Nationwide standardization of minimally invasive right hemicolectomy for colon cancer and development and validation of a video-based competency assessment tool (the Right study).

BACKGROUND: Substantial variation exists when performing a minimally invasive right hemicolectomy (MIRH) due to disparities in training, expertise and differences in implementation of innovations. This study aimed to achieve national consensus on an optimal and standardized MIRH technique for colon cancer and to develop and validate a video-based competency assessment tool (CAT) for MIRH. METHOD: Statements covering all elements of MIRH were formulated. Subsequently, the Delphi technique was used to reach consensus on a standardized MIRH among 76 colorectal surgeons from 43 different centres. A CAT was developed based on the Delphi results. Nine surgeons assessed the same 12 unedited full-length videos using the CAT, allowing evaluation of the intraclass correlation coefficient (ICC). RESULTS: After three Delphi rounds, consensus (≥80% agreement) was achieved on 23 of the 24 statements. Consensus statements included the use of low intra-abdominal pressure, detailed anatomical outline how to perform complete mesocolic excision with central vascular ligation, the creation of an intracorporeal anastomosis, and specimen extraction through a Pfannenstiel incision using a wound protector. The CAT included seven consecutive steps to measure competency of the MIRH and showed high consistency among surgeons with an overall ICC of 0.923. CONCLUSION: Nationwide consensus on a standardized and optimized technique of MIRH was reached. The CAT developed showed excellent interrater reliability. These achievements are crucial steps to an ongoing nationwide quality improvement project (the Right study).

Risk factors for anastomotic leak and postoperative morbidity after right hemicolectomy for colon cancer: results from a prospective, multi-centre, snapshot study in China.

BACKGROUND: Right hemicolectomy is the standard treatment for right-sided colon cancer. There is variation in the technical aspects of performing right hemicolectomy as well as in short-term outcomes. It is therefore necessary to explore best clinical practice following right hemicolectomy in expert centres. METHODS: This snapshot study of right hemicolectomy for colon cancer in China was a prospective, multicentre cohort study in which 52 tertiary hospitals participated. Eligible patients with stage I-III right-sided colon cancer who underwent elective right hemicolectomy were consecutively enrolled in all centres over 10 months. The primary endpoint was the incidence of postoperative 30-day anastomotic leak. RESULTS: Of the 1854 patients, 89.9 per cent underwent laparoscopic surgery and 52.3 per cent underwent D3 lymph node dissection. The overall 30-day morbidity and mortality were 11.7 and 0.2 per cent, respectively. The 30-day anastomotic leak rate was 1.4 per cent. In multivariate analysis, ASA grade > II (P < 0.001), intraoperative blood loss > 50 ml (P = 0.044) and D3 lymph node dissection (P = 0.008) were identified as independent risk factors for postoperative morbidity. Extracorporeal side-to-side anastomosis (P = 0.031), intraoperative blood loss > 50 ml (P = 0.004) and neoadjuvant chemotherapy (P = 0.004) were identified as independent risk factors for anastomotic leak. CONCLUSION: In high-volume expert centres in China, laparoscopic resection with D3 lymph node dissection was performed in most patients with right-sided colon cancer, and overall postoperative morbidity and mortality was low. Further studies are needed to explore the optimal technique for right hemicolectomy in order to improve outcomes further.

Surgical quality assessment of critical view of safety in 283 laparoscopic cholecystectomy videos by surgical residents and surgeons.

