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Cover of Techniques to close the uterus at caesarean birth

Techniques to close the uterus at caesarean birth

Caesarean birth

Evidence review D

NICE Guideline, No. 192

.

London: National Institute for Health and Care Excellence (NICE); .
ISBN-13: 978-1-4731-4052-3

Techniques to close the uterus

Review question

What is the efficacy of single layer closure of the uterus compared with double layer closure at caesarean birth?

Introduction

A caesarean birth is the most common surgical procedure in obstetrics and gynaecology. The uterus is incised to deliver the baby, and needs to be closed once the baby and placenta have been delivered.

Traditionally the uterus was closed in two layers, with a second set of stiches being used after the initial closure. However, the efficacy of double layer closure compared with single layer closure is uncertain, and it is not known if single layer closure increases the risk of wound dehiscence or uterine rupture.

This aim of this review is to determine if single layer closure is as effective and as safe as double layer closure.

Summary of the protocol

Please see Table 1 for a summary of the Population, Intervention, Comparison and Outcome (PICO) characteristics of this review.

Table 1. Summary of the protocol (PICO table).

Table 1

Summary of the protocol (PICO table).

For further details see the review protocol in appendix A.

Methods and process

This evidence review was developed using the methods and process described in Developing NICE guidelines: the manual (2014). Methods specific to this review question are described in the review protocol in appendix A.

Declarations of interest were recorded according to NICE’s 2014 conflicts of interest policy until 31 March 2018. From 1 April 2018, declarations of interest were recorded according to NICE’s 2018 conflicts of interest policy. Those interests declared until April 2018 were reclassified according to NICE’s 2018 conflicts of interest policy (see Register of Interests).

Clinical evidence

Included studies

Fourteen publications were included in the review. These reported on 12 randomised controlled trials (RCTs) (Brocklehurst 2010, Chitra 2004, CORONIS 2013, Darj 1999, El-Gharib 2013, Hauth 1992, Nabhan 2008, Ohel 1996, Poonam 2006, Sood 2005, Xavier 2005, Yasmin 2011) and there were 2 longer term follow up studies of RCTs (Chapman 1997 which followed up Hauth 1992, and CORONIS 2016 which followed up CORONIS 2013).

Of the 12 RCTs included in this review, 6 directly compared single to double layer uterine closure (Brocklehurst 2010, CORONIS 2013, El-Gharib 2013, Hauth 1992, Sood 2005, Yasmin 2011), and 6 compared different caesarean birth techniques that included a comparison of single and double layer uterine closure along with variation in uterine incision, exteriorisation of the uterus (or not), peritoneal closure (or not), skin closure, and suture material (Chitra 2004, Darj 1999, Nabhan 2008, Ohel 1996, Poonam 2006, Xavier 2005).

The 2 follow up studies were of direct comparison of single or double layer uterine closure.

For simplicity, the follow up studies have been combined with the original trial for the analyses (GRADE tables and Forest plots): “CORONIS” includes the results of CORONIS 2013 and CORONIS 2016 and “Hauth/Chapman” includes the results of Hauth 1992 and Chapman 1997. In both cases the follow up publications reported long term outcomes in a subsequent pregnancy and no outcomes are double counted within a single analysis.

All outcomes were reported by at least 1 study. For short term outcomes (use of antibiotics, further operative procedures and blood transfusion), the timing of these was not specified in the publications. We therefore present the occurrence of these outcomes as reported in the studies.

Similarly, any use of antibiotics was not specifically reported as an outcome measure in the majority of trials. However, many trials reported closely related measures – including antibiotic use for wound infection, endometritis, or febrile morbidity. Where antibiotic use was not reported but infection was, this was used as a proxy for antibiotic use, as it was deemed unlikely that a recognised infection would be left untreated by antibiotics following caesarean birth. However, the results for different types of infection are reported separately, rather than pooled.

See the literature search strategy in appendix B and study selection flow chart in appendix C.

Excluded studies

Studies not included in this review with reasons for their exclusions are provided in appendix K.

Summary of clinical studies included in the evidence review

A summary of the studies that were included in this review are presented in Table 2.

Table 2. Summary of included studies.

Table 2

Summary of included studies.

