Showing papers by "Thue Bisgaard published in 2020"

Fluorescence or X-ray cholangiography in elective laparoscopic cholecystectomy: a randomized clinical trial.

Abstract: BACKGROUND Safe laparoscopic cholecystectomy may necessitate biliary imaging, and non-invasive fluorescence cholangiography may have advantages over contrast X-ray cholangiography. This trial compared fluorescence and X-ray cholangiography for visualization of the critical junction between the cystic, common hepatic and common bile ducts. METHODS This non-inferiority blinded RCT included patients who had either intraoperative fluorescence cholangiography using 0·05 mg/kg indocyanine green or X-ray cholangiography during elective laparoscopic cholecystectomy. RESULTS Between March 2015 and August 2018, a total of 120 patients were randomized (60 in each group). There were no drop-outs and 30-day follow-up data were available for all patients. In intention-to-treat analysis, there was no difference between the fluorescence and X-ray cholangiography groups in ability to visualize the critical junction (49 of 60 versus 51 of 60 respectively; P = 0·230). Fluorescence cholangiography was faster by a few minutes: median 2·0 (range 0·5-5·0) versus 4·8 (1·3-17·6) min (P < 0·001). CONCLUSION Fluorescence cholangiography was confirmed to be non-inferior to X-ray cholangiography in visualizing the critical junction during laparoscopic cholecystectomy. Registration number: NCT02344654 ( http://www.clinicaltrials.gov).

Closure of the fascial defect during laparoscopic umbilical hernia repair: a randomized clinical trial.

Abstract: Background The objective of the study was to analyse patient-reported outcome measures (PROMs), seroma formation, long-term recurrence and chronic pain after closure of the fascial defect in patients undergoing laparoscopic umbilical hernia mesh repair. Methods This was a randomized double-blinded trial in patients undergoing elective laparoscopic umbilical hernia repair comparing sutured closure of the fascial defect before intraperitoneal onlay mesh (IPOM) repair with a no-closure IPOM repair. Postoperative pain, movement limitations, discomfort and fatigue were registered before surgery and on postoperative days 1-3, 7 and 30. Seroma formation, quality of life and cosmesis were assessed at day 30, and at 2 years of follow-up. Recurrence (clinical and reoperation) and chronic pain were assessed after 2 years. Results Eighty patients were randomized. Median defect sizes in closure and no-closure groups were 2·5 (range 1·5-4·0) and 2·5 (2·0-5·5) cm respectively (P = 0·895). There were no significant differences in early and late postoperative pain or in any other early or late PROMs, except for early fatigue which was higher in the closure group (P = 0·011). Seroma formation after 30 days was significantly reduced after closure (14 of 40; 35 (95 per cent c.i. 22 to 51) per cent) compared with no closure (22 of 38; 58 (42 to 72) per cent) (P = 0·043). Cumulative recurrence after 2 years was lower in the closure group: 5 of 36 (7 (3 to 17) per cent) versus 12 of 37 (19 (10 to 33) per cent) for no closure (P = 0·047). Conclusion Closure of the fascial defect in laparoscopic umbilical hernia IPOM repair significantly reduced early seroma formation and long-term recurrence without inducing side-effects such as pain, or other early or late PROMs. Registration number: NCT01962480 ( https://www.clinicaltrials.gov).

Low anterior resection syndrome in a Scandinavian population of patients with rectal cancer: a longitudinal follow-up within the QoLiRECT study.

Abstract: Aim Low anterior resection syndrome (LARS) is common after low anterior resection. Our aim was to evaluate the prevalence and 'bother' (subjective, symptom-associated distress) of major LARS after 1 and 2 years, identify possible risk factors and relate the bowel function to a reference population. Method The QoLiRECT (Quality of Life in RECTal cancer) study is a Scandinavian prospective multicentre study including 1248 patients with rectal cancer, of whom 552 had an anterior resection. Patient questionnaires were distributed at diagnosis and after 1, 2 and 5 years. Data from the baseline and at 1- and 2-year follow-up were included in this study. Results The LARS score was calculated for 309 patients at 1 year and 334 patients at 2 years. Prevalence was assessed by a generalized linear mixed effects model. Major LARS was found in 63% at 1 year and 56% at 2 years. Bother was evident in 55% at 1 year, decreasing to 46% at 2 years. Major LARS was most common among younger women (69%). Among younger patients, only marginal improvement was seen over time (63-59%), for older patients there was more improvement (62-52%). In the reference population, the highest prevalence of major LARS-like symptoms was noted in older women (12%). Preoperative radiotherapy, defunctioning stoma and tumour height were found to be associated with major LARS. Conclusion Major LARS is common and possibly persistent over time. Younger patients, especially women, are more affected, and perhaps these patients should be prioritized for early stoma closure to improve the chance of a more normal bowel function.

