Randomized clinical trial of intracutaneously versus transcutaneously sutured ileostomy to prevent stoma-related complications (ISI trial).

BACKGROUND: Ileostomy construction is a common procedure but can be associated with morbidity. The stoma is commonly secured to the skin using transcutaneous sutures. It is hypothesized that intracutaneous sutures result in a tighter adherence of the peristomal skin to the stoma plate to prevent faecal leakage. The study aimed to compare the effect of intracutaneous versus transcutaneous suturing of ileostomies on faecal leakage and quality of life. METHODS: This randomized trial was undertaken in 11 hospitals in the Netherlands. Patients scheduled to receive an ileostomy for any reason were randomized to intracutaneous or transcutaneous suturing (IC and TC groups respectively). The primary outcome was faecal leakage. Secondary outcomes were stoma-related quality of life and costs of stoma-related materials and reinterventions. RESULTS: Between April 2011 and February 2016, 339 patients were randomized to the IC (170) or TC (169) group. Leakage rates were higher in the IC than in the TC group (52·4 versus 41·4 per cent respectively; risk difference 11·0 (95 per cent c.i. 0·3 to 21·2) per cent). Skin irritation rates were high (78·2 versus 72·2 per cent), but did not differ significantly between the groups (risk difference 6·1 (95 per cent c.i. -3·2 to 15·10) per cent). There were no significant differences in quality of life or costs between the groups. CONCLUSION: Intracutaneous suturing of an ileostomy is associated with more peristomal leakage than transcutaneous suturing. Overall stoma-related complications did not differ between the two techniques. Registration number: NTR2369 ( http://www.trialregister.nl).

Home visits as part of a new care pathway (iAID) to improve quality of care and quality of life in ostomy patients: a cluster-randomized stepped-wedge trial.

AIM: Morbidity in patients with an ostomy is high. A new care pathway, including perioperative home visits by enterostomal therapists, was studied to assess whether more elaborate education and closer guidance could reduce stoma-related complications and improve quality of life (QoL), at acceptable cost. METHOD: Patients requiring an ileostomy or colostomy, for any inflammatory or malignant bowel disease, were included in a 15-centre cluster-randomized 'stepped-wedge' study. Primary outcomes were stoma-related complications and QoL, measured using the Stoma-QOL, 3 months after surgery. Secondary outcomes included costs of care. RESULTS: The standard pathway (SP) was followed by 113 patients and the new pathway (NP) by 105 patients. Although the overall number of stoma-related complications was similar in both groups (SP 156, NP 150), the proportion of patients experiencing one or more stoma-related complications was significantly higher in the NP (72% vs 84%, risk difference 12%; 95% CI: 0.3-23.3%). Although in the NP more patients had stoma-related complications, QoL scores were significantly better (P < 0.001). In the SP more patients required extra care at home for their ostomy than in the NP (60.6% vs 33.7%, respectively; risk difference 26.9%, 95% CI: 13.5-40.4%). Stoma revision was done more often in the SP (n = 11) than in the NP (n = 2). Total costs in the SP did not differ significantly from the NP. CONCLUSION: The NP did not reduce the number of stoma-related complications but did lead to improved quality of care and life, against similar costs. Based on these results the NP, including perioperative home visits by an enterostomal therapist, can be recommended.

Factors affecting timing of closure and non-reversal of temporary ileostomies.

BACKGROUND: Although stoma closure is considered a simple surgical intervention, the interval between construction and reversal is often prolonged, and some ileostomies may never be reversed. We evaluated possible predictors for non-reversal and prolonged interval between construction and reversal. MATERIAL AND METHODS: In a cohort study of ileostomy patients treated in a large teaching hospital, we collected data from the surgical complication and enterostomal therapists' registries between January 2001 and December 2011. Parameters responsible for morbidity, mortality, length of stay and time interval between construction and reversal were analysed. RESULTS: Of 485 intentionally temporary ileostomies, 359 were reversed after a median of 5.6 months (IQR 3.8-8.9 months), while 126 (26%) remained permanent. End ileostomy and intra-abdominal abscess independently delayed reversal. Age, end ileostomy, higher body mass index and preoperative radiotherapy were independent factors for non-reversal. Median duration of hospitalisation for reversal was 7.0 days (5-13 days). Morbidity and mortality were 31 and 0.9%, respectively. In 20 patients (5.5%), re-ileostomy was necessary. CONCLUSIONS: A substantial number of ileostomies that are intended to be temporary will never be reversed. If reversed, the interval between construction and reversal is longer than anticipated, while morbidity after reversal and duration of hospitalisation are considerable. Besides a temporary ileostomy, there are two other options: no diversion or a permanent colostomy. Shared decision-making is to be preferred in these situations.

