The Gatekeeper™ for fecal incontinence: Another trial and error

INTRODUCTION

The Gatekeeper™ is the most recent bulking agent used in the treatment of fecal incontinence with no reported complications. This case reports side effects similar to other bulking agents, namely migration of the prosthesis and perianal abscess.

PRESENTATION OF CASE

A 52 year old gentleman presented with a history of fecal soiling. He underwent uncomplicated surgery in 2012 for 6 Gatekeeper™ implantations with only temporary improvements. In 2013, endorectal ultrasound revealed prosthesis migration. In 2014, he presented with a perianal abscess which contained one of the prosthesis.

DISCUSSION

The Gatekeeper™, made of the inert Hyexpan, typically implanted in the intersphincteric region, has been used for the treatment of fecal incontinence since its discontinuation in the treatment of gastroesophageal reflux disease.⁵ The Gatekeeper™ was implemented on a small number of subjects for which the typical side effects of bulking agents were not seen.

CONCLUSION

Larger studies need to be conducted to investigate the advantages or perhaps disadvantages of the Gatekeeper™ over other bulking agents.     

Safety trial of Floseal(®) haemostatic agent in head and neck surgery

INTRODUCTION

Floseal® (Baxter, Hayward, CA, US) can be of value in reducing blood loss and haematoma rates. The manufacturer’s warnings include allergic reaction, poor wound healing and intravascular thrombosis. We aimed to determine whether Floseal® is safe to use in various head and neck surgery (HNS) procedures.

METHODS

A prospective trial was conducted using Floseal® in 42 various consecutive head and neck surgery procedures. Adverse incidents were used as the main outcome measure, including allergic reaction, wound breakdown, wound infection and thrombosis. Secondary outcome measures included haematoma formation, hospital stay, drain times and output.

RESULTS

No adverse incidents were recorded in the trial period. Two patients developed haematomas and required surgical exploration where a bleeding vessel was identified and dealt with.

CONCLUSIONS

Floseal® is safe to be used in head and neck surgery with no adverse effects. A larger number and a control group are required to ascertain its value in reducing blood loss, haematoma formation, drain usage and hospital stay.     

What can be concluded from the ERSPC and PLCO trial data?

ObjectivesThe interim analyses of the long-awaited erSPC and PlCo trial data have generated conflicting conclusions regarding the value of screening for prostate cancer based on measurements of PSA.Materials and methodsWe review the two publications and speculate on reasons underlying the contradicting conclusion of the two studies.ResultsThe apparently negative results of the PlCO trial may be in part because a part of the patients enrolled were “prescreened”, because of failure to biopsy some patients with PSA > 4 ng/ml, because of contamination in the control arm and because of the relatively short follow-up. However, both reports address the serious problem of overdetection and subsequent overtreatment, as the positive predictive value of positive biopsies triggered by positive PSA in the ERPC study was only 24% and many detected cancers were of low-risk.ConclusionsUntil more sensitive and more specific screening tools are available that can detect the few cases of prostate cancer with aggressive biological potential among the majority of indolent cases, physicians and patients must understand that most diagnosed prostate cancers will never lead to death and that men can only profit from early detection if local and systemic treatment are limited to those patients who truly need it.     

Rationale and design of the Randomized Intervention with CPAP in Coronary Artery Disease and Sleep Apnoea – RICCADSA trial

Rationale. Obstructive sleep apnoea (OSA) is common in coronary artery disease (CAD) and a possible cause of increased mortality. To date, there is a lack of randomized controlled trials to draw the conclusion that all CAD patients should be investigated for OSA and subsequently be treated with continuous positive airway pressure (CPAP). Objective. The Randomized Intervention with CPAP in CAD and OSA (RICCADSA) trial is designed to address if CPAP treatment reduces the combined rate of new revascularization, myocardial infarction, stroke and cardiovascular mortality over a 3-year period in CAD patients with OSA. Secondary outcomes include cardiovascular biomarkers, cardiac function and maximal exercise capacity at 3-month- and 1-year follow-ups. Patients and methods. A sample of 400 CAD patients (100 non-sleepy OSA patients randomized to CPAP, 100 to non-CPAP; 100 sleepy OSA patients on CPAP, and 100 CAD patients without OSA) will be included. So far, 240 patients have been enrolled in the trial since December 31, 2005. Conclusion. The RICCADSA trial will contribute to defining the impact of CPAP on prognosis of CAD patients with OSA.     

Does preoperative hydration affect postoperative nausea and vomiting? A randomized, controlled trial

BACKGROUND: It has been suggested that relative hypovolemia due to overnight fasting may result in postoperative nausea and vomiting (PONV). The aim of this study was to investigate the effect of preoperative and intraoperative hydration (the necessary amount of fluid preoperatively to cover the fluid deficit) on PONV. MATERIALS AND METHODS: Two hundred and ten consecutive patients who underwent elective laparoscopic cholecystectomy with The American Society of Anesthesiologists (ASA)-I physical statuses were studied prospectively. The patients were randomly assigned to one of two groups, each having 104 patients. Group 1 received intraoperative volume replacement, but Group-II received preoperative volume replacement. Postoperative antiemetic efficacy was assessed by the ratio of the patients that require an antiemetic over the whole group. RESULTS: The PONV was significantly less detected in the preoperative replacement group (48% in Group 2) than the intraoperative one (64% in Group 1) (P = 0.019). CONCLUSIONS: PONV was reduced when the fluid deficit was replaced preoperatively.     

