L. P. S. Stassen

Mechanical bowel preparation for elective colorectal surgery: a multicentre randomised trial

BACKGROUNDnMechanical bowel preparation is a common practice before elective colorectal surgery. We aimed to compare the rate of anastomotic leakage after elective colorectal resections and primary anastomoses between patients who did or did not have mechanical bowel preparation.nnnMETHODSnWe did a multicentre randomised non-inferiority study at 13 hospitals. We randomly assigned 1431 patients who were going to have elective colorectal surgery to either receive mechanical bowel preparation or not. Patients who did not have mechanical bowel preparation had a normal meal on the day before the operation. Those who did were given a fluid diet, and mechanical bowel preparation with either polyethylene glycol or sodium phosphate. The primary endpoint was anastomotic leakage, and the study was designed to test the hypothesis that patients who are given mechanical bowel preparation before colorectal surgery do not have a lower risk of anastomotic leakage than those who are not. The median follow-up was 24 days (IQR 17-34). We analysed patients who were treated as per protocol. This study is registered with ClinicalTrials.gov, number NCT00288496.nnnFINDINGSn77 patients were excluded: 46 who did not have a bowel resection; 21 because of missing outcome data; and 10 who withdrew, cancelled, or were excluded for other reasons. The rate of anastomotic leakage did not differ between both groups: 32/670 (4.8%) patients who had mechanical bowel preparation and 37/684 (5.4%) in those who did not (difference 0.6%, 95% CI -1.7% to 2.9%, p=0.69). Patients who had mechanical bowel preparation had fewer abscesses after anastomotic leakage than those who did not (2/670 [0.3%] vs 17/684 [2.5%], p=0.001). Other septic complications, fascia dehiscence, and mortality did not differ between groups.nnnINTERPRETATIONnWe advise that mechanical bowel preparation before elective colorectal surgery can safely be abandoned.

Fewer intraperitoneal adhesions with use of hyaluronic acid-carboxymethylcellulose membrane: a randomized clinical trial.

ObjectiveTo assess the effectiveness of bioresorbable Seprafilm membrane in preventing abdominal adhesions in a prospective clinical randomized multicenter trial. Summary Background DataAdhesions occur frequently after abdominal operations and are a common cause of bowel obstruction, chronic abdominal pain, and infertility. To reduce the formation of adhesions, a mechanical barrier composed of hyaluronic acid and carboxymethylcellulose was developed, preventing adherence of tissues after abdominal surgery. MethodsBetween April 1996 and September 1998, all patients requiring a Hartmann procedure for sigmoid diverticulitis or obstructed rectosigmoid were randomized to either intraperitoneal placement of the antiadhesions membrane under the midline during laparotomy and in the pelvis, or as a control. Direct visual evaluation of the incidence and severity of adhesions was performed laparoscopically at second-stage surgery for restoration of the continuity of the colon. ResultsA total of 71 patients were randomized; of these, 42 could be evaluated. The incidence of adhesions did not differ significantly between the two groups, but the severity of adhesions was significantly reduced in the Seprafilm group both for the midline incision and for the pelvic area. Complications occurred in similar numbers in both groups. ConclusionsSeprafilm antiadhesions membrane appears effective in reducing the severity of postoperative adhesions after major abdominal surgery, although the incidence of adhesions was not diminished. The authors recommend using Seprafilm when relaparotomy or second-look intervention is planned. Long-term studies are needed to assess the cost-effectiveness and value of Seprafilm in preventing bowel obstruction, chronic abdominal pain, and infertility.

