Purpose
Evidence regarding local recurrence rates in the initial cases after implementation of robot-assisted total mesorectal excision is limited. This study aims to describe local recurrence rates ...in four large Dutch centres during their initial cases.
Methods
Four large Dutch centres started with the implementation of robot-assisted total mesorectal excision in respectively 2011, 2012, 2015, and 2016. Patients who underwent robot-assisted total mesorectal excision with curative intent in an elective setting for rectal carcinoma defined according to the sigmoid take-off were included. Overall survival, disease-free survival, systemic recurrence, and local recurrence were assessed at 3 years postoperatively. Subsequently, outcomes between the initial 10 cases, cases 11–40, and the subsequent cases per surgeon were compared using Cox regression analysis.
Results
In total, 531 patients were included. Median follow-up time was 32 months (IQR: 19–50. During the initial 10 cases, overall survival was 89.5%, disease-free survival was 73.1%, and local recurrence was 4.9%. During cases 11–40, this was 87.7%, 74.1%, and 6.6% respectively. Multivariable Cox regression did not reveal differences in local recurrence between the different case groups.
Conclusion
Local recurrence rate during the initial phases of implantation of robot-assisted total mesorectal procedures is low. Implementation of the robot-assisted technique can safely be performed, without additional cases of local recurrence during the initial cases, if performed by surgeons experienced in laparoscopic rectal cancer surgery.
Purpose
This study aims to provide an overview of all complications that may occur after construction of an ileostomy or colostomy (loop or end) in daily practice.
Methods
Between July 2007 and April ...2008, all adult patients who underwent any type of intestinal stoma formation were asked to participate in this prospective cohort study. All relevant patient characteristics were gathered. Patients were evaluated for complications eight times in a 1-year postoperative period. Enterostomal therapy nurses scored complications on specially designed forms.
Results
One hundred patients were included; two patients were lost before initial follow-up (FU). During FU, 21% of the patients deceased, and 15% were lost, physically unable to visit the outpatient clinic or withdrew from FU. In 37% of the patients, bowel continuity was restored. Only 26% of the patients were able to complete FU. Overall, 82% of all the patients had one or more stoma-related complications. Most common complications were skin irritation (55%), fixation problems (46%) and leakage (40%). Superficial necrosis, bleeding and retraction occurred in 20%, 14% and 9% of patients, respectively. More stoma related complications were found in stoma’s on inappropriate locations.
Conclusions
In this heterogenic patient population with formation of different stoma types, a high complication rate was detected.
Background
Rectal prolapse—both external rectal prolapse and internal rectal prolapse—is a disabling condition. In view of the overwhelming number of surgical procedures described for the treatment ...of rectal prolapse, a comprehensive update concerning the diagnostic and therapeutic pathway for this condition is required to draw recommendations for clinical practice. This initiative was commissioned by the Dutch Association for Surgery (Nederlandse Vereniging voor Heelkunde) as a multidisciplinary collaboration.
Methods
Nine questions outlining the diagnostic approach, conservative and surgical management of rectal prolapse were selected. A systematic literature search for evidence was then conducted in the Medline and Embase databases.
Results
Recommendations included diagnostic approach, methods to assess complaints of fecal incontinence and/or obstructive defecation and treatment options, both conservative and surgical. A level of evidence was assigned to each statement following the Grades of Recommendation Assessment, Development and Evaluation (GRADE) system.
Conclusions
These guidelines for clinical practice are useful in the diagnosis and treatment of rectal prolapse. There are many statements requiring a higher level of evidence due to a lack of studies.
Background
Surgical options after anterior resection for rectal cancer include a primary anastomosis, anastomosis with a defunctioning stoma, and an end colostomy. This study describes short-term and ...1-year outcomes of these different surgical strategies.
Methods
Patients undergoing surgical resection for primary mid and high rectal cancer were retrospectively studied in seven Dutch hospitals with 1-year follow-up. Short-term endpoints were postoperative complications, re-interventions, prolonged hospital stay, and mortality. One-year endpoints were unplanned readmissions and re-interventions, presence of stoma, and mortality.
Results
Nineteen percent of 388 included patients received a primary anastomosis, 55 % an anastomosis with defunctioning stoma, and 27 % an end colostomy. Short-term anastomotic leakage was 10 % in patients with a primary anastomosis vs. 7 % with a defunctioning stoma (
P
= 0.46). An end colostomy was associated with less severe re-interventions. One-year outcomes showed low morbidity and mortality rates in patients with an anastomosis. Patients with a defunctioning stoma had high (18 %) readmissions and re-intervention (12 %) rates, mostly due to anastomotic leakage. An end colostomy was associated with unplanned re-interventions due to stoma/abscess problems. During follow-up, there was a 30 % increase in patients with an end colostomy.