See the full evidence tables in appendix D and the forest plots in appendix E.

Quality assessment of clinical outcomes included in the evidence review

See the clinical evidence profiles (GRADE tables) in appendix F.

Economic evidence

Included studies

A systematic review of the economic literature was conducted but no economic studies were identified which were applicable to this review question.

See the literature search strategy in appendix B.

Economic model

No economic modelling was undertaken for this review because the committee agreed that other topics were higher priorities for economic evaluation.

Evidence statements

Comparison 1. Single versus double layer closure of the uterus

Critical outcomes
Need for blood transfusion
  • Three randomised controlled trials (N=13171) provided very low quality evidence to show no clinically important difference in the need for blood transfusion between single layer and double layer uterine closure.
Additional surgical procedures
  • One randomised controlled trial (N=9286) provided very low quality evidence to show no clinically important difference in the incidence of any further operative procedures between single layer and double layer uterine closure.
  • One randomised controlled trial (N=9286) provided very low quality evidence to show no clinically important difference in the incidence of any further operative procedures on the wound between single layer and double layer uterine closure.
Uterine rupture (in subsequent pregnancy)
  • One randomised controlled trial (N=3234) provided very low quality evidence to show no clinically important difference in the incidence of uterine rupture in a subsequent pregnancy between single layer and double layer uterine closure.
  • Two randomised controlled trials (N=3378) provided very low quality evidence to show no clinically important difference in the incidence of uterine scar dehiscence in a subsequent pregnancy between single layer and double layer uterine closure.
Important outcomes
Use of antibiotics
  • Five randomised controlled trials (N=12713) provided low quality evidence to show no clinically important difference in the use of antibiotics for wound infection (and wound sepsis) between single layer and double layer uterine closure.
  • Two randomised controlled trials (N=12265) provided very low quality evidence to show no clinically important difference in the use of antibiotics for febrile morbidity between single layer and double layer uterine closure.
  • Two randomised controlled trials (N=10192) provided very low quality evidence to show no clinically important difference in the use of antibiotics for endometritis between single layer and double layer uterine closure.
Morbidly adherent placenta/abnormal invasion of placenta (in subsequent pregnancy)
  • One randomised controlled trial (N=3233) provided very low quality evidence to show no clinically important difference in the incidence of morbidly adherent placenta in a subsequent pregnancy between single layer and double layer uterine closure.
Peri-partum hysterectomy (in subsequent pregnancy)
  • One randomised controlled trial (N=3234) provided very low quality evidence to show no clinically important difference in the incidence of hysterectomy (during the 6 weeks postpartum) in a subsequent pregnancy between single layer and double layer uterine closure
Caesarean birth (in subsequent pregnancy)
  • Two randomised controlled trials (N=3421) provided low quality evidence to show no clinically important difference in the incidence of caesarean birth in a subsequent pregnancy between single layer and double layer uterine closure

Comparison 2. Trials comparing different caesarean birth techniques

Critical outcomes
Need for blood transfusion
  • Three randomised controlled trials (N=1324) provided very low quality evidence to show a clinically important reduction in the need for blood transfusion when using a caesarean birth (CB) technique that included single layer closure, as compared to a technique that included double layer closure.
Additional surgical procedures
  • No evidence was available for this outcome.
Uterine rupture (in subsequent pregnancy)
  • No evidence was available for this outcome.
Important outcomes
Use of antibiotics
  • Two randomised controlled trials (N=196) provided very low quality evidence to show no clinically important difference in the use of antibiotics (for an unspecified reason) between CB techniques that included single or double layer uterine closure.
  • Three randomised controlled trials (N=1324) provided very low quality evidence to show no clinically important difference in the use of antibiotics (for wound infection or wound sepsis) between CB techniques that included single or double layer uterine closure.
Subgroup analysis
  • Two randomised controlled trials (N=1000) provided very low quality evidence to show no clinically important difference in the use of antibiotics (for wound infection or wound sepsis) between single layer and double layer uterine closure in a subgroup of women undergoing primary CB.
  • One randomised controlled trial (N=124) provided very low quality evidence to show no clinically important difference in the use of antibiotics (for wound infection or wound sepsis) between single layer and double layer uterine closure in a subgroup of women undergoing a repeat CB.
Morbidly adherent placenta/abnormal invasion of placenta (in subsequent pregnancy)
  • No evidence was available for this outcome.
Peri-partum hysterectomy (in subsequent pregnancy)
  • No evidence was available for this outcome.
Caesarean birth (in subsequent pregnancy)
  • No evidence was available for this outcome.
Economic evidence statements

No economic evidence was identified which was applicable to this review question.

