Brief Title
Postoperative Pain Results According to Pressure to Form Pneumoperitoneum
Official Title
A Comparison of Postoperative Pain Results According to Pressure to Form Pneumoperitoneum During Robot-assisted Single-port Cholecystectomy; a Randomized Controlled Trial.
Brief Summary
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.
Detailed Description
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.
Study Type
Interventional
Primary Outcome
Visual Analogue Score(VAS)
Secondary Outcome
postoperative complication
Condition
Cholecystitis
Intervention
robotic single port cholecystectomy
Study Arms / Comparison Groups
the low-pressure pneumoperitoneum during surgery
Description: A. Inclusion criteria Patients who underwent elective gallbladder surgery Cholelithiasis Chronic cholecystitis Gallbladder polyps Gallbladder adenoma Porcelain gallbladder 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
108
Start Date
June 2, 2020
Completion Date
December 30, 2021
Primary Completion Date
December 30, 2020
Eligibility Criteria
Inclusion Criteria: Patients who underwent elective gallbladder surgery - Cholelithiasis - Chronic cholecystitis - Gallbladder polyps - Gallbladder adenoma - Porcelain gallbladder Exclusion Criteria: 1. Acute cholecystitis patient group - Necrotic gallbladder - Collapsed gallbladder - Gallbladder pustosis - Gallbladder emphysema - Hemorrhagic gallbladder - Perforated gallbladder 2. cholecystitis with a gallbladder thickness of 4 mm or more on CT or ultrasound 3. cholecystitis with adhesions to surrounding organs due to inflammation of the gallbladder 4. Patient group performing surgery concurrently due to other organ diseases 5. Immunosuppressive patient group - Transplant patient group: Liver transplant patient group (PSLT), Kidney transplant patient group (PSKT) - AIDS patients group 6. Patient group with history of open abdominal surgery 7. Transplant group during open surgery 8. Patients under 19 years of age.
Gender
All
Ages
19 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
Won jong Kim, MD, +82-10-5206-5266, [email protected]
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT04398810
Organization ID
Seoul-09
Responsible Party
Principal Investigator
Study Sponsor
Seoul St. Mary's Hospital
Study Sponsor
Won jong Kim, MD, Study Director, The Catholic University of Korea
Verification Date
May 2020