Randomized Controlled Trial of Awake Transnasal Laser-Assisted Surgery for Benign Laryngeal Lesions.

OBJECTIVE: To compare functional and cost-effectiveness of awake transnasal laser assisted-surgery versus microlaryngeal surgery for benign laryngeal lesions. METHODS: This was a prospective non-inferiority randomized controlled trial conducted from May 2021 to December 2022 at two tertiary referral hospitals in Hong Kong. Patients were block-randomized to receive either awake transnasal laser-assisted surgery or microlaryngeal surgery, with post-operative follow-up in a multidisciplinary voice clinic for 1-year. Primary outcome was Voice Handicap Index (VHI-30). Secondary outcomes included operation time, complications, length of stay, peri-operative discomfort, recurrence, and medical costs. RESULTS: Sixty-one patients were randomized to either awake transnasal laser-assisted surgery (n = 30) and microlaryngeal surgery (n = 31). Both groups had comparable demographics and laryngeal pathologies. Both groups showed significant improvement of VHI-30 score over time and had comparable post-operative VHI-30. Awake transnasal laser-assisted surgery group had a significantly shorter length of stay (0.5 vs. 1 day) and less throat discomfort (2 vs. 4) compared to microlaryngeal surgery group. Intraoperative complications were more common in microlaryngeal surgery group (14.3% vs. 0%). Otherwise, both groups had similar operative time and recurrence rate. Cost-analysis showed a significantly lower hospital cost for awake transnasal laser-assisted surgery (USD 3090) compared to microlaryngeal surgery group (USD 5120). CONCLUSION: Awake transnasal laser-assisted surgery was safe, functionally non-inferior, as measured by VHI-30, to microlaryngeal surgery in managing benign laryngeal lesions, while superior to microlaryngeal surgery in peri-operative discomfort and medical costs. LEVEL OF EVIDENCE: 2 Laryngoscope, 134:3732-3740, 2024.

In-office Transoral Hilar Sialolithotomy: A Cost-Effective and Patient-Centered Procedure.

Transoral sialolithotomy performed in-office under local anesthesia is routinely performed for distal submandibular stones. We demonstrate the senior author's novel practice of in-office transoral sialolithotomy for hilar and intraglandular stones. A review of cases performed by the senior author revealed similar rates of complication and stone recurrence as those reported in the literature from removal under general anesthesia. Laryngoscope, 134:4042-4044, 2024.

Comparing cost and outcomes between peroral endoscopic myotomy and laparoscopic heller myotomy.

BACKGROUND: Peroral endoscopic myotomy (POEM) has previously been shown to be equally if not more expensive than laparoscopic Heller myotomy (LHM). We compare perioperative outcomes and charges between POEM and LHM at a single institution. METHODS: Outcomes and charge data of 33 patients who underwent LHM and 126 patients who underwent POEM were analyzed. Patients who did not present electively were excluded. RESULTS: There were no demographic differences between groups. Patients who underwent POEM had a significantly shorter mean operative time and median length of stay (both p < 0.001). Patients who underwent POEM stopped narcotics earlier and had faster return to activities of daily living (both p < 0.05). When adjusted for inflation, POEM incurred less in hospital charges than LHM (35.5 ± 12.8 vs 30.7 ± 10.3 in thousands of US dollars, p = 0.006). CONCLUSIONS: Patients who underwent POEM compared to LHM had significantly better perioperative outcomes. Our results suggest POEM may be the more cost-effective option.

Cost Considerations for Robotic Surgery.

Transoral robotic surgery (TORS) is a rapidly growing diagnostic and therapeutic modality in otolaryngology-head and neck surgery, having already made a large impact in the short time since its inception. Cost-effectiveness analysis is complex, and a thorough cost-effectiveness inquiry should analyze not only financial consequences but also impact on the health state of the patient. The cost-effectiveness of TORS is still under scrutiny, but the early data suggest that TORS is a cost-effective method compared with other available options when used in appropriately selected patients.

Comparison of costs and short-term clinical outcomes of per-oral endoscopic myotomy and laparoscopic Heller myotomy.

