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Randomized Controlled Trial Comparative Study Clinical Trial
Prospective randomized blinded trial of pulmonary function, pain, and cosmetic results after laparoscopic vs. microlaparoscopic cholecystectomy.
- W Schwenk, J Neudecker, J Mall, B Böhm, and J M Müller.
- Department of General, Visceral, Vascular and Thoracic Surgery, Charité Medical School, Campus Mitte, Humboldt University of Berlin, Schumannstr. 20/21 D-10117 Berlin, Germany.
- Surg Endosc. 2000 Apr 1;14(4):345-8.
BackgroundThe size of laparoscopic instruments has been reduced for use in abdominal video endoscopic surgery. However, it has yet to be proven that microlaparoscopic surgery will actually result in clinically relevant benefits for patients.MethodsFifty patients were randomized in a blinded fashion to receive either elective laparoscopic (MINI), (n = 25) or microlaparoscopic (MICRO) (n = 25) cholecystectomy. Pulmonary function (FVC, FEV (1)), analgesic consumption during patient-controlled analgesia (PCA), pain perception by visual analogue score (VAS), and the cosmetic result (by the patient's self-assessment) were evaluated postoperatively as clinically relevant end points.ResultsAge, sex, body mass index (BMI), preoperative pulmonary function, pain perception, and operative time were similar for the two groups. At 8:00 PM on the day of surgery, FVC (MINI: 1.96 L [range, 1.48-2.48]; MICRO: 2.13 L) [(range, 1.61.-2.50)] and FEV (1) (MINI: 1.17 L/sec) [range, 0.87-1. 48]; MICRO: 1.34 L/sec [range, 1.05.-2.14] were also similar (each p = 0.5). From surgery to the 3rd postoperative day, cumulative PCA morphine doses were comparable (MINI: 0.15 mg/kg bw [range, 0.09-0. 23]; MICRO: 0.21 mg/kg bw [range, 0.10-0.42]; p = 0.4), but overall VAS scores for pain while coughing were higher in the laparoscopic group (406 [range, 358-514]) than in the microlaparoscopic group (365 [range, 215-427]; p = 0.02). The cosmetic result was judged to be slightly superior by the microlaparoscopic patients (10 [range, 9-10]), as compared to those in the laparoscopic (9 [range, 8-10]) group (p = 0.04).ConclusionBecause microlaparoscopic cholecystectomy has some minor advantages over laparoscopic surgery, it should be considered for use in selected patients.
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