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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.
Laparoscopic cholecystectomy was the most common treatment method for gallbladder-related diseases, and robotic cholecystectomy was also currently being performed. Many patients complained pain around the wound, shoulder and back after surgery. Several methods had been attempted to reduce postoperative pain, previous studies showed that oral medications such as NSAIDS, administration of local anesthetics in wounds and abdominal cavity, low-pressure penumoperitoneum, humidification of intraperitoneal washing fluid, And active residual gas suction in the abdominal cavity had been found to relieve postoperative pain.
Robotic cholecystectomy, similar to laparoscopic cholecystectomy, also formed pneumoperitoneum to secure the surgical space during operation. Based on the results published in various studies, it had known that the most effective method of pain relief for laparoscopic pain was to create low-pressure pneumoperitoneum.
In this study, investigators attempted to prove the effectiveness of low pressure pneumoperioneum through a prospective randomized controlled trial between the experimental group with the low-pressure pneumoperitoneum and the control group with the standard-pressure pneumoperitoneum during robotic single-hole cholecystectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the low-pressure pneumoperitoneum during surgery | Experimental | A. Inclusion criteria Patients who underwent elective gallbladder surgery
The experimental group controls the CO2 flow that is injected into the abdominal cavity during surgery and maintains the pressure in the abdominal cavity at a low level of 5 mmHg to perform the surgery. |
|
| the standard-pressure pneumoperitoneum during surgery | Experimental | A. Inclusion criteria Patients who underwent elective gallbladder surgery
In the case of the control group, surgery is performed while maintaining the pressure in the abdominal cavity at 12 mmHg as generally performed during surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| robotic single port cholecystectomy | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Score(VAS) | The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain. | 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative complication | postoperative complication : bile leakage, atelectasis, pneumonia, wound infection, bleeding, etc.. | Participants will be followed for the duration of hospital stay, an expected average of 2 days |
| hospital stay |
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Inclusion Criteria:
Patients who underwent elective gallbladder surgery
Exclusion Criteria:
Acute cholecystitis patient group
cholecystitis with a gallbladder thickness of 4 mm or more on CT or ultrasound
cholecystitis with adhesions to surrounding organs due to inflammation of the gallbladder
Patient group performing surgery concurrently due to other organ diseases
Immunosuppressive patient group
Patient group with history of open abdominal surgery
Transplant group during open surgery
Patients under 19 years of age.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tae ho Hong, MD. PhD | Contact | +82-10-5206-5266 | gshth@catholic.ac.kr | |
| Sung eun Park, MD | Contact | +82-10-5775-9351 | carin337@naver.com |
| Name | Affiliation | Role |
|---|---|---|
| Won jong Kim, MD | The Catholic University of Korea | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of HBP Surgery, Seoul St. Mary's hospital | Seoul | Seocho-gu, Banopo-dong | 137-701 | South Korea |
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| ID | Term |
|---|---|
| D002764 | Cholecystitis |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D005705 | Gallbladder Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D011183 | Postoperative Complications |
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|
hospital stay(days) : The duration between the operation day and the day of discharge
| Participants will be followed for the duration of hospital stay, an expected average of 2 days |
| operation time | operation time(minutes) | Participants will be followed for the duration of hospital stay, an expected average of 2 days |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |