Short-term outcomes of a novel endoscopic clipping device for closure of the internal opening in 100 anorectal fistulas.

BACKGROUND: One hundred consecutive applications of a new clipping device, the OTSC® Proctology (Ovesco Endoscopy AG), were analyzed to assess its efficacy for the treatment of complex anorectal fistulas. METHODS: In patients with anorectal fistulas, minimally invasive surgery with the OTSC® Proctology system was performed according to a standardized technique: the fistula tract was debrided using a special fistula brush, and the clip was applied on the internal fistula opening. In some of the patients, postoperative pain was evaluated using a visual analog scale. After 6 months, the postoperative clinical course and the fistula healing were assessed. RESULTS: A total of 100 OTSC® Proctology procedures were performed in 96 patients with 55 transsphincteric, 38 suprasphincteric, 2 extrasphincteric, and 5 rectovaginal fistulas. In all but 11 fistulas (8 Crohn's disease, 3 ulcerative colitis), the fistulas were of cryptoglandular origin. The median operation time was 32 min (range 17-66 min). There were no major intraoperative technical problems. All patients found the postoperative pain to be tolerable with standard pain medication. The short-term results of 99 clip applications were analyzed: the healing rate for first-line fistula therapy was 79 %, whereas in recurrent fistulas, the success rate was 26 %. OTSC® Proctology was successful in 45 % of fistulas associated with inflammatory bowel disease and in 20 % of rectovaginal fistulas. CONCLUSIONS: OTSC® Proctology provides convincing results as first-line treatment for complex cryptoglandular fistulas. It is a safe, effective, minimally invasive, and sphincter-sparing procedure with postoperative pain comparable to other types of fistula surgery.

Prospective pilot study of anorectal fistula closure with the OTSC Proctology.

AIM: The OTSC Proctology is a surgical device for anorectal fistula closure. It consists of a super-elastic nitinol clip, which is placed (with the aid of a transanal applicator) on the internal fistula opening to achieve healing of the fistula track. A prospective, two-centre clinical pilot study was undertaken to assess the efficacy and safety of the OTSC Proctology in patients with a complex high anorectal fistula. METHOD: In patients with a complex anorectal fistula the primary track was debrided using a special brush and the clip was applied to the internal fistula opening. After 6 months the postoperative clinical course and fistula healing were assessed. RESULTS: Twenty patients with a cryptoglandular anorectal fistula (14 with a transsphincteric fistula and six with a suprasphincteric fistula) were included in the study. There were no intra-operative technical or surgical complications. Postoperatively no patient reported intolerable discomfort or a sensation of a foreign body in the anal region. At 6 months after surgery, 18 (90%) patients had no clinical signs or symptoms of fistula and were considered healed, whereas in two the fistula persisted. In 13 (72%) of these 18 patients, the clip was still in place without causing problems, whereas in three patients the clip had spontaneously detached. In the two remaining patients it was necessary to remove the clip due to discomfort and delayed wound healing. CONCLUSION: Anorectal fistula closure with the OTSC Proctology is an innovative, sphincter-preserving minimally invasive procedure with promising initial results and a high rate of patient satisfaction.

The anal fistula claw: the OTSC clip for anal fistula closure.

AIM: Surgical closure of high or complex anal fistulae is often a difficult challenge. A special Nitinol clip, the OTSC clip (Ovesco AG), was evaluated for fistula closure in a porcine model. METHOD: A total of 20 fistulae were created in 10 animals by seton insertion. Four weeks after fistula induction the setons were removed: one internal fistula opening per animal was left untreated as control whereas the other opening was closed by the OTSC clip using a specially developed transanal clip applicator. The safety and technical feasibility of the clip application were tested. Another 4 weeks later, fistulae were macroscopically assessed for closure. For histological examination, the anorectum including the fistula tract was excised en bloc. RESULTS: Four weeks after clip placement, all external and internal fistula openings were macroscopically closed. The clip application site presented with an increased scarring. Microscopically, 40% of residual tracts and a more intense chronic inflammation were seen in the untreated control fistulae. After clip placement, 10% of the fistulae persisted associated with a higher density of collagen fibres indicating a better fistula scarring and healing. No unexpected side-effects or complications caused by the clip were observed. CONCLUSION: Fistula closure using the OTSC clip represents a promising sphincter-preserving minimally invasive procedure. This study demonstrated the safety and feasibility of the 'anal fistula claw' for fistula closure. In spite of limitations of the porcine model the results justify clinical applications and further investigations.

