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Asian J Endosc Surg ISSN 1758-5902
O R I G I N A L A RT I C L E
Is mechanical bowel preparation still necessary for gynecologic laparoscopic surgery? A meta-analysis Huaping Huang, Haiyan Wang & Mei He Department of Nursing Administration, Mianyang Central Hospital, Mianyang, China
Keywords Gynecologic; laparoscopic surgery; mechanical bowel preparation Correspondence Huaping Huang, No.12 Changjia Alley, Jingzhong Street, Fucheng District, Mianyang, Sichuan, 62100 China. Tel: +86 0816 223 9671 Fax: +86 0816 222 2566 Email: [email protected] The PROSPERO Register Number: CRD42014010021. Received 28 July 2014; revised 19 September 2014; accepted 4 October 2014 DOI:10.1111/ases.12155
Abstract Introduction: A number of studies have proven that mechanical bowel preparation (MBP) has no benefits in elective colorectal surgery. However, studies specifically related to gynecologic laparoscopic surgery are scant. We undertook a meta-analysis to assess the necessity of MBP before gynecologic laparoscopic surgery. Methods: The electronic databases MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials were systematically searched to identify relevant randomized controlled trials. Two authors independently extracted data from each study. The primary outcome of interest was the quality of surgical field. Secondary outcomes of interest included postoperative pain, abdominal swelling, nausea/vomiting, and length of hospital stay. Results: Three studies involving 372 participants were included in the metaanalysis. The results showed that MBP did not significantly increase the overall quality of surgical field exposure (odds ratio, 0.82; 95% confidence interval [CI], 0.46–1.49; P = 0.52). MBP also did not appear to significantly change the mean scores of postoperative pain (weighted mean difference, 0.09; 95%CI, −0.54–0.71; P = 0.79), the incidence of nausea/vomiting (odds ratio, 1.56; 95%CI, 0.80 to 3.03; P = 0.19), the mean scores of abdominal swelling (weighted mean difference, −0.26; 95%CI, −0.83–0.30; P = 0.36), and length of hospital stay (weighted mean difference, 0.05; 95%CI, −0.13– 0.22; P = 0.62). Conclusions: Our results suggest that routine use of MBP for gynecologic laparoscopic surgery should not be recommended. However, additional randomized controlled trials using large samples are needed to confirm these findings.
Introduction Preoperative mechanical bowel preparation (MBP) has traditionally been believed to decrease the risk of complications after gastrointestinal surgery, such as anastomotic leakage and surgical-site infection. However, this dogma is not based on scientific studies but rather on empirical opinion. Recently, an updated meta-analysis involving 5805 participants (2906 assigned to the MBP group, 2899 assigned to the no-preparation group) who underwent elective colorectal surgery showed there were no statistically significant differences between the two groups in the rates of anastomotic leakage (odds ratio [OR], 0.99; 95% confidence internal [CI], 0.74–1.31) and
wound infection (OR, 1.16; 95% CI, 0.95–1.42) (1). The necessity of MBP before elective colorectal surgery should be reconsidered. Although many studies insist that preoperative MBP should be abandoned for elective abdominal surgery, clinical practice has been slow to change. The American Society of Colon and Rectal Surgeons estimated that more than 99% of its members still used some type of MBP as a standard preoperative protocol for elective colorectal surgery (2). Recently, a national Korean survey revealed that about 97.3% of surgeons still routinely ordered MBP in colorectal surgery preparations (3). As the trend in gynecologic surgery shifts toward more minimally invasive approaches, the challenges of cases
Asian J Endosc Surg 8 (2015) 171–179 © 2014 Japan Society for Endoscopic Surgery, Asia Endosurgery Task Force and Wiley Publishing Asia Pty Ltd.
171
Bowel preparation before laparoscopy
H Huang et al.
being performed by laparoscopy continue to increase (4). Gynecologic surgeons commonly use preoperative MBP based on the arguments that this approach can provide adequate visualization, make the procedure easier to perform, and decrease complication risk during laparoscopic surgery (5). Unfortunately, MBP can result in patients’ distress and discomfort, including nausea, vomiting, pain, and abdominal swelling (6,7). Because of a paucity of randomized data on whether MBP before laparoscopic gynecologic surgery is still needed, we conducted this meta-analysis to assess the necessity of MBP before gynecologic laparoscopy.
