34 to yr="1986 -Current"

Appendix 4. Science Citation Index search strategy

#1 Topic=(glue or suture* or tissue adhesiv* or fibrin or N-butyl-2-cyanoacrylate or Tisseel or Tissucol or cyanoacrylate* or polyglycolic* acid* or adhesiv*)
#2 Topic=(mesh)
#3 Topic=(lichtenstein or open or repair or tension-free or hernio*)
#4 Topic=(((inguina* or groin*) near/3 hernia*))
#5 Topic=(multicenter or phase 3 or phase 4 or singl* or doubl* or trebl* or tripl* or blind* or mask* or random* or control* or trial or RCT or group or cross* over* or factorial* or placebo* or volunteer*)
#6 (#1 AND #2 AND #3 AND #4 AND #5)

Appendix 5. CBM (Chinese Biomedical Database) search strategy

全部字段:疝 and 全部字段:缝 and 全部字段:补片 and 全部字段:胶 or 粘 or 氰基丙烯酸酯

Appendix 6. CNKI (China National Knowledge Infrastructure) search strategy

FT="补片" AND FT="缝" AND FT=("胶" + "氰基丙烯酸酯" + "粘") and FT="疝"

Appendix 7. VIP (a full-text database of China) search strategy

U=补片*(U=缝)*(U=(胶+氰基丙烯酸酯+粘))*(U=疝)

Appendix 8. Wanfang databases search strategy

补片*缝*(胶+氰基丙烯酸酯+粘)*疝

Contributions of authors

Draft the protocolSun P with advice from Hu Q/Sun Y
Develop a search strategySun P with advice from Sun Y/the Cochrane Colorectal Cancer Group
Search for trialsSun P with advice from the Cochrane Colorectal Cancer Group
Select which trials to includeSun P/Cheng X with advice from Sun Y
Extract data from trialsSun P/Deng S with advice from Hu Q
Assess risk of biasSun P/Cheng X with advice from Sun Y
Enter data into RevManSun P/Deng S
Carry out the analysisSun P with advice from Sun Y
Interpret the analysisSun P with advice from Zheng Q
Draft the final reviewSun P with advice from Hu Q/Sun Y/Zheng Q/Cheng X/Deng S

Declarations of interest

No potential conflicts of interest are known.

Sources of support

Internal sources

  • Financial support, China.

    From General Surgery, Union Hospital, Huazhong University of Science and Technology

  • Methodological support, China.

    From School of Public Health, Tongji Medical College, Huazhong University of Science and Technology

External sources

  • No sources of support supplied

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