The committee’s discussion of the evidence

Interpreting the evidence
The outcomes that matter most

As double layer closure is currently standard practice, the committee wished to determine if single layer closure is as effective and safe. The committee therefore specified three critical outcomes, which were of primary importance for this review. These were the need for blood transfusion as this is an indication of how successful the surgical closure is, the need for additional surgical procedures in the short term as failure of the closure may require the patient to return to theatre, and the occurrence of uterine rupture in a subsequent pregnancy.

In addition, four important outcomes were identified. These were the use of antibiotics within 7 days of the caesarean birth which may be an indicator of wound infection, and three outcomes related to future pregnancies - the presence of morbidly adherent/abnormally invasive placenta, the need for peri-partum hysterectomy, and caesarean birth in a future pregnancy.

The quality of the evidence

Despite a number of large, well conducted trials in this area, the evidence was downgraded in all studies for a high risk of performance bias (due to the inability to blind the surgeon to allocation). Some studies did not blind outcome assessors to the allocated intervention, therefore were also at high risk of detection bias.

Studies comparing different caesarean surgical methods (comparison 2) were downgraded for indirectness as they compared other differences in technique as well as uterine closure (differences in uterine incision, exteriorisation of the uterus, peritoneal closure, skin closure, and suture material). Finally, a number of rare events were included as relevant outcomes in this evidence review (such as uterine rupture and peri-partum hysterectomy). The small number of events that occurred led to a wide confidence interval around the result, meaning that the data was downgraded for imprecision.

Overall the data was considered to be low to very low quality.

Benefits and harms

The committee reviewed the evidence presented as two separate comparisons. For the trials that specifically compared single and double layer closure, no clinically important difference was identified for any of the outcomes. These trials were considered to most accurately reflect the difference between single and double layer closure. When assessing evidence from the trials which randomised women to different caesarean surgical techniques, the committee noted that the only difference in outcomes was an increased chance of requiring a blood transfusion when a double layer uterine closure technique was used. This comparison had multiple confounding factors as it compared completely different caesarean techniques, and not just uterine closure technique. The committee agreed that the additional blood loss would also be anticipated as a result of the difference in method of opening the abdomen and uterus: in the arm that included double layer closure this involved cutting using scissors/scalpel, compared to the blunt entry used in the arm that included single layer closure.

The committee discussed the low event rate of uterine rupture in a subsequent pregnancy using either technique, as historically this concern was used as the rationale for double layer closure, and agreed that the low incidence and lack of difference between the techniques was reassuring, and indicated that either method could be used safely.

The committee discussed the length of the caesarean procedure, and the desire for clinicians to close the abdomen as quickly as possible, in order to minimise the potential for infection. The committee agreed that the lack of difference in infection rates (antibiotic use) between single and double layer closure was encouraging as it suggested the additional time taken to close the uterus using a second layer of sutures did not give rise to an increased chance of infection.

As there was no difference between single and double layer closure for the majority of outcomes the committee agreed that either technique could be used. The committee added the information about the similar risks of bleeding or uterine rupture in a subsequent pregnancy to the recommendation to provide further context for surgeons who may not be familiar with single layer closure and who may be concerned that single layer closure could increase the risk of these adverse events.

The committee discussed the differing levels of experience of those performing a caesarean procedure, and whether a separate recommendation should be made for those with less experience, but agreed that by recommending that either closure method could be used, the decision to use single or double layer could be made on an individual basis for each woman. The committee discussed which factors should be taken into consideration when deciding which closure to use, and agreed that surgeons would make an individual choice based on the clinical circumstance which would include an assessment of the woman’s clinical presentation. The committee discussed the fact that surgeons may also have different preferences for single or double closure, and that this is in turn may be influenced by their level of experience.

The committee reiterated that where additional layers of suturing were required (for example, due to ongoing bleeding), the surgeon or treating clinician would continue to respond appropriately, as is current practice.

The committee discussed the fact that as double layer uterine closure is currently recommended, surgeons who, for clinical reasons, decide to carry out single layer closure currently document this in the notes. As the recommendation now allows the choice of either single or double layer closure, it will no longer be seen as necessary to justify why a single layer uterine closure has been carried out.

Cost effectiveness and resource use

Allowing surgeons to use single layer closure of the uterus may bring about some small savings due to the use of less suture material, and saving approximately 2 to 15 minutes of operative time.

References

  • Brocklehurst 2010

    Brocklehurst,P., Caesarean section surgical techniques: A randomised factorial trial (CAESAR), BJOG: An International Journal of Obstetrics and Gynaecology, 117, 1366–1376, 2010 [PubMed: 20840692]
  • Chitra 2004

    Chitra, K. L. S., Nirmala, A. P., Gayetri, R., Jayanthi, N. V., Shanthi, J. S., Misgav Ladach cesarean section vs Pfannenstiel cesarean section, Journal of Obstetrics and Gynaecology of India, 54, 473–477, 2004
  • CORONIS
    • CORONIS 2013
      • CORONIS Collaborative Group., Caesarean section surgical techniques (CORONIS): a fractional, factorial, unmasked, randomised controlled trial, Lancet (London, England), 382, 234–48, 2013 [Google Scholar]
    • CORONIS 2016
      • CORONIS collaborative group., Caesarean section surgical techniques: 3 year follow-up of the CORONIS fractional, factorial, unmasked, randomised controlled trial, Lancet (London, England), 388, 62–72, 2016 [PMC free article] [Google Scholar]
  • Darj 1999

    Darj, E., Nordstrom, M. L., The Misgav Ladach method for cesarean section compared to the Pfannenstiel method, Acta Obstetricia et Gynecologica Scandinavica, 78, 37–41, 1999 [PubMed: 9926890]
  • El-Gharib 2013

    EL-Gharib, Mohamed Nabih, Awara, Ahmad. M, Ultrasound Evaluation of the Uterine Scar Thickness after Single Versus Double Layer Closure of Transverse Lower Segment Cesarean Section, Journal of Basic and Clinical Reproductive Sciences, 2, 42–45, 2013
  • Hauth/Chapman
    • Hauth 1992
      • Hauth, J. C., Owen, J., Davis, R. O., Transverse uterine incision closure: one versus two layers, American Journal of Obstetrics and Gynecology, 167, 1108–1111, 1992 [Google Scholar]
    • Chapman 1997
      • Chapman, S. J., Owen, J., Hauth, J. C., One- versus two-layer closure of a low transverse cesarean: The next pregnancy, Obstetrics and Gynecology, 89, 16–8, 1997 [Google Scholar]
  • Nabhan 2008

    Nabhan, A. F., Long-term outcomes of two different surgical techniques for cesarean, International Journal of Gynaecology and Obstetrics, 100, 69–75, 2008 [PubMed: 17904561]
  • Ohel 1996

    Ohel, G., Younis, J. S., Lang, N., Levit, A., Double-layer closure of uterine incision with visceral and parietal peritoneal closure: are they obligatory steps of routine cesarean sections? Journal of Maternal-fetal Medicine, 5, 366–369, 1996 [PubMed: 8972417]
  • Poonam 2006

    Poonam, B.B., Singh, S. N., Raina, A., The Misgav Ladach method: a step forward in the operative technique of caesarean section, Kathmandu University Medical Journal, 4, 198–202, 2006 [PubMed: 18603898]
  • Sood 2005

    Sood, A.K., Single versus double layer closure of low transverse uterine incision at cesarean section, The Journal of Obstetrics and Gynecology of India, 55, 231–236, 2005
  • Xavier 2005

    Xavier, P., Ayres-De-Campos, D., Reynolds, A., Guimarães, M., Costa-Santos, C., Patrício, B., The modified Misgav-Ladach versus the Pfannenstiel-Kerr technique for cesarean section: a randomized trial, Acta Obstetricia et Gynecologica Scandinavica, 84, 878–882, 2005 [PubMed: 16097980]
  • Yasmin 2011

    Yasmin, S., Sadaf, J., Fatima, N., Impact of methods for uterine incision closure on repeat caesarean section scar of lower uterine segment, Journal of the College of Physicians and Surgeons--Pakistan : JCPSP, 21, 522–526, 2011 [PubMed: 21914406]

Appendices

Appendix A. Review protocols

Review protocol for review question: What is the efficacy of single layer closure of the uterus as compared with double layer closure at caesarean birth?

