Appendix B. Supplemental Material Relating to Observational Studies

Appendix B. Supplemental Material relating to Observational Studies

Characteristics of observational studies
Quality assessment of observational studies
Table of results
Summary of results

Supplemental Table 1.Characteristics of observational studies of laparoscopic lavage in perforated diverticulitis since 2009.

Source / Country / Type of Study / Hinchey Grade / Number of Patients / Lavage technique / Type of Colon Resection / Median Follow-up
(Months)
Karoui et al, 20091 / France / Prospective cohort / III / 59 / 15L warm isotonic saline / 1° Resect & Anast. / 21
Lippi,
20092 / Italy / Prospective case series / II-IV / 13 / 3–4L saline / No comparator group / NR
Mazza,
20093 / France / Prospective case series / I-IV / 25 / 4-10L saline / No comparator group / NR
Lam et al, 20094 / Belgium / Retrospective cohort / I-III / 6 / 10L saline / No comparator group / 6
Favuzza et al, 20095 / USA / Retrospective
cohort / Not reported / 7 / Saline (volume unspecified) / No comparator group / NR
White et al, 20106 / Australia / Retrospective
cohort / I-IV / 78 / Rarely >1L saline / 1°. Resect. Anast.
Hartmann
Lap Hartmann / 20
Rogers et al, 20127 / Ireland / Retrospective cohort / Not reported / 427 / Not reported / 1°. Resect. & Anast.
Hartmann / NR
Liang et al, 20128 / USA / Retrospective
Cohort / II-IV / 88 / >4L 5% iodine saline / Lap Hartmann / NR
Zonca, 20139 / Czech Rep. / Retrospective
Cohort / II-IV / 12 / 0.5L 0.2% Taurolidine / No comparator group / NR
Swank et al, 201310 / Netherlands / Retrospective
Cohort / II-III / 38 / 4L saline / No comparator group / 69 (on 28 patients)
Edeiken et al, 201311 / USA / Prospective case series / I-III / 10 / 2-3L saline / No comparator group / NR
Gentile, 201312 / Italy / Retrospective
Cohort / II-III / 30 / NR / Hartmann / 12
Rossi et al, 201413 / Argentina / Retrospective cohort / III / 46 / 3-6L saline / No comparator group. / NR
Rade et al, 201414 / France / Retrospective
Cohort / II-III / 80 / Not reported / No comparator group / NR
Sorrentino et al, 201515 / Italy / Retrospective cohort / II-IV / 70 / 6-8L saline / No comparator group / 54
Horesh et al, 201516 / Israel / Retrospective cohort / II-IV / 10 / 1-3L warm saline / No comparator group / 9

Abbreviations: 1° Resect & Anast: Primary resection & anastomosis, NR: not reported, L; liters.

Supplemental Table 2. Quality assessmentof observational studiesusing MINORS criteria17.

