Evaluation of National Surgical Practice for Lateral Lymph Nodes in Rectal Cancer in an Untrained Setting.

BACKGROUND: Involved lateral lymph nodes (LLNs) have been associated with increased local recurrence (LR) and ipsi-lateral LR (LLR) rates. However, consensus regarding the indication and type of surgical treatment for suspicious LLNs is lacking. This study evaluated the surgical treatment of LLNs in an untrained setting at a national level. METHODS: Patients who underwent additional LLN surgery were selected from a national cross-sectional cohort study regarding patients undergoing rectal cancer surgery in 69 Dutch hospitals in 2016. LLN surgery consisted of either 'node-picking' (the removal of an individual LLN) or 'partial regional node dissection' (PRND; an incomplete resection of the LLN area). For all patients with primarily enlarged (≥7 mm) LLNs, those undergoing rectal surgery with an additional LLN procedure were compared to those  undergoing only rectal resection. RESULTS: Out of 3057 patients, 64 underwent additional LLN surgery, with 4-year LR and LLR rates of 26% and 15%, respectively. Forty-eight patients (75%) had enlarged LLNs, with corresponding recurrence rates of 26% and 19%, respectively. Node-picking (n = 40) resulted in a 20% 4-year LLR, and a 14% LLR after PRND (n = 8; p = 0.677). Multivariable analysis of 158 patients with enlarged LLNs undergoing additional LLN surgery (n = 48) or rectal resection alone (n = 110) showed no significant association of LLN surgery with 4-year LR or LLR, but suggested higher recurrence risks after LLN surgery (LR: hazard ratio [HR] 1.5, 95% confidence interval [CI] 0.7-3.2, p = 0.264; LLR: HR 1.9, 95% CI 0.2-2.5, p = 0.874). CONCLUSION: Evaluation of Dutch practice in 2016 revealed that approximately one-third of patients with primarily enlarged LLNs underwent surgical treatment, mostly consisting of node-picking. Recurrence rates were not significantly affected by LLN surgery, but did suggest worse outcomes. Outcomes of LLN surgery after adequate training requires further research.

[A step-up approach for dealing with rectal foreign bodies]. / Stapsgewijze aanpak bij rectaal corpus alienum.

Patients visiting a hospital with retained rectal foreign bodies can no longer be considered rare and the incidence appears to increase. Currently, little is known about management of patients with retained foreign bodies and there are no medical protocols for situations like this. There is no limit to the type of objects inserted into the anal canal, exposing clinicians to diagnostic and therapeutic dilemmas. Standardised algorithms for patients with retained foreign bodies are needed to avoid serious complications such as perforation or peritonitis. In this article, we present a 59-year-old, 57-year-old and 29-year-old male who visited the emergency department with inserted rectal foreign bodies and we propose a stepwise approach for dealing with retained rectal foreign bodies.

Long-term Results of a Randomized Double-blinded Prospective Trial of a Lightweight (Ultrapro) Versus a Heavyweight Mesh (Prolene) in Laparoscopic Total Extraperitoneal Inguinal Hernia Repair (TULP-trial).

OBJECTIVE: The aim of the randomized clinical trial was to compare the 2 years of clinical outcomes of a lightweight (Ultrapro) vs a heavyweight (Prolene) mesh for laparoscopic total extraperitoneal (TEP) inguinal hernia repair. BACKGROUND: Lightweight meshes reduce postoperative pain and stiffness in open anterior inguinal hernia repair. The discussion about a similar benefit for laparoscopic repair is ongoing, but concerns exist about higher recurrence rates. METHODS: Between March 2010 and October 2012, male patients who presented with a primary, reducible unilateral inguinal hernia who underwent day-case TEP repair were eligible. Outcome parameters included chronic pain, recurrence, foreign body feeling, and quality of life scores. RESULTS: During the study period, 950 patients were included. One year postoperatively the presence of relevant pain (Numeric Rating Score 4-10) was significantly higher in the lightweight mesh group (2.9%) compared with the heavyweight mesh group (0.7%) (P = 0.01), and after 2 years this difference remained significant (P = 0.03). There were 4 (0.8%) recurrent hernias in the heavyweight mesh group and 13 (2.7%) in the lightweight group (P = 0.03). No differences in foreign body feeling or quality of life scores were detected. CONCLUSIONS: In TEP hernia surgery, there was no benefit of lightweight over heavyweight meshes observed 2 years postoperatively.

Pit excision with phenolisation of the sinus tract versus radical excision in sacrococcygeal pilonidal sinus disease: study protocol for a single centre randomized controlled trial.

BACKGROUND: Excision of the pit of the sinus with phenolisation of the sinus tract and surgical excision are two treatment modalities for patients with sacrococcygeal pilonidal sinus disease. Phenolisation seems to have advantages over local sinus excision as it is performed under local anaesthesia with a relatively small surgical procedure, less postoperative pain, minor risk of surgical site infection (8.7%), and only a few days being unable to perform normal activity (mean of 2.3 days). The disadvantage may be the higher risk of recurrence (13%) and the necessity to perform a second phenolisation in a subgroup of patients. Wide surgical excision of sacrococcygeal pilonidal sinus disease has a recurrence rate of 4 to 11%. The disadvantages, however, are postoperative pain, high risk of surgical site infection, and a longer period being unable to perform normal activity (mean of 10 days). The objective of this study is to show that excision of the pit of the sinus of sacrococcygeal pilonidal sinus disease with phenolisation of the sinus tract is a successful first-time treatment modality for sacrococcygeal pilonidal sinus disease accompanied by a quicker return to normal daily activity compared to local excision of the sinus. METHODS/DESIGN: Patients with sacrococcygeal pilonidal sinus disease will be randomly allocated to excision of the pit of the sinus followed by phenol applications of the sinus tract or radical surgical excision of the sinus. Patients are recruited from a single Dutch teaching, non-university hospital. The primary endpoint is loss of days of normal activity/working days. Secondary endpoints are anatomic recurrence rate, symptomatic recurrence rate, quality of life, surgical site infection, time to wound closure, symptoms related to treatment, pain, usage of pain medication and total treatment time. To demonstrate a reduction of return to normal activity from 7.5 days in the excision group to 4 days in the phenolisation group, with 80% power at 5% alpha, a total sample size of 100 is required. DISCUSSION: This study is a randomised controlled trial to provide evidence that phenolisation of the sinus tract compared to radical excision reduces the total number of days unable to perform normal activity. TRIAL REGISTRATION: Dutch trial register NTR4043 , registered on 24 June 2013.

More adequate lymph node dissection after laparoscopic colorectal surgery.

The aim of this study was to determine whether there is a difference in the amount of lymph nodes harvested during open and laparoscopic surgery and whether this might influence the subsequent offering of adjuvant chemotherapy. All patients who underwent colorectal surgery for colorectal malignancies from July 2006 to April 2008 were included in our prospective database and in the study. In the laparoscopic group, 11/55 (20%) patients with stage II tumors had <10 lymph nodes in the pathology specimen when compared with 44/110 (40%) in the open group (P=0.01). The average number of lymph nodes was 12.1 for laparoscopic as compared with 10.2 lymph nodes for open resection (P=0.009). We demonstrate a significant increase in the number of resected lymph nodes with laparoscopic surgery. Significantly more patients in the open surgery group had <10 negative lymph nodes and were subsequently offered chemotherapy for their high-risk stage II colorectal malignancies.

The effect of ultrapro or prolene mesh on postoperative pain and well-being following endoscopic Totally Extraperitoneal (TEP) hernia repair (TULP): study protocol for a randomized controlled trial.

BACKGROUND: The purpose of this study was to describe the rationale and design of a randomized controlled trial analyzing the effects of mesh type (Ultrapro versus Prolene mesh) on postoperative pain and well-being following an endoscopic Totally Extraperitoneal (TEP) repair for inguinal hernias (short: TULP trial). METHODS AND DESIGN: The TULP trial is a prospective, two arm, double blind, randomized controlled trial to assess chronic postoperative pain and quality of life following implantation of a lightweight (Ultrapro) and heavyweight (Prolene) mesh in endoscopic TEP hernia repair. The setting is a high-volume single center hospital, specializing in TEP hernia repair. All patients are operated on by one of four surgeons. Adult male patients (≥18 years of age) with primary, reducible, unilateral inguinal hernias and no contraindications for TEP repair are eligible for inclusion in the study. The primary outcome is substantial chronic postoperative pain, defined as moderate to severe pain persisting ≥ 3 months postoperatively (Numerical Rating Scale, NRS 4-10). Secondary endpoints are the individual development of pain until three years after the TEP procedure, the quality of life (QoL), recurrence rate, patient satisfaction and complications. DISCUSSION: Large prospective randomized controlled studies with a long follow-up evaluating the incidence of chronic postoperative pain following implantation of lightweight and heavyweight mesh in endoscopic (TEP) hernia repair are limited. By studying the presence of pain and quality of life, but also complications and recurrences in a large patient population, a complete efficiency and feasibility assessment of both mesh types in TEP hernia repair will be performed. TRIAL REGISTRATION: The TULP study is registered in the Dutch Trial Register (NTR2131).

Feasibility of enhanced recovery programme in various patient groups.

INTRODUCTION: An accelerated multi-modal rehabilitation programme may improve the recuperation and reduce the complication rate in patients undergoing colorectal surgery. The aim of this study was to see whether fast-track recovery is feasible in various patient groups. PATIENTS AND METHODS: Data on all patients operated for intestinal pathology from July 2006-April 2008 were prospectively collected for this prospective study. All included patients entered a multi-modal rehabilitation programme. Peri- and postoperative complications and readmissions, pathology reports and operation characteristics were recorded prospectively. RESULTS: Three hundred and forty-eight patients underwent colorectal surgery. No difference in readmission rate was found between various patient groups. The only significant differences after multivariate regression analysis were in re-operation rate and length of stay in favour of the elective surgery group. CONCLUSIONS: Fast-track modalities can be introduced with a low complication rate in all patient groups. Length of stay in elderly patients averages 10 days, implying that this group cannot be considered as "fast track", although the same protocol can also be applied in this group. Better organization of the aftercare might however considerably change the length of stay of elderly patients, since postoperative complications do not differ between old and young patients.

Teaching colorectal surgery in the laparoscopic era; is it safe?

OBJECTIVES: With the introduction of laparoscopic colorectal surgery, the question is raised as to whether laparoscopic colectomies can safely be performed by surgical registrars, when supervised by experienced laparoscopic surgeons. In this study we have compared surgical outcomes of surgical registrars, fellows, and staff surgeons in a Dutch teaching hospital. DESIGN, SETTING, AND PARTICIPANTS: Using a prospective database, the surgical outcomes of staff surgeons, fellows, and surgical registrars were compared. Pre- and postoperative complications were evaluated, including anastomotic failure. The percentage of reintervention, mortality, readmission, total hospital stay, and operating time were evaluated. The quality of the surgical resection was assessed by comparing the number of resected lymph nodes in malignant cases and the percentage of patients with adequate resection margins. RESULTS: Analysis was performed in 420 patients. The majority of surgery was performed by staff surgeons. Outcomes of surgery for staff surgeons, fellows, and surgical registrars were comparable with respect to complications, percentage of conversions, and oncological adequacy. CONCLUSIONS: Comprehensive training as a colorectal surgeon should include competence in laparoscopic resections. Our results show that laparoscopic colorectal surgery can safely be performed by surgical registrars with no increase of the number of conversions to laparotomy or the number of complications.

Transanal endoscopic microsurgery versus endoscopic mucosal resection for large rectal adenomas (TREND-study).