INTRODUCTION: Surgical quality assessment has improved the efficacy and efficiency of surgical training and has the potential to optimize the surgical learning curve. In laparoscopic cholecystectomy (LC), the critical view of safety (CVS) can be assessed with a 6-point competency assessment tool (CAT), a task commonly performed by experienced surgeons. The aim of this study is to determine the capability of surgical residents to perform this assessment. METHODS: Both surgeons and surgical residents assessed unedited LC videos using a 6-point CVS, a CAT, using an online video assessment platform. The CAT consists of the following three criteria: 1. clearance of hepatocystic triangle, 2. cystic plate, and 3. two structures connect to the gallbladder, with a maximum of 2 points available for each criterion. A higher score indicates superior surgical performance. The intraclass correlation coefficient (ICC) was employed to assess the inter-rater reliability between surgeons and surgical residents. RESULTS: In total, 283 LC videos were assessed by 19 surgeons and 31 surgical residents. The overall ICC for all criteria was 0.628. Specifically, the ICC scores were 0.504 for criterion 1, 0.639 for criterion 2, and 0.719 for the criterion involving the two structures connected to the gallbladder. Consequently, only the criterion regarding clearance of the hepatocystic triangle exhibited fair agreement, whereas the other two criteria, as well as the overall scores, demonstrated good agreement. In 71% of cases, both surgeons and surgical residents scored a total score either ranging from 0 to 4 or from 5 to 6. CONCLUSION: Compared to the gold standard, i.e., the surgeons' assessments, surgical residents are equally skilled at assessing critical view of safety (CVS) in laparoscopic cholecystectomy (LC) videos. By incorporating video-based assessments of surgical procedures into their training, residents could potentially enhance their learning pace, which may result in better clinical outcomes.

Video-based tools for surgical quality assessment of technical skills in laparoscopic procedures: a systematic review.

BACKGROUND: Quality of surgery has substantial impact on both short- and long-term clinical outcomes. This stresses the need for objective surgical quality assessment (SQA) for education, clinical practice and research purposes. The aim of this systematic review was to provide a comprehensive overview of all video-based objective SQA tools in laparoscopic procedures and their validity to objectively assess surgical performance. METHODS: PubMed, Embase.com and Web of Science were systematically searched by two reviewers to identify all studies focusing on video-based SQA tools of technical skills in laparoscopic surgery performed in a clinical setting. Evidence on validity was evaluated using a modified validation scoring system. RESULTS: Fifty-five studies with a total of 41 video-based SQA tools were identified. These tools were used in 9 different fields of laparoscopic surgery and were divided into 4 categories: the global assessment scale (GAS), the error-based assessment scale (EBAS), the procedure-specific assessment tool (PSAT) and artificial intelligence (AI). The number of studies focusing on these four categories were 21, 6, 31 and 3, respectively. Twelve studies validated the SQA tool with clinical outcomes. In 11 of those studies, a positive association between surgical quality and clinical outcomes was found. CONCLUSION: This systematic review included a total of 41 unique video-based SQA tools to assess surgical technical skills in various domains of laparoscopic surgery. This study suggests that validated SQA tools enable objective assessment of surgical performance with relevance for clinical outcomes, which can be used for training, research and quality improvement programs.

Oncological Outcomes After Anastomotic Leakage After Surgery for Colon or Rectal Cancer: Increased Risk of Local Recurrence.

OBJECTIVE: The aim of this study was to evaluate oncological outcome for patients with and without anastomotic leakage after colon or rectal cancer surgery. SUMMARY OF BACKGROUND DATA: The role of anastomotic leakage in oncological outcome after colorectal cancer surgery is still topic of debate and impact on follow-up and consideration for further treatment remains unclear. METHODS: Patients included in the international, multicenter, non-inferior, open label, randomized, controlled trials COLOR and COLOR II, comparing laparoscopic surgery for curable colon (COLOR) and rectal (COLOR II) cancer with open surgery, were analyzed. Patients operated by abdominoperineal excision were excluded. Both univariate and multivariate analyses were performed to investigate the impact of leakage on overall survival, disease-free survival, local and distant recurrences, adjusted for possible confounders. Primary endpoints in the COLOR and COLOR II trial were disease-free survival and local recurrence at 3-year follow-up, respectively, and secondary endpoints included anastomotic leakage rate. RESULTS: For colon cancer, anastomotic leakage was not associated with increased percentage of local recurrence or decreased disease-free-survival. For rectal cancer, an increase of local recurrences (13.3% vs 4.6%; hazard ratio 2.96; 95% confidence interval 1.38-6.34; P = 0.005) and a decrease of disease-free survival (53.6% vs 70.9%; hazard ratio 1.67; 95% confidence interval 1.16-2.41; P = 0.006) at 5-year follow-up were found in patients with anastomotic leakage. CONCLUSION: Short-term morbidity, mortality, and long-term oncological outcomes are negatively influenced by the occurrence of anastomotic leakage after rectal cancer surgery. For colon cancer, no significant effect was observed; however, due to low power, no conclusions on the influence of anastomotic leakage on outcomes after colon surgery could be reached. Clinical awareness of increased risk of local recurrence after anastomotic leakage throughout the follow-up is mandatory.Trial Registration: Registered with ClinicalTrials.gov, number NCT00387842 and NCT00297791.