Can laparoscopic hernia repair alter function and volume of testis? Randomized clinical trial

Testicular atrophy is a sequela of inguinal hernioplasty. The purpose of this study was to evaluate the effects of Lichtenstein (LHR) and laparoscopic totally extraperitoneal (TEP) hernia repair techniques on testicular function and volume. This study is a randomized prospective clinical trial with the blind assessment of outcome. A total of 26 patients who underwent elective herniorrhaphy for groin hernia were included in the study. Each patient was randomly assigned into one of two groups: either TEP or LHR (n = 13 for each). Six of the patients had bilateral hernia (n = 3 for each group). Luteinizing hormone (LH), follicle stimulating hormone (FSH), testosterone levels, and testicular volume by Doppler ultrasonography were detected just before and 3 months after the operation. LH, FSH levels did not change, when compared preoperative and postoperatively in both groups. Testicular volume and testosterone levels were observed to be significantly decreased after TEP when compared with LHR while no significant preoperative changes were observed between those groups. This affected the testicular volume in normal limits. TEP or LHR could not affect LH, FSH, testosterone values, but TEP could lead a decreasing effect on volume of testis in normal limits.     

Inflammatory response after laparoscopic and conventional colorectal resections – results of a prospective randomized trial

Background: Short-term benefits of laparoscopic relative to conventional colorectal resections have been demonstrated in randomized controlled trials. It has been suggested that a diminished cytokine and acute-phase response may be responsible for these advantages. Methods: In a randomized controlled trial, patients underwent laparoscopic (n=30) or conventional (n=30) resection of colorectal tumors. Plasma levels of interleukin-1 receptor antagonist (IL-1RA), interleukin-6 (IL-6), interleukin-10 (IL-10), and C-reactive protein (CRP) were analyzed repeatedly. Postoperative peak levels and area under the curve values were calculated and compared between groups using the Mann-Whitney U-test. Results: Patient characteristics, preoperative cytokine, and CRP plasma levels were not different between each group. Postoperative peak concentrations of IL-6 (P=0.05) and CRP (P<0.001) and the overall postoperative plasma concentrations of IL-6 (P=0.03) and CRP (P=0.002) were lower in the laparoscopic than in the conventional group. Peak and overall IL-1RA (P=0.2; P=0.2) and IL-10 (P=0.4; P=0.6) plasma concentrations, respectively, were not different between groups. Conclusions: IL-6 and CRP plasma levels were lower after laparoscopic than conventional colorectal resections. The less intense inflammatory response may be an indicator of the milder surgical trauma inflicted by laparoscopic than conventional colorectal resection. Received: 31 March 1999; in revised form: 15 July 1999 Accepted: 20 August 1999     

Randomized trial of different intraabdominal pressures and acid–base balance alterations during laparoscopic cholecystectomy

BACKGROUND: Experimental and clinical studies document risks of acid-base balance alterations toward acidosis and hypercapnia during intraperitoneal carbon dioxide insufflation. The aim of this study was to assess the influence of different insufflation pressures on arterial blood gas changes and acid-base alterations during laparoscopic cholecystectomy and immediately postoperatively. METHODS: Thirty patients were randomized to receive either 10 or 15 mmHg insufflation pressure. Anesthesia was standardized for both groups. The following parameters of acid-base balance were recorded: pH, pCO2, pO2, base excess (BE), HCO3. Suitable data were analyzed by the Mann-Whitney U-test. RESULTS: Pneumoperitoneum with carbon dioxide caused a decrease in pH toward acidosis that was either respiratory or mixed in origin. There were no statistically significant differences in acid-base balance alterations between the two groups of patients. CONCLUSIONS: Carbon dioxide pneumoperitoneum causes alterations of the acid-base balance, mostly of respiratory or mixed type. Lowering of the insufflation pressure from 15 to 10 mmHg does not contribute to the elimination of acid-base balance alterations during laparoscopic cholecystectomy.     

ALA and Photofrin® Fluorescence-guided resection and repetitive PDT in glioblastoma multiforme: a single centre Phase III randomised controlled trial

Glioblastoma multiforme (GBM) carries dismal prognosis and cannot be eradicated surgically because of its wide brain invasion. The objective of this prospective randomised controlled trial was to evaluate ALA and Photofrin fluorescence-guided resection (FGR) and repetitive photodynamic therapy (PDT) in GBM. We recruited 27 patients; 13 were in the study group and 14 were in the control group. The mean survival of the study group was 52.8 weeks compared to 24.6 weeks in the control group (p<0.01). The study group gained on average 20 points on the Karnofsky performance score (p<0.05). There were no differences in complications or hospital stay between the two groups. The mean time to tumour progression was 8.6 months in the study group compared to 4.8 months in the control group (p<0.05). Therefore, ALA and Photofrin fluorescence-guided resection and repetitive PDT offered a worthwhile survival advantage without added risk to patients with GBM. A multicentre randomized controlled trial is warranted to confirm these results.     

