Prospective, randomized, double-blind trial of curriculum-based training for intracorporeal suturing and knot tying.

BACKGROUND: Advanced surgical skills such as laparoscopic suturing are difficult to learn in an operating room environment. The use of simulation within a defined skills-training curriculum is attractive for instructor, trainee, and patient. This study examined the impact of a curriculum-based approach to laparoscopic suturing and knot tying. STUDY DESIGN: Senior surgery residents in a university-based general surgery residency program were prospectively enrolled and randomized to receive either a simulation-based laparoscopic suturing curriculum (TR group, n=11) or standard clinical training (NR group, n=11). During a laparoscopic Nissen fundoplication, placement of two consecutive intracorporeally knotted sutures was video recorded for analysis. Operative performance was assessed by two reviewers blinded to subject training status using a validated, error-based system to an interrater agreement of >or=80%. Performance measures assessed were time, errors, and needle manipulations, and comparisons between groups were made using an unpaired t-test. RESULTS: Compared with NR subjects, TR subjects performed significantly faster (total time, 526+/-189 seconds versus 790+/-171 seconds; p < 0.004), made significantly fewer errors (total errors, 25.6+/-9.3 versus 37.1+/-10.2; p < 0.01), and had 35% fewer excess needle manipulations (18.5+/-10.5 versus 27.3+/-8.6; p < 0.05). CONCLUSIONS: Subjects who receive simulation-based training demonstrate superior intraoperative performance of a highly complex surgical skill. Integration of such skills training should become standard in a surgical residency's skills curriculum.

Construct validity of an objective assessment method for laparoscopic intracorporeal suturing and knot tying.

BACKGROUND: The ideal objective assessment method for laparoscopic technical skills is difficult to achieve in the operating room. Recent "VR2OR" studies have used a blinded, 2-reviewer error-based video tape analysis for intraoperative performance assessment. This study examines the validity of this methodology applied to laparoscopic intracorporeal suturing and knot tying. METHODS: Four groups of subjects--experts (EX), surgery residents trained to expert criterion levels using simulation (TR), surgery residents receiving no supplemental training (NR), and medical students receiving simulation-based training (MS)--performed the fundal suturing portion of a laparoscopic Nissen fundoplication and were video-recorded for analysis. Two separate groups of surgeon reviewers (K.V.S. + M.B.; I.-P.H. + A.G.) were trained to evaluate laparoscopic suturing and knot tying performance using specific metrics. Subjects' operative performance was assessed by reviewers blinded to their training status and scored using an error-based, step specific scoring system to an inter-rater agreement of 80% or greater. Three primary performance measures were assessed: time, errors, and needle manipulations and comparisons between groups were made using a 1-way analysis of variance (ANOVA) with post-test. RESULTS: A total of 40 fundal sutures (10 in each group) were scored by 2 separate rater groups with inter-rater agreement consistently greater than 80%. Inter-rater agreement was highest with the EX group (91%, range 76%-100%) and lowest with the NR group (85%, range 81%-98%). On average, the EX group significantly outperformed the other groups with regards to time (P <.0001), errors (P <.002), and needle manipulations (P <.01). Performance of the TR group was comparable to the EX group with regards to errors and manipulations (P = not significant [NS]), and outperformed the NR and MS groups with regards to time (P <.05 and P <.001). Performance between the NR and MS groups were similar for all 3 measures. CONCLUSIONS: This assessment method demonstrates discriminative validity. Time appears to be the most sensitive indicator of skill level, as significant differences between EX, TR, and NR/MS groups were seen. The methodology is transferable across different reviewers and is acceptable for high-stakes assessment.

Incidental gallbladder carcinoma associated with a cholecystoduodenal fistula.

The development of a cholecystoduodenal fistula may complicate 5% of all patients with cholelithiasis. It has been theorized that a cholecystoduodenal fistula may represent a significant risk factor in the development of gallbladder carcinoma because of the chronic reflux of duodenal contents. We report the case of a patient with a cholecystoduodenal fistula and an early gallbladder cancer to support this theory. Once developed, gallbladder cancer has a very poor prognosis. Early detection with timely resection is necessary to improve the survival rate in gallbladder carcinoma patients.