A Pilot Feasibility Multicenter Study of Patients After Excision of Endometriosis

Objective:

To serve as a pilot feasibility study for a randomized study of excision versus ablation in the treatment of endometriosis by (1) estimating the magnitude of change in symptoms after excision only at multiple referral centers and (2) determining the proportion of women willing to participate in a randomized trial.

Methods:

We performed a multicenter prospective study of women undergoing excision for endometriosis (Canadian Task Force class II-3) at Duke University Center for Endometriosis Research & Treatment (currently the Saint Louis University Center for Endometriosis), Center for Endometriosis Care, Northshore University Health System, Memorial University (Canada), and Florida Hospital. The study comprised 100 female patients, aged 18 to 55 years, with endometriosis-suspected pelvic pain. The intervention was laparoscopic excision only of the abnormal peritoneum suspicious for endometriosis. The main outcome measures were quality of life, pelvic pain, dysmenorrhea, dyspareunia, and bowel and bladder symptoms.

Results:

The mean follow-up period was 8.5 months. Excision of endometriosis showed a significant reduction in all pain scores except bowel symptoms, as well as significant improvement in quality of life. Of the patients, 84% were willing to participate in a randomized study.

Conclusions:

Quality of life is a needed primary outcome for any randomized study comparing excision versus ablation. A multicenter comparative trial is feasible, although quality assurance would have to be addressed. Patients were willing to be randomized even at surgical referral centers.     

Drain After Laparoscopic Cholecystectomy for Acute Calculous Cholecystitis. A Pilot Randomized Study

Drainage after laparoscopic cholecystectomy (LC) for acute calculous cholecystitis (ACC) is used without evidence of its efficacy. The present pilot study was designed to address this issue. After laparoscopic gallbladder removal, 15 patients were randomized to have a drain positioned in the subhepatic space (group A) and 15 patients to have a sham drain (group B). The primary outcome measure was the presence of subhepatic fluid collection at abdominal ultrasonography, performed 24 h after surgery. Secondary outcome measures included postoperative abdominal and shoulder tip pain, use of analgesics, and morbidity. Abdominal ultrasonography did not show any subhepatic fluid collection in eight patients (53.3 %) in group A and in five patients (33.3 %) in group B (P?=?0.462). If present, median (range) subhepatic collection was 50 mL (20–100 mL) in group A and 80 mL (30–120 mL) in group B (P?=?0.573). No significant differences in the severity of abdominal and shoulder pain and use of parenteral ketorolac were found in either group. Two biliary leaks and one subhepatic fluid collection occurred postoperatively. The present study was unable to prove that the drain was useful in LC for ACC, performed in a selected group of patients.     

Effects of Intermittent Pneumatic Compression on Leg Vascular Function in People with Spinal Cord Injury: A Pilot Study

Objective: The purpose of this pilot study was to determine whether 60 mins of intermittent pneumatic compression therapy (IPC) could acutely increase leg blood flow-induced shear stress and enhance vascular endothelial function in persons with spinal cord injury (SCI).

Design: Pretest with multiple posttests, within subject randomized control design.

Setting: University of Southern Mississippi, Spinal Cord Injury Research Program within the School of Kinesiology, recruiting from the local community in Hattiesburg, Jackson, and Gulfport, MS.

Participants: Eight adults with SCI (injury level: T3 and below; ASIA class A-C; age: 41±17 yrs).

Interventions: A 60-min IPC session was performed in one leg (experimental leg; EXP), with the other leg serving as a control (CON).

Outcomes Measures: Posterior-tibial artery shear rate (Doppler-ultrasound) was examined at rest, and at 15 and 45 mins during IPC. Endothelial function was assessed using the flow-mediated dilation (FMD) technique, before and after IPC.

Results: Resting FMD (mm) was similar between legs at rest. A two-way repeated measures ANOVA (leg x time) revealed that during IPC, peak shear rate increased in the EXP leg (215±137 to 285±164 s^?1 at 15 mins; +39±29%, P?=?0.03), with no change occurring in the CON. In addition, FMD significantly increased in the EXP leg (Pre IPC: 0.36±0.14 vs. Post IPC: 0.47±0.17 mm; P?=?0.011, d?=?0.66), with no change occurring in the CON leg.

Conclusion: These preliminary findings suggests that IPC therapy may acutely increase leg shear stress within 15 mins, with a resultant moderate-large improvement in vascular endothelial function after 60 mins in people with SCI.     

Frictional Properties of the Meniscus Improve After Scaffold-augmented Repair of Partial Meniscectomy: A Pilot Study

Background  

To prevent further degeneration, it is desirable to fill a meniscal defect with a supportive scaffold that mimics the mechanics of native tissue. Degradable porous scaffolds have been used, but it is unclear whether the tissue that fills the site of implantation is mechanically adequate, particularly with respect to frictional performance.     

