Incidence of anastomotic leakage using powered circular staplers versus manual circular staplers for left colorectal anastomosis: a cost-effectiveness analysis.

BACKGROUND: Colorectal anastomotic leakage causes severe consequences for patients and healthcare system as it will lead to increased consumption of hospital resources and costs. Technological improvements in anastomotic devices could reduce the incidence of leakage and its economic impact. The aim of the present study was to assess if the use of a new powered circular stapler is cost-effective. METHOD: This observational study included patients undergoing left-sided circular stapled colorectal anastomosis between January 2018 and December 2021. Propensity score matching was carried out to create two comparable groups depending on whether the anastomosis was performed using a manual or powered circular device. The rate of anastomotic leakage, its severity, the consumption of hospital resources, and its cost were the main outcome measures. A cost-effectiveness analysis comparing the powered circular stapler versus manual circular staplers was performed. RESULTS: A total of 330 patients were included in the study, 165 in each group. Anastomotic leakage rates were significantly different (p = 0.012): 22 patients (13.3%) in the manual group versus 8 patients (4.8%) in the powered group. The effectiveness of the powered stapler and manual stapler was 98.27% and 93.69%, respectively. The average cost per patient in the powered group was €6238.38, compared with €9700.12 in the manual group. The incremental cost-effectiveness ratio was - €74,915.28 per patient without anastomotic complications. CONCLUSION: The incremental cost of powered circular stapler compared with manual devices was offset by the savings from lowered incidence and cost of management of anastomotic leaks.

Single-Port vs Conventional Three-Port Video-Assisted Thoracoscopic Pulmonary Wedge Resection: Comparison of Postoperative Pain and Surgical Costs.

PURPOSE: Single-port video-assisted thoracoscopic (VATS) pulmonary wedge resection was reported in 2004. We started using single-port VATS (SPVATS) pulmonary wedge resection in 2017 and compared results between conventional three-port VATS (VATS group) and SPVATS (SPVATS group). METHODS: We identified 145 consecutive patients with VATS group and SPVATS group. Perioperative characteristics including pain and the number of stapler cartridges used were examined as the surgical outcomes, retrospectively. RESULTS: In all, 66 cases of SPVATS group and 79 cases of VATS group pulmonary wedge resection were compared. The rate of epidural anesthesia (p <0.0001) was significantly higher and operative time (p <0.0001) was significantly longer with VATS group than with SPVATS group. The number of stapler cartridges used, duration of drain insertion, and rate of postoperative complications did not differ significantly between groups. Average numerical rating scale (NRS) score on postoperative day 1 and postoperative day 7 (p <0.0001 each), maximum NRS score on postoperative day 7 (p = 0.0082) and amount of 25 mg tramadol (p = 0.0062) were significantly lower in SPVAS group than in VATS group. CONCLUSION: Our results suggest that SPVATS pulmonary wedge resection offers better pain control and cost-effectiveness than three-port VATS pulmonary wedge resection. These findings should contribute to the body of evidence for SPVATS.

A Novel Absorbable Stapler Provides Patient-Reported Outcomes and Cost-Effectiveness Noninferior to Subcuticular Skin Closure: A Prospective, Single-Blind, Randomized Clinical Trial.

BACKGROUND: Deep dermal suturing is critical for scar quality outcomes. The authors evaluated a new, fast medical device for dermal suturing, with the hypothesis of noninferiority with regard to clinical scar and cost-effectiveness. METHODS: A prospective, patient-blind, randomized, multicenter noninferiority study in 26 French hospitals was conducted. Patients were randomized 1:1 to suturing with conventional thread or a semiautomatic stapler. The Patient Scar Assessment Scale was rated at 3 months for primary endpoint effectiveness. Secondary endpoints were cost-effectiveness of the two suturing methods, prevalence of complications, suturing/operating time, Observer Scar Assessment Scale and Patient Scar Assessment Scale score, scar aesthetic quality 18 months after surgery, and occupational exposure to blood during surgery. RESULTS: Six hundred sixty-four patients were enrolled, 660 were randomized, and 649 constituted the full analysis (stapler arm, n = 324; needle arm, n = 325). Primary endpoint Patient Scar Assessment Scale score in the stapler arm was not inferior to that in the needle arm at 3 months or after 18 months. The mean operating time was 180 minutes in the stapler arm and 179 minutes in the needle arm (p = not significant). The mean suturing time was significantly lower in the stapler arm (p < 0.001). There were seven occupational exposures to blood in the needle arm and one in the stapler arm. The two arms did not differ significantly in terms of complications (p = 0.41). The additional cost of using the device was &OV0556;51.57 for the complete-case population. CONCLUSION: Wound healing outcome was no worse than with conventional suturing using a semiautomatic stapler and associated with less occupational exposure to blood. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.

