Closure methods of the appendix stump for complications during laparoscopic appendectomy: Cochrane systematic review
Laparoscopic appendectomy is amongst the most common general surgical procedures performed in the developed world. Arguably, the most critical part of this procedure is effective closure of the appendix stump to prevent catastrophic intra-abdominal complications from a faecal leak into the abdominal cavity. A variety of methods to close the appendix stump are used worldwide; these can be broadly divided into traditional ligatures (such as intracorporeal or extracorporeal ligatures or Roeder loops) and mechanical devices (such as stapling devices, clips, or electrothermal devices). However, the optimal method remains unclear.Objectives
To compare all surgical techniques now used for appendix stump closure during laparoscopic appendectomy.Search methods
In June 2017, we searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 6) in the Cochrane Library, MEDLINE Ovid (1946 to 14 June 2017), Embase Ovid (1974 to 14 June 2017), Science Citation Index - Expanded (14 June 2017), China Biological Medicine Database (CBM), the World Health Organization International Trials Registry Platform search portal, ClinicalTrials.gov, Current Controlled Trials, the Chinese Clinical Trials Register, and the EU Clinical Trials Register (all in June 2017). We searched the reference lists of relevant publications as well as meeting abstracts and Conference Proceedings Citation Index to look for additional relevant clinical trials.Selection criteria
We included all randomised controlled trials (RCTs) that compared mechanical appendix stump closure (stapler, clips, or electrothermal devices) versus ligation (Endoloop, Roeder loop, or intracorporeal knot techniques) for uncomplicated appendicitis.Data collection and analysis
Two review authors identified trials for inclusion, collected data, and assessed risk of bias independently. We performed the meta-analysis using Review Manager 5. We calculated the odds ratio (OR) for dichotomous outcomes and the mean difference (MD) for continuous outcomes, with 95% confidence intervals (CIs).Main results
We included eight randomised studies encompassing 850 participants. Five studies compared titanium clips versus ligature, two studies compared an endoscopic stapler device versus ligature, and one study compared an endoscopic stapler device, titanium clips, and ligature. In our analyses of primary outcomes, we found no differences in total complications (OR 0.97, 95% CI 0.27 to 3.50, 8 RCTs, very low-quality evidence), intraoperative complications (OR 0.93, 95% CI 0.34 to 2.55, 8 RCTs, very low-quality evidence), or postoperative complications (OR 0.80, 95% CI 0.21 to 3.13, 8 RCTs, very low-quality evidence) between ligature and all types of mechanical devices. However, our analyses of secondary outcomes revealed that use of mechanical devices saved approximately nine minutes of total operating time when compared with use of a ligature (mean difference (MD) -9.04 minutes, 95% CI -12.97 to -5.11 minutes, 8 RCTs, very low-quality evidence). However, this finding did not translate into a clinically or statistically significant reduction in inpatient hospital stay (MD 0.02 days, 95% CI -0.12 to 0.17 days, 8 RCTs, very low-quality evidence). Available information was insufficient for reliable comparison of total hospital costs and postoperative pain/quality of life between the two approaches. Overall, evidence across all analyses was of very low quality, with substantial potential for confounding factors. Given the limitations of all studies in terms of bias and the low quality of available evidence, a clear conclusion regarding superiority of any one particular type of mechanical device over another is not possible.Authors' conclusions
Evidence is insufficient at present to advocate omission of conventional ligature-based appendix stump closure in favour of any single type of mechanical device over another in uncomplicated appendicitis.
Mannu Gurdeep S, Sudul Maria K, Bettencourt-Silva Joao H, Cumber Elspeth, Li Fangfang, Clark Allan B, Loke Yoon K
Determining the optimal method of securely closing the base of the appendix during keyhole surgery after removal of the inflamed appendix
Appendicitis is an Inflammation of the appendix. The conventional treatment for this condition involves an operation to remove the appendix, called an appendectomy. In recent years, this operation has been increasingly performed as keyhole surgery - laparoscopic appendectomy. For removal of the appendix during laparoscopic appendectomy, the best method of closing the remaining appendix stump to avoid leakage of bowel contents is unclear. Traditional approaches have involved ligatures and knots. However, in recent years, some surgeons have elected to use automated mechanical devices rather than ligatures, and it is unclear whether these devices reduce complications during laparoscopic appendectomy when compared with ligatures.