Insight into the methodology and uptake of EAES guidelines: a qualitative analysis and survey by the EAES Consensus & Guideline Subcommittee.

BACKGROUND: Over the past 25 years, the European Association for Endoscopic Surgery (EAES) has been issuing clinical guidance documents to aid surgical practice. We aimed to investigate the awareness and use of such documents among EAES members. Additionally, we conceptually appraised the methodology used in their development in order to propose a bundle of actions for quality improvement and increased penetration of clinical practice guidelines among EAES members. METHODS: We invited members of EAES to participate in a web-based survey on awareness and use of these documents. Post hoc analyses were performed to identify factors associated with poor awareness/use and the reported reasons for limited use. We further summarized and conceptually analyzed key methodological features of clinical guidance documents published by EAES. RESULTS: Three distinct consecutive phases of methodological evolvement of clinical guidance documents were evident: a "consensus phase," a "guideline phase," and a "transitional phase". Out of a total of 254 surgeons who completed the survey, 72% percent were aware of EAES guidelines and 47% reported occasional use. Young age and trainee status were associated with poor awareness and use. Restriction by colleagues was the primary reason for limited use in these subgroups. CONCLUSIONS: The methodology of EAES clinical guidance documents is evolving. Awareness among EAES members is fair, but use is limited. Dissemination actions should be directed to junior surgeons and trainees.

Guideline Assessment Project II: statistical calibration informed the development of an AGREE II extension for surgical guidelines.

OBJECTIVE: To inform the development of an AGREE II extension specifically tailored for surgical guidelines. AGREE II was designed to inform the development, reporting, and appraisal of clinical practice guidelines. Previous research has suggested substantial room for improvement of the quality of surgical guidelines. METHODS: A previously published search in MEDLINE for clinical practice guidelines published by surgical scientific organizations with an international scope between 2008 and 2017, resulted in a total of 67 guidelines. The quality of these guidelines was assessed using AGREE II. We performed a series of statistical analyses (reliability, correlation and Factor Analysis, Item Response Theory) with the objective to calibrate AGREE II for use specifically in surgical guidelines. RESULTS: Reliability/correlation/factor analysis and Item Response Theory produced similar results and suggested that a structure of 5 domains, instead of 6 domains of the original instrument, might be more appropriate. Furthermore, exclusion and re-arrangement of items to other domains was found to increase the reliability of AGREE II when applied in surgical guidelines. CONCLUSIONS: The findings of this study suggest that statistical calibration of AGREE II might improve the development, reporting, and appraisal of surgical guidelines.

Guideline Assessment Project: Filling the GAP in Surgical Guidelines: Quality Improvement Initiative by an International Working Group.

