RESUMO
STUDY OBJECTIVE: Determine if independently suturing the vaginal cuff angles in addition to running barbed suture has an effect on patients' perception of postoperative bleeding after laparoscopic hysterectomy. DESIGN: Randomized controlled trial. SETTING: University-based medical center. PATIENTS: Females ages 18-60 undergoing laparoscopic hysterectomy. INTERVENTIONS: Patients were randomly assigned to either cuff closure via single layer of barbed suture (control) vs adding figure-of-eight stitches at each angle (intervention). A survey was given between 10 and 25 days after surgery inquiring about bleeding and dyspareunia. A second survey was given between postoperative days 90-114. Chart review was performed to record emergency room visits, complications, infections, and reoperations during the first 90 postoperative days. RESULTS: n = 117 patients were analyzed. 62 (control) and 55 (intervention). Groups were similar in terms of age (42.92 v 44.29p =.35), BMI (33.79 v 34.06p =.85), diabetes (5.26 % (3/55) v 15.09 % (8/53) p =.08) p =.97). Bleeding was decreased in intervention arm (24.19 % (15/62) v 9.09 % (5/55) p =.03). Median (IQR) pelvic pain score was similar (2.0 (0-5.0) v 2.0 (0-4.0) p =.26). Median total operative time (IQR) (129 min (102, 166) v 139 min (120, 163) p =.39) and median EBL (IQR) (50 mL (30-75) vs 50 mL (20-75) p =.43) were similar. Cuff closure in seconds (IQR) was higher in intervention group (373 sec (323, 518) v 571 sec (520, 715) p <.01). 8/60 control patients visited the ED (13.33 %) v 7/54 (12.96 %) p =.95. Readmissions (1.67 % (1/60) v 1.85 % (1/55) p = 1), re-operations (0 % (0/60) v 1.85 % (1/55) p =.47) and postoperative infections (5.0 % (3/60) v 1.85 % (1/54) p =.62) were similar. Secondary survey showed no significant difference in bleeding (15.38 % (4/26) v 4.35 % (1/23) p =.35) and SF-36 results were similar. CONCLUSION: Independently suturing the vaginal cuff angles reduces patients' perception of vaginal bleeding in the early postoperative period. Incidence of complications, reoperations, and long-term quality of life are similar.
Assuntos
Histerectomia Vaginal , Laparoscopia , Feminino , Humanos , Histerectomia Vaginal/efeitos adversos , Laparoscopia/efeitos adversos , Percepção , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/prevenção & controle , Período Pós-Operatório , Qualidade de Vida , Hemorragia Uterina/etiologia , Hemorragia Uterina/cirurgia , Vagina/cirurgia , Adolescente , Adulto Jovem , Adulto , Pessoa de Meia-IdadeRESUMO
The fluorescent imaging agent IS-001 was determined to be well tolerated in all subjects and has the potential to provide ureter visualization throughout minimally invasive hysterectomy procedures. This study was conducted to evaluate clinical safety and efficacy of a real-time ureter visualization technique for use during hysterectomy surgery. The study drug appears safe, is renally excreted, and allows enhanced ureter visualization when imaged with a clinically approved near-infrared sensitive endoscope. This is a first-in-human study showing preliminary results that the drug is safe and effective during surgery for improved ureter visualization.
Assuntos
Corantes Fluorescentes/administração & dosagem , Histerectomia/métodos , Laparoscopia/métodos , Monitorização Intraoperatória/métodos , Espectroscopia de Luz Próxima ao Infravermelho/métodos , Ureter/diagnóstico por imagem , Adulto , Feminino , Humanos , Pessoa de Meia-Idade , Cirurgia Assistida por Computador/métodos , Adulto JovemRESUMO
BACKGROUND: There are well-described benefits to minimally invasive surgery including decreased blood loss, shorter hospital-stay, and faster recovery. The role of robotic surgery in gynecologic oncology has become increasingly prominent; however limited data are available on quality of life (QOL) after robotic surgery. METHODS: In this prospective, IRB-approved study, women scheduled for robotic surgery for a gynecologic indication between May 2008 and February 2012 completed validated QOL measures at baseline, 6 weeks (6wk), and 4 months postoperative (4mo). Functional status (SF-12), symptom severity and interference (MDASI), sexual function (FSFI), and satisfaction with decision (SWD) were assessed at relevant time points. Differences between groups were evaluated using the Mann-Whitney test. RESULTS: Among 408 women who underwent robotic surgery 278 (68%) completed the QOL measures. Median age was 55.6 years (range 25.7-85.1). Median BMI was 31.3kg/m(2). The majority of patients were white (75%). The most common indication for surgery was endometrial cancer/hyperplasia (59.7%). While physical functioning declined from baseline to 6wk (51.4 to 41.6, p<0.001), it improved by 4mo (53.5). Mental functioning improved over time (baseline 48.6, 6wk 52.8, and 4mo 55.6, p<0.001). Symptom severity decreased over time (p<0.001) as did symptom interference (p<0.001). Sexual function improved significantly from baseline (8.6) to 4mo (20.2, p<0.001). Patients were satisfied with their decision making (SWD=30). CONCLUSION: In this prospective study, general health, symptom burden and sexual function returned to or improved beyond baseline levels within 6 weeks of surgery. Overall, women were satisfied with their decision to undergo robotic surgery.