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Pneumoperitoneum clinical trials

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NCT ID: NCT06413264 Not yet recruiting - Morbid Obesity Clinical Trials

Ultrasonography Guided Pneumoperitoneum for Laparoscopic Surgery in Morbidly Obese Patients

USP
Start date: June 1, 2024
Phase: N/A
Study type: Interventional

Bariatric Surgery for morbid obesity is indicated when BMI > 40 kg/m2 without comorbidities or BMI > 35 kg/m2 with co-morbidities. Different surgeries performed for obesity are classified as restrictive, malabsorptive, and hybrid procedures. Because laparoscopic surgery has increased the interest and growth of bariatric surgery, soaring demand for laparoscopic bariatric surgery from patients has boosted the boom in bariatric surgery worldwide. Achieving pneumoperitoneum is the initial and one of the most crucial steps in any laparoscopic surgery, giving the surgeon working space to operate on a particular organ/organ system. Usually, pneumoperitoneum is achieved either by a closed technique with a veress needle or an open technique with many variations like finger assisted or the conventional open technique. Given the excess amount of subcutaneous fat in morbidly obese patients, putting a veress needle to achieve pneumoperitoneum successfully is particularly challenging which takes a toll on the operating surgeon when he/she is trying to locate the midline one can either overshoot to cause omental emphysema or undershoot getting lost in the subcutaneous fat. It is usually done in the supra umbilical area. Sometimes, due to previous surgical scars other sites are preferred. Sonography is routinely used by radiologists with negligible radiation exposure. Anesthesiologists in the operating room have used it for many assisted procedures like central line insertion / giving nerve blocks. It can also be used in obese patients undergoing metabolic surgery to assist in creating pneumoperitoneum by a veress needle. Advantages of Intraoperative ultrasonography in this particular study : 1. To quantify the thickness of subcutaneous fat 2. To visualise the linea alba and guide the veress needle safely into the peritoneal cavity 3. Real-time visualisation of the pneumoperitoneum created 4. Avoid complications like omental emphysema, bowel or vascular injury

NCT ID: NCT06336746 Not yet recruiting - Clinical trials for Heart Failure, Systolic

Effects of Steep Trendelenburg and Pneumoperitoneum on Cardiac Performance.

Start date: May 1, 2024
Phase:
Study type: Observational

The field of robotic-assisted laparoscopic surgery increases all the time. Older and more fragile patients which are not suitable for major open surgery could be scheduled for robotic- assisted surgery. The peroperative anesthesiological challenges and stresses during this type of surgery could anyway be even more prominent. The extreme positioning of patients during robotic surgery in the pelvis, often 30 degrees head down tilting (Trendelenburg positioning), should increase the work load of the heart significantly. There are no studies concerning fragile patients with heart failure during these conditions. In this study the circulatory effects in patients with normal heart function and preexisting heart failure will be studied during robotic surgery in extreme Trendelenburg positioning During surgery the work load and performance of the heart will be monitored using an esophageal doppler and optical spectrophotometry measuring regional saturation of the brain. This study can identify patients at risk of developing critical circulatory failure during this type of surgery.

NCT ID: NCT06134700 Not yet recruiting - Clinical trials for Renal Cell Carcinoma

Low Pressure Versus Standard Pressure Pneumoperitoneum in Laparoscopic Nephrectomy

Start date: November 15, 2023
Phase: N/A
Study type: Interventional

Laparoscopic nephrectomies are commonly performed these days and are considered gold standard for both benign and malignant diseases as well as for donor nephrectomies. Despite being a widely performed surgery worldwide still there are areas of uncertainties due to lack of evidences. One of such area of dilemma is the optimum pressure of pneumoperitoneum. This study aims to identify if lower pressure of pneumoperitoneum is safe during laparoscopic nephrectomies. This is a hospital based prospective randomized control study. All the patients undergoing laparoscopic nephrectomies at department of urology and kidney transplant surgery will be eligible for study. Patients will be divided into low pressure or standard pressure pneumoperitoneum by simple random sampling and comparison of various intraoperative and post-operative parameters will be done to assess the safety of low pressure pneumoperitoneum

NCT ID: NCT06116383 Not yet recruiting - Pneumoperitoneum Clinical Trials

Evaluation of Renal Perfusion With NIRS in Laparoscopic Surgery

Start date: November 10, 2023
Phase:
Study type: Observational

The investigators aimed to show the renal damage caused by increased intra-abdominal pressure in laparoscopic surgeries and to investigate whether its reflection on NIRS would be clinically effective.The main question it aims to answer are: Does pneumoperitoneum cause renal damage? NRS monitoring will be performed in patients undergoing laparoscopic surgery. Preoperative and postoperative blood tests will be performed at certain hours. N-GAL, urea and creatinine values will be recorded.