We searched for all relevant randomised controlled trials up to 14 June 2017. This systematic review included eight randomised controlled trials involving a total of 850 participants. All trials compared mechanical devices versus ligatures for appendix stump closure. Five of the eight trials compared use of clips versus ligature, two trials compared an automated stapler versus ligature, and one trial compared all three methods.
Use of mechanical devices to close the appendix stump during laparoscopic appendectomy did not make a significant difference in the rate of overall complications when compared with use of a ligature, or in the rate of complications that happened during or after the appendectomy procedure. However, mechanical devices did make the operation nine minutes quicker when compared with ligatures. Mechanical devices did not make a substantial difference in overall hospital stay. We did not have enough information to reliably evaluate hospital costs, pain, or quality of life for either of these comparisons. As a result, we have not found enough evidence at present that would lead us to strongly recommend any particular method over another. More research should be undertaken to better compare available newer methods.
Quality of the evidence
The evidence used to derive our conclusions was generally of low quality. The studies we included for each analysis were vulnerable to different types of bias and contained inconsistencies and imprecision in their results due to small numbers of participants and events in each included study arm. It is likely that future research will substantially change our conclusions; further studies in this field are needed.
Implications for practice
Results of this review show no differences between overall complications associated with mechanical devices and ligature methods during appendix stump closure. In light of this, we cannot unequivocally recommend routine use of mechanical devices in appendix stump closure because reduction in operating time has not translated into any clinically significant reductions in in-patient hospital stay (mean difference 0.02, 95% confidence interval -0.12 to 0.17; I2 = 0%) (Comparison 1 Mechanical appendix stump closure (with endoscopic stapler or clip(s)) versus ligation (with Endoloop or intracorporeal knot), Outcome 5 Hospital stay (in days) between mechanical and ligature.). Similarly, information on the fiscal costs of different mechanical devices is insufficient to show whether additional costs of these devices compared with the costs of ligatures are outweighed by reduced operating time, allowing the possibility of including additional procedures in an operating list. Until such time when these devices show more definitive comparative evidence of efficacy in comparison with each other and with ligatures (as outlined below under Implications for research), it is not possible to advocate omission of conventional ligature-based appendix stump closure in favour of any single mechanical device over another.
Implications for research
For our comparison of types of mechanical devices, we were limited to a single study that met our inclusion criteria. The only studies comparing the efficacy of the Medtronic LigaSure vessel sealing system (Valleylab, Boulder, Colorado, USA), or comparing one versus two ligatures in terms of complication rates, used a quasi-randomisation method and did not meet our inclusion criteria (Sucullu 2009 and Beldi 2004, respectively); therefore we were unable to undertake our planned analyses of these comparisons. Similarly, no robust randomised trials have examined laparoscopic appendectomy using the Ethicon ENSEAL device or the Harmonic scalpel device, and none have compared these against Weck Hem-o-lok Polymer Locking Ligation System (Weck Closure Systems, Research Triangle Park, North Carolina, USA), titanium clip devices, or the Ethicon Endo GIA stapler (Ethicon Endo-Surgery, Inc., Cincinnati, Ohio, USA). Although a plethora of cases series and observational studies from single-centre experiences have used various types of mechanical devices, they have contributed little conclusive evidence of efficacy because of confounding factors inherent in these types of study design.
None of our included studies have reported postoperative bleeding, appendix stump rupture, or purulent peritonitis in either comparison group, and included studies have poorly reported other outcomes such as hospital costs (operation, direct and indirect) and pain/quality of life. Well-designed randomised clinical trials are needed to compare contemporary mechanical sealing devices versus each other and versus conventional ligature-based methods, with particular emphasis on health economic implications and clinically relevant complication rates (such as postoperative peritonitis and appendix stump rupture); they should be designed in a manner that will allow investigators to address the biases identified in existing studies on this topic (see Quality of the evidence). It would be ethically feasible for a double-blinded trial to ensure that (1) the consenting participant is blinded to the method of appendix stump closure used for the duration of postoperative recovery until study completion, unless a complication precludes this; (2) a senior operating surgeon is blinded to identifiable participant details and is not directly involved in the decision to operate or in providing postoperative care; and (3) the participant's responsible healthcare team is blinded to the operative details, unless clinically relevant reasons preclude this. In such trials, blinded investigators may evaluate outcomes. With this approach, a double-blinded surgical randomised trial would be feasible and robust enough to avoid confounding factors such as those evident in the studies included in this review.Get full text at The Cochrane Library
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