Materials and Methods Literature search The electronic databases MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials were systematically searched from their inception to 31 March 31 2014. The searches were restricted to English-language publications. The reference lists of the original and related reviews were also scanned to identify any additional relevant studies. The following MeSH terms or key words were used: “mechanical bowel preparation,” “gynecologic surgery,” and “laparoscopy.” The “Preferred reporting items for systematic reviews and meta-analyses statement” was used to report this meta-analysis (8). Study selection All included studies met the following criteria: (i) study design: randomized controlled trial (RCT); (ii) participants: women who underwent gynecologic laparoscopic surgery; (iii) intervention: oral sodium phosphate solution or single sodium phosphate enema; (iv) comparison intervention: no bowel preparation or other procedures; and (v) outcomes reporting: the quality of surgical field exposure and postoperative data such as pain, abdominal swelling, nausea/vomiting, and length of hospital stay (days). Studies were excluded if they were non-RCT, did not use MBP as an intervention, or had notable overlap between authors, centers, and patients in the published articles. Data extraction and outcome measures Two authors (HH and HW) independently extracted data from each study. Any disagreements were resolved by discussion and consensus. We collected the following information: first author, year of publication, country, number of participants, participant characteristics (age, mean, and SD), definition of intervention, and control. The primary outcome of interest was the quality of surgical field exposure, with surgeons’ ratings of “good”
172
or “excellent” sought. Secondary outcomes of interest included postoperative pain, abdominal swelling, nausea/vomiting, and length of hospital stay. Quality assessment We assessed the quality of each study by using the method described in the Cochrane Handbook for Systematic Reviews of Interventions (9). All studies were assigned a judgment of low, unclear, or high risk of bias for following six items: (i) random sequence generation; (ii) allocation concealment; (iii) blinding of participants and personnel; (iv) blinding of outcome assessment; and (v) incomplete data and selective reporting; and (vi) other sources of bias. Studies with a low risk of bias for all key domains were considered to have a low risk of bias. Studies with a low or unclear risk for all key domains were considered to have an unclear risk of bias. Studies with a high risk of bias for one or more key domains were considered to have a high risk of bias (10). Data analysis All data analyses were performed using Review Manager 5.2 (Cochrane Collaboration, Oxford, UK), according to recommendations from the Cochrane handbook. Differences were expressed as OR with 95%CI for dichotomous outcomes and as WMD with 95%CI for continuous outcomes. We used Cochran’s Q test and the I2 statistic to assess heterogeneity among the combined study results (11). Heterogeneity between included trials was indicated when the P-value for Cochran’s Q test was 50%. If there was significant heterogeneity, the random effects model was applied to pool the data; otherwise, the fixed-effects model was used. P < 0.05 was considered as statistically significant. The small number of included RCT did not allow for the estimation of potential publication bias with the funnel plot method for the outcomes. If the results were presented as median and range values, the means and SD were calculated using the formulas described by Hozo et al. (12).
Results Study selection Figure 1 shows the process of identifying and selecting full-text articles. The initial search identified 626 relevant records, of which 610 were excluded for duplicate studies. Sixteen articles were screened, and 11 of them were excluded. The remaining five articles were assessed for full text review; two were then excluded because one did not report outcomes of interest and the other compared only two different types of MBP (13,14). Therefore, three articles were included in the final meta-analysis (6,15,16).
Asian J Endosc Surg 8 (2015) 171–179 © 2014 Japan Society for Endoscopic Surgery, Asia Endosurgery Task Force and Wiley Publishing Asia Pty Ltd.
Bowel preparation before laparoscopy
H Huang et al.
Figure 1 Selection process for studies included in the meta-analysis.
Table 1 Characteristics of included studies Age (years)
Author, country
Sample size (MBP/control)
MBP
No-MBP
Definition of MBP
Definition of control
Muzii et al.(15), Italy
162 (81/81)
32 (18–65)
34 (18–65)
No preparation
83 (41/42)
34 (23–60)
37 (29–52)
146 (73/73)
40.9 ± 8.0
42.9 ± 9.0
Patients received 90-mL oral sodium phosphate. Patients were asked to drink a granular powder dissolved in water. Patients were administered a single sodium phosphate enema.