A Prospective Randomized Control Study Comparing the Effects of Dermal Staples and Intradermal Sutures on Postoperative Scarring After Thyroidectomy.

BACKGROUND: We compared cosmetic outcomes, pain intensity, and costs between dermal stapling and intradermal suturing in patients who underwent thyroidectomy through cervical incision. PATIENTS AND METHODS: In total, 40 patients were randomly assigned to undergo thyroidectomy through a low cervical incision and dermal closure using either absorbable staples (n = 20, staple group) or interrupted intradermal sutures (n = 20, suture group). Wound complications, cosmetic outcomes (modified Stony Brook Scar Evaluation Scale [SBSES] and Manchester Scar Scale [MSS]), and pain intensity (visual analog scale) were assessed at 1, 4, 12, and 24 weeks postoperatively. The difference in total "wound-closure cost" between the two groups was also analyzed. RESULTS: There were no wound-related complications and no significant differences in SBSES or MSS scores between the two groups (P = 0.609 and P = 0.141, respectively). However, the staple group had significantly higher SBSES scores, compared to the suture group, at 24 wk postoperatively (4.06 ± 0.94 versus 3.26 ± 1.24; P = 0.030, respectively); MSS scores were significantly lower in the staple group than in the suture group at 24 wk postoperatively (6.72 ± 1.27 versus 8.16 ± 2.17, respectively; P = 0.028). Visual analog scale scores were significantly lower in the suture group than in the staple group (P = 0.038). The total wound-closure cost was significantly higher in the staple group than in the suture group (137.10 ± 8.39 versus 81.79 ± 19.95 USD; P < 0.001). CONCLUSIONS: When dermal staples were used, wound complications were absent and long-term cosmetic outcomes were superior; however, pain intensity was higher and the cost was greater, although healing was significantly more rapid, compared to intradermal sutures. Closure using absorbable dermal staples may be safe and effective for cervical incisions during thyroid surgery. Further studies with larger number of participants are needed to confirm our findings.

Safety and Feasibility of a Lower-Cost Stapler in Bariatric Surgery.

BACKGROUND: Laparoscopic staplers are integral to bariatric surgery. Their pricing significantly impacts the overall cost of procedures. An independent device company has designed a stapler handle and single-use reloads for cross-compatibility and equivalency with existing manufacturers, at a lower cost. OBJECTIVES: We aim to demonstrate non-inferior function and cross-compatibility of a newly introduced stapler handle and reloads compared to our institution's current stapling system in a large animal survival study. SETTING: University-affiliated animal research facility, USA. METHODS: Matched small bowel anastomoses were created in four pigs, one with each stapler (a total of two per animal). After 14 days, investigators blinded to stapler type evaluated the anastomoses grossly and microscopically. Each anastomosis was scored on multiple measures of healing. Individual parameters were added for a global "healing score." RESULTS: Clinical stapler function and gross quality of anastomoses were similar between stapler groups. Individual scores for anastomotic ulceration, reepithelialization, granulation tissue, mural healing, eosinophilic infiltration, serosal inflammation, and microscopic adherences were also statistically similar. The mean "healing scores" were equal. While this study was underpowered for subtle differences, safe and reliable performance in large animals still supports the feasibility of introducing new devices into human use. CONCLUSIONS: The new stapler system delivers a similar technical performance and is cross-compatible with currently marketed stapling devices. An equivalent quality device at a lower price point should enable case cost reduction, helping to maintain hospital case margin and procedure value in the face of potentially declining reimbursement. This device may provide a safe and functional alternative to currently used laparoscopic surgical staplers.

[Comparación entre ligadura con lazo hemostático y engrapadora mecánica lineal para el cierre de base apendicular]. / Comparison between endoloop and linear mechanical stapler for the appendicular stump closure.