Long-term patient-reported outcomes and quality of the evidence in ventral hernia mesh repair: a systematic review

Abstract: Patient-reported outcome measures (PROMs) have been increasingly accepted to evaluate the quality of surgery. The impact of a hernia on PROMs and the indication for elective ventral hernia mesh repair are poorly researched. The primary objective in this systematic review was to provide evidence for PROM changes at least 3 months after elective ventral hernia mesh repair. Secondarily, a critical appraisal of the study quality was undertaken. Ovid MEDLINE, PubMed, Ovid Embase, and CENTRAL were searched (year 2000–May 12, 2019) for studies reporting any of 21 predefined PROMs pre- and ≥ 3 months postoperatively following adult ventral hernia mesh repair. A pre-study defined analysis method was used to assess pre- vs. postoperative PROM changes. Quality assessment was guided by criteria formulated by the National Institutes of Health. The search yielded 11,438 potentially eligible studies of which 24 met the inclusion criteria. Most studies were of poor or moderate quality and one study was of high quality. There was no evidence for a clinically relevant postoperative improvement in any PROM following umbilical hernia repair or medium-sized incisional hernia repair. A clinically relevant postoperative improvement of pain, physical impairment, and social involvement was seen in patients with a large-sized incisional hernia repair and stoma-related complaints in patients with a medium-sized parastomal hernia repair. This analysis suggested that a minor subset of PROMs improved in patients undergoing large-sized incisional and medium-sized parastomal hernia repair. High-quality studies are imperative in this extremely often conducted surgical procedure. The review was registered at PROSPERO (CRD42018096671, https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=96671 ).

Differential recurrence after laparoscopic incisional hernia repair: importance of a nationwide registry-based mesh surveillance.

Abstract: BACKGROUND Identification of suboptimal mesh products is essential to improve the outcome after hernia surgery. This study investigated whether a national clinical database combined with administrative registries may serve as a tool for postmarketing evaluation of mesh products for hernia surgery. METHODS This was a propensity score-matched case-control cohort study comparing outcomes in patients undergoing laparoscopic incisional hernia repair with either one particular mesh or any other synthetic mesh. Data on patients registered in the Danish Ventral Hernia Database between 2010 and 2016 were combined with administrative data from the Danish National Patient Registry. The primary outcome was operation for recurrence. Secondary outcomes were 30-day readmission, 30-day reoperation for complications (excluding hernia recurrence), and mortality after 30 and 90 days. RESULTS In total, 740 patients who underwent repair with one particular mesh were matched with 1479 patients who received any other synthetic mesh. The rate of repair for hernia recurrence was significantly higher in the particular mesh group than in the reference group: 12·8 versus 6·3 per cent respectively (hazard ratio 2·09, 95 per cent c.i. 1·57 to 2·79; P < 0·001). Use of the particular mesh increased the risk of readmission (odds ratio (OR) 1·53, 1·16 to 2·01; P = 0·002) and reoperation for a complication (OR 1·60, 1·03 to 2·47, P = 0·030). No difference in mortality was found. CONCLUSION Clinical registries with prospectively collected data can provide long-term surveillance of commercial mesh. Laparoscopic incisional hernia repair with one particular mesh was associated with an increased rate of short-term complications and double the risk of repair for recurrence.

Re-recurrence and pain 12 years after laparoscopic transabdominal preperitoneal (TAPP) or Lichtenstein’s repair for a recurrent inguinal hernia: a multi-centre single-blinded randomised clinical trial

Abstract: Long-term clinical outcome after a recurrent inguinal hernia repair may be associated with the type of repair, that is, laparoscopic or open. The results from previous randomised controlled trials are inconclusive regarding the long-term risk of re-recurrence chronic pain. Accordingly, this trial compared laparoscopic transabdominal preperitoneal repair (TAPP) with Lichtenstein’s repair. The primary outcome was repair for a re-recurrence. The secondary outcome was chronic pain. Multi-centre single-blinded, randomised trial on TAPP vs Lichtenstein’s repair in male patients operated for a recurrent inguinal hernia after a primary open inguinal hernia repair. Follow-up for repair for a re-recurrence was registered in the Danish Hernia Database. Prospective follow-up data were achieved by a structured questionnaire on pain-related functional impairment using the Activities Assessment Scale (AAS-pain). A total of 360 patients were randomised, 297 were mailed the follow-up questionnaire (63 excluded) after median 12 years (range 9–15). A total of 265 patients responded to the questionnaire (response rate 89%). The cumulative rate of repair for re-recurrence after 12 years was 10% (95% confidence interval (CI) 5.3–15.1%) vs 10% (5.6–14.7%) after TAPP or Lichtenstein, respectively (p = 0.764). Moderate/severe AAS-pain was reported by 4% (95% CI 1–8%) vs 7% (95% CI 3–11%) patients after TAPP or Lichtenstein, respectively (p = 0.698) Long-term re-recurrence rate and incidence of chronic pain was surprisingly high respectless of surgical approach and neither TAPP nor Lichtenstein’s procedure was superior to improve surgical results.