NCT ID: NCT06044402 Not yet recruiting - Oxygenation Clinical Trials

Different Tidal Volume on Oxygenation, Respiratory Mechanics, and Pulmonary Complications in Older Patients Undergoing Trendelenburg Pneumoperitoneum Surgery

Start date: October 8, 2023
Phase: N/A
Study type: Interventional

The investigators want to assess the effect of intraoperative low tidal volume vs intermediate tidal volume on respiratory mechanics, oxygenation and pulmonary complications in older patients undergoing Trendelenburg pneumoperitoneum surgery.

NCT ID: NCT05344417 Not yet recruiting - Postoperative Ileus Clinical Trials

Low Pressure Pneumoperitoneum and Postoperative Ileus

Start date: March 30, 2024
Phase: N/A
Study type: Interventional

The investigators are testing the hypothesis that lower pressure pneumoperitoneum during laparoscopic large bowel surgery protects the bowel from postoperative ileus and bowel dysfunction leading to faster recovery and discharge from the hospital. Our study will focus on the effects of high or low intraperitoneal pressure as well as pressure variations on the course of postoperative ileus, time to hospital discharge, and postoperative gastrointestinal dysfunction in adult patients undergoing laparoscopic large bowel resection (i.e., sigmoidectomy and right colectomy). A randomized parallel group study will be conducted involving 5 arms of surgical patients to test whether differences on postoperative ileus outcome parameters occur between high (15 mm Hg) and low pressure pneumoperitoneum (8-12 mm Hg), as well as whether there are differences between the 2 insufflation devices that provide constant or variable intrabdominal pressure throughout the laparoscopic surgery. For high pressure pneumoperitoneum, either neostigmine or sugammadex are used for reversal of moderate neuromuscular blockade. For low pressure pneumoperitoneum, sugammadex is used for reversal of deep neuromuscular blockade. The investigators plan to use 2 types of gas insufflation devices, one of which will provide a relatively stable pressure level throughout surgery (AirSeal® device), and the second one will provide a more variable pressure (Olympus standard insufflation device). Using both pressure modalities, the investigators will study the effects of different pressure characteristics on the course of postoperative ileus, duration of in-hospital treatment, pain level, and the stability of hemodynamic and respiratory parameters during surgery. Changes in intrabdominal pressure during the surgery will be monitored and recorded using a custom software for later analysis of fluctuations in pressure to relate them to outcomes. Other parameters will be obtained from EPIC (IHIS) medical charts. In addition, clinical data on postoperative ileus will be correlated with experimental outcomes from in vitro exploratory studies done using human samples of peritoneal lavage fluid, serum, and a small portion of the surgically removed bowel from each patient (that is otherwise discarded). A panel of inflammatory markers will be analyzed and biochemical, imaging, histological, immunochemical, molecular signaling, and glial activation studies will be done to evaluate the potential mechanisms of dysfunction associated with postoperative ileus.

NCT ID: NCT05040022 Not yet recruiting - Postoperative Pain Clinical Trials

Quality of Recovery Under Low or Standard Pneumoperitoneum Pressure

Start date: October 1, 2021
Phase: Phase 4
Study type: Interventional

The use of low-pressure pneumoperitoneum seems to be able to reduce complications such as postoperative pain. However, the quality of evidence for most studies evaluating this relationship is considered low. The absence of concealment of pneumoperitoneum pressure and the lack of description of neuromuscular blockade characteristics are the main causes of bias. The purpose of this study will be to evaluate by means of a prospective, randomized and double-blinded trial, the quality of recovery (QoR-15) questionnaire of patients undergoing laparoscopic cholecystectomy under moderate neuromuscular blockade, using low pneumoperitoneum pressure or "standard" pressure. Eighty patients submitted to laparoscopic cholecystectomy and randomly distributed in two groups will be included: low pneumoperitoneum pressure (10 mmHg) or "standard" pressure (14 mmHg). The value of abdominal pressure will be kept hidden for all participants, except for the nurse responsible for the operating room. Moderate neuromuscular blockade will be maintained according to Train-of-four count (TOFc) = 3 for all cases.