Lijoi et al.(6), Italy Siedhoff et al.(16), USA
Patients had a total daily fiber intake
Asian J Endosc Surg ISSN 1758-5902
O R I G I N A L A RT I C L E
Is mechanical bowel preparation still necessary for gynecologic laparoscopic surgery? A meta-analysis Huaping Huang, Haiyan Wang & Mei He Department of Nursing Administration, Mianyang Central Hospital, Mianyang, China
Keywords Gynecologic; laparoscopic surgery; mechanical bowel preparation Correspondence Huaping Huang, No.12 Changjia Alley, Jingzhong Street, Fucheng District, Mianyang, Sichuan, 62100 China. Tel: +86 0816 223 9671 Fax: +86 0816 222 2566 Email: [email protected] The PROSPERO Register Number: CRD42014010021. Received 28 July 2014; revised 19 September 2014; accepted 4 October 2014 DOI:10.1111/ases.12155
Abstract Introduction: A number of studies have proven that mechanical bowel preparation (MBP) has no benefits in elective colorectal surgery. However, studies specifically related to gynecologic laparoscopic surgery are scant. We undertook a meta-analysis to assess the necessity of MBP before gynecologic laparoscopic surgery. Methods: The electronic databases MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials were systematically searched to identify relevant randomized controlled trials. Two authors independently extracted data from each study. The primary outcome of interest was the quality of surgical field. Secondary outcomes of interest included postoperative pain, abdominal swelling, nausea/vomiting, and length of hospital stay. Results: Three studies involving 372 participants were included in the metaanalysis. The results showed that MBP did not significantly increase the overall quality of surgical field exposure (odds ratio, 0.82; 95% confidence interval [CI], 0.46–1.49; P = 0.52). MBP also did not appear to significantly change the mean scores of postoperative pain (weighted mean difference, 0.09; 95%CI, −0.54–0.71; P = 0.79), the incidence of nausea/vomiting (odds ratio, 1.56; 95%CI, 0.80 to 3.03; P = 0.19), the mean scores of abdominal swelling (weighted mean difference, −0.26; 95%CI, −0.83–0.30; P = 0.36), and length of hospital stay (weighted mean difference, 0.05; 95%CI, −0.13– 0.22; P = 0.62). Conclusions: Our results suggest that routine use of MBP for gynecologic laparoscopic surgery should not be recommended. However, additional randomized controlled trials using large samples are needed to confirm these findings.
Introduction Preoperative mechanical bowel preparation (MBP) has traditionally been believed to decrease the risk of complications after gastrointestinal surgery, such as anastomotic leakage and surgical-site infection. However, this dogma is not based on scientific studies but rather on empirical opinion. Recently, an updated meta-analysis involving 5805 participants (2906 assigned to the MBP group, 2899 assigned to the no-preparation group) who underwent elective colorectal surgery showed there were no statistically significant differences between the two groups in the rates of anastomotic leakage (odds ratio [OR], 0.99; 95% confidence internal [CI], 0.74–1.31) and
wound infection (OR, 1.16; 95% CI, 0.95–1.42) (1). The necessity of MBP before elective colorectal surgery should be reconsidered. Although many studies insist that preoperative MBP should be abandoned for elective abdominal surgery, clinical practice has been slow to change. The American Society of Colon and Rectal Surgeons estimated that more than 99% of its members still used some type of MBP as a standard preoperative protocol for elective colorectal surgery (2). Recently, a national Korean survey revealed that about 97.3% of surgeons still routinely ordered MBP in colorectal surgery preparations (3). As the trend in gynecologic surgery shifts toward more minimally invasive approaches, the challenges of cases
Asian J Endosc Surg 8 (2015) 171–179 © 2014 Japan Society for Endoscopic Surgery, Asia Endosurgery Task Force and Wiley Publishing Asia Pty Ltd.
171
Bowel preparation before laparoscopy
H Huang et al.
being performed by laparoscopy continue to increase (4). Gynecologic surgeons commonly use preoperative MBP based on the arguments that this approach can provide adequate visualization, make the procedure easier to perform, and decrease complication risk during laparoscopic surgery (5). Unfortunately, MBP can result in patients’ distress and discomfort, including nausea, vomiting, pain, and abdominal swelling (6,7). Because of a paucity of randomized data on whether MBP before laparoscopic gynecologic surgery is still needed, we conducted this meta-analysis to assess the necessity of MBP before gynecologic laparoscopy.
