Antibiotics for infection prevention after excision of the cervical transformation zone

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

doi:10.1002/14651858.CD009957.pub2

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Figure 1

Study flow diagram.

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Figure 2

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

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Analysis 2.1

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

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Analysis 3.1

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

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Analysis 4.1

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

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Analysis 5.1

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

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Analysis 6.1

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

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Analysis 7.1

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

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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)	⊕⊕⊝⊝ low^1,3
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 low^1,2,3,4
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 low^2,3,4,5
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)	⊕⊕⊝⊝ low^2,3
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 low^1,2,3,4
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)	⊕⊕⊝⊝ low^2,3
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 low^1,2,3
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

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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%)

Table 1. Extracted data from Chan 2007 and Foden‐Shroff 1998

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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.

Table 2. Reported data from Gornall 1999

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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]

Comparison 1. Prolonged vaginal discharge

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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]

Comparison 2. Excessive vaginal bleeding

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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]

Comparison 3. Fever

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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]

Comparison 4. Lower abdominal pain

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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]

Comparison 5. Adverse effects

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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]

Comparison 6. Unscheduled medical consultant

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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]

Comparison 7. Additional self‐medication

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