Hip fracture surgery and performance indicators: an analysis of 941 patients operated in a large teaching hospital.

BACKGROUND: In the Netherlands, two performance indicators for the treatment of hip fracture patients have been recently implemented. Both indicators state that surgery within 24 h after admission improves the outcome with regard to 1-year mortality and the amount of re-operations within 1 year. To determine the value of these performance indicators, we conducted a retrospective analysis of 941 hip fracture patients. METHODS: In the period from January 2003 to December 2006, a total of 941 consecutive hip fracture patients were included in this study. We determined the amount of re-operations and the mortality at 1 year after surgery. From June 2005 to December 2006, we could determine whether patients were operated on within 24 h after admission. In this group of 379 patients, we determined if there were differences in the 1-year mortality and the number of re-operations at 1 year with regard to the time window in which these patients were operated on (<24 h or >24 h). RESULTS: Our overall mortality rate at 1 year is 21% (202 patients) and the amount of re-operations within 1 year is 8% (77 procedures). In our subgroup analysis, we found no significant difference in mortality or re-operations if patients were operated on within 24 h or not (number needed to treat of 59 and -31, respectively). CONCLUSION: We conclude that hip fracture surgery within 24 h does not provide significantly better results in terms of 1-year mortality and the amount of re-operations within 1 year.

Improved diagnosis and treatment of anastomotic leakage after colorectal surgery.

AIM: This study aimed at testing feasibility of a standardised postoperative surveillance protocol to reduce delay in the diagnosis of anastomotic leakage (AL) and, subsequently, mortality. MATERIAL AND METHODS: Patient files of patients operated between 1996 and 1999 were reviewed and used as historical controls (n=1066). As a result, a protocol for standardised post-operative surveillance was designed using easily accessible, clinical parameters. Between August 2004 and August 2006, all operated patients with a colorectal anastomosis (n=223) were prospectively subjected to this standardised surveillance. RESULTS: AL was diagnosed in 7.0% of patients in the historical control group and 9.4% of patients in the standardised surveillance group. AL mortality decreased from 39% to 24% with standardised surveillance (n.s.). The delay in AL diagnosis was significantly reduced during standardised surveillance (4 versus 1.5 days, p=0.01), which was confirmed in the multivariate analysis. CONCLUSION: With non-standardised postoperative monitoring, AL was associated with a high mortality rate. Patients were subjected to several additional tests, which were not primarily useful to diagnose AL. Standardised postoperative surveillance for AL was introduced successfully and resulted in a shorter delay between the first signs and symptoms to the confirmation of AL.

To eat or not to eat: facilitating early oral intake after elective colonic surgery in the Netherlands.

BACKGROUND & AIMS: It was shown that patients in the Netherlands remain exposed to unnecessarily prolonged starvation after abdominal surgery. The present study examined whether a structured collaborative effort would help to implement the early start of oral nutrition after colorectal surgery. METHODS: In 2006, twenty-six Dutch hospitals signed up to a "breakthrough project" concerning the implementation of the enhanced recovery after surgery (ERAS) programme with early oral feeding as one of the key elements. Each hospital determined the usual start of food intake by analyzing 50 patients who underwent a colorectal resection in 2004 (n=1126). Subsequently, over the course of one year 861 colorectal surgery patients were treated according to the ERAS programme. The first day that patients were eating before and after the breakthrough project was compared using Kaplan-Meier analyses and Cox regression models. RESULTS: Patients treated according to the ERAS programme were eating 3 days earlier than the patients traditionally treated (p<0.000). Two days after surgery 65% of the ERAS patients were eating normal food versus 7% of the pre-ERAS patients. CONCLUSIONS: The present nationwide collaborative effort was successful in implementing a change towards an early start of oral nutrition after abdominal surgery.