Materials and Methods Literature search The electronic databases MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials were systematically searched from their inception to 31 March 31 2014. The searches were restricted to English-language publications. The reference lists of the original and related reviews were also scanned to identify any additional relevant studies. The following MeSH terms or key words were used: “mechanical bowel preparation,” “gynecologic surgery,” and “laparoscopy.” The “Preferred reporting items for systematic reviews and meta-analyses statement” was used to report this meta-analysis (8). Study selection All included studies met the following criteria: (i) study design: randomized controlled trial (RCT); (ii) participants: women who underwent gynecologic laparoscopic surgery; (iii) intervention: oral sodium phosphate solution or single sodium phosphate enema; (iv) comparison intervention: no bowel preparation or other procedures; and (v) outcomes reporting: the quality of surgical field exposure and postoperative data such as pain, abdominal swelling, nausea/vomiting, and length of hospital stay (days). Studies were excluded if they were non-RCT, did not use MBP as an intervention, or had notable overlap between authors, centers, and patients in the published articles. Data extraction and outcome measures Two authors (HH and HW) independently extracted data from each study. Any disagreements were resolved by discussion and consensus. We collected the following information: first author, year of publication, country, number of participants, participant characteristics (age, mean, and SD), definition of intervention, and control. The primary outcome of interest was the quality of surgical field exposure, with surgeons’ ratings of “good”
172
or “excellent” sought. Secondary outcomes of interest included postoperative pain, abdominal swelling, nausea/vomiting, and length of hospital stay. Quality assessment We assessed the quality of each study by using the method described in the Cochrane Handbook for Systematic Reviews of Interventions (9). All studies were assigned a judgment of low, unclear, or high risk of bias for following six items: (i) random sequence generation; (ii) allocation concealment; (iii) blinding of participants and personnel; (iv) blinding of outcome assessment; and (v) incomplete data and selective reporting; and (vi) other sources of bias. Studies with a low risk of bias for all key domains were considered to have a low risk of bias. Studies with a low or unclear risk for all key domains were considered to have an unclear risk of bias. Studies with a high risk of bias for one or more key domains were considered to have a high risk of bias (10). Data analysis All data analyses were performed using Review Manager 5.2 (Cochrane Collaboration, Oxford, UK), according to recommendations from the Cochrane handbook. Differences were expressed as OR with 95%CI for dichotomous outcomes and as WMD with 95%CI for continuous outcomes. We used Cochran’s Q test and the I2 statistic to assess heterogeneity among the combined study results (11). Heterogeneity between included trials was indicated when the P-value for Cochran’s Q test was 50%. If there was significant heterogeneity, the random effects model was applied to pool the data; otherwise, the fixed-effects model was used. P < 0.05 was considered as statistically significant. The small number of included RCT did not allow for the estimation of potential publication bias with the funnel plot method for the outcomes. If the results were presented as median and range values, the means and SD were calculated using the formulas described by Hozo et al. (12).
Results Study selection Figure 1 shows the process of identifying and selecting full-text articles. The initial search identified 626 relevant records, of which 610 were excluded for duplicate studies. Sixteen articles were screened, and 11 of them were excluded. The remaining five articles were assessed for full text review; two were then excluded because one did not report outcomes of interest and the other compared only two different types of MBP (13,14). Therefore, three articles were included in the final meta-analysis (6,15,16).
Asian J Endosc Surg 8 (2015) 171–179 © 2014 Japan Society for Endoscopic Surgery, Asia Endosurgery Task Force and Wiley Publishing Asia Pty Ltd.
Bowel preparation before laparoscopy
H Huang et al.
Figure 1 Selection process for studies included in the meta-analysis.
Table 1 Characteristics of included studies Age (years)
Author, country
Sample size (MBP/control)
MBP
No-MBP
Definition of MBP
Definition of control
Muzii et al.(15), Italy
162 (81/81)
32 (18–65)
34 (18–65)
No preparation
83 (41/42)
34 (23–60)
37 (29–52)
146 (73/73)
40.9 ± 8.0
42.9 ± 9.0
Patients received 90-mL oral sodium phosphate. Patients were asked to drink a granular powder dissolved in water. Patients were administered a single sodium phosphate enema.
Lijoi et al.(6), Italy Siedhoff et al.(16), USA
Patients had a total daily fiber intake