Impact on Fertility After Failure of Restorative Proctocolectomy in Men and Women With Ulcerative Colitis: A 17-Year Cohort Study.

Abstract: Background Impact of restorative proctocolectomy failure on fertility has not been studied and is greatly relevant. Objective The purpose of this study was to evaluate the impact of restorative proctocolectomy failure on birth rate in women and men, along with in vitro fertilization incidence and success. Design This was a retrospective registry-based cohort study over 17 years. Settings Records for parenting a child were cross-linked with patient records. In women, in vitro fertilization records were cross-linked. All data were prospectively registered. Patients Patients of fertile age with ulcerative colitis between 1994 and 2010 were identified in Danish national databases. Patients with restorative proctocolectomy and restorative proctocolectomy failure were identified as subgroups. Main outcome measures Birth rate ratios and in vitro fertilization incidence and success were measured. Results We included 11,939 women and 13,569 men with ulcerative colitis. A total of 711 women and 730 men had restorative proctocolectomy; 114 women and 90 men had failure. Birth rate in women with failure was significantly reduced compared with women without (birth rate ratio = 0.50 (95% CI, 0.29-0.82)). In men with failure, birth rate tended to be lower compared with men without (birth rate ratio = 0.74 (95% CI, 0.51-1.05)). In vitro fertilization incidence was similar with and without failure (HRs adjusted for age at start of follow-up = 0.98 (95% CI, 0.58-1.67]). In vitro fertilization success was significantly lower with failure compared with ulcerative colitis (OR adjusted for age at start of follow-up = 0.36 (95% CI, 0.4-0.92)). Limitations Information on patients leading up to restorative proctocolectomy failure is lacking. Failure patients may have had children during a period with pouch function. Therefore, the impact of failure may be underestimated. Conclusions Restorative proctocolectomy failure impairs birth rate, primarily in women. Although in vitro fertilization incidence is similar in women with and without failure, the likelihood of giving birth after in vitro fertilization is reduced. See Video Abstract at http://links.lww.com/DCR/B202. IMPACTO SOBRE LA FERTILIDAD DESPUeS DEL FRACASO DE LA PROCTOCOLECTOMiA RESTAURADORA EN HOMBRES Y MUJERES CON COLITIS ULCEROSA: UN ESTUDIO DE COHORTE DE 17 AnOS: No se ha estudiado el impacto de la falla de la proctocolectomia restauradora en la fertilidad y es muy relevante.Evaluar el impacto del fracaso de la proctocolectomia restauradora en la tasa de natalidad en mujeres y hombres, junto con la incidencia y el exito de la fertilizacion in vitro.Estudio de cohorte retrospectivo basado en el registro de mas de 17 anos.Los registros de crianza de un nino se cruzaron con los registros de pacientes. En las mujeres, los registros de fertilizacion in vitro se cruzaron. Todos los datos se regitraron de forma prospectiva.Los pacientes de edad fertil con colitis ulcerosa entre 1994-2010 fueron identificados en las bases de datos nacionales danesas. Los pacientes con proctocolectomia restauradora y fracaso de la proctocolectomia restauradora se identificaron como subgrupos.Tasas de natalidad e incidencia y exito de la fertilizacion in vitro.Se incluyeron 11939 mujeres y 13569 hombres con colitis ulcerosa. 711 mujeres y 730 hombres tuvieron proctocolectomia restauradora; 114 mujeres y 90 hombres tuvieron fracaso. La tasa de natalidad en las mujeres con fracaso se redujo significativamente en comparacion con las mujeres sin fracaso (tasa de natalidad: 0,50; IC del 95% [0,29; 0,82]). En los hombres con fracaso, la tasa de natalidad tendio a ser mas baja en comparacion con los hombres sin fracaso (tasa de natalidad: 0,74; IC del 95% [0,51; 1,05]). La incidencia de fertilizacion in vitro fue similar con y sin falla (aHR: 0.98, IC 95% [0.58; 1.67]). El exito de la fertilizacion in vitro fue significativamente menor con el fracaso en comparacion con la colitis ulcerosa (aOR: 0.36 IC 95% [0.4; 0.92]).Falta informacion sobre los pacientes que conducen al fracaso de la proctocolectomia restauradora. Los pacientes con fracaso pueden haber tenido hijos durante un periodo con funcion de bolsa. Por lo tanto, el impacto del fracaso puede ser subestimado.El fracaso de la proctocolectomia restauradora afecta la tasa de natalidad, principalmente en mujeres. Aunque la incidencia de la fertilizacion in vitro es similar en las mujeres con y sin fracaso, la probabilidad de dar a luz despues de la fertilizacion in vitro se reduce. Consulte Video Resumen en http://links.lww.com/DCR/B202. (Traduccion-Dr Gonzalo Hagerman).