Source / Aim / Inclusion / Collection / Endpoints / Blinding / Follow up period / Loss of follow up / Power / Control / Time period / Equivalence / Statistics
Karoui et al, 20091 / 2 / 0 / 0 / 2 / 0 / 2 / 2 / 0 / 2 / 0 / 0 / 2
Lippi,
20092 / 2 / 2 / 0 / 2 / 0 / 2 / 2 / 0 / N/A / N/A / N/A / N/A
Mazza,
20093 / 2 / 2 / 0 / 2 / 0 / 2 / 2 / 0 / N/A / N/A / N/A / N/A
Lam et al, 20094 / 1 / 2 / 0 / 0 / 0 / 1 / 2 / 0 / N/A / N/A / N/A / N/A
Favuzza et al, 20095 / 1 / 1 / 0 / 0 / 0 / 1 / 1 / 0 / N/A / N/A / N/A / N/A
White et al, 20106 / 1 / 1 / 0 / 1 / 0 / 1 / 1 / 0 / 2 / 1 / 1 / 1
Rogers et al, 20127 / 2 / 2 / 0 / 2 / 0 / 2 / 1 / 1 / 2 / 2 / 1 / 2
Liang et al, 20128 / 2 / 2 / 2 / 1 / 0 / 2 / 2 / 0 / 1 / 2 / 2 / 1
Zonca, 20139 / 1 / 0 / 0 / 0 / 0 / 1 / 0 / 0 / N/A / N/A / N/A / N/A
Swank et al, 201310 / 2 / 0 / 1 / 2 / 0 / 1 / 1 / 1 / N/A / N/A / N/A / N/A
Edeiken et al, 201311 / 0 / 0 / 1 / 1 / 0 / 0 / 1 / 0 / N/A / N/A / N/A / N/A
Gentile, 201312 / 2 / 0 / 0 / 2 / 0 / 2 / 0 / 0 / 2 / 2 / 2 / 1
Rossi et al, 201413 / 2 / 2 / 2 / 2 / 0 / 1 / 1 / 0 / N/A / N/A / N/A / N/A
Rade et al, 201414 / 2 / 2 / 2 / 2 / 0 / 1 / 1 / 0 / N/A / N/A / N/A / N/A
Sorrentino et al, 201515 / 2 / 2 / 1 / 1 / 0 / 2 / 2 / 0 / N/A / N/A / N/A / N/A
Horesh et al, 201516 / 1 / 0 / 0 / 1 / 0 / 2 / 0 / 0 / N/A / N/A / N/A / N/A

Reported & Adequate = 2, Reported & Inadequate = 1, Not Reported = 0.

Criteria of Control, Time Period, Equivalence and Statistics are not applicable (N/A) where no comparative group is included in the study.

Source / Laparoscopic lavage n / Colon resection n
No. / LOS / Reoperations / Perc. drain / Pts. with stoma / Deaths / No. / LOS / Reoperations / Perc. drain / Pts. with stoma / Deaths
Total / For Infection / Other indic. / Total / For Infection / Other indic.
Karoui, 20091 / 35 / 8 / 1 / 0 / 1 / 1 / * / 0 / 24 / 17 / 2 / 0 / 2 / 1 / 0 / 0
Lippi,
20092 / 13 / * / 1 / 1 / 0 / 1 / * / 3 / N/A / N/A / N/A / N/A / N/A / N/A / N/A / N/A
Mazza,
20093 / 25 / 13.8 / 0 / 0 / 0 / 1 / 0 / 0 / N/A / N/A / N/A / N/A / N/A / N/A / N/A / N/A
Lam,
20094 / 6 / 11 / 3 / 3 / 0 / 0 / 3 / * / N/A / N/A / N/A / N/A / N/A / N/A / N/A / N/A
Favuzza, 20095 / 7 / 7.7 / 1 / 1 / 0 / 0 / 0 / 0 / N/A / N/A / N/A / N/A / N/A / N/A / N/A / N/A
White, 20106 / 35 / 14 / 8 / 5 / 3 / * / * / 0 / 39 / 19 / * / * / * / * / * / 5
Rogers, 20127 / 427 / 10 / * / * / * / * / * / 17 / 2028 / 20 / * / * / * / * / * / 210
Liang, 20128 / 47 / 6.6 / 3 / 3 / 0 / * / 1 / 0 / 41 / 16.3 / 0 / * / * / * / 41 / 1
Zonca, 20139 / 12 / 8.5 / 2 / 1 / 1 / * / 1 / 0 / N/A / N/A / N/A / N/A / N/A / N/A / N/A / N/A
Swank, 201310 / 38 / 10 / 5 / 3 / 2 / * / 4 / 4 / N/A / N/A / N/A / N/A / N/A / N/A / N/A / N/A
Edeiken, 201311 / 8 / * / 0 / 0 / 0 / 2 / 2 / * / N/A / N/A / N/A / N/A / N/A / N/A / N/A / N/A
Gentile, 201312 / 14 / 10.5 / * / * / * / * / * / 1 / 16 / 19 / * / * / * / * / * / 4
Rossi, 201413 / 46 / 6 / 5 / 5 / 0 / 1 / 4 / 0 / N/A / N/A / N/A / N/A / N/A / N/A / N/A / N/A
Rade, 201414 / 71 / 12 / 11 / 11 / * / * / * / 4 / N/A / N/A / N/A / N/A / N/A / N/A / N/A / N/A
Sorrentino, 201515 / 63 / 7 / 6 / 6 / 0 / * / * / * / N/A / N/A / N/A / N/A / N/A / N/A / N/A / N/A
Horesh, 201516 / 10 / 11 / 0 / 0 / 0 / 3 / 1 / 0 / N/A / N/A / N/A / N/A / N/A / N/A / N/A / N/A