Conclusions
This study showed a high 1-year morbidity rate after anterior resection for rectal cancer. A defunctioning stoma was associated with a high risk for late complications including anastomotic leakage. An end colostomy is a safe alternative to prevent anastomotic leakage, but stomal problems cannot be ignored. Selecting low-risk patients for an anastomosis may lead to favorable short- and 1-year outcomes.
Perforated colon cancer (PCC) is a distinct clinical entity with implications for treatment and prognosis, however data on PCC seems scarce. The aim of this systematic review is to provide a ...comprehensive overview of the recent literature on clinical outcomes of PCC.
A systematic literature search of MEDLINE (PubMed), Embase, Cochrane library and Google scholar was performed. Studies describing intentionally curative treatment for patients with PCC since 2010 were included. The main outcome measures consisted of short-term surgical complications and long-term oncological outcomes.
Eleven retrospective cohort studies were included, comprising a total of 2696 PCC patients. In these studies, various entities of PCC were defined. Comparative studies showed that PCC patients as compared to non-PCC patients have an increased risk of 30-day mortality (8–33% vs 3–5%), increased post-operative complications (33–56% vs 22–28%), worse overall survival (36–40% vs 48–65%) and worse disease-free survival (34–43% vs 50–73%). Two studies distinguished free-perforations from contained perforations, revealing that free-perforation is associated with significantly higher 30-day mortality (19–26% vs 0–10%), lower overall survival (24–28% vs 42–64%) and lower disease-free survival (15% vs 53%) as compared to contained perforations.
Data on PCC is scarce, with various PCC entities defined in the studies included. Heterogeneity of the study population, definition of PCC and outcome measures made pooling of the data impossible. In general, perforation, particularly free perforation, seems to be associated with a substantial negative effect on outcomes in colon cancer patients undergoing surgery. Better definition and description of the types of perforation in future studies is essential, as outcomes seem to differ between types of PCC and might require different treatment strategies.
Do parental characteristics and treatment with ART affect perinatal outcomes in singleton pregnancies?
Both parental and ART treatment characteristics affect perinatal outcomes in singleton ...pregnancies.
Previous studies have shown that singleton pregnancies resulting from ART are at risk of preterm birth. ART children are lighter at birth after correction for duration of gestation and at increased risk of congenital abnormalities compared to naturally conceived children. This association is confounded by parental characteristics that are also known to affect perinatal outcomes. It is unclear to which extent parental and ART treatment characteristics independently affect perinatal outcomes.
All IVF clinics in the Netherlands (n = 13) were requested to provide data on all ART treatment cycles (IVF, ICSI and frozen-thawed embryo transfers (FET)), performed between 1 January 2000, and 1 January 2011, which resulted in a pregnancy. Using probabilistic data-linkage, these data (n = 36 683) were linked to the Dutch Perinatal Registry (Perined), which includes all children born in the Netherlands in the same time period (n = 2 548 977).
Analyses were limited to singleton pregnancies that resulted from IVF, ICSI or FET cycles. Multivariable models for linear and logistic regression were fitted including parental characteristics as well as ART treatment characteristics. Analyses were performed separately for fresh cycles and for fresh and FET cycles combined. We assessed the impact on the following perinatal outcomes: birth weight, preterm birth below 37 or 32 weeks of gestation, congenital malformations and perinatal mortality.
The perinatal outcomes of 31 184 out of the 36 683 ART treatment cycles leading to a pregnancy were retrieved through linkage with the Perined (85% linkage). Of those, 23 671 concerned singleton pregnancies resulting from IVF, ICSI or FET. Birth weight was independently associated with both parental and ART treatment characteristics. Characteristics associated with lower birth weight included maternal hypertensive disease, non-Dutch maternal ethnicity, nulliparity, increasing duration of subfertility, hCG for luteal phase support (compared to progesterone), shorter embryo culture duration, increasing number of oocytes retrieved and fresh embryo transfer. The parental characteristic with the greatest effect size on birth weight was maternal diabetes (adjusted difference 283 g, 95% CI 228-338). FET was the ART treatment characteristic with the greatest effect size on birth weight (adjusted difference 100 g, 95% CI 84-117) compared to fresh embryo transfer. Preterm birth was more common among mothers of South-Asian ethnicity. Preterm birth was less common among multiparous women and women with 'male factor' as treatment indication (compared to 'tubal factor').