Table 3. Review protocol for uterine closure techniques

Appendix B. Literature search strategies

Literature search strategies for review question: What is the efficacy of single layer closure of the uterus as compared with double layer closure at caesarean birth?

Review question search strategies

Databases: Medline; Medline EPub Ahead of Print; and Medline In-Process & Other Non-Indexed Citations

Date of last search: 21/11/2018

Databases: Embase; and Embase Classic

Date of last search: 21/11/2018

Databases: Cochrane Central Register of Controlled Trials; and Cochrane Database of Systematic Reviews

Date of last search: 21/11/2018

Health economics search strategies

Databases: Medline; Medline EPub Ahead of Print; and Medline In-Process & Other Non-Indexed Citations

Date of last search: 21/11/2018

Databases: Embase; and Embase Classic

Date of last search: 21/11/2018

Database: Cochrane Central Register of Controlled Trials

Date of last search: 21/11/2018

Appendix C. Clinical evidence study selection

Clinical study selection for review question: What is the efficacy of single layer closure of the uterus as compared with double layer closure at caesarean birth?

Figure 1. Study selection flow chart

Appendix D. Clinical evidence tables

Clinical evidence tables for review question: What is the efficacy of single layer closure of the uterus as compared with double layer closure at caesarean birth?

Table 4. Clinical evidence tables for uterine closure techniques (PDF, 375K)

Appendix E. Forest plots

Forest plots for review question: What is the efficacy of single layer closure of the uterus as compared with double layer closure at caesarean birth?

This section includes forest plots only for outcomes that are meta-analysed. Outcomes from single studies are not presented here, but the quality assessment for these outcomes is provided in the GRADE profiles in appendix F.

Appendix F. GRADE tables

GRADE tables for review question: What is the efficacy of single layer closure of the uterus as compared with double layer closure at caesarean birth?

Table 5. Comparison 1. Trials specifically comparing uterine closure method (single versus double layer closure)

Table 6. Comparison 2. Trials comparing different caesarean birth techniques

Appendix G. Economic evidence study selection

Economic evidence study selection for review question: What is the efficacy of single layer closure of the uterus as compared with double layer closure at caesarean birth?

No evidence was identified which was applicable to this review question.

Figure 11. Study selection flow chart

Appendix H. Economic evidence tables

Economic evidence tables for review question: What is the efficacy of single layer closure of the uterus as compared with double layer closure at caesarean birth?

No evidence was identified which was applicable to this review question.

Appendix I. Economic evidence profiles

Economic evidence profiles for review question: What is the efficacy of single layer closure of the uterus as compared with double layer closure at caesarean birth?

No evidence was identified which was applicable to this review question.

Appendix J. Economic analysis

Economic evidence analysis for review question: What is the efficacy of single layer closure of the uterus as compared with double layer closure at caesarean birth?

No economic analysis was conducted for this review question.

Appendix K. Excluded studies

Excluded studies for review question: What is the efficacy of single layer closure of the uterus as compared with double layer closure at caesarean birth?

Economic studies

No economic evidence was identified for this review.

Appendix L. Research recommendations

Research recommendations for review question: What is the efficacy of single layer closure of the uterus as compared with double layer closure at caesarean birth?

No research recommendations were made for this review question.

Final

Evidence review

This evidence review was developed by the National Guideline Alliance which is a part of the Royal College of Obstetricians and Gynaecologists

Disclaimer: The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.

Local commissioners and/or providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties.

NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the Welsh Government, Scottish Government, and Northern Ireland Executive. All NICE guidance is subject to regular review and may be updated or withdrawn.

Copyright © NICE 2021.
Bookshelf ID: NBK569606PMID: 33877755

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