3D laparoscopy does not reduce operative duration or errors in day-case laparoscopic cholecystectomy: a randomised controlled trial

Katie E Schwab, Nathan J Curtis, Martin B Whyte, Ralph V Smith, Timothy A Rockall, Karen Ballard, Iain C Jourdan, Katie E Schwab, Nathan J Curtis, Martin B Whyte, Ralph V Smith, Timothy A Rockall, Karen Ballard, Iain C Jourdan

Abstract

Background: Contemporary 3D platforms have overcome past deficiencies. Available trainee and laboratory studies suggest stereoscopic imaging improves performance but there is little clinical data or studies assessing specialists. We aimed to determine whether stereoscopic (3D) laparoscopic systems reduce operative time and number of intraoperative errors during specialist-performed laparoscopic cholecystectomy (LC).

Methods: A parallel arm (1:1) randomised controlled trial comparing 2D and 3D passive-polarised laparoscopic systems in day-case LC using was performed. Eleven consultant surgeons that had each performed > 200 LC (including > 10 3D LC) participated. Cases were video recorded and a four-point difficulty grade applied. The primary outcome was overall operative time. Subtask time and the number of intraoperative consequential errors as identified by two blinded assessors using a hierarchical task analysis and the observational clinical human reliability analysis technique formed secondary endpoints.

Results: 112 patients were randomised. There was no difference in operative time between 2D and 3D LC (23:14 min (± 10:52) vs. 20:17 (± 9:10), absolute difference - 14.6%, p = 0.148) although 3D surgery was significantly quicker in difficulty grade 3 and 4 cases (30:23 min (± 9:24), vs. 18:02 (± 7:56), p < 0.001). No differences in overall error count was seen (total 47, median 1, range 0-4 vs. 45, 1, 0-3, p = 0.62) although there were significantly fewer 3D gallbladder perforations (15 vs. 6, p = 0.034).

Conclusion: 3D laparoscopy did not reduce overall operative time or error frequency in laparoscopic cholecystectomies performed by specialist surgeons. 3D reduced Calot's dissection time and operative time in complex cases as well as the incidence of iatrogenic gallbladder perforation (NCT01930344).

Keywords: 3D; Cholecystectomy; Gallbladder; Laparoscopic; Three-dimensional; Trial.

Conflict of interest statement

Ms. Schwab, Mr. Curtis, Dr. Whyte, Mr. Smith, Prof. Rockall, Prof. Ballard and Mr. Jourdan confirm they hold no conflict of interest or financial ties to disclose.

Figures

Fig. 1
Fig. 1
Trial CONSORT diagram. 136 day-case LC were performed during the study period. 16 (11.7%) were not approached due to researcher unavailability. Of the 120 patients screened for eligibility, 113 approached with 112 consenting to trial entry (99.1%, 82.4% of all unit LC). Attrition was 11%, equal between the arms and inside study design. Incomplete video was the main reason
Fig. 2
Fig. 2
Gallbladder grade is seen to have a larger impact on operative time. 3D was significantly faster for grade 3 and 4 cases

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