[Splenectomy in a large general hospital: often caused by iatrogenic injury, often causing multiple complications; poor adherence to post-operative guidelines for vaccination and prophylaxis]. / Splenectomie in een groot algemeen ziekenhuis: vaak iatrogeen letsel als oorzaak, veel complicaties tot gevolg; naleving postoperatieve richtlijnen voor vaccinatie en profylaxe gebrekkig.

OBJECTIVE: To assess the indications, complications and mortality associated with splenectomy in a large general hospital, and to evaluate adherence to guidelines for postoperative vaccination and prophylactic antibiotics. DESIGN: Retrospective, descriptive. METHOD: Data were collected on 106 patients who underwent splenectomy between 1999 and 2004. Indications for surgery, complications, duration of hospitalisation, and vaccination status were investigated retrospectively. Patients were contacted by telephone for a structured interview regarding vaccination and antibiotic prophylaxis. RESULTS: Of the 95 patients with sufficient data for analysis, 41 underwent elective surgery and 54 underwent non-elective surgery, including 37 who required splenectomy due to iatrogenic injury. Posteroperative complications arose in 45 patients, including 23 who developed serious complications. 10 patients died due to complications, including 7 who died within one month after the procedure. Vaccination coverage for the entire group was 58%. CONCLUSION: In this large general hospital, splenectomy was often performed due to iatrogenic injury and was associated with a relatively high complication rate. Adherence to guidelines on vaccination and prophylactic antibiotics could be improved.

Splenic abscesses caused by a reptile-associated salmonella infection.

Salmonella infections are not very uncommon. The source generally has to be looked for in food. The syndrome concerns mostly gastro-enteritis. We present a 17-year-old girl with sepsis caused by splenic abscesses which was successfully treated with splenectomy and antibiotics. After analysis (blood and surgical specimen samples), she appeared to be infected with Salmonella type Telelkebir, a rare variant that is associated with exotic animal species, mainly reptiles. The same variant was cultivated from the faeces of the reptile pets that were held in the patients' home. We describe a case with a not often recognized source and an unusual course of Salmonella infection. Exotic pets can be a source of Salmonella infections with a catastrophic course of the disease even in healthy people.

Introduction of preoperative radiotherapy in the treatment of operable rectal cancer in the Southwest region of the Netherlands.

INTRODUCTION: After publication of the results of the Dutch TME-trial preoperative radiotherapy followed by TME-surgery was introduced in July 2001 in the region of the comprehensive cancer centre Rotterdam as standard treatment for rectal cancer. The aim of this study is to identify the compliance to a new standardized treatment protocol i.e. the introduction of preoperative radiotherapy and to analyze the results of rectal cancer treatment in the Cancer Centre Rotterdam Region. PATIENTS AND METHODS: A total of 521 patients with adenocarcinoma of the rectum were included in the period from 2001 to 2003. All patients were treated with curative intent. RESULTS: There was a significant increase of preoperative radiotherapy for patients with a tumour in the lower two-third of the rectum (21% versus 69%, p<0.001). Peri-operative mortality rate was 2.7% and overall anastomotic leakage rate was 10.3%. There was a significant increase in the occurrence of anastomotic leakage in end-to-end anastomoses (p<0.0001). Most anastomotic leakages occurred when patients were operated in between 4 and 8 days after the end of radiotherapy. Several aspects such as continence for urine and faeces and sexual functions were poorly registered. The total number of lymph nodes registered in pathology reports was low. The rate of reported circumferential margins increased from 37% to 70% after feedback to the regional pathology working group. CONCLUSION: The regional quality of rectal cancer surgery is conform preset quality-demands. There was a significant increase in the percentage preoperative radiotherapy, but still about 25% of patients who qualified for radiotherapy did not receive radiation. Pathology reports improved during registration, which illustrates the importance of registration to assess and improve quality of rectal cancer treatment.

Satisfaction and complications in post-bariatric surgery abdominoplasty patients.

