Cholecystolithiasis
Conditions
Keywords
pain
Brief summary
The purpose of this study is to determine the effect of warmed, humidified carbon dioxide Insufflation vs standard carbon dioxide in laparoscopic cholecystectomy.
Detailed description
Patients undergoing warmed, humidified carbon dioxide (CO2) insufflation for laparoscopic cholecystectomy will have less postoperative pain than patients undergoing laparoscopic cholecystectomy with standard CO2 insufflation. The study design is a double-blind, prospective, randomized study comparing patients undergoing laparoscopic cholecystectomy with standard CO2 insufflation vs those receiving warmed, humidified CO2. Main variables included postoperative pain (rated with a visual analog scales) and analgesic requirements.
Interventions
DEVICEOptitherm® device activated
The use of Optitherm® device, which was attached to the insufflation equipment in all of the patients but was only activated by the single scrub nurse in those patients randomized to group B.
DEVICEOptitherm® device inactivated
The use of Optitherm® device, which was attached to the insufflation equipment in all of the patients but was inactivated in group A.
Sponsors
Kepler University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of cholecystolithiasis
Exclusion criteria
* Clinical diagnosis of cholecystolithiasis with cholecystitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain (Rated With a Visual Analog Scale for Pain) | operation day | postoperative pain (rated with a visual analog scale for pain) and analgesic requirements at operation day. The visual analog scale for pain ranged from 0-10 (0 is no pain, 10 is Maximum of pain) |
Secondary
| Measure | Time frame |
|---|---|
| Core Temperature | one day postoperativly |
Countries
Austria
Participant flow
Recruitment details
Approval from the local institutional ethics committee was obtained on June 2011. Between July 1st, 2011 and December 28nd, 2013, a total of 148 patients were scheduled for laparoscopic cholecystectomy at the General Hospital in Linz, Austria
Pre-assignment details
Patients converted intraoperative to open cholecystectomy or those undergoing a concomitant procedure were excluded from the study. Irregularities of the study protocol (absence of rectal probe, missing consent form, conversion to open cholecystectomy) entailed in exclusion of the study. Patients with acute cholecystitis were excluded of the study.
Participants by arm
| Arm | Count |
|---|---|
| Group A: Insufflation With Cold Gas Insufflation with cold gas during laparoskopic cholecystectomy | 67 |
| Group B Insufflation with warm gas during laparoskopic cholecystectomy | 81 |
| Total | 148 |
Baseline characteristics
| Characteristic | Group A: Insufflation With Cold Gas | Group B | Total |
|---|---|---|---|
| Age, Continuous | 55.87 years STANDARD_DEVIATION 14.44 | 55.68 years STANDARD_DEVIATION 16.93 | 55.7 years STANDARD_DEVIATION 15.14 |
| Region of Enrollment Austria | 67 participants | 81 participants | 148 participants |
| Sex: Female, Male Female | 46 Participants | 57 Participants | 103 Participants |
| Sex: Female, Male Male | 21 Participants | 24 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 67 | 0 / 81 |
| serious Total, serious adverse events | 0 / 67 | 0 / 81 |
Outcome results
Primary
Pain (Rated With a Visual Analog Scale for Pain)
postoperative pain (rated with a visual analog scale for pain) and analgesic requirements at operation day. The visual analog scale for pain ranged from 0-10 (0 is no pain, 10 is Maximum of pain)
Time frame: operation day
Primary
Pain (Rated With a Visual Analog Scale for Pain)
postoperative pain (rated with a visual analog scale for pain) and analgesic requirements at operation day. The visual analog scale for pain ranged from 0-10 (0 is no pain, 10 is Maximum of pain)
Time frame: first postoperative day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A: Insufflation With Cold Gas | Pain (Rated With a Visual Analog Scale for Pain) | 2.22 units on a scale 0-10 | Standard Deviation 0.97 |
| Group B | Pain (Rated With a Visual Analog Scale for Pain) | 1.92 units on a scale 0-10 | Standard Deviation 0.84 |
Secondary
Core Temperature
Time frame: one day postoperativly
Secondary
Core Temperature
core temperature during laparoscopic cholecystectomy using a rectal probe
Time frame: during operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A: Insufflation With Cold Gas | Core Temperature | 36.85 degree celsius | Standard Deviation 0.46 |
| Group B | Core Temperature | 37.07 degree celsius | Standard Deviation 0.35 |