Functional and Structural Plasticity Co-express in a Left Premotor Region During Early Bimanual Skill Learning.

Abstract: Introduction: Motor skill learning triggers functional reorganization of regional brain activity already after short periods of training. Recent studies suggest that microstructural change may emerge at similar timescales, but the spatiotemporal profiles of functional and structural plasticity have rarely been traced in parallel. Recently, we demonstrated that five days of endoscopic skill training induced changes in task-related brain activity in the ventral premotor cortex (PMv) and other areas of the ventrolateral grasping network. Here, we analyzed microstructural data, collected during the same experiment, to investigate if microstructural plasticity overlaps temporally and spatially with the training-induced changes in task-related brain activity. Materials and Methods: Thirty-nine students were divided into a full-routine group (n = 20), that underwent three endoscopy training sessions in the MR-scanner as well as a 5-day virtual reality (VR)-endoscopy training and a brief-routine group (n = 19), that only performed the three in-scanner endoscopy training sessions. Diffusion Tensor Imaging (DTI)-derived fractional anisotropy (FA) and resting-state functional magnetic resonance imaging (rs-fMRI) were collected at baseline, after the first and after the last VR-training session. Results: The full-routine group showed significant FA changes in a left-hemispheric subcortical cluster underlying the PMv region, for which we previously had demonstrated functional plasticity during endoscopy training in the same participants. Functional (task-related fMRI) and structural (FA) changes showed the largest change from the first to the second scan, suggesting similar temporal dynamics. In the full-routine group, the FA change in the subcortical cluster underlying left PMv scaled positively with the individual improvement in endoscopic surgery. Conclusion: Microstructural white-matter plasticity mirrors the spatiotemporal profile of task-dependent plasticity task during a five-day course of endoscopy skill training. The observed similarities motivate future research into the interplay between functional and structural plasticity during early skill acquisition.

Association of Primary Ventral Hernia and Pregnancy

Abstract: Objective To determine the optimal timing of elective repair, the primary objective of this study was to assess if parity at the time of repair and subsequent pregnancy were associated with reoperation for recurrence. The secondary objective was to examine if parity was associated with hernia formation requiring surgical repair. Summary background data Women of childbearing age constitute 18% of patients operated on for a primary ventral hernia, but consensus is lacking on the management in women who might subsequently become pregnant. Methods In this nationwide retrospective cohort-study, all women born in Denmark from 1962 to 1971 were eligible for inclusion and followed from age 15 to 45 years. The follow-up rate was 100%. Data on pregnancies and surgical procedures were obtained from the Danish Medical Birth Registry and National Patient Registry. Extended Cox regression and Poisson regression were used for statistical analysis. Results In total, 470,646 women were included, of whom 2113 underwent repair of a primary ventral hernia. The 10-year cumulative incidence of reoperation for recurrence was 14.1% (95% CI 12.3%-16.0%). Parity at the time of repair was not associated with reoperation for recurrence, while a subsequent pregnancy was associated with a 1.6-fold increased risk (hazard ratio 1.58, 95% CI 1.08-2.31). Parous women had a 7-fold increased risk of undergoing hernia repair compared with nulliparous, in an age-adjusted model (incidence rate ratio 7.04, 95% CI 5.87-8.43). Conclusion To reduce the risk of hernia recurrence, the optimal timing of elective repair is after the last pregnancy.

Laparoscopic or open paediatric inguinal hernia repair - a systematic review.

