Fluorescence or X-ray cholangiography in elective laparoscopic cholecystectomy: a randomized clinical trial.

BACKGROUND: Safe laparoscopic cholecystectomy may necessitate biliary imaging, and non-invasive fluorescence cholangiography may have advantages over contrast X-ray cholangiography. This trial compared fluorescence and X-ray cholangiography for visualization of the critical junction between the cystic, common hepatic and common bile ducts. METHODS: This non-inferiority blinded RCT included patients who had either intraoperative fluorescence cholangiography using 0·05 mg/kg indocyanine green or X-ray cholangiography during elective laparoscopic cholecystectomy. RESULTS: Between March 2015 and August 2018, a total of 120 patients were randomized (60 in each group). There were no drop-outs and 30-day follow-up data were available for all patients. In intention-to-treat analysis, there was no difference between the fluorescence and X-ray cholangiography groups in ability to visualize the critical junction (49 of 60 versus 51 of 60 respectively; P = 0·230). Fluorescence cholangiography was faster by a few minutes: median 2·0 (range 0·5-5·0) versus 4·8 (1·3-17·6) min (P < 0·001). CONCLUSION: Fluorescence cholangiography was confirmed to be non-inferior to X-ray cholangiography in visualizing the critical junction during laparoscopic cholecystectomy. Registration number: NCT02344654 ( http://www.clinicaltrials.gov).

ANTECEDENTES: La práctica de una colecistectomía laparoscópica segura puede requerir imágenes de la vía biliar, en las cuales la colangiografía con fluorescencia no invasiva puede tener ventajas sobre la colangiografía con contraste con rayos X. Este ensayo comparó la colangiografía con fluorescencia con la colangiografía con rayos X para la visualización de la unión crítica entre el conducto cístico, el conducto hepático común y los conductos biliares comunes. MÉTODOS: Ensayo clínico aleatorizado, ciego, de no inferioridad que incluyó a 120 pacientes en los que durante la colecistectomía laparoscópica electiva se practicó una colangiografía con fluorescencia intraoperatoria utilizando 0,05 mg/kg de verde de indocianina o una colangiografía con rayos X. RESULTADOS: De marzo de 2015 a agosto de 2018, se aleatorizaron un total de 120 pacientes (6 en cada grupo), en los que no hubo abandonos y con datos de seguimiento de 30 días disponibles en todos ellos. Basado en un análisis por intención de tratamiento, la capacidad de visualizar la unión crítica fue igual entre los dos grupos (49/60 versus 51/60, P = 0,23). La colangiografía con fluorescencia fue más rápida de realizar, en unos pocos minutos (mediana 2 min (rango 0,5-5,0) versus 5 min (rango 5,2-17,6), P < 0,001). CONCLUSIÓN: Se confirmó que la colangiografía con fluorescencia no fue inferior a la colangiografía con rayos X para visualizar la unión crítica durante la colecistectomía laparoscópica.

Closure of the fascial defect during laparoscopic umbilical hernia repair: a randomized clinical trial.

BACKGROUND: The objective of the study was to analyse patient-reported outcome measures (PROMs), seroma formation, long-term recurrence and chronic pain after closure of the fascial defect in patients undergoing laparoscopic umbilical hernia mesh repair. METHODS: This was a randomized double-blinded trial in patients undergoing elective laparoscopic umbilical hernia repair comparing sutured closure of the fascial defect before intraperitoneal onlay mesh (IPOM) repair with a no-closure IPOM repair. Postoperative pain, movement limitations, discomfort and fatigue were registered before surgery and on postoperative days 1-3, 7 and 30. Seroma formation, quality of life and cosmesis were assessed at day 30, and at 2 years of follow-up. Recurrence (clinical and reoperation) and chronic pain were assessed after 2 years. RESULTS: Eighty patients were randomized. Median defect sizes in closure and no-closure groups were 2·5 (range 1·5-4·0) and 2·5 (2·0-5·5) cm respectively (P = 0·895). There were no significant differences in early and late postoperative pain or in any other early or late PROMs, except for early fatigue which was higher in the closure group (P = 0·011). Seroma formation after 30 days was significantly reduced after closure (14 of 40; 35 (95 per cent c.i. 22 to 51) per cent) compared with no closure (22 of 38; 58 (42 to 72) per cent) (P = 0·043). Cumulative recurrence after 2 years was lower in the closure group: 5 of 36 (7 (3 to 17) per cent) versus 12 of 37 (19 (10 to 33) per cent) for no closure (P = 0·047). CONCLUSION: Closure of the fascial defect in laparoscopic umbilical hernia IPOM repair significantly reduced early seroma formation and long-term recurrence without inducing side-effects such as pain, or other early or late PROMs. Registration number: NCT01962480 ( https://www.clinicaltrials.gov).

