Category Archives: Great Debates

Early vs late drain removal after pancreatectomy

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One discussion this week included early vs late drain removal in pancreatectomy.

References: Beane JD, et al. Variation of drain management after pancreatoduodenectomy: early versus delayed removal. Annals of Surgery. 2017 Oct. doi: 10.1097/SLA.0000000000002570

Deminski J, et al. Early removal of intraperitoneal drainage after pancreatoduodenectomy in patients without postoperative fistula at POD3: results of a randomized clinical trial. Journal of Visceral Surgery. 2019 Jan 31. pii: S1878-7886(18)30084-5. doi: 10.1016/j.jviscsurg.2018.06.006

Summary:  Early drain removal after pancreatoduodenectomy, when guided by postoperative day (POD) 1 drain fluid amylase (DFA-1), is associated with reduced rates of clinically relevant postoperative pancreatic fistula (CR-POPF).

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Laparoscopic entry techniques

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One discussion this week involved laparoscopic entry techniques.

Reference: Ahmad G, et al. Laparoscopic entry techniques. The Cochrane Database of Systematic Reviews. 2019 Jan 18;1:CD006583. doi: 10.1002/14651858.CD006583.pub5

Summary: In their updated systematic review on the topic, Ahmed et al (2019) included 57 RCTs including four multi-arm trials, with a total of 9865 participants, and evaluated 25 different laparoscopic entry techniques.

Overall, evidence was insufficient to support the use of one laparoscopic entry technique over another. Researchers noted an advantage of direct trocar entry over Veress needle entry for failed entry. Most evidence was of very low quality; the main limitations were imprecision (due to small sample sizes and very low event rates) and risk of bias associated with poor reporting of study methods.

Open-entry vs closed-entry: Evidence was insufficient to show whether there were differences between groups for:

  • vascular injury (Peto OR 0.14, 95% CI 0.00 to 6.82; 4 RCTs; n=915; I²=N/A)
  • visceral injury (Peto OR 0.61, 95% CI 0.06 to 6.08; 4 RCTs; n=915: I²=0%)
  • failed entry (Peto OR 0.45, 95% CI 0.14 to 1.42; 3 RCTs; n=865; I²=63%)

Direct trocar vs Veress needle entry: Trial results show a reduction in failed entry into the abdomen with the use of a direct trocar in comparison with Veress needle entry (Peto OR 0.24, 95% CI 0.17 to 0.34; 8 RCTs; n=3185; I²=45%; moderate-quality evidence).

Direct vision entry vs Veress needle entry: Evidence was insufficient to show whether there were differences between groups in rates of:

  • vascular injury (Peto OR 0.39, 95% CI 0.05 to 2.85; 1 RCT; n=186)
  • visceral injury (Peto OR 0.15, 95% CI 0.01 to 2.34; 2 RCTs; n=380; I²=N/A)

Direct vision entry vs open entry: Evidence was insufficient to show whether there were differences between groups in rates of:

  • visceral injury (Peto OR 0.13, 95% CI 0.00 to 6.50; 2 RCTs; n=392; I²=N/A)
  • solid organ injury (Peto OR 6.16, 95% CI 0.12 to 316.67; 1 RCT; n=60)
  • failed entry (Peto OR 0.40, 95% CI 0.04 to 4.09; 1 RCT; n=60)

Radially expanding (STEP) trocars vs non-expanding trocars: Evidence was insufficient to show whether there were differences between groups in rates of:

  • vascular injury (Peto OR 0.24, 95% Cl 0.05 to 1.21; 2 RCTs; n=331; I²=0%)
  • visceral injury (Peto OR 0.13, 95% CI 0.00 to 6.37; 2 RCTs; n=331)
  • solid organ injury (Peto OR 1.05, 95% CI 0.07 to 16.91; 1 RCT; n=244)

(Ahmed et al, 2019, p.2)

Perioperative fluid management: restrictive vs liberal regimens

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One discussion this week included restrictive vs liberal perioperative fluid management on the development of perioperative acute kidney injury.