Total Extraperitoneal Inguinal Hernia Repair Compared With Lichtenstein (the Level-trial): A Randomized Controlled Trial

Background:This randomized controlled trial was designed to compare the most common technique for open mesh repair (Lichtenstein) with the currently preferred minimally invasive technique (total extra peritoneal, TEP) for the surgical correction of inguinal hernia. Methods:A total of 660 patients were randomized to Lichtenstein or TEP procedure. Primary outcomes were postoperative pain, length of hospital stay, period until complete recovery, and quality of life (QOL). Recurrences, operating time, complications, chronic pain, and costs were secondary endpoints. This study was registered at www.clinicaltrials.gov and carries the ID: NCT00788554. Results:About 336 patients were randomized to TEP, and 324 to Lichtenstein repair. TEP was associated with less postoperative pain until 6 weeks postoperatively (P = 0.01). Chronic pain was comparable (25% vs. 29%). Less impairment of inguinal sensibility was seen after TEP (7% vs. 30%, P = 0.01). Mean operating time for a unilateral hernia with TEP was longer (54 vs. 49 minutes, P = 0.03) but comparable for bilateral hernias. Incidence of adverse events during surgery was higher with TEP (5.8% vs. 1.6%, P < 0.004), but postoperative complications (33% vs. 33%), hospital stay and QOL were similar. After TEP, patients had a faster recovery of daily activities (ADL) and less absence from work (P = 0.01). After a mean follow-up of 49 months, recurrences (3.8% vs. 3.0%, P = 0.64) and total costs (&U20AC;3.096 vs. &U20AC;3.198) were similar. Conclusion:TEP procedure was associated with more adverse events during surgery but less postoperative pain, faster recovery of daily activities, quicker return to work, and less impairment of sensibility after 1 year. Recurrence rates and chronic pain were comparable. TEP is recommended in experienced hands.

Requirements for the design and implementation of checklists for surgical processes

BackgroundThe use of checklists is a promising strategy for improving patient safety in all types of surgical processes inside and outside the operating room. This article aims to provide requirements and implementation of checklists for surgical processes.MethodsThe literature on checklist use in the operating room was reviewed based on research using Medline, Pubmed, and Google Scholar. Although all the studies showed positive effects and important benefits such as improved team cohesion, improved awareness of safety issues, and reduction of errors, their number still is limited. The motivation of team members is considered essential for compliance. Currently, no general guidelines exist for checklist design in the surgical field. Based on the authors’ experiences and on guidelines used in the aviation industry, requirements for the checklist design are proposed. The design depends on the checklist purpose, philosophy, and method chosen. The methods consist of the “call-do-response” approach,” the “do-verify” approach, or a combination of both. The advantages and disadvantages of paper versus electronic solutions are discussed. Furthermore, a step-by-step strategy of how to implement a checklist in the clinical situation is suggested.ConclusionsThe use of structured checklists in surgical processes is most likely to be effective because it standardizes human performance and ensures that procedures are followed correctly instead of relying on human memory alone. Several studies present promising and positive first results, providing a solid basis for further investigation. Future research should focus on the effect of various checklist designs and strategies to ensure maximal compliance.

Validation of a new basic virtual reality simulator for training of basic endoscopic skills

BackgroundThe aim of this study was to establish content, face, concurrent, and the first step of construct validity of a new simulator, the SIMENDO, in order to determine its usefulness for training basic endoscopic skills.MethodsThe validation started with an explanation of the goals, content, and features of the simulator (content validity). Then, participants from eight different medical centers consisting of experts (≥100 laparoscopic procedures performed) and surgical trainees (<100) were informed of the goals and received a “hands-on tour” of the virtual reality (VR) trainer. Subsequently, they were asked to answer 28 structured questions about the simulator (face validity). Ratings were scored on a scale from 1 (very bad/useless) to 5 (excellent/very useful). Additional comments could be given as well. Furthermore, two experiments were conducted. In experiment 1, aimed at establishing concurrent validity, the training effect of a single-handed hand–eye coordination task in the simulator was compared with a similar task in a conventional box trainer and with the performance of a control group that received no training. In experiment 2 (first step of construct validity), the total score of task time, collisions, and path length of three consecutive runs in the simulator was compared between experts (>100 endoscopic procedures) and novices (no experience).ResultsA total of 75 participants (36 expert surgeons and 39 surgical trainees) filled out the questionnaire. Usefulness of tasks, features, and movement realism were scored between a mean value of 3.3 for depth perception and 4.3 for appreciation of training with the instrument. There were no significant differences between the mean values of the scores given by the experts and surgical trainees. In response to statements, 81% considered this VR trainer generally useful for training endoscopic techniques to residents, and 83% agreed that the simulator was useful to train hand–eye coordination. In experiment 1, the training effect for the single-handed task showed no significant difference between the conventional trainer and the VR simulator (concurrent validity). In experiment 2, experts scored significantly better than novices on all parameters used (construct validity).ConclusionContent, face, and concurrent validity of the SIMENDO is established. The simulator is considered useful for training eye–hand coordination for endoscopic surgery. The evaluated task could discriminate between the skills of experienced surgeons and novices, giving the first indication of construct validity.