Delayed Rupture of the Extensor Hallucis Longus and Extensor Digitorum Communis Tendons After Breaching the Anterior Capsule with a Radiofrequency Probe During Ankle Arthroscopy: A Case Report

A 40-year-old man with early arthritis, loose bodies, and anterolateral joint impingement symptoms in his left ankle, which was refractory to noninvasive therapeutic modalities for 1 year, underwent ankle arthroscopy and radiofrequency thermal ablation. The anterior capsule of the ankle joint was breached by the radiofrequency probe while the loose bodies were removed from the anterior recess, exposing the extensor tendons and resulting in a delayed spontaneous rupture of the extensor hallucis longus tendon and extensor tendons to the second and third toes. The extensor hallucis longus tendon was repaired with a semitendinosus tendon graft, and extensor digitorum tendons underwent primary repair. The patient regained full function and was symptom free 1 year after surgery.     

Power Doppler Sonography and Clinical Monitoring for Hyaluronic Acid Treatment of Rhizarthrosis: A Pilot Study

Trapeziometacarpal (TMC) joint osteoarthritis (OA) is a common disabling condition in which the impact of visco-supplementation has to be ascertained. We aim to evaluate the efficacy of high molecular weight hyaluronic acid (HA) ultrasound (US)-guided intra-articular injection of TMC joints in OA. 32 TMC joints of 16 patients with symptomatic thumb base OA were treated with three injections of high molecular weight HA at 1-week intervals. Before injection, at week 0, 1, 2, and 24 all patients underwent clinical and US examination. A significant clinical improvement was obtained by the decrease in visual analog scale for pain after 2 weeks of treatment (p = 0.0003) and this result is maintained at week 24 (p = 0.009). The Dreiser’s index also decreased after week 2 and remain stable after 6 months. Power Doppler signal significantly decreased after 2 weeks of treatment (p = 0.02), even if this result was not maintained at week 24. No significant decrease in the synovial hypertrophy score was observed during the study. Our preliminary study suggests that US-guided TMC injections by high molecular weight HA may be effective in decreasing local inflammation and pain.     

Hypothermic Machine Perfusion as an Alternative to Biopsy Assessment in Transplantation of Kidneys Donated After Cardiocirculatory Death: A Pilot Study

BackgroundTransplantation of kidneys from donation after cardiocirculatory death (DCD) donors is becoming an ever-increasing reality. So far, biopsy histologic assessment is the main parameter for evaluation of graft suitability, but it has several drawbacks and has poor reliability. The aim of this study is to verify if real-time renal resistance (RR) measurement during hypothermic machine perfusion (HMP) can be used as a reliable parameter to evaluate the quality of grafts from DCD and extracorporeal membrane oxygenation (ECMO) donors.MethodsFrom January 2015 to September 2018, HMP has been systematically applied to all organs from DCD and ECMO donors. All grafts underwent preimplantation biopsy histologic assessment with Karpinski’s score. Single kidney transplants (SKTs) or double kidney transplants (DKTs) were performed according to biopsy score results. Kidneys were considered suitable for transplant if RR reached ≤ 1.0 within 3 hours of perfusion. RR trend and postoperative outcome were analyzed considering biopsy score and donor type.ResultsA total of 30 kidneys (15 from DCD and 15 from ECMO donors) were used to perform 26 transplants (22 SKTs and 4 DKTs). Considering RR trend, all grafts were considered suitable for transplant within 1 hour of perfusion. Biopsy confirmed this result in all cases, and median score was 3 (range, 0-7). SKT score kidneys had lower starting RR than DKT ones (1.88 vs 2.88; P = .04) but identical final RR (0.58 vs 0.57; P = .76). DKT recipients had faster postoperative creatinine reduction than SKT recipients but similar postoperative day 30 value (1.42 vs 1.15 mg/dL; P = .20). No differences were found between DCD and ECMO grafts in terms of RR trend and postoperative outcome.ConclusionsHMP can be an alternative to histologic biopsy assessment for evaluation of transplant suitability of DCD and ECMO kidneys. If acceptability threshold is reached, SKT can be performed in all cases. ECMO donors should be considered like DCD donors.     

Gender Differences in Subjective Sleep After Trauma and the Development of Posttraumatic Stress Disorder Symptoms: A Pilot Study

Women are at higher risk than men for developing posttraumatic stress disorder (PTSD) following certain types of trauma such as accidents and assaults. Sleep disturbances have been implicated in the development of PTSD. Although gender differences in objective sleep soon after trauma have been found in a prior polysomnographic study, gender differences in subjective sleep soon after trauma and their associations to the development of PTSD have not been examined. This pilot study prospectively examined whether gender moderated the relationship between subjective sleep soon after trauma and PTSD symptom development. Injury patients (17 women, 28 men) completed a sleep questionnaire and a 1‐week sleep diary 2 weeks after their injuries, and the Clinician Administered PTSD Scale at 7‐weeks postinjury. Results showed that women reported greater frequency of nightmares and disruptive nocturnal behaviors (e.g., hot flashes, memories/nightmares about trauma) following the trauma and more severe PTSD symptoms at 7 weeks. Further, gender moderated the relationship between sleep‐onset latency and PTSD symptom severity, such that longer sleep‐onset latency predicted more severe PTSD symptoms in men, but less severe PTSD symptoms in women. These findings suggest that gender‐specific mechanisms may underlie the relationship between sleep impairment and the development of PTSD.     