BACKGROUND: Recent non-randomized studies suggest that extended endoscopic mucosal resection (EMR) is equally effective in removing large rectal adenomas as transanal endoscopic microsurgery (TEM). If equally effective, EMR might be a more cost-effective approach as this strategy does not require expensive equipment, general anesthesia and hospital admission. Furthermore, EMR appears to be associated with fewer complications.The aim of this study is to compare the cost-effectiveness and cost-utility of TEM and EMR for the resection of large rectal adenomas. METHODS/DESIGN: Multicenter randomized trial among 15 hospitals in the Netherlands. Patients with a rectal adenoma > or = 3 cm, located between 1-15 cm ab ano, will be randomized to a TEM- or EMR-treatment strategy. For TEM, patients will be treated under general anesthesia, adenomas will be dissected en-bloc by a full-thickness excision, and patients will be admitted to the hospital. For EMR, no or conscious sedation is used, lesions will be resected through the submucosal plane in a piecemeal fashion, and patients will be discharged from the hospital. Residual adenoma that is visible during the first surveillance endoscopy at 3 months will be removed endoscopically in both treatment strategies and is considered as part of the primary treatment. Primary outcome measure is the proportion of patients with recurrence after 3 months. Secondary outcome measures are: 2) number of days not spent in hospital from initial treatment until 2 years afterwards; 3) major and minor morbidity; 4) disease specific and general quality of life; 5) anorectal function; 6) health care utilization and costs. A cost-effectiveness and cost-utility analysis of EMR against TEM for large rectal adenomas will be performed from a societal perspective with respectively the costs per recurrence free patient and the cost per quality adjusted life year as outcome measures. Based on comparable recurrence rates for TEM and EMR of 3.3% and considering an upper-limit of 10% for EMR to be non-inferior (beta-error 0.2 and one-sided alpha-error 0.05), 89 patients are needed per group. DISCUSSION: The TREND study is the first randomized trial evaluating whether TEM or EMR is more cost-effective for the treatment of large rectal adenomas. TRIAL REGISTRATION NUMBER: (trialregister.nl) NTR1422.

Laparoscopic ileocolic resection versus infliximab treatment of distal ileitis in Crohn's disease: a randomized multicenter trial (LIR!C-trial).

BACKGROUND: With the availability of infliximab, nowadays recurrent Crohn's disease, defined as disease refractory to immunomodulatory agents that has been treated with steroids, is generally treated with infliximab. Infliximab is an effective but expensive treatment and once started it is unclear when therapy can be discontinued. Surgical resection has been the golden standard in recurrent Crohn's disease. Laparoscopic ileocolic resection proved to be safe and is characterized by a quick symptom reduction. The objective of this study is to compare infliximab treatment with laparoscopic ileocolic resection in patients with recurrent Crohn's disease of the distal ileum with respect to quality of life and costs. METHODS/DESIGN: The study is designed as a multicenter randomized clinical trial including patients with Crohn's disease located in the terminal ileum that require infliximab treatment following recent consensus statements on inflammatory bowel disease treatment: moderate to severe disease activity in patients that fail to respond to steroid therapy or immunomodulatory therapy. Patients will be randomized to receive either infliximab or undergo a laparoscopic ileocolic resection. Primary outcomes are quality of life and costs. Secondary outcomes are hospital stay, early and late morbidity, sick leave and surgical recurrence. In order to detect an effect size of 0.5 on the Inflammatory Bowel Disease Questionnaire at a 5% two sided significance level with a power of 80%, a sample size of 65 patients per treatment group can be calculated. An economic evaluation will be performed by assessing the marginal direct medical, non-medical and time costs and the costs per Quality Adjusted Life Year (QALY) will be calculated. For both treatment strategies a cost-utility ratio will be calculated. Patients will be included from December 2007. DISCUSSION: The LIR!C-trial is a randomized multicenter trial that will provide evidence whether infliximab treatment or surgery is the best treatment for recurrent distal ileitis in Crohn's disease. TRIAL REGISTRATION: Nederlands Trial Register NTR1150.

Cryptococcal breast abscess.

A cryptococcal abscess of the breast is uncommon and may mimic a neoplastic lesion. We describe a patient with an isolated cryptococcal infection of the breast, which was treated with oral fluconazole in combination with surgical excision. With the exception of diabetes mellitus type II, no underlying predisposing illness was identified.