References: Brandstrup B, et al. Effects of intravenous fluid restriction on postoperative complications: comparison of two perioperative fluid regimens: a randomized assessor-blinded multicenter trial. Annals of Surgery. 2003 Nov;238(5):641-648.

Myles PS, et al. Restrictive versus liberal fluid therapy for major abdominal surgery. NEJM. 2018 Jun 14;378:2263-2274. doi:10.1056/NEJMoa1801601

Summary: Traditional intravenous-fluid regimens administered during abdominal surgery deliver up to 7 liters of fluid on the day of surgery. Some small trials have shown that a more restrictive fluid regimen led to fewer complications and a shorter hospital stay. However, the evidence for fluid restriction during and immediately after abdominal surgery is inconclusive. Fluid restriction could increase the risk of hypotension and decrease perfusion in the kidney and other vital organs, leading to organ dysfunction, but excessive intravenous-fluid infusion may increase the risk of pulmonary complications, acute kidney injury, sepsis, and poor wound healing (Myles 2018).

Each of the RCTs below compare restrictive vs liberal fluid management, with conflicting conclusions.

BRANDSTRUB ET AL (2003)

This multicenter RCT involved 172 patients allocated to either a restricted or a standard intraoperative and postoperative intravenous fluid regimen. The restricted regimen aimed at maintaining preoperative body weight; the standard regimen resembled everyday practice. The primary outcome measures were complications; the secondary measures were death and adverse effects.

Results: The restricted intravenous fluid regimen significantly reduced postoperative complications both by intention-to-treat (33% versus 51%, P = 0.013) and per-protocol (30% versus 56%, P = 0.003) analyses. The numbers of both cardiopulmonary (7% versus 24%, P = 0.007) and tissue-healing complications (16% versus 31%, P = 0.04) were significantly reduced. No patients died in the restricted group compared with 4 deaths in the standard group (0% versus 4.7%, P = 0.12). No harmful adverse effects were observed.

Conclusion: The restricted perioperative intravenous fluid regimen aiming at unchanged body weight reduces complications after elective colorectal resection.

MYLES ET AL (2018)

This international trial randomly assigned 3000 patients who had an increased risk of complications while undergoing major abdominal surgery to receive a restrictive or liberal intravenous-fluid regimen during and up to 24 hours after surgery. The primary outcome was disability-free survival at 1 year. Key secondary outcomes were acute kidney injury at 30 days, renal-replacement therapy at 90 days, and a composite of septic complications, surgical-site infection, or death.

Results: Up to 24 hours after surgery, 1490 patients in the restrictive fluid group had a median intravenous-fluid intake of 3.7 liters, as compared with 6.1 liters in 1493 patients in the liberal fluid group. The rate of disability-free survival at 1 year was 81.9% in the restrictive fluid group and 82.3% in the liberal fluid group. The rate of AKI was 8.6% in the restrictive fluid group and 5.0% in the liberal fluid group. The rate of septic complications or death was 21.8% in the restrictive fluid group and 19.8% in the liberal fluid group; rates of surgical-site infection (16.5% vs. 13.6%) and renal-replacement therapy (0.9% vs. 0.3%) were higher in the restrictive fluid group, but the between-group difference was not significant after adjustment for multiple testing.

Conclusion: Among patients at increased risk for complications during major abdominal surgery, a restrictive fluid regimen was not associated with a higher rate of disability-free survival than a liberal fluid regimen and was associated with a higher rate of acute kidney injury.

Additional Reading: Romagnoli S, Ricci Z, Ronco C. Perioperative acute kidney injury: prevention, early recognition, and supportive measures. Nephron. 2018;140(2):105-110.