INTRODUCCIÓN: En las últimas décadas es creciente el abordaje por mínima invasión de patologías abdominales debido a sus beneficios evidentes. El cuadro apendicular es la principal emergencia quirúrgica, con diferentes métodos del cierre de la base apendicular. En este artículo comparamos dicho cierre con engrapadora lineal o ligadura con lazo hemostático, para analizar la frecuencia de complicaciones como absceso, dehiscencia y seroma. MÉTODO: Se realizó un estudio prospectivo, observacional y descriptivo, con un total de 703 procedimientos, empleando en 567 pacientes ligadura con lazo hemostático y en 136 engrapadora lineal, operados por los mismos cirujano y equipo quirúrgico, con curva de aprendizaje concluida. RESULTADOS: Las complicaciones referidas en el presente estudio son absceso (n = 5), dehiscencia (n = 3) y seroma (n = 3). De acuerdo con las fases de la patología apendicular: fase 1 o apéndice congestivo, no presentaron complicaciones; fase 2 o supurativo, se reportó un caso de dehiscencia de herida quirúrgica con el uso de ligadura con lazo hemostático; fase 3 o necrótico, se reportó un caso de seroma en un paciente tratado con ligadura con lazo hemostático; y fase 4 o perforado, se encuentra diferencia significativa en el caso de abscesos, reportando cinco con el uso de ligadura con lazo hemostático y ninguno con engrapadora lineal. CONCLUSIONES: En nuestro estudio no existe diferencia estadísticamente significativa entre el uso de engrapadora lineal o ligadura con lazo hemostático en las fases apendiculares 1-3; en la fase 4 es de utilidad significativa el uso de engrapadora lineal ante la incidencia de abscesos. INTRODUCTION: In the last decades, the approach by minimally invasive surgery of abdominal pathologies is growing due to its evident benefits; the appendicular cases being the main surgical emergency, with different methods of closing the appendicular base. In this article, we compared the appendicular base closure with linear stapler and endoloop, to analyze the frequency of complications such as abscess, dehiscence and seroma. METHOD: A prospective, observational and descriptive study was conducted, with a total of 703 procedures, using 567 endoloop patients and 136 linear stapler, operated by the same surgeon and surgical team, with a completed learning curve. RESULTS: The complications referred in the present study were patients with abscess (n = 5), dehiscence (n = 3) and seroma (n = 3). According to the phases of the appendiceal pathology: phase 1 or congestive appendix did not present complications; phase 2 or suppurative was reported one case of surgical wound dehiscence in the use of endoloop; in phase 3 or necrotic, one case of seroma was reported in a patient treated with endoloop; while in phase 4 or perforated there is a significant difference in the case of abscesses, reporting five in the use of endoloop and none in the case of a linear stapler. CONCLUSIONS: In our study there is no statistically significant difference between the use of linear stapler or endoloop in the early appendicular phases; being of significant utility in Phase 4 the use of linear stapler for the incidence of abscesses.

Initial Experience with the Use of a Robotic Stapler for Robot-Assisted Donor Nephrectomy.

INTRODUCTION: Since the first description of robot-assisted laparoscopic donor nephrectomy for living donor renal transplantation, additional studies have noted outcomes comparable to traditional laparoscopic surgery. Urologists have embraced the technical advantages of the robotic approach, including improved dissection and more accurate graft preservation. With the advent of robotic stapling, we aim to demonstrate the feasibility of the use of robotic stapling for living-donor nephrectomies. MATERIALS AND METHODS: Ten cases of da Vinci® EndoWrist® Stapler use during robot-assisted donor nephrectomy by a single surgeon are reported. Variables examined included patient anatomy, estimated blood loss (EBL), warm ischemia time (WIT), postoperative complications, and graft function at follow-up. The costs of the laparoscopic and robotic staplers at our institution are reported. RESULTS: One right and nine left nephrectomies were performed by a single surgeon. Eight living donors had a single renal artery and vein, while two had multiple renal arteries and renal veins. A single vascular stapler load (45-mm, white cartridge) was used for vessels in all cases. WIT was <6 minutes in each case, and EBL ranged from 13 to 100 mL. Sufficient length on the renal artery and vein was obtained to execute anastomoses in all cases. Only one patient had postoperative complications that were related to anesthesia. Graft function of recipients and postoperative renal function has been adequate to date. The cost of using the robotic stapler was $705 (EndoWrist Stapler), and the cost of the laparoscopic stapler (Endo GIA™ Stapler; Medtronic, Dublin, Ireland) was $494.06. CONCLUSIONS: The use of robotic stapler is feasible in terms of patient safety, technique, postoperative outcomes, and cost in both left- and right-sided living-donor robotic nephrectomies. Further research is needed to confirm the benefit and safety of EndoWrist stapler use in robotic donor nephrectomies compared to laparoscopic stapler use.