Transfer validity of laparoscopic knot-tying training on a VR simulator to a realistic environment: A randomized controlled trial

BackgroundLaparoscopic suturing is one of the most difficult tasks in endoscopic surgery, requiring extensive training. The aim of this study was to determine the transfer validity of knot-tying training on a virtual-reality (VR) simulator to a realistic laparoscopic environment.MethodsTwenty surgical trainees underwent basic eye–hand coordination training on a VR simulator (SIMENDO, DelltaTech, Delft, the Netherlands) until predefined performance criteria were met. Then, they were randomized into two groups. Group A (the experimental group) received additional training with the knot-tying module on the simulator, during which they had to tie a double laparoscopic knot ten times. Group B (controls) did not receive additional manual training.Within a week the participants tied a double knot in the abdominal cavity of an anaesthetized porcine model. Their performance was captured on digital video and coded. Objective analysis parameters were: time taken to tie the knot and number of predefined errors made. Subjective assessments were also made by two laparoscopic surgeons using a global rating list with a five-point Likert scale.ResultsTrainees in group A (nxa0=xa09) were significantly faster than the controls (nxa0=xa010), with a median of 262 versus 374 seconds (pxa0=xa00.034). Group A made a significantly lower number of errors than the controls (median of 24 versus 36 errors, pxa0=xa00.030). Subjective assessments by the laparoscopic experts did not show any significant differences in economy of movement and erroneous behavior between the two groups.ConclusionSurgical trainees who received knot-tying training on the VR simulator were faster and made fewer errors than the controls. The VR module is a useful tool to train laparoscopic knot-tying. Opportunities arose to improve simulator-based instruction that might enhance future training.

Problems with technical equipment during laparoscopic surgery - An observational study

BackgroundThis study was designed to investigate the incidence of technical equipment problems during laparoscopic procedures.MethodsA video-capturing system was used, consisting of an analog video recorder with three camera image inputs and a microphone. Problems with all technical equipment used by the surgical team, such as the insufflator, diathermy apparatus, monitors, light source, camera and camera unit, endoscope, suction devices, and instruments, were registered.ResultsIn total, 30 procedures were randomly videotaped. In 87% (26/30) of the procedures, one or more incidents with technical equipment (49 incidents) or instruments (9 incidents) occurred. In 22 of those incidents (45%) the technical equipment was not correctly positioned or not present at all; in the other 27 (55%), the equipment malfunctioned as a result of a faulty connection (9), a defect (5), or the wrong setting of the equipment (3). In 10 (20%) cases the exact cause of equipment malfunctioning was unclear.ConclusionsThe incidence of problems with laparoscopic technical equipment is high. To prevent such problems, improvement and standardization of equipment is needed, combined with the incorporation of checklist use before the start of a surgical procedure. Future research should be aimed at development, implementation, and evaluation of these measures into the operating room.

Construct validity and assessment of the learning curve for the SIMENDO endoscopic simulator.

