Methods of Colostomy Construction: No Effect on Parastomal Hernia Rate: Results from Stoma-const-A Randomized Controlled Trial.

OBJECTIVE: The primary objective of this trial was to compare the parastomal hernia rates 1 year after the construction of an end colostomy by 3 surgical techniques: cruciate incision, circular incision in the fascia and using prophylactic mesh. Secondary objectives were evaluation of postoperative complications, readmissions/reoperations, and risk factors for parastomal hernia. SUMMARY OF BACKGROUND DATA: Colostomy construction techniques have been explored with the aim to improve function and reduce stoma complications, but parastomal herniation is frequent with an incidence of approximately 50%. METHODS: A randomized, multicenter trial was performed in 3 hospitals in Sweden and Denmark; all patients scheduled to receive an end colostomy were asked to participate. Parastomal hernia within 12 months was determined by computed tomography of the abdomen in prone position and by clinical assessment. Complications, readmissions, reoperations, and risk factors were also assessed. RESULTS: Two hundred nine patients were randomized to 1 of the 3 arms of the study. Patient demographics were similar in all 3 groups. Assessment of parastomal hernia was possible in 185 patients. The risk ratio (95% confidence interval) for parastomal hernia was 1.25 (0.83; 1.88), and 1.22 (0.81; 1.84) between cruciate versus circular and cruciate versus mesh groups, respectively. There were no statistically significant differences between the groups with regard to parastomal hernia rate. Age and body mass index were found to be associated with development of a parastomal hernia. CONCLUSION: We found no significant differences in the rates of parastomal hernia within 12 months of index surgery between the 3 surgical techniques of colostomy construction.

Stoma-related complications: a report from the Stoma-Const randomized controlled trial.

AIM: The impact of construction techniques on the development of stoma complications is partly undiscovered. The aim of this paper was to report and analyse the impact of the three surgical techniques in a randomized controlled trial Stoma-Const on stoma-related complications as well as identifying risk factors and patient-reported stoma function as a planned secondary analysis. METHODS: This was a randomized, multicenter trial where all patients scheduled to receive an end colostomy were invited to participate. Patients were randomized to one of three techniques for stoma construction; cruciate fascial incision, circular incision or prophylactic mesh. Stoma complications were assessed by a surgeon and stoma care nurses within 1 year postoperatively. RESULTS: Two hundred and nine patients were randomized. Patient demographics were similar in all three groups. Data on stoma-related complications were available for analysis in 201 patients. A total of 127 patients (63%) developed some type of stoma complication within 1 year after surgery. The risk ratio (95% CI) for stoma complications was 0.93 (0.73; 1.2) between cruciate vs. circular incision groups and 1.02 (0.78; 1.34) between cruciate vs. mesh groups. There were no statistically significant differences between the groups regarding parastomal hernia rate and no risk factors could be identified. CONCLUSION: This randomized trial confirmed a high prevalence of stoma-related complications but could not identify an impact of surgical technique or identify modifiable risk factors for stoma-related complications.

Associations between intraoperative factors and surgeons' self-assessed operative satisfaction.

BACKGROUND: Little is known concerning what may influence surgeon satisfaction with a surgical procedure and its associations with intraoperative factors. The objective was to explore the relationships between surgeons' self-assessed satisfaction with performed radical prostatectomies and intraoperative factors such as technical difficulties and intraoperative complications as reported by the surgeon subsequent to the operation. METHODS: We utilized prospectively collected data from the controlled LAPPRO trial where 4003 patients with prostate cancer underwent open (ORP) or robot-assisted laparoscopic (RALP) radical prostatectomy. Patients were included from fourteen centers in Sweden during 2008-2011. Surgeon satisfaction was assessed by questionnaires at the end of each operation. Intraoperative factors included time for the surgical procedure as well as difficulties and complications in various steps of the operation. To model surgeon satisfaction, a mixed effect logistic regression was used. Results were presented as odds ratios (OR) with 95% confidence intervals (CI). RESULTS: The surgeons were satisfied in 2905 (81%) and dissatisfied in 702 (19%) of the surgical procedures. Surgeon satisfaction was not statistically associated with type of surgical technique (ORP vs. RALP) (OR 1.36, CI 0.76; 2.43). Intraoperative factors such as technical difficulties or complications, for example, suturing of the anastomosis was negatively associated with surgeon satisfaction (OR 0.24, CI 0.19; 0.30). CONCLUSIONS: Our data indicate that technical difficulties and/or intraoperative complications were associated with a surgeon's level of satisfaction with an operation.