Tumor model for laparoscopy in pediatric oncology: subperitoneal inoculation of human hepatoblastoma cells in nude rats.

BACKGROUND: Minimally invasive surgery (MIS) for diagnostic or even ablative purposes in pediatric oncology is gradually evolving, but little is known about its biological consequences and surgical complications. Especially for hepatoblastoma (HB), no study on the influence of laparoscopy is available yet. A special tumor model could facilitate a variety of investigations. The present study introduces a laparoscopic technique to create subperitoneal metastases of human HB. METHODS: 7 immuno-incompetent (rnu/rnu) rats (mean weight 198 g) received a stab incision in the lower abdomen to insert a 4 mm scope. Under laparoscopic guidance (CO2 pressure of 1 mmHg, flow of 0.2 l/min) an 18 G needle was introduced, to inject several subperitoneal deposits of the tumor cell suspension (HuH6, 3 x 10 (6) in 1 ml of RPMI-1640 medium). Tumor growth was allowed for 6 - 7 weeks and finally the animals were laparoscopically evaluated for peritoneal metastases. Each suspicious lesion was harvested for histology. RESULTS: One animal was investigated after 6 weeks without evidence of tumor growth. After 7 weeks, in 4 out of 6 animals at least one lesion could be detected. Histology revealed HB in all specimens. CONCLUSION: Subperitoneal inoculation of human HB cells in nude rats achieves intraabdominal tumor growth. The present model allows a variety of laparoscopic strategies and their oncological impact to be studied. Thus it may contribute to the development of distinct oncological concepts for MIS in children with HB.

Fluorescence-guided minimally invasive parathyroidectomy: a novel detection technique for parathyroid glands.

BACKGROUND: Detection of normal and pathologic parathyroid glands often is difficult because of their variability in number and location. The feasibility and efficacy of a fluorescence technique for identifying parathyroids have already been proved in an experimental setting. This is the first report of human fluorescence-guided parathyroidectomy. METHODS: A 72-year-old man with primary hyperparathyroidism underwent minimally invasive videoscopically assisted parathyroidectomy after photosensitization with aminolevulinic acid. Under special fluorescence illumination by the D-light, a unilateral directed neck exploration was performed. RESULTS: The enlarged adenoma and an atrophic parathyroid gland could be identified rapidly and removed because of their intense red fluorescence. Surrounding structures such as thyroid, muscles, and soft tissue remained nonfluorescent and could easily be distinguished from the parathyroid glands. CONCLUSIONS: The aminolevulinic acid-induced fluorescence technique represents a convincing visual detection method for intraoperative identification of parathyroid glands. The technique serves as an additional tool requiring only moderate technical and clinical expenditure for help in guiding dissection down to a preoperatively localized adenoma. When used together with preoperative ultrasonography and sestamibi scan, the fluorescence technique may justify a unilateral, minimally invasive approach for selected patients.

Methylene blue in the evaluation of gastrointestinal tract integrity: potential limitations.

INTRODUCTION: The integrity of the gastrointestinal tract can be evaluated by oral or rectal application of methylene blue. In the presence of anastomotic leaks or fistulas, methylene blue can be recovered in adjacent drains. However, parts of the dye can biochemically be reduced by intestinal bacteria to its colorless form leucomethylene blue, limiting the prediction of the test. MATERIALS AND METHODS: Diluted methylene blue was added to different concentrations of bacterial suspensions of Escherichia coli and Enterococcus faecalis. The time for discoloration of the suspension was measured. RESULTS: Reduction of methylene blue to leucomethylene blue was observed in both types of bacterial suspension. A 10(8) bacterial concentration discolorated the dye within 1 h in the E. faecalis suspension, respectively 2.5 h in the E. coli suspension. Longer bacterial interaction with methylene blue reduced the bacterial concentration required to achieve complete discoloration. DISCUSSION: Methylene blue can reliably be used as routine diagnostic test for the assessment of upper gastrointestinal integrity, where bacterial load is low. In the lower gastrointestinal tract, where bacterial load is generally higher, the dye can indicate leaks, only if extended intestinal passage after oral ingestion is avoided. In all other cases, the examiner has to be aware of false-negative results by bacterial discoloration of methylene blue.

