Single-incision laparoscopic cholecystectomy is associated with improved cosmesis scoring at the cost of significantly higher hernia rates

1-year results of a prospective randomized, multicenter, single-blinded trial of traditional multiport laparoscopic cholecystectomy vs single-incision laparoscopic cholecystectomy

Jeffrey M. Marks, Melissa Lapinska, Roberto Tacchino, Kurt Roberts, Raymond Onders, George Denoto, Gary Gecelter, Eugene Rubach, Homero Rivas, Arsalla Islam, Nathaniel Soper, Paraskevas Paraskeva, Alexander Rosemurgy, Sharona Ross, Sajani Shah

Research output: Contribution to journalArticle

119 Citations (Scopus)

Abstract

Background: Minimally invasive techniques have become an integral part of general surgery with recent investigation into single-incision laparoscopic cholecystectomy (SILC). This study presents the final 1-year results of a prospective, randomized, multicenter, single-blinded trial of SILC vs multiport cholecystectomy (4PLC). Study Design: Patients with biliary colic and documented gallstones or polyps or with biliary dyskinesia were randomized to SILC vs 4PLC. Data measures included operative details, adverse events, and conversion to 4PLC or laparotomy. Patients were followed for 12 months. Results: Two hundred patients underwent randomization to SILC (n = 119) or 4PLC (n = 81). Enrollment ranged from 1 to 50 patients with 4 sites enrolling >25 patients. Total adverse events were not significantly different between groups (36% 4PLC vs 45% SILC; p = 0.24), as were severe adverse events (4% 4PLC vs 10% SILC; p = 0.11). Incision-related adverse events were higher after SILC (11.7% vs 4.9%; p = 0.13), but all of these were listed as mild or moderate. Total hernia rates were 1.2% (1 of 81) in 4PLC patients vs 8.4% (10 of 119) in SILC patients (p = 0.03). At 1-year follow-up, cosmesis scores continued to favor SILC (p < 0.0001). Conclusions: Results of this trial show SILC to be a safe and feasible procedure when compared with 4PLC, with similar total adverse events but with an identified significant increase in hernia formation. Cosmesis scoring and patient preference at 12 months continue to favor SILC, and more than half of the patients were willing to pay more for a single-site surgery over a standard laparoscopic procedure. Additional longer-term population-based studies are needed to clarify if this increased rate of hernia formation as compared with 4PLC will continue to hold true.

Original languageEnglish (US)
Pages (from-to)1037-1047
Number of pages11
JournalJournal of the American College of Surgeons
Volume216
Issue number6
DOIs
StatePublished - Jun 1 2013
Externally publishedYes

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Laparoscopic Cholecystectomy
Hernia
Biliary Dyskinesia
Colic
Patient Preference
Cholecystectomy
Gallstones
Random Allocation
Polyps
Laparotomy

All Science Journal Classification (ASJC) codes

  • Surgery

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Single-incision laparoscopic cholecystectomy is associated with improved cosmesis scoring at the cost of significantly higher hernia rates : 1-year results of a prospective randomized, multicenter, single-blinded trial of traditional multiport laparoscopic cholecystectomy vs single-incision laparoscopic cholecystectomy. / Marks, Jeffrey M.; Lapinska, Melissa; Tacchino, Roberto; Roberts, Kurt; Onders, Raymond; Denoto, George; Gecelter, Gary; Rubach, Eugene; Rivas, Homero; Islam, Arsalla; Soper, Nathaniel; Paraskeva, Paraskevas; Rosemurgy, Alexander; Ross, Sharona; Shah, Sajani.

In: Journal of the American College of Surgeons, Vol. 216, No. 6, 01.06.2013, p. 1037-1047.

