Mohsen Alhashemi1,2,3, Mohammed Almahroos4,5,6, Julio F Fiore5,6, Pepa Kaneva5,6, Juan Mata Gutierrez4,5,6, Amy Neville7, Melina C Vassiliou4,5,6, Gerald M Fried4,5,6, Liane S Feldman4,5,6. 1. Department of Surgery, McGill University, Montreal, QC, Canada. mohsen.alhashemi@mail.mcgill.ca. 2. Steinberg-Bernstein Centre for Minimally Invasive Surgery, McGill University Health Centre, Montreal, QC, Canada. mohsen.alhashemi@mail.mcgill.ca. 3. McGill University Health Centre, 1650 Cedar Avenue, Rm L9-309, Montreal, QC, H3G 1A4, Canada. mohsen.alhashemi@mail.mcgill.ca. 4. Department of Surgery, McGill University, Montreal, QC, Canada. 5. Steinberg-Bernstein Centre for Minimally Invasive Surgery, McGill University Health Centre, Montreal, QC, Canada. 6. McGill University Health Centre, 1650 Cedar Avenue, Rm L9-309, Montreal, QC, H3G 1A4, Canada. 7. Department of Surgery, University of Ottawa, Ottawa, Canada.
Abstract
INTRODUCTION: We conducted a randomized trial comparing minilaparoscopic cholecystectomy (MLC) to conventional laparoscopic cholecystectomy (CLC) to determine whether MLC accelerated recovery of physical activity after elective surgery (NCT01397565). METHODS: A total of 115 patients scheduled for elective cholecystectomy were randomized to either CLC or MLC. Both procedures used a 10-mm umbilical port, but the three upper abdominal ports were 5 mm in CLC and 3 mm in MLC. Primary outcome was self-reported physical activity 1 month after surgery as estimated by Community Health Activities Model Program for Seniors questionnaire (kcal/kg/week). Secondary outcomes were umbilical pain, abdominal pain, nausea and fatigue (VAS, 1-10), and cosmetic result at one and 3 months. Patients received identical surgical dressings for 1 week, and assessors were blinded to group allocation. RESULTS: Forty-two patients randomized to CLC group and 33 patients randomized to MLC remained in the trial and were analyzed. Both groups were similar at baseline characteristics. In the MLC group, at least one 5-mm port was used in 17 (51.5 %) mainly due to unavailability of ML equipment. Median (IQR) physical activity for the CLC and MLC groups was similar at baseline (23.4 [13.1, 44.6] vs 23.6 [14.2, 66.9] kcal/kg/week, p = 0.35) and at 1 month (20 [7.9, 52.5] vs 16.8 [11.8, 28.6] kcal/kg/week, p = 0.90). One month post-op, umbilical pain and abdominal pain were similar, but the CLC group reported higher fatigue (4 [1-5] vs 1 [0-4], p = 0.05) and worse scar appearance scores (4 [3, 4] vs 4.5 [4, 5], p = 0.009). At 3 months, the CLC group had worse scar appearance (4 [3-5] vs 5 [4-5], p = 0.02) and lower scar satisfaction scores (4 [3, 4] vs 4 [3.5-4], p = 0.04). CONCLUSION:Recovery of physical activity was similar after MLC and CLC. MLC resulted in less fatigue and better scar appearance and satisfaction. These benefits were seen despite the need to upsize one or more ports in more than half of patients related to availability of the miniature instruments.
RCT Entities:
INTRODUCTION: We conducted a randomized trial comparing minilaparoscopic cholecystectomy (MLC) to conventional laparoscopic cholecystectomy (CLC) to determine whether MLC accelerated recovery of physical activity after elective surgery (NCT01397565). METHODS: A total of 115 patients scheduled for elective cholecystectomy were randomized to either CLC or MLC. Both procedures used a 10-mm umbilical port, but the three upper abdominal ports were 5 mm in CLC and 3 mm in MLC. Primary outcome was self-reported physical activity 1 month after surgery as estimated by Community Health Activities Model Program for Seniors questionnaire (kcal/kg/week). Secondary outcomes were umbilical pain, abdominal pain, nausea and fatigue (VAS, 1-10), and cosmetic result at one and 3 months. Patients received identical surgical dressings for 1 week, and assessors were blinded to group allocation. RESULTS: Forty-two patients randomized to CLC group and 33 patients randomized to MLC remained in the trial and were analyzed. Both groups were similar at baseline characteristics. In the MLC group, at least one 5-mm port was used in 17 (51.5 %) mainly due to unavailability of ML equipment. Median (IQR) physical activity for the CLC and MLC groups was similar at baseline (23.4 [13.1, 44.6] vs 23.6 [14.2, 66.9] kcal/kg/week, p = 0.35) and at 1 month (20 [7.9, 52.5] vs 16.8 [11.8, 28.6] kcal/kg/week, p = 0.90). One month post-op, umbilical pain and abdominal pain were similar, but the CLC group reported higher fatigue (4 [1-5] vs 1 [0-4], p = 0.05) and worse scar appearance scores (4 [3, 4] vs 4.5 [4, 5], p = 0.009). At 3 months, the CLC group had worse scar appearance (4 [3-5] vs 5 [4-5], p = 0.02) and lower scar satisfaction scores (4 [3, 4] vs 4 [3.5-4], p = 0.04). CONCLUSION: Recovery of physical activity was similar after MLC and CLC. MLC resulted in less fatigue and better scar appearance and satisfaction. These benefits were seen despite the need to upsize one or more ports in more than half of patients related to availability of the miniature instruments.
Authors: Ioannis D Gkegkes; Michael N Mavros; Vangelis G Alexiou; George Peppas; Stavros Athanasiou; Matthew E Falagas Journal: Surg Innov Date: 2011-09-16 Impact factor: 2.058
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