OBJECTIVE: The aim of the study was to identify clinical practice guidelines published by surgical scientific organizations, assess their quality, and investigate the association between defined factors and quality. The ultimate objective was to develop a framework to improve the quality of surgical guidelines. SUMMARY BACKGROUND DATA: Evidence on the quality of surgical guidelines is lacking. METHODS: We searched MEDLINE for clinical practice guidelines published by surgical scientific organizations with an international scope between 2008 and 2017. We investigated the association between the following factors and guideline quality, as assessed using the AGREE II instrument: number of guidelines published within the study period by a scientific organization, the presence of a guidelines committee, applying the GRADE methodology, consensus project design, and the presence of intersociety collaboration. RESULTS: Ten surgical scientific organizations developed 67 guidelines over the study period. The median overall score using AGREE II tool was 4 out of a maximum of 7, whereas 27 (40%) guidelines were not considered suitable for use. Guidelines produced by a scientific organization with an output of ≥9 guidelines over the study period [odds ratio (OR) 3.79, 95% confidence interval (CI), 1.01-12.66, P = 0.048], the presence of a guidelines committee (OR 4.15, 95% CI, 1.47-11.77, P = 0.007), and applying the GRADE methodology (OR 8.17, 95% CI, 2.54-26.29, P < 0.0001) were associated with higher odds of being recommended for use. CONCLUSIONS: Development by a guidelines committee, routine guideline output, and adhering to the GRADE methodology were found to be associated with higher guideline quality in the field of surgery.

Personalised perioperative care by e-health after intermediate-grade abdominal surgery: a multicentre, single-blind, randomised, placebo-controlled trial.

BACKGROUND: Instructing and guiding patients after surgery is essential for successful recovery. However, the time that health-care professionals can spend with their patients postoperatively has been reduced because of efficiency-driven, shortened hospital stays. We evaluated the effect of a personalised e-health-care programme on return to normal activities after surgery. METHODS: A multicentre, single-blind, randomised controlled trial was done at seven teaching hospitals in the Netherlands. Patients aged 18-75 years who were scheduled for laparoscopic cholecystectomy, inguinal hernia surgery, or laparoscopic adnexal surgery for a benign indication were recruited. An independent researcher randomly allocated participants to either the intervention or control group using computer-based randomisation lists, with stratification by sex, type of surgery, and hospital. Participants in the intervention group had access to a perioperative, personalised, e-health-care programme, which managed recovery expectations and provided postoperative guidance tailored to the patient. The control group received usual care and access to a placebo website containing standard general recovery advice. Participants were unaware of the study hypothesis and were asked to complete questionnaires at five timepoints during the 6-month period after surgery. The primary outcome was time between surgery and return to normal activities, measured using personalised patient-reported outcome measures. Intention-to-treat and per-protocol analyses were done. This trial is registered in the Netherlands National Trial Register, number NTR4699. FINDINGS: Between Aug 24, 2015, and Aug 12, 2016, 344 participants were enrolled and randomly allocated to either the intervention (n=173) or control (n=171) group. 14 participants (4%) were lost to follow-up, with 330 participants included in the primary outcome analysis. Median time until return to normal activities was 21 days (95% CI 17-25) in the intervention group and 26 days (20-32) in the control group (hazard ratio 1·38, 95% CI 1·09-1·73; p=0·007). Complications did not differ between groups. INTERPRETATION: A personalised e-health intervention after abdominal surgery speeds up the return to normal activities compared with usual care. Implementation of this e-health programme is recommended in patients undergoing intermediate-grade abdominal, gynaecological, or general surgical procedures. FUNDING: ZonMw.

Electronic Health Program to Empower Patients in Returning to Normal Activities After Colorectal Surgical Procedures: Mixed-Methods Process Evaluation Alongside a Randomized Controlled Trial.