OBJECTIVE: Per-Oral Endoscopic Myotomy (POEM) has seen increasing application and comparisons to laparoscopic Heller myotomy (LHM). The aim of the present study was to compare perioperative and short-term outcomes, and costs between the two procedures at a single institution. METHODS: Fifty-one consecutive patients documented in a prospective IRB approved database from January 2014 to December 2017 were included. Perioperative data, pre-operative and 3-month postoperative Eckardt Scores, and cost data were compared. RESULTS: Median hospital stay was comparable between POEM and LHM (1 day each). Complications were minor (Clavien-Dindo 1, 2) and rare in both groups. Median Eckardt scores improved significantly after POEM (5 to 0) and LHM (5 to 0). Normalized median costs were comparable: 14 201 USD (POEM) vs. 13 328 USD (LHM) p = 0.45. CONCLUSIONS: POEM demonstrates comparable clinical outcomes and costs to LHM. Long-term issues related to GERD require ongoing assessment in POEM patients. SUMMARY: In patients with achalasia, extended myotomy of the lower esophageal sphincter offers excellent palliation of symptoms. In the last decades, laparoscopic Heller myotomy (LHM) has been the gold standard. Over the past decade, per-oral endoscopic myotomy (POEM) has seen wide application in specialized centers worldwide. In our patient cohort, we demonstrate, that POEM can be introduced with similar outcomes and costs compared to LHM.

Hysterectomy by transvaginal natural orifice transluminal endoscopic surgery versus laparoscopy as a day-care procedure: a randomised controlled trial.

OBJECTIVE: To compare hysterectomy by transvaginal natural orifice transluminal endoscopic surgery (vNOTES) versus total laparoscopic hysterectomy (TLH) as a day-care procedure. DESIGN: Parallel group, 1:1 randomised single-centre single-blinded trial, designed as a non-inferiority study with a margin of 15%. SETTING: Belgian teaching hospital. POPULATION: Women aged 18-70 years scheduled to undergo hysterectomy for benign indications. METHODS: Randomisation to TLH (control group) or vNOTES (experimental group). Stratification according to uterine volume. Blinding of participants and outcome assessors. MAIN OUTCOME MEASURES: The primary outcome was hysterectomy by the allocated technique. We measured the proportion of women leaving within 12 hours after hysterectomy and the length of hospital stay as secondary outcomes. RESULTS: We randomly assigned 70 women to vNOTES (n = 35) or TLH (n = 35). The primary endpoint was always reached in both groups: there were no conversions. We performed a sensitivity analysis for the primary outcome, assuming one conversion in the vNOTES group and no conversions in the TLH group: the one-sided 95% upper limit for the differences in proportions of conversion was estimated as 7.5%, which is below the predefined non-inferiority margin. More women left the hospital within 12 hours after surgery after vNOTES: 77 versus 43%, difference 34% (95% CI 13-56%), P = 0.007. The hospital stay was shorter after vNOTES: 0.8 versus 1.3 days, mean difference -0.5 days, (95% CI -0.98 to -0.02), P = 0.004. CONCLUSIONS: vNOTES is non-inferior to TLH for successfully performing hysterectomy without conversion. Compared with TLH, vNOTES may allow more women to be treated in a day-care setting. TWEETABLE ABSTRACT: RCT: vNOTES is just as good as laparoscopy for successful hysterectomy without conversion but allows more day-care surgery.

New insertion method of transnasal ileus tube for small bowel obstruction: Anterior balloon method.

BACKGROUND: Small bowel obstruction (SBO) is usually caused by postoperative adhesions and malignant disease, and decompression is effective for SBO. Our previous case report suggested that a new transnasal ileus tube insertion method, the anterior balloon method (ABM), could achieve decompression for adhesive SBO. AIMS: The study aimed to investigate the effectiveness of a new method for inserting transnasal ileus tubes in patients with SBO. METHODS: Altogether, 134 patients with small bowel obstruction treated from January 2011 to December 2017 were reviewed. The patients were categorized into two groups: those with the new method that inserts an anterior balloon (ABM group: 52 patients, 2014-2017) versus those with the ordinary insertion method (OIM group: 82 patients, 2011-2014). RESULTS: The patients' characteristics and symptoms on admission were similar in the ABM and OIM groups. Adhesions were the main cause of ileus in the two groups. The insertion time duration was significantly shorter in the ABM group than in OIM group (28.4 ± 9.1 vs. 33.5 ± 13.0 min; p = 0.01). The ABM group also had significantly longer tubes than OIM group (222.4 ± 32.2 vs. 157.4 ± 31.7 cm; p < 0.001), which resulted in a significantly shorter time until clinical symptoms were relieved in ABM group. There were no significant differences in adverse events between the two groups. CONCLUSIONS: The ABM group had shorter insertion duration and longer tubes than those of OIM group. The ABM might become a preferred therapeutic choice to achieve decompression in patients with SBO.