Videoscopic fluorescence diagnosis of peritoneal and thoracic metastases from human hepatoblastoma in nude rats.

BACKGROUND: Various medical disciplines are employing photodynamic diagnosis (PDD) when searching for malignancies. It is still unknown whether pediatric solid tumors such as hepatoblastoma are susceptible to this technique as well. METHODS: Human hepatoblastoma cells were injected into the abdomen or right thoracic cavity of nude rats. Tumor growth was allowed for 7 weeks. Then, photosensitization was induced by peritoneal lavage with 5-aminolevulinic acid (ALA). Applying the Storz PDD system and one 4-mm scope, all animals were investigated by videoscopic white light diagnosis (WD) and PDD. Suspicious lesions were marked and analyzed by spectrometry and histology. RESULTS: Positive fluorescence was documented for every tumor seen by WD in the abdomen or right thoracic cavity. Spectrometry of lesions showed a 6.34-fold increased fluorescence intensity. Histology revealed hepatoblastoma in all specimens. CONCLUSIONS: Human hepatoblastoma can be detected by PDD in a rat model. Considering the clinical success of this method in other specialties, our findings indicate that further investigations to evaluate the benefit of PDD for children with hepatoblastoma should be performed.

[ARDS after unreamed femoral nailing]. / ARDS nach unaufgebohrter Oberschenkelmarknagelung.

An 18-year-old male patient sustained right-sided femoral and 2nd degree open tibial shaft fractures following a motorcycle accident. Further injuries, and thoracic injury in particular, were excluded clinically and radiologically. Early stabilization of the fractures was achieved by external fixation of the tibia followed by unreamed femoral nailing.Postoperatively, severe deterioration of pulmonary function led to the progressive development of an adult respiratory distress syndrome (ARDS) and necessitated extracorporal membrane oxygenation (ECMO) of the ventilated patient for 89 h. Subsequently, the patient's gas exchange parameters improved allowing extubation 1 week after the accident. Secondary tibia nailing and further recovery of the patient were uneventful.

Photodynamic therapy for esophageal diseases: a clinical update.

Photodynamic therapy (PDT) is a "drug and device" therapy that combines the use of a photosensitizing agent and a photosensitizer (a drug that selectively accumulates and is preferentially retained in dysplastic or neoplastic cells). When activated by light of a specific wavelength in the presence of oxygen, the photoactive compound produces rapid cell death in the target tissue. While studied in nearly every area of medicine, PDT has been applied most extensively in the treatment of Barrett's mucosa, dysplasia, and early and advanced cancer of the esophagus. This article represents an extensive survey of literature to review the experience gained with PDT and to assess its clinical value in the management of esophageal diseases.

[Mimicry of a liver abscess as hepatocellular carcinoma]. / Mimikry eines Leberabszesses als hepatozelluläres Karzinom.

HISTORY: We report on a 82 year-old male who presented with chronic pain in the right upper abdomen, nausea and vomitus. An uncomplicated laparoscopic cholecystectomy occurred eight years and a hepatitis 60 years before. Clinical examination showed a normal abdominal status without palpable liver, spleen, enlarged lymph nodes or masses. He had no icteric skin and sclera. INVESTIGATIONS: The patient was afebrile without leukocytosis. The tumour markers CEA, CA 19 - 9 and AFP were negative. Ultrasound of the abdomen showed a normal homogeneous echotexture of the liver without signs of cholestasis or cirrhosis. In segment 6 a 3 cm large hypoechoic cystic formation with a central echogenic structure with acoustic shadowing was noted. Magnetic resonance revealed a 2.8 x 3.6 cm large lesion in the dorsal region of segment 6 of the liver, infiltrating the perihepatic fat. Pathologic lymph nodes and metastases were not found. DIAGNOSIS AND TREATMENT: At laparotomy, the tumour appeared to be malignant with invasion to the perirenal fat. Complete resection with negative margins included segment 6 of the liver and the adjacent fat (the kidney itself was not infiltrated). The cut specimen also showed signs of malignancy with central necrosis. However, histology of the resected specimen revealed a sterile liver abscess without malignancy, but with microscopic foreign bodies. The patient had an uneventful recovery without postoperative complications. CONCLUSIONS: This case report demonstrates the difficulty encountered in the differential diagnosis of inflammatory processes and malignant tumours. Chronic inflammatory changes may mimic solid neoplasms. Despite adequate magnetic resonance imaging and thorough intraoperative examination, the correct diagnosis was finally found by histology. The most likely genesis of the abscess are lost gallstones during cholecystectomy.