Research output: Contribution to journalArticle

Marks, Jeffrey M. ; Lapinska, Melissa ; Tacchino, Roberto ; Roberts, Kurt ; Onders, Raymond ; Denoto, George ; Gecelter, Gary ; Rubach, Eugene ; Rivas, Homero ; Islam, Arsalla ; Soper, Nathaniel ; Paraskeva, Paraskevas ; Rosemurgy, Alexander ; Ross, Sharona ; Shah, Sajani. / Single-incision laparoscopic cholecystectomy is associated with improved cosmesis scoring at the cost of significantly higher hernia rates : 1-year results of a prospective randomized, multicenter, single-blinded trial of traditional multiport laparoscopic cholecystectomy vs single-incision laparoscopic cholecystectomy. In: Journal of the American College of Surgeons. 2013 ; Vol. 216, No. 6. pp. 1037-1047.
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title = "Single-incision laparoscopic cholecystectomy is associated with improved cosmesis scoring at the cost of significantly higher hernia rates: 1-year results of a prospective randomized, multicenter, single-blinded trial of traditional multiport laparoscopic cholecystectomy vs single-incision laparoscopic cholecystectomy",
abstract = "Background: Minimally invasive techniques have become an integral part of general surgery with recent investigation into single-incision laparoscopic cholecystectomy (SILC). This study presents the final 1-year results of a prospective, randomized, multicenter, single-blinded trial of SILC vs multiport cholecystectomy (4PLC). Study Design: Patients with biliary colic and documented gallstones or polyps or with biliary dyskinesia were randomized to SILC vs 4PLC. Data measures included operative details, adverse events, and conversion to 4PLC or laparotomy. Patients were followed for 12 months. Results: Two hundred patients underwent randomization to SILC (n = 119) or 4PLC (n = 81). Enrollment ranged from 1 to 50 patients with 4 sites enrolling >25 patients. Total adverse events were not significantly different between groups (36{\%} 4PLC vs 45{\%} SILC; p = 0.24), as were severe adverse events (4{\%} 4PLC vs 10{\%} SILC; p = 0.11). Incision-related adverse events were higher after SILC (11.7{\%} vs 4.9{\%}; p = 0.13), but all of these were listed as mild or moderate. Total hernia rates were 1.2{\%} (1 of 81) in 4PLC patients vs 8.4{\%} (10 of 119) in SILC patients (p = 0.03). At 1-year follow-up, cosmesis scores continued to favor SILC (p < 0.0001). Conclusions: Results of this trial show SILC to be a safe and feasible procedure when compared with 4PLC, with similar total adverse events but with an identified significant increase in hernia formation. Cosmesis scoring and patient preference at 12 months continue to favor SILC, and more than half of the patients were willing to pay more for a single-site surgery over a standard laparoscopic procedure. Additional longer-term population-based studies are needed to clarify if this increased rate of hernia formation as compared with 4PLC will continue to hold true.",
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T1 - Single-incision laparoscopic cholecystectomy is associated with improved cosmesis scoring at the cost of significantly higher hernia rates

T2 - 1-year results of a prospective randomized, multicenter, single-blinded trial of traditional multiport laparoscopic cholecystectomy vs single-incision laparoscopic cholecystectomy

AU - Marks, Jeffrey M.

AU - Lapinska, Melissa

AU - Tacchino, Roberto

AU - Roberts, Kurt

AU - Onders, Raymond

AU - Denoto, George

AU - Gecelter, Gary

AU - Rubach, Eugene

AU - Rivas, Homero

AU - Islam, Arsalla

AU - Soper, Nathaniel

AU - Paraskeva, Paraskevas

AU - Rosemurgy, Alexander

AU - Ross, Sharona

AU - Shah, Sajani

PY - 2013/6/1

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N2 - Background: Minimally invasive techniques have become an integral part of general surgery with recent investigation into single-incision laparoscopic cholecystectomy (SILC). This study presents the final 1-year results of a prospective, randomized, multicenter, single-blinded trial of SILC vs multiport cholecystectomy (4PLC). Study Design: Patients with biliary colic and documented gallstones or polyps or with biliary dyskinesia were randomized to SILC vs 4PLC. Data measures included operative details, adverse events, and conversion to 4PLC or laparotomy. Patients were followed for 12 months. Results: Two hundred patients underwent randomization to SILC (n = 119) or 4PLC (n = 81). Enrollment ranged from 1 to 50 patients with 4 sites enrolling >25 patients. Total adverse events were not significantly different between groups (36% 4PLC vs 45% SILC; p = 0.24), as were severe adverse events (4% 4PLC vs 10% SILC; p = 0.11). Incision-related adverse events were higher after SILC (11.7% vs 4.9%; p = 0.13), but all of these were listed as mild or moderate. Total hernia rates were 1.2% (1 of 81) in 4PLC patients vs 8.4% (10 of 119) in SILC patients (p = 0.03). At 1-year follow-up, cosmesis scores continued to favor SILC (p < 0.0001). Conclusions: Results of this trial show SILC to be a safe and feasible procedure when compared with 4PLC, with similar total adverse events but with an identified significant increase in hernia formation. Cosmesis scoring and patient preference at 12 months continue to favor SILC, and more than half of the patients were willing to pay more for a single-site surgery over a standard laparoscopic procedure. Additional longer-term population-based studies are needed to clarify if this increased rate of hernia formation as compared with 4PLC will continue to hold true.

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