A low cost and stepwise training model for skull base repair using a suturing and knotting technique during endoscopic endonasal surgery.

PURPOSE: Cerebrospinal fluid leakage is always the primary complication during the endoscopic endonasal skull base surgery. Dural suturing technique may supply a rescue method. However, suturing and knotting in such a deep and narrow space are difficult. Training in the model can improve skills and setting a stepwise curriculum can increase trainers' interest and confidence. METHODS: We constructed an easy model using silicone and acrylic as sphenoid sinus and using the egg-shell membrane as skull base dura. The training is divided into three steps: Step 1: extracorporeal knot-tying suture on the silicone of sphenoid sinus, Step 2: intra-nasal knot-tying suture on the same silicone, and Step 3: intra-nasal egg-shell membrane knot-tying suture. Fifteen experienced microneurosurgical neurosurgeons (Group A) and ten inexperienced PGY residents (Group B) were recruited to perform the tasks. Performance measures were time, suturing and knotting errors, and needle and thread manipulations. The third step was assessed through the injection of full water into the other side of the egg to verify the watertight suture. The results were compared between two groups. RESULTS: Group A finishes the first and second tasks in significantly less time (total time, 125.1 ± 10.8 vs 195.8 ± 15.9 min) and fewer error points (2.4 ± 1.3 vs 5.3 ± 1.0) than group B. There are five trainers in group A who passed the third step, this number in group B was only one. CONCLUSIONS: This low cost and stepwise training model improved the suture and knot skills for skull base repair during endoscopic endonasal surgery. Experienced microneurosurgical neurosurgeons perform this technique more competent.

Financial outcomes of transoral robotic surgery: A narrative review.

OBJECTIVE: To determine the current cost impact and financial outcomes of transoral robotic surgery in Otolaryngology. DATA SOURCES: A narrative review of the literature with a defined search strategy using Pubmed, MEDLINE, CINAHL, and Web of Science. REVIEW METHODS: Using keywords ENT or otolaryngology, cost or economic, transoral robotic surgery or TORs, searches were performed in Pubmed, MEDLINE, CINAHL, and Web of Science and reviewed by the authors for inclusion and analysis. RESULTS: Six total papers were deemed appropriate for analysis. All addressed cost impact of transoral robotic surgery (TORs) as compared to open surgical methods in treating oropharyngeal cancer and/or the identification of the primary tumor within unknown primary squamous cell carcinoma. Results showed TORs to be cost-effective. CONCLUSION: Transoral robotic surgery is currently largely cost effective for both treatment and diagnostic procedures. However, further studies are needed to qualify long-term data.

Higher cost of single incision laparoscopic cholecystectomy due to longer operating time. A study of opportunity cost based on meta-analysis.

BACKGROUND: We aimed to calculate the opportunity cost of the operating time to demonstrate that single incision laparoscopic cholecystectomy (SILC) is more expensive than classic laparoscopic cholecystectomy (CLC). METHODS: We identified studies comparing use of both techniques during the period 2008-2016, and to calculate the opportunity cost, we performed another search in the same period of time with an economic evaluation of classic laparoscopy. We performed a meta-analysis of the items selected in the first review considering the cost of surgery and surgical time, and we analyzed their differences. We subsequently calculated the opportunity cost of these time differences based on the design of a cost/time variable using the data from the second literature review. RESULTS: Twenty-seven articles were selected from the first review: 26 for operating time (3.138 patients) and 3 for the cost of surgery (831 patients), and 3 articles from the second review. Both echniques have similar operating costs. Single incision laparoscopy surgery takes longer (16.90min) to perform (p <0.00001) and this difference represents an opportunity cost of 755.97 € (cost/time unit factor of 44.73 €/min). CONCLUSIONS: SILC costs the same as CLC, but the surgery takes longer to perform, and this difference involves an opportunity cost that increases the total cost of SILC. The value of the opportunity cost of the operating time can vary the total cost of a surgical technique and it should be included in the economic evaluation to support the decision to adopt a new surgical technique.