Thoracoscopic fluorescence diagnosis (TFD) of pleural malignancies: experimental studies.

BACKGROUND: Fluorescence diagnosis (FD) using the photosensitiser 5-aminolaevulinic acid (ALA) was experimentally combined with conventional video assisted thoracic surgery (VATS) to improve tumour staging in advanced lung cancer with pleural tumour spread. METHODS: A disseminated pleural carcinosis affecting the entire pleural cavity was induced by inoculation of human adenocarcinoma cells in nude rats. After 5-7 weeks of tumour growth the animals were randomised into six groups with different photosensitisation parameters. Pleural lavage was performed either with 1.5% or 3.0% ALA solution. Photosensitisation times varied were 2, 4, or 6 hours. Conventional white light VATS was first performed to evaluate tumour growth in the pleural cavity. Fluorescence illumination of the light source, the D-light, was then used to examine the site for additional tumours which were previously invisible. The tumour fluorescence intensity was measured spectrometrically and compared with normal tissue. RESULTS: Compared with conventional white light VATS alone, thoracoscopic fluorescence diagnosis (TFD) detected up to 30% additional pleural malignant lesions. The highest diagnostic sensitivity was reached 6 hours after 3.0% ALA pleural lavage. Photosensitiser accumulation in the tumour, measured indirectly by spectrometry, was up to 11 times higher than in normal tissue. CONCLUSIONS: TFD increases sensitivity of VATS for tumour staging. It may prevent unnecessary thoracotomies in cancer patients and facilitate surgical planning.

Fluorescence diagnosis of colorectal neoplasms: a review of clinical applications.

Detection of dysplasia and early-stage carcinoma of the lower gastrointestinal tract is important in the prevention and curative treatment of cancer. Fluorescence-based endoscopic imaging and spectrometry promise a supplemental technique for conventional endoscopy. Fluorescence diagnosis is characterized by the stimulation of exogenous or endogenous fluorophores in malignant or precancerous tumor cells. The emitted fluorescence allows the identification of lesions that are otherwise occult in conventional endoscopy. A review of literature was performed to examine the experience gained with fluorescence diagnosis and to assess its clinical value in the detection of colorectal diseases.

[Photodynamic therapy in the gastrointestinal tract. Possibilities and limits]. / Photodynamische Therapie im Gastrointestinaltrakt. Möglichkeiten und Grenzen.

BACKGROUND: Photodynamic therapy (PDT) is characterized by the extensive selective accumulation of a photoactive agent, the photosensitizer, in malignant or precancerous tumour cells. The photoactive compound is activated by light beam of a specific wavelength and causes cell death. A significant proportion of patients with gastrointestinal malignancies cannot undergo curative treatment, as either the cancer is too advanced or the patient's general constitution is too poor to allow invasive strategies. In such cases, PDT has already proven to be a promising therapeutic modality for selected dysplasias and malignancies in the gastrointestinal tract. MATERIAL AND METHODS: A retrospective review of the literature was performed in order to determine the experience gained with PDT and to assess its clinical value in the curative and palliative management of gastrointestinal neoplasms. RESULTS: PDT seems to be an adequate treatment for selected forms of early cancer and small lesions of the GI tract or for small residual areas after the tumour has been debulked by other techniques (e.g. limited surgical resection, thermal ablation). Especially for patients who refuse or are ineligible for conventional surgery, PDT offers promising results compared to currently accepted clinical approaches. CONCLUSIONS: As a primary or adjuvant mode for either curative or palliative treatment of gastrointestinal neoplasms, PDT is a potentially effective, minimally invasive therapeutic modality. However, further clinical assessment by means of comparative, standardized studies is essential to the definition of its role in oncology.