BACKGROUND: Long-term recovery takes longer than expected despite improved surgical techniques and Enhanced Recovery After Surgery programs. An electronic health (eHealth) care program ("ikherstel") was developed to partially substitute perioperative care for patients undergoing colorectal surgical procedures. Successfully tested eHealth programs are not always implemented in usual care, and it is, therefore, important to evaluate the process to optimize future implementation. OBJECTIVE: The aim of this study was to evaluate whether the eHealth intervention was executed as planned. METHODS: A mixed-methods process evaluation was carried out alongside a multicenter randomized controlled trial (RCT). This evaluation was performed using the Linnan and Steckler framework for the quantitative part of this study, measuring the components reach, dose delivered, dose received, fidelity, and participants' attitudes. Total implementation scores were calculated using the averaging approach, in which the sum of all data points is divided by the number of data points and the total adherence to the protocol is measured. For the qualitative part, the Unified Theory of Acceptance and Use of Technology framework was used. The quantitative data were based on participants' questionnaires, a logistic database, a weblog, and participants' medical files and were obtained by performing semistructured interviews with participants of the RCT. RESULTS: A total of 151 participants of 340 eligible patients were included in the RCT, of which 73 participants were allocated to the intervention group. On the basis of the quantitative process data, total implementation scores for the website, mobile app, electronic consult, and activity tracker were 64%, 63%, 44%, and 67%, respectively. Participants in the qualitative part experienced the program as supportive and provided guidance on their recovery process after colorectal surgery. Most frequently mentioned barriers were the limited interaction with and feedback from health care professionals and the lack of tailoring of the convalescence plan in case of a different course of recovery. CONCLUSIONS: The intervention needs more interaction with and feedback from health care professionals and needs more tailored guidance in case of different recovery or treatment courses. To ensure a successful implementation of the program in daily practice, some adjustments are required to optimize the program in a blended care form. TRIAL REGISTRATION: Netherlands Trial Registry NTR5686; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC= 5686 (Archieved by WebCite at http://www.webcitation.org/75LrJaHrr).

Electronic Health Program to Empower Patients in Returning to Normal Activities After General Surgical and Gynecological Procedures: Intervention Mapping as a Useful Method for Further Development.

BACKGROUND: Support for guiding and monitoring postoperative recovery and resumption of activities is usually not provided to patients after discharge from the hospital. Therefore, a perioperative electronic health (eHealth) intervention ("ikherstel" intervention or "I recover" intervention) was developed to empower gynecological patients during the perioperative period. This eHealth intervention requires a need for further development for patients who will undergo various types of general surgical and gynecological procedures. OBJECTIVE: This study aimed to further develop the "ikherstel" eHealth intervention using Intervention Mapping (IM) to fit a broader patient population. METHODS: The IM protocol was used to guide further development of the "ikherstel" intervention. First, patients' needs were identified using (1) the information of a process evaluation of the earlier performed "ikherstel" study, (2) a review of the literature, (3) a survey study, and (4) focus group discussions (FGDs) among stakeholders. Next, program outcomes and change objectives were defined. Third, behavior change theories and practical tools were selected for the intervention program. Finally, an implementation and evaluation plan was developed. RESULTS: The outcome for an eHealth intervention tool for patients recovering from abdominal general surgical and gynecological procedures was redefined as "achieving earlier recovery including return to normal activities and work." The Attitude-Social Influence-Self-Efficacy model was used as a theoretical framework to transform personal and external determinants into change objectives of personal behavior. The knowledge gathered by needs assessment and using the theoretical framework in the preparatory steps of the IM protocol resulted in additional tools. A mobile app, an activity tracker, and an electronic consultation (eConsult) will be incorporated in the further developed eHealth intervention. This intervention will be evaluated in a multicenter, single-blinded randomized controlled trial with 18 departments in 11 participating hospitals in the Netherlands. CONCLUSIONS: The intervention is extended to patients undergoing general surgical procedures and for malignant indications. New intervention tools such as a mobile app, an activity tracker, and an eConsult were developed. TRIAL REGISTRATION: Netherlands Trial Registry NTR5686; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5686.

Conversions in laparoscopic surgery for rectal cancer.

