Intermediate results of a prospective randomized controlled trial of traditional four-port laparoscopic cholecystectomy versus single-incision laparoscopic cholecystectomy

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

Research output: Contribution to journalArticle

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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 a prospective, randomized, multicenter, single-blind trial of SILC compared with fourport cholecystectomy (4PLC) with the goal of assessing safety, feasibility, and factors predicting outcomes. Methods Patients with biliary colic and documented gallstones or polyps or with biliary dyskinesia were randomized to SILC or 4PLC. Data measures included operative details, adverse events, and conversion to 4PLC or laparotomy. Pain, cosmesis, and quality-of-life scores were documented. Patients were followed for 12 months. Results Two hundred patients were randomized to SILC (n = 117) or 4PLC (n = 80) (3 patients chose not to participate after randomization). Patients were similar except for body mass index (BMI), which was lower in the SILC patients (28.9 vs. 31.0, p = 0.011). One SILC patient required conversion to 4PLC. Operative time was longer for SILC (57 vs. 45 min, p < 0.0001), but outcomes, including total adverse events, were similar (34% vs. 38%, p = 0.55). Cosmesis scores favored SILC (p < 0.002), but pain scores were lower for 4PLC (1 point difference in 10-point scale, p < 0.028) despite equal analgesia use. Wound complications were greater after SILC (10% vs. 3%, p = 0.047), but hernia recurrence was equivalent for both procedures (1.3% vs. 3.4%, p = 0.65). Univariate analysis showed female gender, SILC, and younger age to be predictors for increased pain scores, while SILC was associated with improved cosmesis scores. Conclusions In this multicenter randomized controlled trial of SILC versus 4PLC, SILC appears to be safe with a similar biliary complication profile. Pain scores and wound complication rates are higher for SILC; however, cosmesis scores favored SILC. For patients preferring a better cosmetic outcome and willing to accept possible increased postoperative pain, SILC offers a safe alternative to the standard 4PLC. Further follow-up is needed to detail the long-term risk of wound morbidities, including hernia recurrence.

Original languageEnglish (US)
Pages (from-to)1296-1303
Number of pages8
JournalSurgical Endoscopy and Other Interventional Techniques
Volume26
Issue number5
DOIs
StatePublished - May 1 2012
Externally publishedYes

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Laparoscopic Cholecystectomy
Randomized Controlled Trials
Pain
Hernia
Wounds and Injuries
Biliary Dyskinesia
Recurrence
Colic
Cholecystectomy
Gallstones
Operative Time
Postoperative Pain
Random Allocation
Polyps
Cosmetics
Analgesia
Laparotomy

All Science Journal Classification (ASJC) codes

  • Surgery

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Intermediate results of a prospective randomized controlled trial of traditional four-port laparoscopic cholecystectomy versus single-incision laparoscopic cholecystectomy. / Lapinska, Melissa; Marks, Jeffrey M.; Roberts, Kurt; Tacchino, Roberto; Onders, Raymond; DeNoto, George; Rivas, Homero; Islam, Arsalla; Soper, Nathaniel; Gecelter, Gary; Rubach, Eugene; Paraskeva, Paraskevas; Shah, Sajani.

In: Surgical Endoscopy and Other Interventional Techniques, Vol. 26, No. 5, 01.05.2012, p. 1296-1303.

Research output: Contribution to journalArticle

Lapinska, Melissa ; Marks, Jeffrey M. ; Roberts, Kurt ; Tacchino, Roberto ; Onders, Raymond ; DeNoto, George ; Rivas, Homero ; Islam, Arsalla ; Soper, Nathaniel ; Gecelter, Gary ; Rubach, Eugene ; Paraskeva, Paraskevas ; Shah, Sajani. / Intermediate results of a prospective randomized controlled trial of traditional four-port laparoscopic cholecystectomy versus single-incision laparoscopic cholecystectomy. In: Surgical Endoscopy and Other Interventional Techniques. 2012 ; Vol. 26, No. 5. pp. 1296-1303.
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title = "Intermediate results of a prospective randomized controlled trial of traditional four-port laparoscopic cholecystectomy versus 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 a prospective, randomized, multicenter, single-blind trial of SILC compared with fourport cholecystectomy (4PLC) with the goal of assessing safety, feasibility, and factors predicting outcomes. Methods Patients with biliary colic and documented gallstones or polyps or with biliary dyskinesia were randomized to SILC or 4PLC. Data measures included operative details, adverse events, and conversion to 4PLC or laparotomy. Pain, cosmesis, and quality-of-life scores were documented. Patients were followed for 12 months. Results Two hundred patients were randomized to SILC (n = 117) or 4PLC (n = 80) (3 patients chose not to participate after randomization). Patients were similar except for body mass index (BMI), which was lower in the SILC patients (28.9 vs. 31.0, p = 0.011). One SILC patient required conversion to 4PLC. Operative time was longer for SILC (57 vs. 45 min, p < 0.0001), but outcomes, including total adverse events, were similar (34{\%} vs. 38{\%}, p = 0.55). Cosmesis scores favored SILC (p < 0.002), but pain scores were lower for 4PLC (1 point difference in 10-point scale, p < 0.028) despite equal analgesia use. Wound complications were greater after SILC (10{\%} vs. 3{\%}, p = 0.047), but hernia recurrence was equivalent for both procedures (1.3{\%} vs. 3.4{\%}, p = 0.65). Univariate analysis showed female gender, SILC, and younger age to be predictors for increased pain scores, while SILC was associated with improved cosmesis scores. Conclusions In this multicenter randomized controlled trial of SILC versus 4PLC, SILC appears to be safe with a similar biliary complication profile. Pain scores and wound complication rates are higher for SILC; however, cosmesis scores favored SILC. For patients preferring a better cosmetic outcome and willing to accept possible increased postoperative pain, SILC offers a safe alternative to the standard 4PLC. Further follow-up is needed to detail the long-term risk of wound morbidities, including hernia recurrence.",
author = "Melissa Lapinska and Marks, {Jeffrey M.} and Kurt Roberts and Roberto Tacchino and Raymond Onders and George DeNoto and Homero Rivas and Arsalla Islam and Nathaniel Soper and Gary Gecelter and Eugene Rubach and Paraskevas Paraskeva and Sajani Shah",
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T1 - Intermediate results of a prospective randomized controlled trial of traditional four-port laparoscopic cholecystectomy versus single-incision laparoscopic cholecystectomy