Pretransplant Numbers of CD16+ Monocytes as a Novel Biomarker to Predict Acute Rejection After Kidney Transplantation: A Pilot Study

Acute rejection is one of the major immunological determinants of kidney graft function and survival. Early biomarkers to predict rejection are lacking. Emerging evidence reveals a crucial role for the monocyte/macrophage lineage cells in the pathogenesis of rejection. We hypothesized that higher pretransplant numbers of proinflammatory CD16+ monocytes can predict rejection. The study cohort consisted of 104 kidney transplant recipients (58 with no rejection and 46 with biopsy‐proven rejection) and 33 healthy persons. Posttransplant median follow‐up time was 14.7 mo (interquartile range 0.3–34 mo). Pretransplantation blood samples were analyzed by flow cytometry for monocyte immunophenotypes. Groups were compared by Cox regression models for the occurrence of acute rejection. We documented a significantly increased absolute number of pretransplant CD16+ monocytes in patients who developed biopsy‐proven rejection after transplantation compared with those with no rejection (hazard ratio [HR] 1.60, 95% CI 1.28–2.00, p < 0.001) and healthy persons (HR 1.47, 95% CI 1.18–1.82, p < 0.001). In parallel, significantly fewer absolute numbers of CD16? monocytes were observed at pretransplant time points in rejectors versus nonrejectors (HR 0.74, 95% CI 0.58–0.94, p < 0,014). A higher pretransplant number of CD16+ monocytes is significantly associated with a higher risk of acute rejection after kidney transplantation.     

Variations in the Thickness of the Plantar Fascia After Training Based in Training Race. A Pilot Study

Plantar fascia (PF) is a connective tissue made up of mostly type 1 collagen that is subjected to constant loads. This study evaluated the effect of continuous running on tissue stress in the PF by measuring changes in the thickness of the PF using ultrasound scans. It was a cross-sectional study involving 24 runners from the University of Valencia, recruited as volunteers between December 2018 and February 2019. A variety of data was recorded: (age, body mass index, type of footwear, number of workouts per week, KM run per week, sports injuries in the last year, pre and postrace ultrasound PF measurements). There were significant differences in the 3 postrace measurements of the left foot (<0.001). PF thicknesses were measured before and after running, with a minimal average difference of 0.4 mm in the medial and central fascicles, and 0.3 mm in the lateral fascicle. We observed PF thicknesses above 4mm in asymptomatic patients with no signs of vascularisation, proving that increased PF thickness is not the only criterion for diagnosis of plantar fasciitis.     

Tapping into the Influence of Keratinocyte Allografts and Biocenosis on Healing of Chronic Leg Ulcers: Split-Ulcer Controlled Pilot Study

BACKGROUND: Cultured keratinocytes may represent an alternative therapy aiming at boosting leg ulcer healing. There is no evidence-based study comparing objectively the healing rate of split-ulcer portions covered or not covered by cultured keratinocytes. OBJECTIVE: To assess the effect of cultured keratinocytes on the healing rate of leg ulcers. METHOD: Five applications of fresh (cela, XCELLentis, Ghent, Belgium) or frozen (CryoCeal, XCELLentis) cultured allogeneic keratinocytes were performed at weekly intervals to treat large leg ulcers (mean diameter > 5 cm) in four patients. A split-ulcer study was designed to secure a control area covered only by petrolatum gauze. Clinical, planimetric, bacteriologic, and immunohistologic assessments of the keratinocyte-treated and control parts of the ulcers were performed. RESULTS: Compared with controls, planimetry revealed a beneficial effect afforded by cryopreserved cultured keratinocytes on the ulcer healing rate of two of four ulcers (+12 and 81%). The healing effect was obtained on the ulcers associated with the lowest bacterial load. Cultured keratinocytes did not qualitatively and quantitatively modify the ulcer biocenosis. They did not affect the number of any type of inflammatory cells present in the granulation tissue (type I dermal dendrocytes, macrophages, T lymphocytes, granulocytes). No specific side effect of cultured keratinocytes was evidenced. CONCLUSION: In this small case series, it appears that cultured allogeneic keratinocytes may be helpful in the healing process of venous leg ulcers. However, a clean wound with reduced bacterial load seems to be the prerequisite condition for obtaining a beneficial effect.