BACKGROUND: Laparoscopic surgery offers patients with rectal cancer short-term benefits and similar survival rates as open surgery. However, selecting patients who are suitable candidates for laparoscopic surgery is essential to prevent intra-operative conversion from laparoscopic to open surgery. Clinical and pathological variables were studied among patients who had converted laparoscopic surgeries within the COLOR II trial to improve patient selection for laparoscopic rectal cancer surgery. METHODS: Between January 20, 2004, and May 4, 2010, 1044 patients with rectal cancer enrolled in the COLOR II trial and were randomized to either laparoscopic or open surgery. Of 693 patients who had laparoscopic surgery, 114 (16 %) were converted to open surgery. Predictive factors were studied using multivariate analyses, and morbidity and mortality rates were determined. RESULTS: Factors correlating with conversion were as follows: age above 65 years (OR 1.9; 95 % CI 1.2-3.0: p = 0.003), BMI greater than 25 (OR 2.7; 95 % CI 1.7-4.3: p < 0.001), and tumor location more than 5 cm from the anal verge (OR 0.5; CI 0.3-0.9). Gender was not significantly related to conversion (p = 0.14). In the converted group, blood loss was greater (p < 0.001) and operating time was longer (p = 0.028) compared with the non-converted laparoscopies. Hospital stay did not differ (p = 0.06). Converted procedures were followed by more postoperative complications compared with laparoscopic or open surgery (p = 0.041 and p = 0.042, respectively). Mortality was similar in the laparoscopic and converted groups. CONCLUSIONS: Age above 65 years, BMI greater than 25, and tumor location between 5 and 15 cm from the anal verge were risk factors for conversion of laparoscopic to open surgery in patients with rectal cancer.

Morbidity associated with colostomy reversal after cytoreductive surgery and HIPEC.

BACKGROUND: Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) has improved the survival in selected colorectal cancer patients with peritoneal metastases. In these patients, the risk of a low anastomosis is sometimes diminished through the creation of a colostomy. Currently, the morbidity and mortality associated with the reversal of the colostomy in this population is unknown. METHODS: Our study involved two prospectively collected databases including all patients who underwent CRS-HIPEC. We identified all consecutive patients who had a colostomy and requested a reversal. The associations between four clinical and ten treatment-related factors with the outcome of the reversal procedure were determined by univariate analysis. RESULTS: 21 of 336 patients (6.3 %) with a stoma with a mean age of 50.8 (standard deviation 10.2) years underwent a reversal procedure. One patient was classified as American Society of Anesthesiologists (ASA) grade III, 6 as ASA grade II, and the remaining as ASA grade I. Median time elapsed between HIPEC and reversal was 394 days (range 133-1194 days). No life-threatening complications or mortality were observed after reversal. The reversal-related morbidity was 67 %. Infectious complications were observed in 7 patients (33 %). Infectious complications after HIPEC were negatively correlated with the ultimate restoration of bowel continuity (P = 0.05). Bowel continuity was successfully restored in 71 % of the patients. CONCLUSIONS: Although the restoration of bowel continuity after CRS-HIPEC was successful in most patients, a relatively high complication rate was observed. Patients with infectious complications after HIPEC have a diminished chance of successful restoration of bowel continuity.

Laparoscopic versus open surgery for rectal cancer (COLOR II): short-term outcomes of a randomised, phase 3 trial.

BACKGROUND: Laparoscopic surgery as an alternative to open surgery in patients with rectal cancer has not yet been shown to be oncologically safe. The aim in the COlorectal cancer Laparoscopic or Open Resection (COLOR II) trial was to compare laparoscopic and open surgery in patients with rectal cancer. METHODS: A non-inferiority phase 3 trial was undertaken at 30 centres and hospitals in eight countries. Patients (aged ≥18 years) with rectal cancer within 15 cm from the anal verge without evidence of distant metastases were randomly assigned to either laparoscopic or open surgery in a 2:1 ratio, stratified by centre, location of tumour, and preoperative radiotherapy. The study was not masked. Secondary (short-term) outcomes-including operative findings, complications, mortality, and results at pathological examination-are reported here. Analysis was by modified intention to treat, excluding those patients with post-randomisation exclusion criteria and for whom data were not available. This study is registered with ClinicalTrials.gov, number NCT00297791. FINDINGS: The study was undertaken between Jan 20, 2004, and May 4, 2010. 1103 patients were randomly assigned to the laparoscopic (n=739) and open surgery groups (n=364), and 1044 were eligible for analyses (699 and 345, respectively). Patients in the laparoscopic surgery group lost less blood than did those in the open surgery group (median 200 mL [IQR 100-400] vs 400 mL [200-700], p<0·0001); however, laparoscopic procedures took longer (240 min [184-300] vs 188 min [150-240]; p<0·0001). In the laparoscopic surgery group, bowel function returned sooner (2·0 days [1·0-3·0] vs 3·0 days [2·0-4·0]; p<0·0001) and hospital stay was shorter (8·0 days [6·0-13·0] vs 9·0 days [7·0-14·0]; p=0·036). Macroscopically, completeness of the resection was not different between groups (589 [88%] of 666 vs 303 [92%] of 331; p=0·250). Positive circumferential resection margin (<2 mm) was noted in 56 (10%) of 588 patients in the laparoscopic surgery group and 30 (10%) of 300 in the open surgery group (p=0·850). Median tumour distance to distal resection margin did not differ significantly between the groups (3·0 cm [IQR 2·0-4·8] vs 3·0 cm [1·8-5·0], respectively; p=0·676). In the laparoscopic and open surgery groups, morbidity (278 [40%] of 697 vs 128 [37%] of 345, respectively; p=0·424) and mortality (eight [1%] of 699 vs six [2%] of 345, respectively; p=0·409) within 28 days after surgery were similar. INTERPRETATION: In selected patients with rectal cancer treated by skilled surgeons, laparoscopic surgery resulted in similar safety, resection margins, and completeness of resection to that of open surgery, and recovery was improved after laparoscopic surgery. Results for the primary endpoint-locoregional recurrence-are expected by the end of 2013. FUNDING: Ethicon Endo-Surgery Europe, Swedish Cancer Foundation, West Gothia Region, Sahlgrenska University Hospital.