Outcome and Cost Analysis of Hand-Sewn and Stapled Anastomoses in the Reversal of Loop Ileostomy.

Diverting loop ileostomies are common procedures for protecting high-risk anastomoses. There is little consensus on the most ideal technique both in terms of cost efficiency and outcome. Data for this study were collected from 101 patients who underwent loop ileostomy reversal between 2009 and 2014 at Morristown Medical Center. Of the 101 patients included in the review, 57 received a hand-sewn anastomosis (HS-A) and 44 received a stapled anastomosis (S-A). Average total hospital charges for stapled anastomoses were significantly greater than that for hand-sewn anastomoses, as were total operating room supply costs. When the total cost of the operation itself was considered, S-A cases were still found to be significantly greater than HS-A cases. Hospital room charges, total lab charges, pathology charges, and EKG/ECG charges were all greater for S-A cases than HS-A cases. Overall costs were greater for S-As than hand-sewn anastomoses and because of a lack of difference in procedure length, stapler supply costs were not offset. Complication rates and length of stay were also similar between the techniques. We found S-A cases to be more costly and have a greater cost/hour than HS-A cases.

Looped suture versus stapler device in pediatric laparoscopic appendectomy: a comparative outcomes and intraoperative cost analysis.

BACKGROUND: Appendiceal ligation during pediatric laparoscopic appendectomy (LA) may be performed using looped suture versus stapler. Controversy regarding the utility of either method exists. Clinical outcomes and cost analysis of LA with both methods were compared. METHODS: All pediatric LA were performed from fiscal years 2013 and 2014 by two pediatric surgeons. While one surgeon used looped suture, the other used stapler exclusively. chi-Square tests were performed to analyze associations. RESULTS: Two hundred thirty-eight cases were analyzed where looped suture versus stapler LA was performed in 46% and 54% of patients, respectively. Operating room costs were $317.10 and $707.12/person for looped suture and stapler LA, respectively (P<0.0001). Difference in cost of $390.02/person was attributed solely to ligation type. On bivariate analysis, rate of in-hospital complications, length of stay, return-to-ER and readmission within 30 days did not significantly differ between groups. CONCLUSION: A comparative analysis of looped suture versus stapler device during LA for pediatric appendicitis revealed that postoperative complications, length of stay, ER visits and readmissions were not significantly different. Looped suture LA was significantly more cost efficient than stapler LA. In pediatric appendicitis, appendiceal ligation during LA may be performed safely and cost effectively with looped suture versus stapler. TYPE OF STUDY: Cost effectiveness LEVEL OF EVIDENCE: III.

A pragmatic multicentre randomised controlled trial comparing stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease: the eTHoS study.