AU - Lapinska, Melissa

AU - Marks, Jeffrey M.

AU - Roberts, Kurt

AU - Tacchino, Roberto

AU - Onders, Raymond

AU - DeNoto, George

AU - Rivas, Homero

AU - Islam, Arsalla

AU - Soper, Nathaniel

AU - Gecelter, Gary

AU - Rubach, Eugene

AU - Paraskeva, Paraskevas

AU - Shah, Sajani

PY - 2012/5/1

Y1 - 2012/5/1

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 a prospective, randomized, multicenter, single-blind trial of SILC compared with fourport cholecystectomy (4PLC) with the goal of assessing safety, feasibility, and factors predicting outcomes. Methods Patients with biliary colic and documented gallstones or polyps or with biliary dyskinesia were randomized to SILC or 4PLC. Data measures included operative details, adverse events, and conversion to 4PLC or laparotomy. Pain, cosmesis, and quality-of-life scores were documented. Patients were followed for 12 months. Results Two hundred patients were randomized to SILC (n = 117) or 4PLC (n = 80) (3 patients chose not to participate after randomization). Patients were similar except for body mass index (BMI), which was lower in the SILC patients (28.9 vs. 31.0, p = 0.011). One SILC patient required conversion to 4PLC. Operative time was longer for SILC (57 vs. 45 min, p < 0.0001), but outcomes, including total adverse events, were similar (34% vs. 38%, p = 0.55). Cosmesis scores favored SILC (p < 0.002), but pain scores were lower for 4PLC (1 point difference in 10-point scale, p < 0.028) despite equal analgesia use. Wound complications were greater after SILC (10% vs. 3%, p = 0.047), but hernia recurrence was equivalent for both procedures (1.3% vs. 3.4%, p = 0.65). Univariate analysis showed female gender, SILC, and younger age to be predictors for increased pain scores, while SILC was associated with improved cosmesis scores. Conclusions In this multicenter randomized controlled trial of SILC versus 4PLC, SILC appears to be safe with a similar biliary complication profile. Pain scores and wound complication rates are higher for SILC; however, cosmesis scores favored SILC. For patients preferring a better cosmetic outcome and willing to accept possible increased postoperative pain, SILC offers a safe alternative to the standard 4PLC. Further follow-up is needed to detail the long-term risk of wound morbidities, including hernia recurrence.

AB - Background Minimally invasive techniques have become an integral part of general surgery, with recent investigation into single-incision laparoscopic cholecystectomy (SILC). This study presents a prospective, randomized, multicenter, single-blind trial of SILC compared with fourport cholecystectomy (4PLC) with the goal of assessing safety, feasibility, and factors predicting outcomes. Methods Patients with biliary colic and documented gallstones or polyps or with biliary dyskinesia were randomized to SILC or 4PLC. Data measures included operative details, adverse events, and conversion to 4PLC or laparotomy. Pain, cosmesis, and quality-of-life scores were documented. Patients were followed for 12 months. Results Two hundred patients were randomized to SILC (n = 117) or 4PLC (n = 80) (3 patients chose not to participate after randomization). Patients were similar except for body mass index (BMI), which was lower in the SILC patients (28.9 vs. 31.0, p = 0.011). One SILC patient required conversion to 4PLC. Operative time was longer for SILC (57 vs. 45 min, p < 0.0001), but outcomes, including total adverse events, were similar (34% vs. 38%, p = 0.55). Cosmesis scores favored SILC (p < 0.002), but pain scores were lower for 4PLC (1 point difference in 10-point scale, p < 0.028) despite equal analgesia use. Wound complications were greater after SILC (10% vs. 3%, p = 0.047), but hernia recurrence was equivalent for both procedures (1.3% vs. 3.4%, p = 0.65). Univariate analysis showed female gender, SILC, and younger age to be predictors for increased pain scores, while SILC was associated with improved cosmesis scores. Conclusions In this multicenter randomized controlled trial of SILC versus 4PLC, SILC appears to be safe with a similar biliary complication profile. Pain scores and wound complication rates are higher for SILC; however, cosmesis scores favored SILC. For patients preferring a better cosmetic outcome and willing to accept possible increased postoperative pain, SILC offers a safe alternative to the standard 4PLC. Further follow-up is needed to detail the long-term risk of wound morbidities, including hernia recurrence.

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