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Laparoscopic Surgery clinical trials

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NCT ID: NCT03928171 Completed - Clinical trials for Laparoscopic Surgery

The Effect of Intra-abdominal Pressure on Peritoneal Perfusion During Laparoscopic Colorectal Surgery

PERFUSION
Start date: June 13, 2018
Phase: N/A
Study type: Interventional

Peritoneal perfusion during laparoscopic surgery is quantified by video recording after intravenous injection of indocyanine green at a pneumoperitoneum pressure of 8, 12 and 16 mmHg.

NCT ID: NCT03573557 Completed - Clinical trials for Laparoscopic Surgery

Improved Intra-operative Safety From Optimal Selection of Anti-slip Surface

Start date: June 5, 2018
Phase: N/A
Study type: Interventional

To identify the best surface to minimize the risk of intra-operative slipping when placed in Trendelenburg position. The outcomes of interest are to minimize the amount of movement from predefined anatomic landmarks and maximize the ease of performing the intended surgery. The study consists of performing a randomized trial comparing 3 common anti-slip surfaces to determine which surface provides the best result in terms of safety and cost.

NCT ID: NCT03506555 Completed - Clinical trials for Laparoscopic Surgery

Laparoscopic Access in General Surgery: the Closed (Veress Needle) Technique Versus the Open (Hasson) Technique

Start date: November 1, 2014
Phase: N/A
Study type: Interventional

A randomised controlled trial (RCT) comparing the closed (Veress needle) with the open (Hasson) laparoscopic entry technique in haemodynamically stable patients undergoing either emergency or elective surgical procedures was conducted over a 13-month period. The success rate and complications related to the technique were recorded and analysed.

NCT ID: NCT03467711 Completed - Clinical trials for Laparoscopic Surgery

The Use of Tidal Volume Challenge of Dynamic Parameters During Laparoscopic Surgery

Start date: March 16, 2018
Phase:
Study type: Observational

Laparoscopy is increasingly used for major abdominal and pelvic surgery. As this approach is also recommended in elderly patients with serious comorbidities, optimal fluid therapy guidance during this procedure is important. Many studies have reported that less invasive dynamic indices such as pulse pressure variation (PPV) and stroke volume variation (SVV), which are derived from the arterial pressure waveform, are superior to static indices to predict fluid responsiveness. PPV and SVV are based on the heart-lung interaction and reflect cyclic changes in stroke volume induced by mechanical ventilation in the closed-chest condition. Therefore, their ability to predict fluid responsiveness can be affected by factors that influence the arterial tone or the compliance of the respiratory system. Laparoscopic surgery for the abdominal visceral organs requires pneumoperitoneum and the Trendelenburg position to optimize surgical conditions, and can reduce cardiac output and respiratory compliance. Accordingly, the usefulness of PPV and SVV in predicting fluid responsiveness during laparoscopic surgery under these conditions may be questioned. It has been clearly shown that the values of dynamic parameters are significantly correlated with the magnitude of VT. Min et al. reported that augmentation of PPV and SVV via a temporary increase in VT from 8 to 12 ml/kg improved their predictive power in the inconclusive zone with respect to fluid responsiveness (PPV values of 9% and 13%, respectively). Another recent study reported that on increasing VT from 6 to 8 ml/kg, augmented PPV and SVV, as well as their absolute changes, predicted fluid responsiveness with high sensitivity and specificity, even in critically ill patients receiving low VT. Therefore, the aim of the current study was to investigate whether increasing VT from 6 to 8 ml/kg would improve the predictive power of PPV and SVV in patients undergoing robot-assisted laparoscopic surgery in the Trendelenburg position under lung-protective ventilation. We also assessed the ability of absolute changes in PPV and SVV values induced by a temporary increase in VT from 6 to 8 ml/kg to predict fluid responsiveness.

NCT ID: NCT03382210 Completed - Colorectal Surgery Clinical Trials

Impact of a Colorectal Enhanced Recovery Program Implementation on Clinical Outcomes and Institutional Costs

Start date: January 11, 2013
Phase: N/A
Study type: Observational

Importance: The Enhanced Recovery Program (ERP) for perioperative care of the surgical patient reduces the postoperative metabolic response and organ dysfunction thereby accelerating functional recovery. Consequently, the hospital length of stay (LOS) may be reduced, with no increase in morbidity and mortality rates resulting in a potential economic benefit. Objective: To determine impact on postoperative recovery and cost-effectiveness of implementing an ERP for colorectal surgery in an Italian academic center. Design, Setting, and Participants: A prospective consecutive series of patients (N=100) undergoing elective colorectal resection completing a standardized ERP in 2013-2015 (ERP group) will be compared to patients (N=100) operated on at the same Italian University hospital in 2010-2011 (Pre-ERP group) before introducing ERP program. The exclusion criteria are: age>80 years old, ASA score IV, tumour stage IV, and inflammatory bowel disease. Exposures: ERP for perioperative care. Main Outcomes and Measures: To evaluate the impact of colorectal ERP implementation on hospital LOS proxy of functional recovery. Secondary outcomes include: postoperative complications, 30-day readmission and mortality, protocol adherence, nursing workload, cost-effectiveness, and factors predicting prolonged hospital LOS. Patients' satisfaction in ERP group will also be prospectively evaluated.