Abstract: INTRODUCTION Inguinal hernia repair is the most common surgical procedure in paediatric patients. Despite limited evidence, an increasing number of surgeons suggest laparoscopic repair as an alternative to the gold standard of open repair. This review critically analysed post-operative clinical outcome on open versus laparoscopic inguinal hernia repair in paediatric patients. Before initiating the study, recurrence was defined as the primary outcome, and secondary outcomes were early post-operative pain, operation time and surgical site infections. METHODS The PRISMA guidelines were followed. Using strict inclusion and exclusion criteria, the following databases were searched: MEDLINE, Cochrane Library, Web of Science and Embase (May 2019). Retrospective and uncontrolled studies were excluded. RESULTS Five studies were identified, four randomised controlled trials (n = 272) and one controlled prospective study (n = 85) which included a total of 357 patients. Generally, the studies included few patients, were highly heterogenic and were overall of moderate quality. With a follow-up time ranging from three months to 14 years, there was no difference in recurrence rate after unilateral open (0-2%) versus unilateral laparoscopic (0-4%) or bilateral open versus bilateral laparoscopic repair (n = 281; p > 0.05 in all studies). There were no other significant differences in any of the outcomes, including post-operative pain (p > 0.05). CONCLUSIONS There is no solid evidence that clinical outcome is improved after laparoscopic paediatric inguinal hernia repair compared with the gold standard.

Increased Gastrointestinal Surgical Hospital Burden After Laparoscopic Gastric Bypass for Obesity: A Nationwide 5-years Follow-up Study.

Abstract: Objective To study long-term gastrointestinal surgical hospital burden (hospital readmissions and gastrointestinal surgical procedures) after laparoscopic gastric bypass. Background Little is known about gastrointestinal surgical hospital burden after laparoscopic gastric bypass. Methods Danish patients undergoing laparoscopic gastric bypass (BMI >35-50) from January 1, 2005 to December 31, 2013 were included (100% follow-up). The nonsurgical reference group were individuals with BMI of ≥ 30 drawn from The Danish National Health Surveys from 2005 to 2013. The primary outcome was gastrointestinal surgical hospital burden. Secondary outcome was mortality. Age, body mass index (BMI), gender, and calendar time (time of surgery and nonsurgical survey), diabetes status was adjusted for in a multivariate Poisson regression model. Results 13,582 bariatric surgical patients and 45,948 reference individuals were included with a mean follow-up time of 4.7 years (SD 2.4). The incidence rate ratio (IRR) for hospital re-re-admission was 2.17 higher in the intervention group (95% CI 2.04-2.31). Sensitivity analysis showed that patients operated before 2010 had a higher incidence for re-re-admission than after. IRR for surgical gastrointestinal procedures was 6.56 (CI 6.15-6.99) and 3.04 (CI 3.51-4.17) after 1 and 5 years for the intervention group compared with the reference group. Surgery for internal hernia was the most common abdominal procedure. The mortality odds ratio was 0.84 (CI 0.65-0.96). Conclusions Gastrointestinal surgical hospital burden was significantly higher in the first 5 years after gastric bypass compared with a matched nonsurgical reference group of obese citizens.

Author response to: Comment on: Closure of the fascial defect during laparoscopic umbilical hernia repair: a randomized clinical trial

Abstract: Editor Thank you for giving us the opportunity to comment on the correspondence by Dr. Ramakrishna and co-workers to our recent study1. Pain at day 1 is an important limiting factor for early discharge after minor laparoscopic same-day surgery. Umbilical hernia repair is often conducted as ambulatory surgery requiring early pain control and is therefore a relevant outcome2,3. The present study hypothesised that closure of the fascial defect increase tissue tension, and thus, may increase early postoperative pain1. As noted in our work, we included patients with preoperative clinically measured defect sizes of 2-6 cm. However, defects were measured intraoperatively, and intraoperative defects less than 2 cm were allowed. Therefore, a few patients were randomised in the study despite having a defect of 1⋅5 cm4. Study data was analysed according to intention to treat (ITT) principle. Dr. Ramakrishna criticises that data on seroma and recurrence was not analysed as ITT. However, the data was incomplete due to few dropouts during followup period1. There were no crossovers. Long-term recurrence was analysed using Kaplan Meier analysis, and was expressed by cumulative incidence, taking “time to event” and “no. at risk” into account. This analysis is well-accepted and recommended for recurrence analysis5. Thus, the simple incidence and the cumulative incidence will not be alike. We agree that the recurrence rates in the study were (too) high. The use of Physiomesh and our definition of recurrence (reoperation for recurrence plus clinical recurrence) may be reasons for the high recurrence rate. It is well-accepted that reoperation as a proxy for recurrence underestimates clinical recurrence rate with 2-3-fold after umbilical hernia repair6. In conclusion, we think the study results are valid, clinically relevant, and potentially impact daily surgical practice.