Comparison of results from a randomized trial 1 year after laparoscopic Nissen and Toupet fundoplications

Background

The fundoplication of choice for the surgical treatment of gastroesophageal reflux disease (GERD) still is debated. Multichannel intraluminal impedance monitoring (MII) has not been used to compare objective data, and comparative subjective data on laparoscopic Nissen and Toupet fundoplications are scarce.

Methods

This study randomly allocated 125 patients with documented chronic GERD to either laparoscopic floppy Nissen fundoplication (LNF; n = 62) or laparoscopic Toupet fundoplication (LTF; n = 63). The Gastrointestinal Quality of Life Index (GIQLI), symptom grading, esophageal manometry, and MII data were documented preoperatively and 1 year after surgery. The pre- and postprocedure data were compared. Statistical significance was set at a p value lower than 0.01 (NCT01321294).

Results

Both procedures resulted in significantly improved GIQLI and GERD symptoms. Preoperative dysphagia improved in both groups, but the improvement reached significance only in the LTF group. The ability to belch was shown to be significantly more decreased after LNF than after LTF. Gas-bloat and “atypical” extraesophageal symptoms also were decreased after surgery (p < 0.01). However, bowel symptoms were virtually unchanged in both groups. Both procedures resulted in significantly improved lower esophageal sphincter pressures. The improvement was greater in the LNF group than in the LTF group (p < 0.01). The DeMeester score and the numbers of total, acid, proximal, upright, and recumbent reflux episodes decreased in both groups after surgery (p < 0.01). No significant difference between the procedures in terms of MII data was found. Six patients (4.8 %) had to undergo reoperation because of intrathoracic slipping of the wrap. All the patients had undergone LNF.

Conclusions

Both procedures proved to be equally effective in improving quality of life and GERD symptoms. However, the reoperation and dysphagia rates were lower and the ability to belch was higher after LTF than after LNF.     

Toward noninvasive follow-up of low-risk bladder cancer – Rationale and concept of the UroFollow trial*

BackgroundFollow-up recommendations for patients with nonmuscle invasive bladder cancer (NMIBC) are largely based upon expert opinion. A growing body of evidence suggests that current follow-up strategies for bladder cancer patients with low and intermediate risk represent overdiagnosis and may lead to overtreatment. The goal of this study is to explore the options of a noninvasive follow-up in patients with pTa G1-2/low-grade NMIBC.MethodsThe risks and options for a urine marker-guided, noninvasive follow-up of patients with pTa G1-2/low-grade NMIBC were defined and the study design for a prospective randomized trial (UroFollow) was developed based upon the current literature.ResultsThe investigators postulated that follow-up of patients with pTa G1-2/low-grade NMIBC requires a high sensitivity of urinary tumor markers. However, data from prospective studies with prediagnostic urine samples are scarce, even for approved markers, and cross-sectional studies with symptomatic patients overestimate the sensitivity. So far, cell-based markers (e.g., uCyt+ and UroVysion) in urine appeared to have higher sensitivities and specificities in low-grade NMIBC than urine cytology and markers analyzing soluble tumor-associated antigens. Marker panels are more sensitive than single-marker approaches at the expense of a lower specificity. Given a prospective randomized comparison with a marker sensitivity of 80% compared to usual care with cystoscopy, the sample size calculation yielded that 62 to 185 patients under study per arm are needed depending on different recurrence rates.ConclusionsBased upon these findings the UroFollow trial has been designed as a prospective randomized study comparing a noninvasive marker-based (UroVysion, NMP22, urine cytology, and ultrasound) follow-up with the current standard of care over a period of 3 years.     

Intra-operative rewarming with Hot Dog(®) resistive heating and forced-air heating: a trial of lower-body warming

Resistive heating is an alternative to forced‐air warming which is currently the most commonly used intra‐operative warming system. We therefore tested the hypothesis that rewarming rates are similar with Hot Dog^® (Augustine Biomedical) resistive and Bair Hugger^® (Arizant) forced‐air heating systems. We evaluated 28 patients having major maxillary tumour surgery. During the establishment of invasive monitoring, patients became hypothermic, dropping their core temperature to about 35 °C. They were then randomly assigned to rewarming with lower‐body resistive (n = 14) or forced‐air (n = 14) heating, with each system set to ‘high’. Our primary outcome was the rewarming rate during active heating over a core temperature range from 35 to 37 °C. Morphometric characteristics were comparable in both groups. Temperature increased at twice the rate in patients assigned to forced‐air warming, with an estimated mean (SE) slope of 0.49 (0.03) °C.h^?1 vs 0.24 (0.02) °C.h^?1 (p < 0.001). Resistive heating warmed at half the rate of forced air.