Cost-effectiveness of per oral endoscopic myotomy relative to laparoscopic Heller myotomy for the treatment of achalasia.

BACKGROUND: Per oral endoscopic myotomy (POEM) has recently emerged as a viable option relative to the classic approach of laparoscopic Heller myotomy (LHM) for the treatment of esophageal achalasia. In this cost-utility analysis of POEM and LHM, we hypothesized that POEM would be cost-effective relative to LHM. METHODS: A stochastic cost-utility analysis of treatment for achalasia was performed to determine the cost-effectiveness of POEM relative to LHM. Costs were estimated from the provider perspective and obtained from our institution's cost-accounting database. The measure of effectiveness was quality-adjusted life years (QALYs) which were estimated from direct elicitation of utility using a visual analog scale. The primary outcome was the incremental cost-effectiveness ratio (ICER). Uncertainty was assessed by bootstrapping the sample and computing the cost-effectiveness acceptability curve (CEAC). RESULTS: Patients treated within an 11-year period (2004-2016) were recruited for participation (20 POEM, 21 LHM). During the index admission, the mean costs for POEM ($8630 ± $2653) and the mean costs for LHM ($7604 ± $2091) were not significantly different (P = 0.179). Additionally, mean QALYs for POEM (0.413 ± 0.248) were higher than that associated with LHM (0.357 ± 0.338), but this difference was also not statistically significant (P = 0.55). The ICER suggested that it would cost an additional $18,536 for each QALY gained using POEM. There was substantial uncertainty in the ICER; there was a 48.25% probability that POEM was cost-effective at the mean ICER. At a willingness-to-pay threshold of $100,000, there was a 68.31% probability that POEM was cost-effective relative to LHM. CONCLUSIONS: In the treatment of achalasia, POEM appears to be cost-effective relative to LHM depending on one's willingness-to-pay for an additional QALY.

Cost-Effectiveness Analysis of Radiation Therapy Versus Transoral Robotic Surgery for Oropharyngeal Squamous Cell Carcinoma.

PURPOSE: The objective of this study was to compare the cost-effectiveness of transoral robotic surgery (TORS) versus the standard treatment modality for oropharyngeal squamous cell carcinoma (OPSCC), radiation therapy (RT), in a subset of patients with early-stage OPSCC. METHODS AND MATERIALS: We developed a microsimulation state-transition model associated with RT and TORS for patients with clinically staged T1N0M0 to T2N1M0 OPSCC. Transition probabilities, utilities, and costs for each health state were estimated from recently published data and discounted by 3% annually over a lifetime time horizon. Model outcomes included lifetime costs (in 2014 US dollars), health benefits (quality-adjusted life-years [QALYs]), and cost-effectiveness ratios from a societal perspective. RESULTS: Under base-case assumptions, TORS was associated with modest gains in QALYs. RT yielded 10.43 QALYs at a cost of $123,410 per patient, whereas TORS yielded 11.10 QALYs at a cost of $178,480. This resulted in an incremental cost-effectiveness ratio of $82,190/QALY gained. The incremental cost-effectiveness ratio was most sensitive to the need for adjuvant therapy, cost of late toxicity, age at diagnosis, disease state utilities, and discount rate. Accounting for joint parameter uncertainty, RT had a higher probability of demonstrating a cost-effective profile compared with TORS, at 54% compared with 46%. CONCLUSIONS: By use of standard benchmarks for cost-effectiveness in the United States, TORS may be a cost-effective alternative for the subset of patients with early-stage OPSCC but demonstrates considerable sensitivity to assumptions around quality of life.

Management of early colonic neoplasia: where are we now and where are we heading?

