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Cochrane Database of Systematic Reviews

Antibióticos para la prevención de infecciones después de la escisión de la zona de transformación cervical

Información

DOI:
https://doi.org/10.1002/14651858.CD009957.pub2Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 21 enero 2017see what's new
Tipo:
  1. Intervention
Etapa:
  1. Review
Grupo Editorial Cochrane:
  1. Grupo Cochrane de Cáncer ginecológico, neurooncología y otros cánceres

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

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Autores

  • Chumnan Kietpeerakool

    Correspondencia a: Department of Obstetrics and Gynaecology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand

    [email protected]

  • Bandit Chumworathayi

    Department of Obstetrics and Gynaecology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand

  • Jadsada Thinkhamrop

    Department of Obstetrics and Gynaecology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand

  • Butsakorn Ussahgij

    Medical Library, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand

  • Pisake Lumbiganon

    Department of Obstetrics and Gynaecology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand

Contributions of authors

Chumnan Kietpeerakool: developed and completed the review
Bandit Chumworathayi: conceived the review question, developed, co‐ordinated the review.
Jadsada Thinkamrop: performed part of the editing of the review and advised on part of the review.
Butsakorn Ussahgij: searched for potential eligible studies and advised on part of the review
Pisake Lumbiganon: co‐ordinated the development of the review, edited the review, and advised on the review.
All authors approved the final version of the review prior to submission.

Sources of support

Internal sources

  • Department of Obstetrics and Gynaecology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.

  • Cochrane Thailand, Thailand.

External sources

  • Thailand Research Fund (Distinguished Professor Award), Thailand.

Declarations of interest

CK: None known
BC: None known
JT: None known
BU: None known
PL: None known

Acknowledgements

We thank Gail Quinn, Clare Jess and Tracey Harrison for their rigorous contribution to the editorial process; Jo Platt and Jane Hayes for designing the search strategies and running the search; and Jo Morrison for clinical and editorial advice. We thank the referees for many helpful suggestions and comments, some of these include Khadra Galaal and Jennifer Cove.

This project was supported by the National Institute for Health Research, via Cochrane Infrastructure to the Cochrane Gynaecological, Neuro‐oncology and Orphan Cancer Group. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, NHS or the Department of Health.

Version history

Published

Title

Stage

Authors

Version

2017 Jan 21

Antibiotics for infection prevention after excision of the cervical transformation zone

Review

Chumnan Kietpeerakool, Bandit Chumworathayi, Jadsada Thinkhamrop, Butsakorn Ussahgij, Pisake Lumbiganon

https://doi.org/10.1002/14651858.CD009957.pub2

2012 Jul 11

Antibiotics for infection prevention after excision of the cervical transformation zone

Protocol

Bandit Chumworathayi, Banchong Udomthavornsuk, Jadsada Thinkhamrop, Pisake Lumbiganon

https://doi.org/10.1002/14651858.CD009957

Differences between protocol and review

Types of interventions

In the review, we additionally stated the details of antibiotic regimen as "Antibiotic regimen includes the followings: administration route (for example intravenous, intramuscular, oral, vaginal); number of doses (for example, single versus multiple doses).

Types of outcome measures

In the review protocol, we stated that primary outcome was genital infections occurring within seven days of excision of the cervical transformation zone including (a) cervix: cervicitis 24 hours following the procedure as defined by one or more of the symptoms and signs; delayed bleeding; redness; pus or offensive discharge; positive gram stain; positive culture; (b) uterus or adnexa: pelvic inflammatory disease (PID) assessed by vaginal examination for all women 24 hours after the procedure, found to have clinical evidence of PID (cervical excitation, pelvic organ tenderness, or both); and (c) sepsis or other serious infection or infectious complications, either with or without fever, defined as body temperature higher than 38o Celsius on at least two occasions more than four hours apart, 24 hours after the procedure. Secondary outcome was adverse effects of antibiotics including adverse drug reactions, which were defined as any medical complications related to drug metabolisms; allergy, liver failure, renal failure, etc. according to the CTCAE version 4 (CTCAE 2010) and drug interactions.

In attempts to cover a broad range of outcome measures for infectious complications following excision of the cervical transformation zone, we revised this section in this review as follows; Primary outcomes: (1) Infectious complications (defined as any documented sites of infection identified by cultivation or clinical symptoms and signs, or both), measured as the proportion of participants who developed each of the following within eight weeks of surgery: cervicitis, endometritis, pelvic inflammatory disease, prolonged vaginal discharge, severe vaginal bleeding, lower abdominal pain, fever, and additional antibiotic treatment; (2) Antibiotic resistance.

Secondary outcomes included (1) Adverse effects‐related to antibiotics: classified according to Common Terminology Criteria for Adverse Events (CTCAE 2010) as follows: gastrointestinal disorders (nausea, vomiting, anorexia, diarrhoea); immune system disorders (allergic reaction, anaphylaxis) blood and lymphatic system disorders (leucopenia, anaemia, thrombocytopenia, neutropenia); skin (stomatitis, mucositis, alopecia, allergy); nervous system disorders; genitourinary; and other side effects not categorised above; (2) unscheduled medical consultant (for any reasons); and (3) additional self‐medication .