NCT ID: NCT04947982 Not yet recruiting - Gynecologic Surgery Clinical Trials

Low Versus Standard Pressure Pneumoperitoneum

Start date: July 1, 2021
Phase: N/A
Study type: Interventional

The role of laparoscopy in gynecological and gyne-oncological surgery has dramatically increased over the past decades. Although laparoscopic procedure has several advantages over open surgery such as reduced blood loss, faster recovery earlier return to normal activities and work, however, postoperative pain and some hemodynamic changes sometimes discomforts the patients, lessening quality of life at postoperative period [1-3]. In clinical practice the majority of laparoscopic procedures are performed using standard pressure pneumoperitoneum (SPP, 12-15 mmHg) [1-3]. These noticeable adverse effects are associated with of creation of pneumoperitoneum with carbon dioxide (CO2) but it is requisite in all laparoscopic surgery for adequate visualization and operative manipulation. The incidence of pain after gynecologic laparoscopies has been reported to vary from 35% to 63% [4,5]. A randomized controlled trial has demonstrated that there may be more intense pain and greater analgesia requirements in the immediate postoperative period after laparoscopic surgery than after laparotomy [6]. The origin of pain after laparoscopy is multifactorial and complex. It can be differentiated into abdominal pain and shoulder pain [7]. The precise causes for such pain are still obscure. Abdominal pain may be attributed to stretching of the abdominal cavity, and peritoneal irritation due to entrapment of dissolved CO2 [1-7]. Intraperitoneal acidosis, mucosal ischemia and compression of the splanchnic nerve as a consequence of the pneumoperitoneum may also be relevant factors [8,9]. On the other hand, shoulder pain is related to phrenic nerve and diaphragm irrigation due to residual CO2 in the subdiaphragmatic space [7-9]. In addition to pain, CO2 insufflation and a concomitant steep head-down (Trendelenburg, TP) position in surgical procedure also cause an increase in intra-abdominal pressure, which unfavorably affect patients homeostasis, inducing a significant change in the respiratory and cardiovascular system, lessening perfusion in abdominal organs and blood flow in the inferior vena cava, and posing an increased risk of thrombotic disease [10,11]. Low-pressure pneumoperitoneum (LPP, 7-10 mmHg) is recommended to minimize the adverse side effects associated with SPP [12]. There are several reports on the safety of low CO2 pneumoperitoneum pressure (LPP) in gynecological laparoscopic procedures however their trials have some limitations due to the small sample size, performed in only short laparoscopic procedures, and inadequate to assess the surgical impression of visualization [13-16]. Thus, further studies are still required. Therefore, the purpose of this randomized controlled trial (RCT) is to assess the effect of LPP versus SPP on metabolic response, postoperative pain scores, surgical field visualization.

NCT ID: NCT04398810 Not yet recruiting - Postoperative Pain Clinical Trials

Postoperative Pain Results According to Pressure to Form Pneumoperitoneum

Start date: June 2, 2020
Phase: N/A
Study type: Interventional

This study showed the difference in postoperative pain between the groups that performed surgery with the low-pressure pneumoperitoneum and the group that performed surgery in the standard-pressure pneumoperitoneum when robotic single-hole cholecystectomy was performed. The primary purpose of the study was to compare the differences in the visual analog scale (VAS) between the two groups and to demonstrate the effectiveness of pain relief after surgery. Secondly, the effect of the low-pressure pneumoperitoneum on the patient's postoperative recovery and outcome was compared with the control group by comparing the length of stay, operation time, and postoperative complications.

NCT ID: NCT04259112 Not yet recruiting - Diabetes Mellitus Clinical Trials

Effect of Pneumoperitoneum and Neuromuscular Block on Renal Function in Diabetes Patients

Start date: October 1, 2020
Phase: N/A
Study type: Interventional

In this single center, double-blind, randomized controlled clinical trial, we will include 648 diabetes patients aged 18-70 undergoing laparoscopic pelvic tumor resection. They will be randomized to the following four groups: high-pressure pneumoperitoneum (10mmHg)+ deep neuromuscular block group, high-pressure pneumoperitoneum (15mmHg)+moderate neuromuscular block group, low-pressure pneumoperitoneum + deep neuromuscular block group and low-pressure pneumoperitoneum+moderate neuromuscular block group. Deep neuromuscular block is defined as post tetanic count (PTC) 1-2, and low neuromuscular block is defined as train-of-four (TOF) twitch 1-2. The outcomes will be indicators for acute kidney injury and surgical condition.