BACKGROUND: Haemorrhoids are a benign anorectal condition and are highly prevalent in the UK population. Treatments involve clinic-based procedures and surgery. The surgical procedures available include stapled haemorrhoidopexy (SH) and traditional haemorrhoidectomy (TH), and over 25,000 operations are performed for haemorrhoids annually in the UK. The disease is therefore important both to patients and to health service commissioners. Debate remains as to which of these surgical procedures is the most clinically effective and cost-effective. OBJECTIVE: The aim of this study was to compare the clinical effectiveness and cost-effectiveness of SH with that of TH. DESIGN: A large, open two-arm parallel-group pragmatic multicentre randomised controlled trial involving 32 UK hospitals and a within-trial cost-benefit analysis. A discrete choice experiment was conducted to estimate benefits (willingness to pay). PARTICIPANTS: Patients with grades II-IV haemorrhoids who had not previously undergone SH or TH were included in the study. INTERVENTIONS: Participants were randomised to receive either SH or TH. Randomisation was minimised at 1 : 1, in accordance with baseline EuroQol-5 Dimensions, three-level version (EQ-5D-3L) score, haemorrhoid grade, sex and centre, via an automated system. MAIN OUTCOME MEASURES: The primary outcome was area under the quality-of-life curve measured using the EQ-5D-3L descriptive system over 24 months, and the primary economic outcome was the incremental cost-effectiveness ratio. Secondary outcomes included disease-specific quality of life, recurrence, complications, further interventions and costs. RESULTS: Between January 2011 and August 2014, 777 patients were randomised (389 to receive SH and 388 to receive TH). There were 774 participants included in the analysis as a result of one post-randomisation exclusion in the SH arm and two in the TH arm. SH was less painful than TH in the short term. Surgical complications were similar in both arms. EQ-5D-3L score was higher for the SH arm in the first 6 weeks after surgery, but over 24 months the TH group had significantly better EQ-5D-3L scores (-0.073, 95% confidence interval -0.140 to -0.006; p = 0.0342). Symptoms and further interventions were significantly fewer in the TH arm at 24 months. Continence was better in the TH arm and tenesmus occurred less frequently. The number of serious adverse events reported was 24 out of 337 (7.1%) for participants who received SH and 33 out of 352 (9.4%) for those who received TH. There were two deaths in the SH arm, both unrelated to the eTHoS (either Traditional Haemorrhoidectomy or Stapled haemorrhoidopexy for haemorrhoidal disease) study. Patient preference did not seem to influence the treatment difference. SH was dominated by TH as it cost more and was less effective. The net benefit for the TH arm was higher than that for the SH arm. LIMITATIONS: Neither the participants nor the assessors were masked to treatment assignment and final recruitment was slightly short of the total target of 800. There were also substantial missing follow-up data. CONCLUSIONS: While patients who received SH had less short-term pain, after 6 weeks, recurrence rates, symptoms, re-interventions and quality-of-life measures all favoured TH. In addition, TH is cheaper. As part of a tailored management plan for haemorrhoids, TH should be considered over SH as the surgical treatment of choice for haemorrhoids refractory to clinic-based interventions. FUTURE WORK: Perform an updated meta-analysis incorporating recently conducted European trials [eTHoS, HubBLe (haemorrhoidal artery ligation versus rubber band ligation for the management of symptomatic second-degree and third-degree haemorrhoids) and LingaLongo (Cost-effectiveness of New Surgical Treatments for Haemorrhoidal Disease)]. TRIAL REGISTRATION: Current Controlled Trials ISRCTN80061723. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 70. See the NIHR Journals Library website for further project information.

Endostapler versus Hem-O-Lok clip to secure the appendiceal stump and mesoappendix during laparoscopic appendectomy.

BACKGROUND: Our study evaluates the safety and cost of using the Hem-O-Lok (HOL) clip in laparoscopic appendectomy (LA). METHOD: We prospectively compared 30-day postoperative outcomes and cost between HOL clip and endoscopic stapler (ES) in LA at a single institution. RESULTS: HOL clip was used in 45 out of 92 LA. Perforated appendicitis (29.8% vs. 11.1%, P = 0.027) and postoperative complications were more common in the ES group (19.2% vs. 2.2%, p = 0.009). In multivariate analysis, HOL clip was associated with lower complications rate (OR = 0.05, 95% CI 0.003-0.744; p = 0.030). In propensity score matched cohort, complications were not different (p > 0.05). In patients with non-perforated appendicitis, HOL use increased operative time by 10 min on average (p = 0.004). Minimum ES cost per single appendectomy was $273.13, while HOL clip cost was $32.14. CONCLUSION: The use of HOL clip in LA is safe and it reduced the costs of the procedure in comparison to the use of ES.

Surgical glue in laparoscopic sleeve gastrectomy: An initial experience and cost-effectiveness analysis.

