Postoperative Pain Results According to Pressure to Form Pneumoperitoneum
A Comparison of Postoperative Pain Results According to Pressure to Form Pneumoperitoneum During Robot-assisted Single-port Cholecystectomy; a Randomized Controlled Trial.
1 other identifier
interventional
108
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2020
CompletedFirst Posted
Study publicly available on registry
May 21, 2020
CompletedStudy Start
First participant enrolled
June 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2021
CompletedMay 21, 2020
May 1, 2020
7 months
May 12, 2020
May 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
postoperative complication
Participants will be followed for the duration of hospital stay, an expected average of 2 days
hospital stay
Participants will be followed for the duration of hospital stay, an expected average of 2 days
operation time
Participants will be followed for the duration of hospital stay, an expected average of 2 days
Study Arms (2)
the low-pressure pneumoperitoneum during surgery
EXPERIMENTALA. 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.
the standard-pressure pneumoperitoneum during surgery
EXPERIMENTALA. Inclusion criteria Patients who underwent elective gallbladder surgery * Cholelithiasis * Chronic cholecystitis * Gallbladder polyps * Gallbladder adenoma * Porcelain gallbladder 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.
Interventions
1. Local anesthetic administration during wound incision In the experimental group and the control group, a local anesthetic was administered to the wound surface when a glove port was installed on the navel at the start of surgery. (bupivacaine 0.5% 14ml subcutaneous injection) 2. Residual gas aspiration 3. Pulmonary recruitment maneuver In both the experimental group and the control group, before the operation was completed and the wound was closed, the patient was taken to the Trenedelenburg position, and then the pressure of 60 cm H2o in the abdomen was applied, and manual inflation was performed twice, 5 seconds at a time, and pulmonary recruitment was performed. 4. Warming of the washing solution in the abdominal cavity
Eligibility Criteria
You may qualify if:
- Patients who underwent elective gallbladder surgery
- Cholelithiasis
- Chronic cholecystitis
- Gallbladder polyps
- Gallbladder adenoma
- Porcelain gallbladder
You may not qualify if:
- Acute cholecystitis patient group
- Necrotic gallbladder
- Collapsed gallbladder
- Gallbladder pustosis
- Gallbladder emphysema
- Hemorrhagic gallbladder
- Perforated gallbladder
- 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
- Transplant patient group: Liver transplant patient group (PSLT), Kidney transplant patient group (PSKT)
- AIDS patients group
- Patient group with history of open abdominal surgery
- Transplant group during open surgery
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of HBP Surgery, Seoul St. Mary's hospital
Seoul, Seocho-gu, Banopo-dong, 137-701, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Won jong Kim, MD
The Catholic University of Korea
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 12, 2020
First Posted
May 21, 2020
Study Start
June 2, 2020
Primary Completion
December 30, 2020
Study Completion
December 30, 2021
Last Updated
May 21, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share