Due to the retrospective nature of our study, we cannot prove causality. Further limitations of our study were the inability to adjust for mothers giving birth more than once in our dataset, missing values for several variables and limited information on parental lifestyle and general health.
Multiple parental and ART treatment characteristics affect perinatal outcomes, with birth weight being influenced by the widest range of factors. This highlights the importance of assessing both parental and ART treatment characteristics in studies that focus on the health of ART-offspring, with the purpose of modifying these factors where possible. Our results further support the hypothesis that the embryo is sensitive to its early environment.
This study was funded by Foreest Medical School, Alkmaar, the Netherlands (grants: FIO 1307 and FIO 1505). B.W.M. reports grants from NHMRC and consultancy for ObsEva, Merck KGaA, iGenomics and Guerbet. F.B. reports research support grants from Merck Serono and personal fees from Merck Serono. A.C. reports travel support from Ferring BV. and Theramex BV. and personal fees from UpToDate (Hyperthecosis), all outside the remit of the current work. The remaining authors report no conflict of interests.
N/A.
Background
The results of the DIRECT trial, an RCT comparing conservative management with elective sigmoid resection in patients with recurrent diverticulitis or persistent complaints, showed that ...elective sigmoid resection leads to higher quality of life. The aim of this study is to determine the cost‐effectiveness of surgical treatment at 1‐ and 5‐year follow‐up from a societal perspective.
Methods
Clinical effectiveness and resource use were derived from the DIRECT trial. The actual resource use and quality of life (EQ‐5D‐3L™ score) were documented prospectively per individual patient and analysed according to the intention‐to‐treat principle for up to 5 years after randomization. The main outcome was the incremental cost‐effectiveness ratio (ICER), expressed as costs per quality‐adjusted life‐year (QALY).
Results
The study included 106 patients, of whom 50 were randomized to surgery and 56 to conservative treatment. At 1‐ and 5‐year follow‐up an incremental effect (QALY difference between groups) of 0·06 and 0·43 respectively was found, and an incremental cost (cost difference between groups) of €6957 and €2674 respectively, where surgery was more expensive than conservative treatment. This resulted in an ICER of €123 365 per additional QALY at 1‐year follow‐up, and €6275 at 5 years. At a threshold of €20 000 per QALY, operative treatment has 0 per cent probability of being cost‐effective at 1‐year follow‐up, but a 95 per cent probability at 5 years.
Conclusion
At 5‐year follow‐up, elective sigmoid resection in patients with recurring diverticulitis or persistent complaints was found to be cost‐effective. Registration number: NTR1478 (www.trialregistrer.nl).
Maintained benefits
BACKGROUND:Pelvic floor disorders are a major public health issue. For female genital prolapse, sacrocolpopexy is the gold standard. Laparoscopic ventral mesh rectopexy is a relatively new and ...promising technique correcting rectal prolapse. There is no literature combining the 2 robotically assisted techniques.
OBJECTIVE:This study was designed to evaluate the safety, quality of life, and functional and sexual outcomes of robot-assisted sacrocolporectopexy for multicompartment prolapse of the pelvic floor.
DESIGN:This was a prospective, observational cohort study.
SETTINGS:The study was conducted in a tertiary care setting.
PATIENTS:All sexually active patients undergoing robot-assisted sacrocolporectopexy at our institution between 2012 and 2014 were included.
INTERVENTION:Robot-assisted sacrocolporectopexy was the study intervention.
MAIN OUTCOME MEASURES:Preoperative and postoperative (12 months) questionnaires using the Urinary Distress Inventory, Pescatori Incontinence Scale, Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, and Pelvic Floor Impact Questionnaire were completed. In addition Wexner and Vaizey incontinence scores and the Wexner constipation score were recorded postoperatively.
RESULTS:Fifty-one patients underwent robot-assisted sacrocolporectopexy (median follow-up, 12.5 months). The simplified Pelvic Organ Prolapse Quantification improved significantly (p < 0.0005) for all 4 of the anatomic landmarks. Both median fecal (preoperative and postoperative Pescatori 4 vs 3, p = 0.002) and urinary incontinence scores (Urinary Distress Inventory, 27.8 vs 22.2; p < 0.0005) improved significantly at 12 months. Postoperatively median Wexner (3) and Vaizey incontinence (6) and Wexner Constipation (7) scores were noted. A positive effect on sexual function (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire score 31.8 vs 35.9; p = 0.002) and quality of life for each compartment (p < 0.0005) was observed. One patient (2%) developed mesh erosion. No multicompartment recurrences were detected.