RATIONALE, AIMS, AND OBJECTIVES: Laparoscopic sleeve gastrectomy (LSG) is one of the most common bariatric procedures. Gastric leaks and bleeding are the most frequent complications, associated with a high clinical and economic burden. The best method of staple line reinforcement in LSG is debated. Surgical glue is one of the options available. The aim of this study was to assess the safety, efficiency, and relative cost-effectiveness of surgical glue used to perform LSG in morbid obese adults as compared with standard stapling. METHODS: A prospective, observational, and comparative before-after study was conducted. All consecutive patients undergoing LSG at Montpellier University Hospital in 2011 and 2012 were included and treated according to 2 groups: standard stapling (n = 99, group 1) and surgical glue reinforcement (n = 94, group 2). Clinical and economic outcomes were measured after 6 months. RESULTS: The duration of intervention was significantly shorter in group 2 (68 vs 82 minutes, P = .001). There was no significant difference regarding complications, but leaks in group 1 were more severe. Group 2 was also associated with a reduced initial length of stay (4.8 vs 5.2 days, P = .01). Six-month readmissions and total length of stay were also shorter in group 2 (5.5 vs 6.1 days, P = .003). Surgical glue use was associated with a significant reduction in the initial inpatient cost (€5488 vs €6152, P = .005) and in the 6-month total inpatient cost, including readmissions (€6006 vs €6754, P = .005). The incremental cost of glue to avoid a severe complication was -€5446.33 (95 confidence interval, -8202.01 to -2690.66). CONCLUSIONS: Surgical glue might be a safe and cost-effective intervention in laparoscopic sleeve gastrectomy.

No clinical benefit from routine histologic examination of stapler doughnuts at low anterior resection for rectal cancer.

BACKGROUND: The aim of this study was to evaluate the clinical utility and cost-effectiveness of routine histologic examination of the doughnuts from stapled anastomoses in patients undergoing a low anterior resection for rectal cancer. METHODS: We performed a retrospective review of 486 patients who underwent a low anterior resection with stapled anastomosis for rectal cancer between 2002 and 2015 at 3 institutions. Pathologic findings in the doughnuts and their impact on patient management were recorded. Tumor characteristics that may influence how often doughnuts were included in the pathology report were analyzed. An approximate cost of histologic examination of doughnuts was also calculated. RESULTS: A total of 412 patients (85%) had doughnuts included in their pathology reports. Two patients had cancer cells in their doughnuts, and both patients had a positive distal margin in their primary tumor specimen; 33 patients had benign findings in their doughnuts. Pathologic examination of the doughnut did not change clinical management in any patient. Patients with rectosigmoid tumors were less likely to have their doughnuts included in the pathology report compared to patients with low tumors (P = .003). Doughnuts were not bundled with the primary tumor specimen in 374 (77%) of our patients; in these patients, pathologic analysis of the doughnut added an additional cost of approximately $643 per specimen. CONCLUSION: This study demonstrates no clinical benefit in sending anastomotic doughnuts for histopathologic evaluation after performing a low anterior resection with a stapled anastomosis for rectal cancer. Overall cost may be decreased if doughnuts are not analyzed or if they are bundled with the primary tumor specimen.

Comparing Steri-Strip and surgical staple wound closures after primary total knee arthroplasties.

BACKGROUND: Steri-Strips (3M, Two Harbors, MN, USA) have recently been employed for skin closures after orthopedic surgeries. Here we compare the performance of Steri-Strips and skin staples for wound closure after primary total knee arthroplasties (TKAs). METHODS: A total of 76 consecutive osteoarthritic knees (71 patients) that underwent a primary TKA at our facility were included in this study. Thirty-eight knees received Steri-Strips for wound closure and were evaluated prospectively. The other 38 knees were closed with skin staples (Staple group) and evaluated retrospectively. RESULTS: No deep or superficial infections developed in this series. Although Steri-Strips detached from three knees during the 10-day postoperative period, no dehiscence was observed. Thirteen knees developed blisters around the surgical incision in the Steri-Strip group compared with five knees in the Staple group. The average operative time for the Steri-Strip group was 60.6 min (SD 7.3) compared with 54.1 min (SD 6.9) in the Staple group. There were significant differences in operative time (p < 0.001) and tourniquet time (p < 0.001) between the two groups. The average time until patients were permitted to start showering was significantly shorter in the Steri-Strip group (p = 0.0496). The material cost for Steri-Strips was approximately $3.00 USD for one operation compared with $26 USD for skin staplers. CONCLUSIONS: Wound closure with Steri-Strips after a TKA does not require postoperative material removal and may have improved safety, comfort, cosmesis and cost-effectiveness compared with traditional skin closures. LEVEL OF EVIDENCE: Level II, Prognostic study.

Comparison of stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease (eTHoS): a pragmatic, multicentre, randomised controlled trial.