Personalised electronic health programme for recovery after major abdominal surgery: a multicentre, single-blind, randomised, placebo-controlled trial.

BACKGROUND: Despite the adoption of minimally invasive techniques, recovery after abdominal surgery takes a long time. Electronic health (eHealth) modalities can provide guidance to patients, facilitating early return to normal activities. We aimed to assess the impact of a personalised eHealth programme on patients' return to normal activities after major abdominal surgery. METHODS: This single-blind, randomised, placebo-controlled trial was done at 11 teaching hospitals in the Netherlands. Eligible participants were aged 18-75 years who underwent a laparoscopic or open colectomy or hysterectomy. An independent researcher randomly allocated participants (in a 1:1 ratio) to either the intervention or control group by use of computer-based randomisation lists, with stratification by sex, type of surgery, and hospital. Participants in the intervention group had access to a perioperative, personalised eHealth programme consisting of both standard face-to-face care and eHealth, that comprised interactive tools offering goal attainment and a personalised outcome measurement, which managed recovery expectations and provided postoperative guidance tailored to each patient. Patients were provided with an activity tracker and had access to a website and mobile app with an electronic consultation (eConsult) functionality. The control group received standard care and access to a placebo website containing recovery advice provided by the hospital. The primary outcome was the number of days between surgery and personalised return to normal activities, assessed with Kaplan-Meier curves. Intention-to-treat and per-protocol analyses were done with a Cox regression model. This trial is registered with the Netherlands National Trial Register (NTR5686). FINDINGS: Between Feb 11, 2016, and Aug 9, 2017, 355 participants were randomly assigned to the intervention (n=178) or control (n=177) groups. 342 participants were included in the intention-to-treat analysis. The median time until return to normal activities was 52 days (IQR 33-111) in the intervention group, and 65 days (39-152) in the control group (adjusted hazard ratio 1·30 [95% CI 1·03-1·64]; p=0·027). The frequency of postoperative complications did not differ between groups. INTERPRETATION: This eHealth programme, delivering personalised care based on goal attainment scaling, enabled patients to return to their normal activities 13 days earlier than those who received standard care. FUNDING: ZonMw.

Morbidity of hand-assisted laparoscopic splenectomy compared to conventional laparoscopic splenectomy: a 6-year review.