Correction to: The Surgical Teams' Perception of the Effects of a Routine Intraoperative Pause.

In the original article there is an error in the legend in Fig. 4. Following is corrected Fig. 4.

The Surgical Teams' Perception of the Effects of a Routine Intraoperative Pause.

BACKGROUND: A pause routine may reduce stress and errors during surgery. The aim of this study was to explore how the team, divided into the different professional groups, perceived the implementation of a pause routine and its possible impact on safety. METHODS: A pause routine was introduced at a University hospital operating theatre in Sweden in 2013. Questionnaires were distributed about 1 year later to all members of the operating theatre team. The questions included different perspectives of possible effects of the pause routine. RESULTS: A majority were positive to scheduled pauses. The surgeons often felt refreshed and at times changed their view on both anatomy and their surgical strategy. They were also perceived by other team members as improved regarding communication. All groups felt that patient safety was promoted. There were differences by profession in perception of team communication. CONCLUSIONS: The pause routine was well perceived by the surgical team. A majority believed that scheduled and regular pauses contribute to improved patient safety and better team communication. There were also findings of differences in communication and experience of team coherence between personnel categories that could benefit from further acknowledgement and exploration.

The perceived benefit of intraoperative stress modifiers for surgeons: an experimental simulation study in volunteers.

BACKGROUND: During surgery, surgeons often work under stressful conditions, which could affect patient safety. Reducing intraoperative stress for surgeons could benefit surgeons and subsequently patients. It is difficult to study stress and stress relief in real life situations due to the multitude of confounding factors. The aim of this study was to evaluate simulated intraoperative stressors on surgeons' stress levels and the effect of an intervention (pause including a sugar-containing drink) during standardized experiments (simulated operations). METHODS: An experimental interventional study was conducted using a simulator. The healthy surgeon volunteers were randomized to intervention and control in a cross-over design. Primary endpoint was salivary cortisol difference between a pause including a sugar containing drink (intervention) and controls. Secondary endpoints were change in heart rate, change in self-perceived stress measured by the State Trait Anxiety Inventory (STAI), and experience of the intraoperative pause. Endpoints were calculated with a mixed effect analysis of covariance (ANCOVA) model. RESULTS: Seventeen surgeons performed 32 experiments. There was no statistically significant difference in salivary cortisol between simulations with and without a pause including a sugar-containing drink; percent reduction, 8% (0.92 (95%CI:0.72;1.18)), p-value = 0.469. The surgeons' self-estimation of intervention was positive, but there was no statistically significant difference in heart rate or STAI. CONCLUSIONS: The surgeons' experience of a pause including a drink was positive but there were no differences in physiological outcomes of the intervention. Lessons learned from this study could contribute to optimizing design of future studies. TRIAL REGISTRATION: Clinicaltrials.gov NCT04626648 , Registered November 6, 2020, retrospectively registered.

Changes in safety climate and teamwork in the operating room after implementation of a revised WHO checklist: a prospective interventional study.

