Cholelithiasis Clinical Trial
Official title:
Using Pre-Operative Incentive Spirometer Reduces Chances of Basal Ateletasis in Patients Undergoing Upper Abdominal Surgeries- A Randomized Control Trial
ABSTRACT Objective: To compare frequency of basal atelectasis in patients undergoing upper abdominal surgery who are provided pre-operative incentive spirometry versus those not provided pre-operative incentive spirometry
After patient selection through "non-probability consecutive sampling" Investigator recorded baseline characteristics of our patients including age, gender and body mass index (BMI). Once recorded, patients will be randomly divided into two equal groups (each containing 37 patients). In group A or "incentive spirometry group" patients were directed to start incentive spirometry, 48 hours prior to surgery. They were given an incentive spirometer and were briefed that they should inhale into the mouth piece of spirometer to lift the balls to the roof of tube and hold for five seconds and then exhale. 13 They were asked to perform 10 such breaths for 6 times in a day till surgery under direct supervision of researcher and this was charted in patient file. In group B or "no incentive spirometry group" patients were not asked to perform incentive spirometry. After this, all the included patients underwent upper abdominal surgery by expert surgical team under general anesthesia. Type of surgery (Laparoscopic Cholecystectomy / Open Cholecystectomy / perforated duodenal repair/ Epigastric Hernia Repair / Gastrojejunostomy) and duration for which patient was on ventilator support (in minutes) was documented. After surgery, all the patients were given adequate analgesia and antibiotics as per standard hospital protocol. Patients were assessed at 48 hours after surgery for presence of basal atelectasis which will be diagnosed clinically by presence of new onset respiratory symptoms "cough, crackles, tachypnea and reduced breath sounds at bases" and by chest X-ray "presence of basal opacification, crowded air bronchograms, crowded pulmonary vasculature and compensatory hyper-expansion of surrounding unaffected lung". "The statistical package for social sciences (SPSS) version 22 software was used for statistical analysis of the data. Normality of test will be checked using Shapiro-Wilk test which showed that age and BMI were normally distributed while duration of ventilatory support was non-normal data. For qualitative variables frequency and percentages were used, whereas for quantitative data mean ± standard deviation and median (IQR) were used. Qualitative variables (gender, type of surgery and presence of basal atelectasis) were compared between groups with the use of chi-square test. Quantitative variable (age and BMI) were compared between groups using Student t-test while (duration of ventilatory support) were compared between groups using Mann-Whittney U-test. A p-value of ≤ 0.05 was considered significant". ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00616616 -
Single Incision Laparoscopy
|
N/A | |
Completed |
NCT00530998 -
Minimally Invasive Surgery: Using Natural Orfices
|
||
Recruiting |
NCT00416234 -
Laparoendoscopic Rendez Vous Versus Standard Two Stage Approach for the Management of Cholelithiasis/Choledocholithiasis
|
N/A | |
Recruiting |
NCT05975385 -
Acupuncture for Prevention of Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
|
N/A | |
Recruiting |
NCT06038201 -
Cholecystectomy vs EUS-guided GBD With Stone Removal
|
N/A | |
Not yet recruiting |
NCT03981315 -
Bile Composition in Healthy and Gallstones Patients
|
||
Completed |
NCT01824186 -
Trial Comparing Pain in Single-incision Laparoscopic Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy
|
N/A | |
Completed |
NCT00606762 -
Comparison Between Low Pressure Versus High Pressure Laparoscopic Cholecystectomy
|
N/A | |
Completed |
NCT00971750 -
Laparoscopic Versus Transabdominal Ultrasound in Morbidly Obese Patients
|
N/A | |
Active, not recruiting |
NCT04279223 -
Does Using a 5 mm Telescope in Laparoscopic Cholecystectomy Reduce the Incidence of Trocar Site Hernia?
|
N/A | |
Terminated |
NCT01708109 -
Optimal Handling of Common Bile Duct Calculus, a Prospective Study
|
N/A | |
Completed |
NCT01881399 -
Fluorescence Versus Intraoperative Cholangiography in the Visualization of Biliary Tree Anatomy
|
N/A | |
Withdrawn |
NCT01146184 -
Single Incision Laparoscopic Cholecystectomy Using a Flexible Endoscope and Ethicon Manually Articulating Devices (MAD)
|
N/A | |
Terminated |
NCT00910325 -
Natural Orifice Translumenal Endoscopic Surgery: Laparoscopic-Assisted Transvaginal Cholecystectomy
|
Phase 1/Phase 2 | |
Completed |
NCT04672902 -
Treatment of Mirizzi Syndrome
|
||
Completed |
NCT03180229 -
Granisetron Effect on Hemodynamic Changes in Laparoscopic Cholecystectomy
|
Phase 4 | |
Not yet recruiting |
NCT01339325 -
Laparo-endoscopic Single Site (LESS) Cholecystectomy Versus Standard LAP-CHOLE
|
Phase 4 | |
Completed |
NCT02375529 -
A Trial of Single Incision Versus Four Ports Laparoscopic Cholecystectomy
|
N/A | |
Terminated |
NCT00486655 -
NOTES-Assisted Laparoscopic Cholecystectomy Surgery
|
N/A | |
Completed |
NCT00131131 -
Epidemiology of Gallbladder Sludge and Stones in Pregnancy
|
N/A |