BackgroundThe SIMENDO is an affordable virtual reality simulator designed to train basic psychomotor skills for endoscopic surgery. This study aimed first to establish construct validity by determining which parameters can discriminate groups with different experience levels, and second to establish the extent to which training is useful by determining when inexperienced groups reach expert level.MethodsThe study participants were divided into four groups according to their experience with endoscopic procedures: experienced group (group A, >50 procedures performed, nxa0=xa015), intermediate group (group B, 1–50 procedures performed, nxa0=xa018), endoscope navigation group (group C, endoscope navigation experience, nxa0=xa014), and novice group (group D, no endoscopic experience, nxa0=xa014). Each participant performed three repetitions of six consecutive exercises. The parameters studied were task time, path length of the instruments, and number of errors (collisions). Some participants continued training up to 10 repetitions to get insight in the learning curve.ResultsGroup A (expert) outperformed all the other groups (B, C, and D) in terms of total median task time (pxa0<xa00.05), groups C and D in terms of path length, and group D in terms of collision frequency in the first two repetitions. Group B (intermediate) outperformed group D (novice) in total time and endoscope path length for all repetitions, and group C (camera navigation) outperformed group D (novice) in the first repetition. Less experienced groups D and C did not reach expert level for the task time within 10 repetitions, and group B reached it after the eighth repetition (pxa0<xa00.05).ConclusionThe study was able to establish construct validity for the training program with the simulator under study. The learning curve showed that training with this simulator is useful for subjects with or without limited endoscopic experience. Furthermore, previous endoscopic camera navigation already improves motor skills to more than the basic level.

Randomized clinical trial of total extraperitoneal inguinal hernioplasty vs lichtenstein repair: A long-term follow-up study

HYPOTHESISnMesh repair is generally preferred for surgical correction of inguinal hernia, although the merits of endoscopic techniques over open surgery are still debated. Herein, minimally invasive total extraperitoneal inguinal hernioplasty (TEP) was compared with Lichtenstein repair to determine if one is associated with less postoperative pain, hypoesthesia, and hernia recurrence.nnnDESIGNnProspective multicenter randomized clinical trial.nnnSETTINGnAcademic research.nnnPATIENTSnSix hundred sixty patients were randomized to TEP or Lichtenstein repair.nnnMAIN OUTCOME MEASURESnThe primary outcome was postoperative pain. Secondary end points were hernia recurrence, operative complications, operating time, length of hospital stay, time to complete recovery, quality of life, chronic pain, and operative costs.nnnRESULTSnAt 5 years after surgery, TEP was associated with less chronic pain (Pxa0=xa0.004). Impairment of inguinal sensibility was less frequently seen after TEP vs Lichtenstein repair (1% vs 22%, Pxa0<xa0.001). Operative complications were more frequent after TEP vs Lichtenstein repair (6% vs 2%, Pxa0<xa0.001), while no difference was noted in length of hospital stay. After TEP, patients had faster time to return to daily activities (Pxa0<xa0.002) and less absence from work (Pxa0=xa0.001). Although operative costs were higher for TEP, total costs were comparable for the 2 procedures, as were overall hernia recurrences at 5 years after surgery. However, among experienced surgeons, significantly lower hernia recurrence rates were seen after TEP (Pxa0<xa0.001).nnnCONCLUSIONSnIn the short term, TEP was associated with more operative complications, longer operating time, and higher operative costs; however, total costs were comparable for the 2 procedures. Chronic pain and impairment of inguinal sensibility were more frequent after Lichtenstein repair. Although overall hernia recurrence rates were comparable for both procedures, hernia recurrence rates among experienced surgeons were significantly lower after TEP. Patient satisfaction was also significantly higher after TEP. Therefore, TEP should be recommended in experienced hands. Trial Registrationxa0 clinicaltrials.gov Identifier: NCT00788554.

Fundamental aspects of learning minimally invasive surgical skills.

With the introduction of minimally invasive surgery (MIS) the necessity to develop training methods to learn skills outside the operating room (OR) became clear. Several training simulators have become commercially available. However, fundamental research into the requirements for effective and efficient training in MIS is still lacking. Yet in the literature several learning models have been described that may be used when designing the structure of a training program. While learning skills, three stages can be observed: cognitive, associative and autonomous. The learning cycle also includes different learning styles and, moreover, every trainee has his/her preferred learning style. Furthermore, training should be adapted to the level of behaviour: skill‐based, rule‐based or knowledge‐based. Training of complex skills should include multiple performance objectives, such as just‐in‐time supportive information and part‐task practice. Finally, motivation for training can be created by assessment. In conclusion, several theories on learning can be found in the literature. These theories may help in the development of effective training programs for training MIS skills outside the OR.