LIMITATIONS:This was a observational study with a limited follow-up, no control group, and no preoperatively validated constipation score.
CONCLUSIONS:Robot-assisted sacrocolporectopexy is a safe and effective technique for multicompartment prolapse in terms of functional outcome, quality of life, and sexual function.
Background
For relief of bowel obstruction in left-sided obstructive colon cancer (LSOCC), a self-expandable metal stent (SEMS) or decompressing stoma (DS) can be placed. In a curative setting, these ...two strategies have been extensively studied as a bridge to elective resection. Guidelines recommend SEMS as the preferred option in the palliative setting, but adherence in daily practice is unknown. Therefore, this study aimed to gain more insight into patients with LSOCC who received palliative treatment with SEMS or DS at a national level.
Methods
A retrospective population-based cohort study was conducted in the Netherlands. Data from the Netherlands Cancer Registry (NCR) on all patients with LSOCC treated with DS or SEMS not followed by resection of the primary tumour between January 1, 2015, and December 31, 2019, were analysed. Type of treatment (DS or SEMS) for different clinical scenarios, was the main outcome of this study, and was also evaluated over the years (2015–2019).
Results
Palliative treatment with SEMS or DS for LSOCC was performed in 1077 patients, of whom 79.2% had metastatic disease (M1). Patients without metastatic disease (M0) were older (≥ 80 years M0 67.4%, M1 25.3%,
P
< 0.001), had a worse clinical condition (ASA III 51.4% versus 36.37%, ASA IV-V 13.3% versus 4.0%
P <
0.001) and presented with higher tumour stage (cT4 55.4% versus 33.5%, %
P <
0.001). DS was performed in 91.5% of the patients and SEMS in 8.5%. The proportion of DS did not significantly differ between patients with M1 and M0 (91.8% vs. 90.2% respectively,
P
= 0.525). No increase in SEMS application was observed over the years, with a stable overall proportion of DS of 91–92% per year. In the multivariable analyses, ninety-day mortality and overall survival were not significantly different between SEMS and DS.
Conclusions
This study revealed that DS was the primary treatment modality for palliative management of LSOCC in the Netherlands between 2015 and 2019, while the guidelines recommended SEMS as preferred treatment. For patients with LSOCC eligible for stenting in the palliative setting, SEMS placement should become more available and accessible as the preferred treatment option, to avoid a stoma in the terminal phase of life.
Dose-escalated chemoradiation (CRT) for locally advanced rectal cancer did not result in higher complete response rates but initiated more tumor regression in the randomized RECTAL-BOOST trial ...(Clinicaltrials.gov NCT01951521). This study compared patient reported outcomes between patients who received dose-escalated CRT (5 × 3 gray boost + CRT) or standard CRT for 2 years after randomization.
Patients with locally advanced rectal cancer who were participating in the RECTAL-BOOST trial filled out European Organisation for Research and Treatment of Cancer QLQ-C30 and CR29 questionnaires on quality of life (QoL) and symptoms at baseline, 3, 6, 12, 18, and 24 months after start of treatment. Between-group differences in functional QoL domains were estimated using a linear mixed-effects model and expressed as effect size (ES). Symptom scores were compared using Mann-Whitney U test.
Patients treated with dose-escalated CRT (boost group, n = 51) experienced a significantly stronger decline in global health at 3 and 6 months (ES -0.4 and ES -0.4), physical functioning at 6 months (ES -1.1), role functioning at 3 and 6 months (ES -0.8 and ES -0.6), and social functioning at 6 months (ES -0.6), compared with patients treated with standard CRT (control group, n = 64). The boost group reported significantly more fatigue at 3 and 6 months (83% vs 66% respectively 89% vs 76%), pain at 3 and 6 months (67% vs 36% respectively 80% vs 44%), and diarrhea at 3 months (45% vs 29%) compared with the control group. From 12 months onwards, QoL and symptoms were similar between groups, apart from more blood/mucus in stool in the boost group.
In patients with locally advanced rectal cancer, dose-escalated CRT resulted in a transient deterioration in global health, physical, role, and social functioning and more pain, fatigue and diarrhea at 3 and 6 months after start of treatment compared with standard CRT. From 12 months onwards, the effect of dose-escalated CRT on QoL largely resolved.
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