Intraoperative fluorescence visualization of the parathyroid gland in rats.

Bilateral neck exploration is the standard procedure of primary hyperparathyroidism. Preoperative localization is not mandatory. Intraoperative visualization methods help to avoid unsuccessful explorations and to reduce morbidity rates. In our study, the application of 5-Aminolevulinic acid (5-ALA), a precursor in the heme biosynthesis pathway, led to Protoporphyrin IX (PpIX) accumulation within the parathyroid gland (PTG). PpIX, a metabolite of 5-ALA, causes red fluorescence (635 nm) when stimulated by light of a defined wavelength. Largely invisible under conventional illumination, all PTGs were fluorescence positive and detectable after PpIX targeting and blue light excitation (380-440 nm). Point spectrometry to measure fluorescence intensities, showed a fluorescence ratio between PTG and surrounding thyroid gland tissue of 5.7:1 (p < 0.001). Fluorescence guided PTG biopsies showed no false positive findings in histology. 5-ALA induced PpIX fluorescence to detect PTGs suggests to be a highly sensitive intraoperative visualization method. Hence, the performance of minimally invasive video-assisted parathyroidectomy will be facilitated by this innovative technique.

Systemic vs local administration of delta-aminolevulinic acid for laparoscopic fluorescence diagnosis of malignant intra-abdominal tumors. Experimental study.

BACKGROUND: Administration of delta-aminolevulinic acid (ALA) either systemically or locally results in tumor-specific accumulation of protoporphyrin IX (PpIX). When excited with light at a defined wavelength and viewed with the appropriate filter cells containing PpIX, have a characteristic red fluorescence. We evaluated both locally (intraperitoneally [i.p.]) and systemically (intravenously [i.v.]) administered ALA to compare its effectiveness for laparoscopic fluorescent visualization of intraperitoneal tumors. METHODS: Peritoneal carcinosis was induced in rats using colon carcinoma cells (CC531). Photosensitization was achieved either by intravenous (i.v. group) or intraperitoneal (i.p. group) application of ALA solution. Staging laparoscopy was performed in both groups, first using conventional white light and subsequently using blue light (380-440 nm) to excite PpIX-induced fluorescence. RESULTS: Conventional white light laparoscopy showed 142 visible intraperitoneal tumor foci in the i.p. group and 116 such foci in the i.v. group. In the i.p. group, all tumors (100%) also were fluorescence positive, whereas in the i.v. group only 32 of the tumors (28%) showed the typical red fluorescence. In the i.p. group, 30 additional tumors were detected by fluorescence excitation (21%), as compared with eight additional tumors in the i.v. group (7%). CONCLUSIONS: Fluorescence laparoscopy after local (i.p.) photosensitization with ALA is a more reliable and effective method than systemic (i.v.) photosensitization for the detection of small or occult i.p. tumors.

Evaluation of the effectiveness of portable low-bandwidth telemedical applications for postoperative followup: initial results.

BACKGROUND: The idea of using telemedical applications to evaluate patients remotely is several decades old. It has already been established that x-ray images (and magnetic resonance images) can be transferred using a personal computer and a modem, and many other such applications have been implemented. Over the past 50 years the expense and technical demands of the equipment involved in telemedicine have hindered its widespread deployment. The purpose of this study is to evaluate the ability of a mobile, low-bandwidth telemedicine platform to achieve real-time postoperative visits in the home. STUDY DESIGN: This evaluation was designed to evaluate the feasibility of performing a real-time clinical visit with computer and telecommunications hardware and software. A nurse and medical student (for information gathering only) made postoperative visits at patients' homes while the physician stayed at the office. Clinical evaluations were performed by using low-resolution and frame-rate video, high-resolution still images, and simultaneous telephony over a standard telephone line. These remote visits were followed by a standard visit in the office. Eleven patients were included, all of whom had undergone various laparoscopic procedures. They lived 5 to 240 miles from their surgeon. Efficiency was measured by recording the time required to capture and send data required by the physician to make a clinical decision. The time expense was measured at both the patients' and physician's locations. Technical issues were evaluated and patient satisfaction was assessed by standardized objective questionnaires. The accuracy of the evaluation at the remote visit was determined with a standard office visit. RESULTS: No technical problems were observed. The mean total time of the housecall at the remote site was 86 minutes (range 60 to 160 minutes) and at the base station site was 41 minutes (range 21 to 71 minutes). After personnel became familiar with the system, the last three visits averaged 61 and 25 minutes at the two sites, respectively. This corresponds favorablywith current time requirements for visiting nurses and office visits. The patients were highly satisfied with the home visit and, on average, rated the experience as 4.8 out of a maximum of 5. CONCLUSIONS: Followup visits in patients' homes after laparoscopic procedures can be accomplished by transmitting simultaneous voice, low-resolution video, and high-resolution still images to accurately perform postoperative evaluations over standard telephone lines, with time requirements and clinical accuracy similar to those of standard visits.