Salmasi V, et al. Relationship between intraoperative hypotension, defined by either reduction from baseline or absolute thresholds, and acute kidney and myocardial injury after noncardiac surgery: a retrospective cohort analysis. Anesthesiology. 2017;126:47-65. doi:10.1097/ALN.0000000000001432

OpenAnesthesia. Encyclopedia: Fluid Management. OpenAnesthesia. 2019. International Anesthesia Research Society. Retrieved from: http://www.openanesthesia.org/fluid-management/

Sugarbaker vs Keyhole repair in parastomal hernias

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One discussion this week involved the Sugarbaker repair vs Keyhole repair.

Reference: DeAsis FJ et al. Current state of laparoscopic parastomal hernia repair: a meta-analysis. World Journal of Gastroenterology. 2015 Jul 28;21(28):8670-8677. doi: 10.3748/wjg.v21.i28.8670

Summary:  The primary differences between keyhole repair and Sugarbaker repair are the orientation of the bowel and the presence of a slit in the mesh. In the modified Sugarbaker approach, the bowel is exteriorized through the side of the mesh, whereas in the Keyhole approach the bowel is inserted through a 2 to 3 cm slit in the center of mesh. Both methods apply the mesh intraperitoneally (DeAsis et al, 2015, p.8673).

DeAsis et al (2015) performed a systematic review of PubMed and Medline. The primary outcome analyzed was recurrence of parastomal hernia. Secondary outcomes were mesh infection, surgical site infection, obstruction requiring reoperation, death, and other complications.

In an analysis of 15 articles involving 469 patients, the recurrence rate was 10.2% (95%CI: 3.9-19.0) for the modified laparoscopic Sugarbaker approach, and 27.9% (95%CI: 12.3-46.9) for the keyhole approach. There were no intraoperative mortalities reported and six mortalities during the postoperative course.

The review concluded that the non-slit mesh modified Sugarbaker approach and the slit mesh Keyhole approach are currently the most reported options for laparoscopic repair. When choosing between the two, a modified Sugarbaker technique appears to be a superior method given the low recurrence rates compared to the keyhole technique if an ePTFE mesh is used (p.8676).

Early versus delayed cholecystectomy

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A discussion in December compared early versus delayed cholecystectomy.

References: Ackerman J, et al. Beware of the interval cholecystectomy. The Journal of Trauma and Acute Care Surgery. 2017 Jul;83(10):55-60. Full-text for Emory users.

Gurusamy KS, Davidson C, Gludd C, Davidson BR. Early versus delayed laparoscopic cholecystectomy for people with acute cholecystitis (Review). Cochrane Database of Systematic Reviews. 2013 Jun 30;(6):CD005440. Full-text for Emory users.

Summary: Cochrane’s review on early vs delayed cholecystectomy included 6 trials and 488 individuals. Of those, 244 received laparoscopic cholecystectomy early (within 7 days of presentation), while the remaining 244 received it at least 6 weeks after index admission with acute cholecystitis. The primary conclusion is that “based on information from a varied number of participants as well as trials at high risk of bias, early laparoscopic cholecystectomy during acute cholecystitis appears safe and shortens the total hospital stay [by 4 days]” (p.2).

There was no significant difference in operating time. Only one of the trials measured time to return to work, nothing that patients in the early group returned to work an average of 11 days earlier than the delayed group. Four trials did not report any gallstone-related complications; one trial reported five, including two people with cholangitis. In five trials, one-sixth of people in the delayed group had either non-resolution or recurrence of symptoms before their planned operation and had to have emergency laparoscopic cholecystectomy (p.6).

Using the terms immediate and interval, Ackerman et al (2017) conducted a retrospective cohort analysis to quantify the morbidity and mortality associated with a delayed, or interval cholecystectomy (IC). Of all patients admitted to 7 hospitals within the same healthcare system, 337 had percutaneous cholecystostomy (PC), 177 (52.5%) of those also had an interval cholecystectomy (IC). The table below illustrates the outcomes:

ic outcomes

(Ackerman et al, 2017, p.57)