BACKGROUND: Inter-professional teamwork in the operating room is important for patient safety. The World Health Organization (WHO) checklist was introduced to improve intraoperative teamwork. The aim of this study was to evaluate the safety climate in a Swedish operating room setting before and after an intervention, using a revised version of the WHO checklist to improve teamwork. METHODS: This study is a single center prospective interventional study. Participants were personnel working in operating room teams including surgeons, anesthesiologists, scrub nurses, nurse anaesthetists and nurse assistants. The study started with pre-interventional observations of the WHO checklist use followed by education on safety climate, the WHO checklist, and non-technical skills in the operating room. Thereafter a revised version of the WHO checklist was introduced. Post-interventional observations regarding the performance of the WHO checklist were carried out. The Safety Attitude Questionnaire was used to assess safety climate at baseline and post-intervention. RESULTS: At baseline we discovered a need for improved teamwork and communication. The participants considered teamwork to be important for patient safety, but had different perceptions of good teamwork between professions. The intervention, a revised version of the WHO checklist, did not affect teamwork climate. Adherence to the revision of the checklist was insufficient, dominated by a lack of structure. CONCLUSIONS: There was no significant change in teamwork climate by use of the revised WHO checklist, which may be due to insufficient implementation, as a lack of adherence to the WHO checklist was detected. We found deficiencies in teamwork and communication. Further studies exploring how to improve safety climate are needed. TRIAL REGISTRATION: NCT02329691.

A survey of surgeons' perception and awareness of intraoperative time utilization.

BACKGROUND: Surgical teams' awareness of the time needed to perform specific phases of a surgical procedure is likely to improve communication in the operating theatre and benefit patient safety. The aim of this study was to assess surgeons' awareness of time utilization and the actual time needed to perform specific phases of an operation. METHODS: A survey was conducted to examine the method and design for a larger study. Interviews were conducted with 18 surgeons, and surgical time was measured during 21 colon cancer resections. Correlation analyses were performed to explore the factors that might affect operating time. RESULTS: The surgical phase with the greatest variation in time was dissection/resection (43-308 minutes). On a group level, no statistically significant differences were found between estimated and measured surgical procedural times for partial or full resections (160.4 versus 173.0 minutes, p = 0.539). However, interindividual variation was substantial. There was a positive significant correlation between long duration of dissection/resection and longer time to close the abdomen (r = 0.464, p = 0.039), as well as between long duration of a hand-sewn anastomosis and time needed to close the abdomen (r = 0.536, p = 0.018). CONCLUSIONS: It can be difficult for a single surgeon to estimate the time required for a partial or full surgical procedure. A larger study might provide additional time estimates and identify variables that affect surgical time. The data could be of interest in the planning and scheduling of surgical resources, thus improving theatre team communication and patient safety.

Stoma-Const--the technical aspects of stoma construction: study protocol for a randomised controlled trial.

BACKGROUND: The construction of a colostomy is a common procedure, but the evidence for the different parts of the construction of the colostomy is lacking. Parastomal hernia is a common complication of colostomy formation. The aim of this study is to standardise the colostomy formation and to compare three types of colostomy formation (one including a mesh) regarding the development of parastomal hernia. METHODS/DESIGN: Stoma-Const is a Scandinavian randomised trial comparing three types of colostomy formation. The primary endpoint is parastomal herniation as shown by clinical examination or CT scan within one year. Secondary endpoints are re-admission rate, postoperative complications (classified according to Clavien-Dindo), stoma-related complications (registered in the case record form at stoma care nurse follow-up), total length of hospital stay during 12 months, health-related quality of life and health economic analysis as well as re-operation rate and mortality within 30 days and 12 months of primary surgery. Follow-up is scheduled at 4-6 weeks, and 6 and 12 months. Inclusion is set at 240 patients. DISCUSSION: Parastomal hernia is a common complication after colostomy formation. Several studies have been performed with the aim to reduce the rate of this complication. However, none are fully conclusive and data on quality of life and health economy are lacking. The aim of this study is to develop new standardised techniques for colostomy formation and evaluate this with patient reported outcomes as well as clinical and radiological assessment. TRIAL REGISTRATION: Clinicaltrials.gov, NCT01694238.2012-09-24.