Searching other source

In the review, we added Index to theses (ProQuest Dissertations & Theses: UK & Ireland) and the WHO International Clinical Trial Registry (http://apps.who.int/trialsearch/Default.aspx) as additional databases to be searched. In addition, we added the lists of conferences used for searching abstracts and proceedings

Data synthesis

We additionally stated in the review that "we prepared a ’Summary of findings’ table to present the results of the meta‐analysis, based on the methods described in Chapter 11 of the Cochrane Handbook for Systematic Reviews of Interventions (Schunemann 2011). We presented the results of the meta‐analysis for the primary outcome and adverse events as outlined in the 'Types of outcome measures’ section".

Assessment of reporting biases

As there was only three trials that met our inclusion criteria, we were unable to construct funnel plots to determine the possibility of publication bias as previously stated in the review protocol. In future update of this review, we will construct funnel plots corresponding to meta‐analyses of the primary outcome to assess the possibility of publication bias if we identify a sufficient number of included studies (i.e. more than 10). We will also carry out sensitivity analyses to investigate the effect on the pooled results if the funnel plots are asymmetrical.

Subgroup analysis and investigation of heterogeneity

All three included trials in this review relate primarily to cervical transformation zone excision using electrical wire loop. Therefore, subgroup analyses according to the types of excisional techniques as mentioned in the review protocol was not feasible.

Keywords

MeSH

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.

Study flow diagram.
Figuras y tablas -
Figure 1

Study flow diagram.

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
Figuras y tablas -
Figure 2

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

Comparison 1 Prolonged vaginal discharge, Outcome 1 Number of participants who experienced prolonged vaginal discharge.
Figuras y tablas -
Analysis 1.1

Comparison 1 Prolonged vaginal discharge, Outcome 1 Number of participants who experienced prolonged vaginal discharge.

Comparison 2 Excessive vaginal bleeding, Outcome 1 Number of participants who had to be admitted for postoperative bleeding.
Figuras y tablas -
Analysis 2.1

Comparison 2 Excessive vaginal bleeding, Outcome 1 Number of participants who had to be admitted for postoperative bleeding.

Comparison 3 Fever, Outcome 1 Number of participants who developed fever.
Figuras y tablas -
Analysis 3.1

Comparison 3 Fever, Outcome 1 Number of participants who developed fever.

Comparison 4 Lower abdominal pain, Outcome 1 Number of participants who experienced lower abdominal pain.
Figuras y tablas -
Analysis 4.1

Comparison 4 Lower abdominal pain, Outcome 1 Number of participants who experienced lower abdominal pain.

Comparison 5 Adverse effects, Outcome 1 Number of participants who experienced any adverse effects related to antibiotics.
Figuras y tablas -
Analysis 5.1

Comparison 5 Adverse effects, Outcome 1 Number of participants who experienced any adverse effects related to antibiotics.

Comparison 6 Unscheduled medical consultant, Outcome 1 Number of participants who received additional medical consultant (for any reasons).
Figuras y tablas -
Analysis 6.1

Comparison 6 Unscheduled medical consultant, Outcome 1 Number of participants who received additional medical consultant (for any reasons).

Comparison 7 Additional self‐medication, Outcome 1 Number of participants who had additional self‐medication.
Figuras y tablas -
Analysis 7.1

Comparison 7 Additional self‐medication, Outcome 1 Number of participants who had additional self‐medication.

Antibiotics compared with placebo or no treatment for infection prevention after excision of the cervical transformation zone

Patient or population: Women undergoing excision of the cervical transformation zone for cervical neoplasia

Settings: Outpatients setting, the colposcopy clinic

Intervention: Prophylactic antibiotics

Comparison: Placebo or no treatment

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

[Placebo or no treatment]

[Antibiotics]

Number of participants who experienced prolonged vaginal discharge

Follow‐up period: 2 weeks after the procedure

103 per 1000

133 per 1000
(74 to 238)

RR 1.29 (0.72 to 2.31)

348
(1 study)

⊕⊕⊝⊝
low1,3

Number of participants who had to be admitted for post‐procedure bleeding

Follow‐up period: 2‐3 weeks after the procedure

31 per 1000

38 per 1000
(16 to 87)

RR 1.21

(0.52 to 2.82)

638

(2 studies)

⊕⊝⊝⊝
very low1,2,3,4

Number of participants who developed fever

Follow‐up period: 3 weeks after the procedure

7 per 1000

16 per 1000
(1 to 171)

RR 2.23

(0.20 to 24.36)

290

(1 study)

⊕⊝⊝⊝
very low2,3,4,5

Number of participants who experienced lower abdominal pain

Follow‐up period: 3 weeks after the procedure

163 per 1000

168 per 1000
(99 to 289)

RR 1.03

(0.61 to 1.72)

290

(1 study)