BACKGROUND: Laparoscopic splenectomy (LS) has several advantages over the open procedure but can be technically demanding when performed in patients with massive splenomegaly. We hypothesized that patients who undergo hand-assisted LS (HALS) may experience the benefits of LS while having their enlarged spleens removed safely. METHODS: We reviewed the charts of patients who underwent HALS or LS between January 2003 and June 2008. Evaluated parameters included intraoperative and early postoperative morbidity and mortality, conversion to open surgery, need for blood transfusion, length of postoperative hospital stay, patient demographics, diagnosis leading to splenectomy, splenic weight and number of postoperative days to resuming normal diet. Differences were analyzed while controlling for splenic weight and malignant diagnosis using multiple linear and logistic regression analysis. RESULTS: In all, 103 patients underwent splenectomy (23 HALS, 80 LS). Patients who had HALS were older and had larger spleens, and a greater proportion had malignant diagnoses. We observed no significant differences in morbidity, conversion to open surgery or need for blood transfusion. The mean length of postoperative stay, duration of surgery and days to resuming full diet were longer in the HALS group. No patients died. No group differences were significant after controlling for splenic weight and malignant diagnosis. CONCLUSION: The morbidity associated with HALS is comparable to that with LS. The longer duration of surgery and hospital stay for HALS patients was likely related to greater splenic weight, older age and greater proportion of malignant diagnoses. Hand-assisted LS is a viable alternative to open surgery in patients with massive spleens.

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 (euro3.096 vs. euro3.198) 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.

Survival after laparoscopic surgery versus open surgery for colon cancer: long-term outcome of a randomised clinical trial.

BACKGROUND: Laparoscopic surgery for colon cancer has been proven safe, but debate continues over whether the available long-term survival data justify implementation of laparoscopic techniques in surgery for colon cancer. The aim of the COlon cancer Laparoscopic or Open Resection (COLOR) trial was to compare 3-year disease-free survival and overall survival after laparoscopic and open resection of solitary colon cancer. METHODS: Between March 7, 1997, and March 6, 2003, patients recruited from 29 European hospitals with a solitary cancer of the right or left colon and a body-mass index up to 30 kg/m(2) were randomly assigned to either laparoscopic or open surgery as curative treatment in this non-inferiority randomised trial. Disease-free survival at 3 years after surgery was the primary outcome, with a prespecified non-inferiority boundary at 7% difference between groups. Secondary outcomes were short-term morbidity and mortality, number of positive resection margins, local recurrence, port-site or wound-site recurrence, and blood loss during surgery. Neither patients nor health-care providers were blinded to patient groupings. Analysis was by intention-to-treat. This trial is registered with ClinicalTrials.gov, number NCT00387842. FINDINGS: During the recruitment period, 1248 patients were randomly assigned to either open surgery (n=621) or laparoscopic surgery (n=627). 172 were excluded after randomisation, mainly because of the presence of distant metastases or benign disease, leaving 1076 patients eligible for analysis (542 assigned open surgery and 534 assigned laparoscopic surgery). Median follow-up was 53 months (range 0.03-60). Positive resection margins, number of lymph nodes removed, and morbidity and mortality were similar in both groups. The combined 3-year disease-free survival for all stages was 74.2% (95% CI 70.4-78.0) in the laparoscopic group and 76.2% (72.6-79.8) in the open-surgery group (p=0.70 by log-rank test); the difference in disease-free survival after 3 years was 2.0% (95% CI -3.2 to 7.2). The hazard ratio (HR) for disease-free survival (open vs laparoscopic surgery) was 0.92 (95% CI 0.74-1.15). The combined 3-year overall survival for all stages was 81.8% (78.4-85.1) in the laparoscopic group and 84.2% (81.1-87.3) in the open-surgery group (p=0.45 by log-rank test); the difference in overall survival after 3 years was 2.4% (95% CI -2.1 to 7.0; HR 0.95 [0.74-1.22]). INTERPRETATION: Our trial could not rule out a difference in disease-free survival at 3 years in favour of open colectomy because the upper limit of the 95% CI for the difference just exceeded the predetermined non-inferiority boundary of 7%. However, the difference in disease-free survival between groups was small and, we believe, clinically acceptable, justifying the implementation of laparoscopic surgery into daily practice. Further studies should address whether laparoscopic surgery is superior to open surgery in this setting.