A simplified technique for laparoscopic jejunostomy and gastrostomy tube placement.

BACKGROUND: Percutaneous endoscopic gastrostomy and jejunostomy tube placement have long been considered the standard for supplying enteral nutrition when oral intake is not possible. Both have well-documented roles and limitations and are associated with a higher than generally appreciated incidence of aspiration. A distally placed tube in the jejunum decreases the chance of this morbid complication. Additionally, when percutaneous endoscopic gastrostomy is indicated but cannot be done for technical reasons, a minimally invasive alternative is desirable. METHODS: In prior series, the techniques suggested for laparoscopic enteral access have characteristics that are either difficult for the average surgeon to duplicate, or use nonstandard anchoring techniques of the bowel to the abdominal wall. A simple, laparoscopically directed, percutaneous technique utilizing cost-effective appliances is described, and suggested indications are outlined. RESULTS: This technique has been successfully applied in 46 patients with minimal complications. CONCLUSIONS: A simplified technique for laparoscopic jejunostomy and gastrostomy tube placement is described. This has been successfully deployed in 46 patients with minimal morbidity. The procedure lessens the need for sophisticated suturing skills and duplicates standard small bowel to abdominal wall fixation methods.

Spectrometry supports fluorescence staging laparoscopy after intraperitoneal aminolaevulinic acid lavage for gastrointestinal tumours.

Conventional staging laparoscopy in combination with fluorescence diagnosis has proven to be an effective modality in the detection of macroscopically occult intraperitoneal tumours and metastases. Rats with induced peritoneal carcinosis are photosensibilized by intraperitoneal aminolaevulinic acid (ALA) lavage. After visualization of the tumour foci, the emission from the lesions is measured spectrometrically and the fluorescence analysed quantitatively ('optical biopsy'). There is a considerable accordance between imaging by fluorescence diagnosis laparoscopy and point spectrometry in the detection of peritoneal malignancies. Compared with surrounding healthy peritoneum, tumour-positive areas show significantly higher fluorescence intensities in spectrometry.

Minilaparoscopy without general anesthesia for the diagnosis of acute appendicitis.

The timely diagnosis of intra-abdominal pathology continues to be an elusive problem. Delays in diagnosis and therapeutic decision making are continuing dilemmas in patients who are females of childbearing age, elderly, obese or immunosuppressed. Minilaparoscopy without general anesthesia potentially can provide an accurate, cost-effective method to assist in the evaluation of patients with acute abdominal pain. Laparoscopy without general anesthesia is not a new technique, but with the combination of two emerging factors--1) the introduction of new technology with the development of improved, smaller laparoscopes and instruments, and 2) the shifting of emphasis on healthcare to a more cost-effective managed care environment--its value and widespread utilization is being reconsidered. We report the case of a 22 year old female with an acute onset of increasing abdominal and pelvic pain. Despite evaluation by general surgery, gynecology, emergency room staff, as well as, non-invasive testing, a clear diagnosis could not be made. In view of this, minilaparoscopy without general anesthesia was performed and revealed an acute, retrocecal appendicitis. The diagnosis was made with the assistance from the conscious patient. The utilization of this technique greatly expedited the treatment of this patient. Full-sized laparoscopic equipment was then used to minimally invasively remove the diseased appendix under general anesthesia. Both procedures were well tolerated by the patient.