BACKGROUND: Two commonly performed surgical interventions are available for severe (grade II-IV) haemorrhoids; traditional excisional surgery and stapled haemorrhoidopexy. Uncertainty exists as to which is most effective. The eTHoS trial was designed to establish the clinical effectiveness and cost-effectiveness of stapled haemorrhoidopexy compared with traditional excisional surgery. METHODS: The eTHoS trial was a large, open-label, multicentre, parallel-group, pragmatic randomised controlled trial done in adult participants (aged 18 years or older) referred to hospital for surgical treatment for grade II-IV haemorrhoids. Participants were randomly assigned (1:1) to receive either traditional excisional surgery or stapled haemorrhoidopexy. Randomisation was minimised according to baseline EuroQol 5 dimensions 3 level score (EQ-5D-3L), haemorrhoid grade, sex, and centre with an automated system to stapled haemorrhoidopexy or traditional excisional surgery. The primary outcome was area under the quality of life curve (AUC) measured with the EQ-5D-3L descriptive system over 24 months, assessed according to the randomised groups. The primary outcome measure was analysed using linear regression with adjustment for the minimisation variables. This trial is registered with the ISRCTN registry, number ISRCTN80061723. FINDINGS: Between Jan 13, 2011, and Aug 1, 2014, 777 patients were randomised (389 to receive stapled haemorrhoidopexy and 388 to receive traditional excisional surgery). Stapled haemorrhoidopexy was less painful than traditional excisional surgery in the short term and surgical complication rates were similar between groups. The EQ-5D-3L AUC score was higher in the traditional excisional surgery group than the stapled haemorrhoidopexy group over 24 months; mean difference -0·073 (95% CI -0·140 to -0·006; p=0·0342). EQ-5D-3L was higher for stapled haemorrhoidopexy in the first 6 weeks after surgery, the traditional excisional surgery group had significantly better quality of life scores than the stapled haemorrhoidopexy group. 24 (7%) of 338 participants who received stapled haemorrhoidopexy and 33 (9%) of 352 participants who received traditional excisional surgery had serious adverse events. INTERPRETATION: As part of a tailored management plan for haemorrhoids, traditional excisional surgery should be considered over stapled haemorrhoidopexy as the surgical treatment of choice. FUNDING: National Institute for Health Research Health Technology Assessment programme.

Cost-effectiveness of New Surgical Treatments for Hemorrhoidal Disease: A Multicentre Randomized Controlled Trial Comparing Transanal Doppler-guided Hemorrhoidal Artery Ligation With Mucopexy and Circular Stapled Hemorrhoidopexy.

OBJECTIVE: To compare Doppler-guided hemorrhoidal artery ligation (DGHAL) with circular stapled hemorrhoidopexy (SH) in the treatment of grade II/III hemorrhoidal disease (HD). BACKGROUND: DGHAL is a treatment option for symptomatic HD; existing studies report limited risk and satisfactory outcomes. DGHAL has never before been compared with SH in a large-scale multi-institutional randomized clinical trial. METHODS: Three hundred ninety-three grade II/III HD patients recruited in 22 centers from 2010 to 2013 were randomized to DGHAL (n = 197) or SH (n = 196). The primary endpoint was operative-related morbidity at 3 months (D.90) based on the Clavien-Dindo surgical complications grading. Total cost, cost-effectiveness, and clinical outcome were assessed at 1 year. RESULTS: At D.90, operative-related adverse events occurred after DGHAL and SH, respectively, in 47 (24%) and 50 (26%) patients (P = 0.70). DGHAL resulted in longer mean operating time (44±16 vs 30±14 min; P < 0.001), less pain (postoperative and at 2 wks visual analogic scale: 2.2 vs 2.8; 1.3 vs 1.9; P = 0.03; P = 0.013) and shorter sick leave (12.3 vs 14.8 d; P = 0.045). At 1 year, DGHAL led to more residual grade III HD (15% vs 5%) and a higher reoperation rate (8% vs 4%). Patient satisfaction was >90% for both procedures. Total cost at 1 year was greater for DGHAL [&OV0556;2806 (&OV0556;2670; 2967) vs &OV0556;2538 (&OV0556;2386; 2737)]. The D.90, incremental cost-effectiveness ratio (ICER) was &OV0556;7192 per averted complication. At 1 year DGHAL strategy was dominated. CONCLUSIONS: DGHAL and SH are viable options in grade II/III HD with no significant difference in operative-related risk. Although resulting in less postoperative pain and shorter sick leave, DGHAL was more expensive, took longer, and provided a possible inferior anatomical correction suggesting an increased risk of recurrence.