BACKGROUND: Bariatric surgery is an expanding field, with subsequent increases in the number of patients seeking additional corrective procedures including abdominoplasty. Complication rates and body image changes may be different from the general population seeking corrective procedures. METHODS: We performed a retrospective study by questionnaire and chart-based review of the patients who underwent laparoscopic adjustable gastric banding (LAGB) and abdominoplasty at our hospital between 1995 and 2004. Outcome variables included minor and major complications and satisfaction with body image and functional outcome. RESULTS: Patients who returned the completed questionnaire were included in the study (n = 25). The most prevalent complications were seroma formation (25%) and wound infections requiring antibiotics (13%). Hygiene, mobility and general functional capacity improved in 68%, 72%, and 80%, respectively. Body satisfaction and body mass index (BMI) did not markedly change, while self-efficacy improved after abdominoplasty. CONCLUSION: Abdominoplasty is a safe and effective method of body contour correction in patients with massive weight loss after bariatric surgery. However, a BMI as close to the ideal as possible is necessary for the complication rate to approach that of the general population undergoing abdominoplasty. Patients should be made aware of the difference in body image changes after abdominoplasty as compared to post-LAGB, as well as the trend towards an unchanged BMI.

Prolonged skin staining after intradermal use of patent blue in sentinel lymph node biopsy for breast cancer.

AIMS: To investigate the duration of staining of the skin after intradermal injection of patent blue during sentinel lymph node biopsy (SLNB) for breast cancer. METHODS: The clinical data of 33 consecutive patients who underwent a SLNB in combination with breast conserving therapy (BCT) in our hospital were retrospectively reviewed. Also, patients were interviewed at intervals of 3 months until the blue staining of their skin had disappeared. RESULTS: At mean follow-up of 18 months (range: 12-28) patent blue was visible at the site of injection after 3, 6, 9 and 12 months in 70, 64, 44 and 41% of the patients, respectively. CONCLUSIONS: Use of the intradermal injection technique of patent blue during sentinel lymph node biopsy in BCT may result in remarkably long discolouring of the skin at the site of injection.

[Two patients with a non-palpable, subcutaneously implanted contraceptive]. / Twee patiënten met een niet-palpabel, subcutaan ingebracht anticonceptivum.

Two women, 33 and 31 years of age, were referred to a surgeon for the removal of a previously implanted hormonal contraceptive after the general practitioner had attempted this without success. However, no foreign body could be detected in either patient by surgery, echography and MRI and by X-ray, echography and MRI, respectively. They were then referred to a gynaecologist. In the first patient, a low level of etonogestrel confirmed that there was no contraceptive in her body. Subcutaneous contraceptives are sometimes implanted incorrectly. If the rod is not palpable at the site of insertion, then the etonogestrel level should be determined first of all. If the hormone level indicates that a rod is indeed present, then echography or MRI may be considered to localise it before resorting to surgical exploration. Many problems can be prevented by proper implantation.

Adjustable silicone gastric banding: a series with three cases of band erosion.

BACKGROUND: Among the various operations used for surgical treatment of morbid obesity, adjustable silicone gastric banding (ASGB) is the least invasive. Many good results have been described. During extended follow-up, however, serious complications may occur. We briefly describe our results with ASGB and will focus on three cases of band erosion. METHODS: From January 1996 to December 1998, 91 patients underwent laparoscopic adjustable gastric banding in our clinic. Follow-up until now is 100%. RESULTS: Body Mass Index (BMI) in this series decreased from 44.7 at time of operation to 34.8 at 18 months of follow-up (42 patients). Complications, minor and major, occurred in 27.5%. Three patients are described in which the gastric band migrated and had to be removed operatively. CONCLUSIONS: Satisfactory weight loss can be established by ASGB. However, serious and potentially lethal complications can occur. In view of the former Angelchik esophageal antireflux prosthesis, abandoned because of its notorious migration, we must be aggressive in evaluating band migration. Thus, we plead for international registration of adjustable silicone gastric banding.

[Surgical thoracoscopy; initial results in 13 patients]. / Chirurgische thoracoscopie; eerste ervaringen bij 13 patiënten.