Supplemental Table 3.Systematic review of observational studies using laparoscopic lavage in the treatment of perforated diverticulitis.

* Not reported; LOS; Length of post-operative stay.Perc. Drain; CT-guided percutaneous drain placement.Criteria of Control, Time Period, Equivalence and Statistics are not applicable (N/A) where no comparative group is included in the study.

Systematic Review of Observational Studies

Characteristics of the 16 relevant observational studies are detailed in Supplemental Table 1. Observational studies included patients with Hinchey classification ranging from I to IV.Three observational studies did not state the volume and type of fluid used for lavage. In those that did report this, saline was generally used with volumes ranging from one to ten litres. The only studies using antiseptic or antibiotic containing fluid for irrigation of the peritoneal cavity included Liang et al who used 5% iodine saline and Zonca et al who used 0.2% Taurolidine8,9.

Each study was assessed for risk of bias. Observational studies were assessed using the MINORs criteria (Supplemental Table 2). Most observational studies did not have a comparator group and were not prospective in the nature of the data collection which resulted in poor scoring by the MINORs criteria. This suggests that most these studies are of poor quality and are at risk of bias. Four studies achieved a score of 2 in 6 or more MINORs criteria. These higher quality reports were from Karoui et al, Rogers et al, Liang et al and Gentile et al1,7,8,12.

Results from the observational studies are summarized in Supplemental Table 3. Most observational studies reported that approximately 10-20% of patients undergoing laparoscopic lavage for perforated diverticulitis required reoperation for infection.Karoui et al reported no operations for infection in either the laparoscopic lavage or resection group specifically for infection, or deaths1. Length of stay was shorter in the lavage group compared against the resection group(8 vs. 17 days). Liang et al representing one of the larger reports achieving a higher quality rating based on the MINORs criteria,studied 88 patients with perforated Hinchey grade II – IV diverticulitis 8. ASA score, morbidity and Hinchey grade were similar between groups. Three of 47 patients who underwent laparoscopic lavage required reoperation for peritonitis, compared with none of the 41 patients requiring reoperation who underwent a laparoscopic Hartmann procedure. More patients in the latter group; however, suffered from pulmonary and wound complications. Rogers et al reported from a large Irish database, that 17 patients (4%) undergoing laparoscopic lavage died within a year, as compared with 210 deaths (9%) in those undergoing colon resection 7. Reoperation rates were not reported. The lavage group; however, contained a higher percentage of patients at extremes of age as compared with the colon resection group. In the study by Gentile et al, there was a lack of granular data regarding reoperation12. However, length of stay was about half in the laparoscopic lavage group, with only one death in, compared with four deaths in the resection group. More recent, lower qualitystudies by Rade et al and Sorrentino et alreport series’ of patients undergoing laparoscopic lavage for perforated diverticulitis14,15. Rates of reoperation for infection were 10.8% and 9.5%, respectively. Only Rade et al reported mortality which was at 5.6%. Among the many other case series and observational studies,death is rarely reported following laparoscopic lavage for perforated diverticulitis.

References

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2.Lippi CE, Beatini L, Cervia S, et al. [Laparoscopic lavage and drainage in the surgical treatment of diverticular disease complicated by peritonitis]. Chirurgia italiana. 2009;61(4):467-474.

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