Clinical and Economic Evaluation of Absorbable Staple Line Buttressing in Sleeve Gastrectomy in High-Risk Patients.

BACKGROUND: Gastric leaks and bleeding are the most important complications after laparoscopic sleeve gastrectomy (LSG). The use of absorbable membranes as staple line reinforcement may decrease this risk. On the other hand, these materials bring additional costs and their economic impact is not well known. The purpose of this study was to assess the clinical and economic performance of one of the commercially available buttressing absorbable materials when treating a high-risk population. METHODS: A retrospective, observational, and comparative study was conducted at Montpellier University Hospital, France, between July 2013 and September 2014. Patients undergoing LSG, who were at a high risk for leaks and bleeding, were included and treated according to two groups: no buttressing (July 2013 to January 2014) and buttressing (February 2014 to September 2014). Clinical and economic outcomes were measured throughout the first 6 months. RESULTS: Two hundred two patients were included in the study: 116 during the no stapling reinforcement period and 86 during the buttressing period. Baseline characteristics were similar. There was no significant difference between the two groups regarding gastric leaks. However, buttressing reduced hemorrhagic complications (0 vs 8.6 %, p = 0.005) and decreased average total hospital costs for the first hospitalization (5768 vs 6025 €, p < 0.001), as well as 6-month total inpatient cost (5944 vs. 6246 €, p < 0.001). CONCLUSIONS: Staple line reinforcement with absorbable material reduces bleeding in high-risk population. Therefore, this type of material can also result in cost-savings.

Costs of Leaks and Bleeding After Sleeve Gastrectomies.

BACKGROUND: Leaks and bleeding are serious postoperative complications after a sleeve gastrectomy (SG). The objective of the present study was to evaluate the costs of leaks and bleeding after SG. METHODS: A retrospective analysis was conducted of a prospective cohort of primary SGs between August 2006 and September 2013 in a bariatric center. All SGs were performed consistently without reinforcement of the staple line. Abscesses adjacent to the staple line were also regarded as leaks. Data were collected on all diagnostic and therapeutic measures necessary to manage leaks or bleeding, days of hospitalization and parenteral feeding, number of blood products, antibiotics, and additional outpatient department visits. RESULTS: One thousand two hundred sixty one patients underwent a SG. Leaks occurred in 32 (2.5%) and bleeding in 27 (2.1%) patients. Median additional costs for leaks were 9284 (range 1748-125,684) and 4267 (range 1524-40,022) for bleeding. Prolonged hospitalization in the ward and ICU accounted for the majority of costs, 50.3 and 31.4%, respectively, for leaks and 42.0 and 34.8% for bleeding. CONCLUSIONS: These data provide insight into the costs of major complications after SG. A wide range is seen especially due to prolonged hospitalization in the ward and ICU. High costs are an additional argument to reduce complication rate. These data should be considered when analyzing the cost-effectiveness of staple line reinforcement.

Laparosocopic Appendectomy, Cost-Effectiveness of Three Different Techniques Used to Close the Appendix Stump.

UNLABELLED: It is generally agreed that laparoscopic appendectomy is a valuable operative method. The aim of the study was to evaluate cost-effectiveness of three different techniques used to close the appendix stump. MATERIAL AND METHODS: We conducted a retrospective study that compared three groups of patients who were operated on laparoscopically for acute appendicitis in 2013 at our institution. We used an endoscopic clip to close the appendix stump in the first group (n=20), endoscopic stapler was applied in the second group (n=20), and in the third group of patients the appendix base was closed with a laparoscopic suture (n=20). These groups were matched by age, sex and BMI. RESULTS: The average operative cost was the highest in the second group. Cost of the laparoscopic appendectomy with the application of the endoscopic clip was significantly lower (first group) and comparable to the third group. Observed differences in total hospitalization costs were associated only with the chosen appendix stump closure technique. CONCLUSIONS: Clip closure of the appendix base is an easy and cost-effective procedure. The laparoscopic suture technique is the cheapest but technically demanding. According to our experience endoscopic stapler may be useful in some cases, although it is the most expensive method.