⊕⊕⊝⊝
low2,3

Number of participants who experienced any adverse effects related to antibiotics

Follow‐up period: 2‐3 weeks after the procedure

37 per 1000

63 per 1000
(31 to 124)

RR 1.69

(0.85 to 3.34)

638

(2 studies)

⊕⊝⊝⊝
very low1,2,3,4

Number of participants who received additional medical consultant (for any reasons)

Follow‐up period: 3 weeks after the procedure

33 per 1000

88 per 1000
(32 to 255)

RR 2.68

(0.97 to 7.41)

290

(1 study)

⊕⊕⊝⊝
low2,3

Number of participants who had additional self‐medication

Follow‐up period: 3 weeks after the procedure

72 per 1000

88 per 1000
(40 to 192)

RR 1.22

(0.56 to 2.67)

290

(1 study)

⊕⊕⊝⊝
very low1,2,3

*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.

1Based on the high risk of attrition bias (high rate of incomplete participants' record charts)
2 Based on high risk of detection bias (mainly due to lack of blinding of participants)
3 The analyses were not performed on an intention‐to‐treat basis
4 Small number of events in the analyses
5 Sparsness of data

Figuras y tablas -
Table 1. Extracted data from Chan 2007 and Foden‐Shroff 1998

Study

Antibiotic group

Placebo or no treatment

Number of participants who experienced prolonged vaginal discharge

Foden‐Shroff 1998

23/173 (13.3%)

18/175 (10.3%)

Number of participants who had to be admitted for post‐procedure bleeding

Foden‐Shroff 1998

2/173 (1.2%)

3/175 (1.7%)

Chan 2007

9/137 (6.6%)

7/153 (4.6%)

Number of participants who experienced lower abdominal pain

Chan 2007

23/137 (16.8%%)

25/153 (16.3%)

Number of participants who developed fever

Chan 2007

2/137 (1.5%)

1/153 (0.7%)

Number of participants who experienced adverse events

Foden‐Shroff 1998

20/173 (11.6%)

12/175 (6.9%)

Chan 2007

0/137 (0%)

0/153 (0%)

Number of participants who required unscheduled medical consultation

Chan 2007

12/137 (8.8%)

5/153 (3.3%)

Number of participants reported to have additional self‐medication

Chan 2007

12/137 (8.8%)

11/153 (7.2%)

Figuras y tablas -
Table 1. Extracted data from Chan 2007 and Foden‐Shroff 1998
Table 2. Reported data from Gornall 1999

Outcomes reported in Gornall 1999

Sultrin (sample size = n)

Control (sample size = 77‐n)

95% confidence interval

P value

Mean duration of bleeding (days)

15.2

11.2

‐7.7 to ‐0.2

0.04

Mean duration of discharge (days)

16.4

13.1

‐7.2 to 0.7

0.11

Mean duration of pain (days)

7.7

5.7

‐5.4 to 1.5

0.26

Number of participants who received additional antibiotic therapy

2

7

Not reported

Not reported

Number of participants who had to be admitted for postoperative bleeding

0

2

Not reported

Not reported

Numbers of the participant in each comparison group were not reported.

Figuras y tablas -
Table 2. Reported data from Gornall 1999
Comparison 1. Prolonged vaginal discharge

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of participants who experienced prolonged vaginal discharge Show forest plot

1

348

Risk Ratio (IV, Random, 95% CI)

1.29 [0.72, 2.31]

Figuras y tablas -
Comparison 1. Prolonged vaginal discharge
Comparison 2. Excessive vaginal bleeding

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of participants who had to be admitted for postoperative bleeding Show forest plot

2

638

Risk Ratio (IV, Random, 95% CI)

1.21 [0.52, 2.82]

Figuras y tablas -
Comparison 2. Excessive vaginal bleeding
Comparison 3. Fever

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of participants who developed fever Show forest plot

1

290

Risk Ratio (IV, Random, 95% CI)

2.23 [0.20, 24.36]

Figuras y tablas -
Comparison 3. Fever
Comparison 4. Lower abdominal pain

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of participants who experienced lower abdominal pain Show forest plot

1

290

Risk Ratio (IV, Random, 95% CI)

1.03 [0.61, 1.72]

Figuras y tablas -
Comparison 4. Lower abdominal pain
Comparison 5. Adverse effects

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of participants who experienced any adverse effects related to antibiotics Show forest plot

2

638

Risk Ratio (IV, Random, 95% CI)

1.69 [0.85, 3.34]

Figuras y tablas -
Comparison 5. Adverse effects
Comparison 6. Unscheduled medical consultant

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of participants who received additional medical consultant (for any reasons) Show forest plot

1

290

Risk Ratio (IV, Random, 95% CI)

2.68 [0.97, 7.41]

Figuras y tablas -
Comparison 6. Unscheduled medical consultant
Comparison 7. Additional self‐medication

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of participants who had additional self‐medication Show forest plot

1

290

Risk Ratio (IV, Random, 95% CI)

1.22 [0.56, 2.67]

Figuras y tablas -
Comparison 7. Additional self‐medication