Recurrence rate after absorbable tack fixation of mesh in laparoscopic incisional hernia repair.

BACKGROUND: The mesh fixation technique in laparoscopic incisional hernia repair may influence the rates of hernia recurrence and chronic pain. This study investigated the long-term risk of recurrence and chronic pain in patients undergoing laparoscopic incisional hernia repair with either absorbable or non-absorbable tacks for mesh fixation. METHODS: This was a nationwide consecutive cohort study based on data collected prospectively concerning perioperative information and clinical follow-up. Patients undergoing primary, elective, laparoscopic incisional hernia repair with absorbable or non-absorbable tack fixation during a 4-year interval were included. Follow-up was by a structured questionnaire regarding recurrence and chronic pain, supplemented by clinical examination, and CT when indicated. Recurrence was defined as either reoperation for recurrence or clinical/radiological recurrence. RESULTS: Of 1037 eligible patients, 84·9 per cent responded to the questionnaire, and 816 were included for analysis. The median observation time for the cohort was 40 (range 0-72) months. The cumulative recurrence-free survival rate was 71·5 and 82·0 per cent after absorbable and non-absorbable tack fixation respectively (P = 0·007). In multivariable analysis, the use of absorbable tacks was an independent risk factor for recurrence (hazard ratio 1·53, 95 per cent c.i. 1·11 to 2·09; P = 0·008). The rate of moderate or severe chronic pain was 15·3 and 16·1 per cent after absorbable and non-absorbable tack fixation respectively (P = 0·765). CONCLUSION: Absorbable tack fixation of the mesh was associated with a higher risk of recurrence than non-absorbable tacks for laparoscopic mesh repair of incisional hernia, but did not influence chronic pain.

Gaze-shift dynamics in subjects with and without symptoms of convergence insufficiency: influence of monocular preference and the effect of training.

We studied gaze-shift dynamics during several gaze-shift tasks and during reading, in five subjects with convergence insufficiency (C.I., a diminished ability to converge), and in ten subjects without C.I. Furthermore, we studied the effect of vergence training in order to verify previous claims that orthoptic exercises can improve vergence performance. We recorded binocular eye movements with the scleral coil technique. Subjects switched fixation between nearby and distant light emitting diodes (LEDs) arranged in isovergence arrays (distances 35 and 130 cm) in a dimly lit room. In both the C.I. and non-C.I. group, two classes of subjects occurred: vergence responders and saccadic responders. During pure vergence tasks, saccadic responders made saccades with no or little vergence; vergence responders made vergence movements with no or small saccadic components. In saccadic responders, fixation of nearby targets was monocular. Subjects with a preferred eye, according to our determination, used the preferred eye. The five C.I. subjects showed idiosyncratic responses with insufficient vergence during most trials. They all had a tendency to alternate fixation between the left and right eye. Vergence-version tasks always elicited larger vergence components than pure vergence tasks. During a reading task, vergence angles were more accurate than during gaze-shifts between LEDs. After the pre-training sessions, nine subjects (one of which had C.I.) practised a pure vergence task three times a day for at least 2 weeks. Vergence amplitudes of four of these subjects were larger after training. We conclude that vergence training can change oculomotor performance. Although C.I. is often associated with abnormal vergence dynamics, there are no typical C.I. vergence dynamics. Unstable monocular preferences may play a role in the aetiology of C.I.