In various diagnostic and therapeutic thoracic operations the use of thoracoscopy can replace the more radical thoracotomy. On account of the development of endoscopic video systems and specialised instrumentation, this technique is increasingly being used. Our first experiences with this new development in thoracic surgery are promising. In the period July 1991-June 1992 we performed 14 thoracoscopic operations in the Merwede Hospital in Dordrecht, for the surgical treatment of spontaneous pneumothorax (8x), for open lung biopsy (5x) and for resection of a peripheral benign tumour of the lung (Ix). No major complications occurred and patient recovery was surprisingly fast. Because of the decreased operation trauma, for several procedures already established via thoracotomy, the surgical thoracoscopy can be regarded as a great improvement in thoracic surgery.

Sequential metabolic characteristics following portacaval shunt in rats.

A portacaval shunt (PCS) model is frequently employed to study phenomena inherent in portal-systemic shunting of splanchnic blood. In many species, a PCS induces hepatic insufficiency, accompanied by encephalopathy. Rats operated on with a 'nonsuture' technique tolerate a PCS better and exhibit no or only slight encephalopathy. Age and environment seem to have a large impact on the ability to tolerate a PCS. This explains the discrepancies between the results of different investigators and the varying time periods reported between the PCS operation and the optimal time for experiments. To characterize the PCS model (button technique) in rats with respect to metabolic parameters in our field of interest, we studied three groups of male Sprague-Dawley rats--non-operated (n = 12); sham-operated (n = 12) and PCS (n = 13)--for 4 weeks following surgery. Body weight in the PCS group decreased for 1 week after surgery and then increased at about the same rate as in the control groups. Plasma immunoreactive insulin, plasma immunoreactive glucagon (IRG) and aromatic amino acid concentrations were highest 1 week after surgery and tended to normalize in the next weeks. Plasma branched-chain amino acid (BCAA) concentrations were decreased in the 1st, 2nd and 3rd week after surgery, after which normalization occurred. These data demonstrate that after 3-4 weeks, male Sprague-Dawley rats start to recover from the metabolic disturbances caused by PCS with regard to the parameters measured. Therefore, experiments in this area, especially those relating to BCAA metabolism, should be carried out 2-3 weeks after the shunt operation (button technique).

Liver damage as a potential source of error in the estimation of myocardial infarct size from plasma creatine kinase activity.

The occurrence of liver damage was investigated in patients with uncomplicated acute myocardial infarction (AMI). Cumulative plasma release of creatine kinase (CK) and alpha-hydroxybutyrate dehydrogenase (HBD) was compared with release of alanine aminotransferase (ALT). Up to 48 h after AMI, the appearance of ALT could be fully explained by myocardial ALT release. Thereafter additional release of ALT occurred, indicating liver damage. A possible effect of liver function on the rate of elimination of CK from plasma was studied in the dog. Complete temporary arrest of hepatic blood supply was obtained after previous implantation of a portacaval shunt, ligation of secondary inflows and blockade of retrograde perfusion. Neither these preliminary haemodynamic interventions nor the acute arrest of hepatic blood flow had any effect on the disappearance rate of CK from plasma. It is concluded that some liver damage commonly occurs in patients after AMI. However, this phenomenon does not interfere with the estimation of infarct size because the elimination of CK from plasma is unaltered during total hepatic ischaemia.

Percutaneous transhepatic drainage and insertion of an endoprosthesis for obstructive jaundice.

As a consequence of the good results with percutaneous transhepatic cholangiography using the Chiba needle, a similar technique was employed for percutaneous transhepatic drainage and insertion of a percutaneous transhepatic endoprostheses. Herein we have described the technique and results of percutaneous transhepatic cholangiography with the Chiba needle in 45 patients and of combined percutaneous transhepatic drainage and insertion of an endoprosthesis in a consecutive group of 69 patients with obstructive jaundice. In the latter group, 50 patients had a malignant lesion. Of these, 38 were subject to continuous drainage, 14 externally and 24 with an endoprosthesis. The percutaneous transhepatic drainage and insertion of an endoprosthesis procedure brings a new dimension to preoperative decompression of the bile ducts and palliative treatment of obstructive jaundice in high-risk patients.