NCT ID: NCT03045835 Completed - Clinical trials for Laparoscopic Surgery

Baska ® Mask Versus Endotracheal Tube in Laparoscopic Cholecystectomy

Start date: March 1, 2017
Phase: N/A
Study type: Interventional

Baska mask is a new novel supraglottic airway device with many salient features. The investigators aim to determine the benefit of BASKA mask as an effective airway device for laparoscopic surgery, and whether it can even substitute endotracheal intubation, in order to smoothen the surgery and anaesthesia process as well as reduce perioperative complications.

NCT ID: NCT02896036 Completed - Laparoscopy Clinical Trials

Veress Entry With/Without Concomitant CO2

Start date: August 2016
Phase: N/A
Study type: Interventional

Purpose: The primary objective is to compare the time required for adequate intraperitoneal insufflation (from skin incision to reaching intraperitoneal pressure of 15 mmHg). Also the number of attempts needed before successful entry is achieved. The secondary objectives will evaluate rates of secondary outcomes measures such as; failed entry, extra peritoneal insufflation, vascular injury, visceral injury, gas embolism, solid organ injury, and omental injury between the two techniques. Study design: prospective randomized control trial Hypothesis: The investigators hypothesize that participant's undergoing laparoscopic surgery for benign Gynecologic indications at TGH who undergo laparoscopic entry technique of Veress needle entry with concomitant CO2 insufflation will require less time to achieve a 15 mmHg of intraperitoneal pressure as opposed to Veress needle entry with subsequent CO2 insufflation, and will require less number of attempts to achieve successful entry.

NCT ID: NCT02630329 Completed - Clinical trials for Laparoscopic Surgery

Notes Adnexectomy for Benign Pathology Compared to Laparoscopic Excision

NOTABLE
Start date: February 3, 2016
Phase: N/A
Study type: Interventional

Objective: To compare vNOTES (vaginal Natural Orifice Transluminal Endoscopic Surgery) and established laparoscopic removal of benign adnexal masses Study design: Randomized controlled/single center/single-blinded/parallel-group/non-inferiority/efficacy trial. Study population: Women aged 18 to 70 years with symptomatic or persistent benign adnexal masses detected by clinical examination and ultrasound. Randomization: Women will be randomly allocated to undergo one of two techniques for removal of the benign adnexal mass immediately before surgery by using a computer generated randomization list. The investigators will use stratified randomization according to the cyst diameter. Intervention: Women will be treated by a surgeon who is not blinded to the treatment allocation and who is equally skilled in performing both techniques. In the intervention group a vNOTES technique will be used. Control: In the control group surgery will be done by a classical laparoscopic technique. Participants, nursing staff and outcome assessors will be blinded. Main study parameters/endpoints: Primary outcomes: successful removal of a benign adnexal mass without spill. Secondary outcomes: the proportion of women discharged the same day based on their own preference; postoperative pain scores using a VAS (Visual Analogue Scale) measured between day 1 till 7 by the participating women following surgery and the total amount of analgesics used as described in the standardized pain treatment protocol between day 1 till 7; postoperative infection defined by lower abdominal pain with fever > 38°C and positive clinical signs or laboratory findings; per- or postoperative complications according to the Clavien- Dindo classification detected during the first six weeks of surgery; duration of the surgical procedure; incidence and intensity of dyspareunia recorded by the participants at 3 and 6 months by self-reporting using a simple questionnaire and VAS scale; sexual wellbeing recorded by the participants at 3 and 6 months by SSFS (Short Sexual Functioning Scale); direct costs associated up to 6 weeks after the surgical intervention with both procedures.

NCT ID: NCT02541656 Completed - Clinical trials for Laparoscopic Surgery

Dynamic Preload Dependence Indices in Laparoscopic Surgery

VPP Coelio
Start date: January 2015
Phase: N/A
Study type: Interventional

A goal-directed fluid management is definitely beneficial in high risk surgery. The fluid administration can be directed by cardiac output monitoring which evaluate the response to repeated fluid challenge or by preload dependence indices. These indices are not well validated in laparoscopic surgery while pneumoperitoneum can alter venous return or pulmonary compliance. The aim of the study is to study the validity of pulse pressure variation to predict fluid response under laparoscopic conditions and to describe the effect of the pneumoperitoneum on the dynamic preload indicators, i.e. the pulse pressure variation, the plethysmographic waveform of pulse oximetry variation and the stroke volume variation.

NCT ID: NCT02536521 Completed - Clinical trials for Laparoscopic Surgery

Predictive Variables of the Hemodynamic Effect During the Laparoscopic Surgery in Children

Lapa-BP
Start date: August 2015
Phase: N/A
Study type: Observational

This prospective observational study aimed to identify the intraoperative variables to predict the hemodynamic change according to intra-abdominal pressure in the children undergoing laparoscopic surgery. The intraoperative variables includes Pulse pressure variation (PPV), systolic pressure variation (SPV), stoke volume variation (SVV), Pulse oximeter plethysmographic waveform amplitude (△POP),and pleth variability index (PVI).