INTRODUCTION: There have been considerable advances in the endoscopic treatment of colorectal neoplasia. The development of endoscopic submucosal dissection and full thickness resection techniques is changing the way benign disease and early cancers are managed. This article reviews the evidence behind these new techniques and discusses where this field is likely to move in the future. Areas covered: A PubMed literature review of resection techniques for colonic neoplasia was performed. The clinical and cost effectiveness of endoscopic mucosal resection (EMR) is examined. The development of endoscopic submucosal dissection (ESD) and knife assisted resection is described and issues around training reviewed. Efficacy is compared to both EMR and transanal endoscopic microsurgery. The future is considered, including full thickness resection techniques and robotic endoscopy. Expert commentary: The perceived barriers to ESD are falling, and views that such techniques are only possible in Japan are disappearing. The key barriers to uptake will be training, and the development of educational programmes should be seen as a priority. The debate between TEMS and ESD will continue, but ESD is more flexible and cheaper. This will become less significant as the number of endoscopists trained in ESD grows and some TEMS surgeons may shift across towards ESD.

POEM is a cost-effective procedure: cost-utility analysis of endoscopic and surgical treatment options in the management of achalasia.

BACKGROUND: Achalasia is a rare motility disorder of the esophagus. Treatment is palliative with the goal of symptom remission and slowing the progression of the disease. Treatment options include per oral endoscopic myotomy (POEM), laparoscopic Heller myotomy (LM) and endoscopic treatments such as pneumatic dilation (PD) and botulinum toxin type A injections (BI). We evaluate the economics and cost-effectiveness of treating achalasia. METHODS: We performed cost analysis for POEM, LM, PD and BI at our institution from 2011 to 2015. Cost of LM was set to 1, and other procedures are presented as percentage change. Cost-effectiveness was calculated based on cost, number of interventions required for optimal results for dilations and injections and efficacy reported in the current literature. Incremental cost-effectiveness ratio was calculated by a cost-utility analysis using quality-adjusted life year gained, defined as a symptom-free year in a patient with achalasia. RESULTS: Average number of interventions required was 2.3 dilations or two injections for efficacies of 80 and 61 %, respectively. POEM cost 1.058 times the cost of LM, and PD and BI cost 0.559 and 0.448 times the cost of LM. Annual cost per cure over a period of 4 years for POEM, and LM were consistently equivalent, trending the same as PD although this has a lower initial cost. The cost per cure of BI remains stable over 3 years and then doubles. CONCLUSION: The cost-effectiveness of POEM and LM is equivalent. Myotomy, either surgical or endoscopic, is more cost-effective than BI due to high failure rates of the economical intervention. When treatment is being considered BI should be utilized in patients with less than 2-year life expectancy. Pneumatic dilations are cost-effective and are an acceptable approach to treatment of achalasia, although myotomy has a lower relapse rate and is cost-effective compared to PD after 2 years.

Postoperative outcomes and quality of life following hysterectomy by natural orifice transluminal endoscopic surgery (NOTES) compared to laparoscopy in women with a non-prolapsed uterus and benign gynaecological disease: a systematic review and meta-analysis.

OBJECTIVE: To critically appraise studies comparing benefits and harms in women with benign disease without prolapse undergoing hysterectomy by natural orifice transluminal endoscopic surgery (NOTES) versus laparoscopy. STUDY DESIGN: We followed the PRISMA guidelines. We searched MEDLINE, EMBASE and CENTRAL for randomised controlled trials (RCTs), controlled clinical trials (CCTs) and cohort studies comparing NOTES with laparoscopy assisted vaginal hysterectomy (LAVH) or total laparoscopic hysterectomy (TLH) in women bound to undergo removal of a non-prolapsed uterus for benign disease. Two authors searched and selected studies, extracted data and assessed the risk of bias independently. Any disagreement was resolved by discussion or arbitration. RESULTS: We did not find RCTs but retrieved two retrospective cohort studies comparing NOTES with LAVH. The study quality as assessed by the Newcastle-Ottawa scale was acceptable. Both studies reported no conversions. The operative time in women treated by NOTES was shorter compared to LAVH: the mean difference (MD) was -22.04min (95% CI -28.00min to -16.08min; 342 women; 2 studies). There were no differences for complications in women treated by NOTES compared to LAVH: the risk ratio (RR) was 0.57 (95% CI 0.17-1.91; 342 women; 2 studies). The length of stay was shorter in women treated by NOTES versus LAVH: the MD was -0.42days (95% CI -0.59days to -0.25days; 342 women; 2 studies). There were no differences for the median VAS scores at 12h between women treated by NOTES (median 2, range 0-6) or by LAVH (median 2, range 0-6) (48 women, 1 study). There were no differences in the median additional analgesic dose request in women treated by NOTES (median 0, range 0-6) or by LAVH (median 1, range 0-5) (48 women, 1 study). The hospital charges for treatment by NOTES were higher compared to LAVH: the mean difference was 137.00 € (95% CI 88.95-185.05 €; 294 women; 1 study). CONCLUSIONS: At the present NOTES should be considered as a technique under evaluation for use in gynaecological surgery. RCTs are needed to demonstrate its effectiveness.

Simultaneous Bilateral Endonasal Endoscopic Dacryocystorhinostomy: A Low Cost, Fast, and Successful Method.

The etiology of primary nasolacrimal duct obstruction is largely unknown, and this disease may occur bilaterally in a small percentage of patients. In this retrospective study, the authors aimed to discuss the cost, operation time, complications, and success rate of simultaneous bilateral endonasal endoscopic surgery. Twenty-eight patients (16 female, 12 male) were enrolled in this study, with a mean age of 55 years old (range: 43-76). The success rate was 91% (51/56), and the mean operation time was 44 minutes. Only minor and transient complications were observed in 2 of the patients. Overall, the authors believe that a bilateral endoscopic dacryocystorhinostomy would be useful in a single session, based on its advantages of low morbidity, low cost, and high success.

HALON-hysterectomy by transabdominal laparoscopy or natural orifice transluminal endoscopic surgery: a randomised controlled trial (study protocol).

INTRODUCTION: Natural orifice transluminal endoscopic surgery (NOTES) uses natural body orifices to access the cavities of the human body to perform surgery. NOTES limits the magnitude of surgical trauma and has the potential to reduce postoperative pain. This is the first randomised study in women bound to undergo hysterectomy for benign gynaecological disease comparing NOTES with classical laparoscopy. METHODS AND ANALYSIS: All women aged 18-70 years, regardless of parity, consulting at our practice with an indication for hysterectomy due to benign gynaecological disease will be eligible. After stratification according to uterine size on clinical examination, participants will be randomised to be treated by laparoscopy or by transvaginal NOTES. Participants will be evaluated on day 0, days 1-7 and at 3 and 6 months. The following data will be collected: the proportion of women successfully treated by removing the uterus by the intended approach as randomised; the proportion of women admitted to the inpatient hospital; postoperative pain scores measured twice daily by the women from day 1 to 7; the total amount of analgesics used from day 1 to 7; readmission during the first 6 weeks; presence and intensity of dyspareunia and sexual well-being at baseline, 3 and 6 months (Short Sexual Functioning Scale (SSFS) scale); duration of surgery; postoperative infection or other surgical complications; direct and indirect costs incurred up to 6 weeks following surgery. The primary outcome will be the proportion of women successfully treated by the intended technique; all other outcomes are secondary. ETHICS AND DISSEMINATION: The study was approved on 1 December 2015 by the Ethics Committee of the Imelda Hospital, Bonheiden, Belgium. The first patient was randomised on 17 December 2015. The last participant randomised should be treated before 30 November 2017. The results will be presented in peer-reviewed journals and at scientific meetings within 4 years after starting recruitment. TRIAL REGISTRATION NUMBER: NCT02631837; Pre-results.

A Western Perspective on "New NOTES" from POEM to Full-thickness Resection and Beyond.

Most new natural orifice translumenal endoscopic surgery procedures originated in Asia; therefore, most data come from operators and a health care environment different from those in the West. We provide a Western perspective. We discuss East-West differences; review areas in which the United States is leading the way; and discuss the vagaries of coding and reimbursement. In the United States, reimbursement remains problematic. A Current Procedural Terminology code for peroral endoscopic myotomy is inevitable given the rapidly accumulating overwhelmingly positive outcomes data. However, coordinated efforts may help accelerate the process.