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Postoperative Pain Results According to Pressure to Form Pneumoperitoneum

Primary Purpose

Cholecystitis, Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
robotic single port cholecystectomy
Sponsored by
Seoul St. Mary's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholecystitis focused on measuring robot cholecystectomy, low-pressure pneumoperitoneum, postoperative pain

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of HBP Surgery, Seoul St. Mary's hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

the low-pressure pneumoperitoneum during surgery

the standard-pressure pneumoperitoneum during surgery

Arm 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.

A. 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

postoperative complication
postoperative complication : bile leakage, atelectasis, pneumonia, wound infection, bleeding, etc..
hospital stay
hospital stay(days) : The duration between the operation day and the day of discharge
operation time
operation time(minutes)

Full Information

First Posted
May 12, 2020
Last Updated
May 18, 2020
Sponsor
Seoul St. Mary's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04398810
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 2, 2020 (Anticipated)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul St. Mary's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystitis, Postoperative Pain
Keywords
robot cholecystectomy, low-pressure pneumoperitoneum, postoperative pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
the low-pressure pneumoperitoneum during surgery
Arm Type
Experimental
Arm 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.
Arm Title
the standard-pressure pneumoperitoneum during surgery
Arm Type
Experimental
Arm Description
A. 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.
Intervention Type
Procedure
Intervention Name(s)
robotic single port cholecystectomy
Intervention Description
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) Residual gas aspiration 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. Warming of the washing solution in the abdominal cavity
Primary Outcome Measure Information:
Title
Visual Analogue Score(VAS)
Description
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.
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
postoperative complication
Description
postoperative complication : bile leakage, atelectasis, pneumonia, wound infection, bleeding, etc..
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 2 days
Title
hospital stay
Description
hospital stay(days) : The duration between the operation day and the day of discharge
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 2 days
Title
operation time
Description
operation time(minutes)
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who underwent elective gallbladder surgery Cholelithiasis Chronic cholecystitis Gallbladder polyps Gallbladder adenoma Porcelain gallbladder Exclusion Criteria: 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 Patients under 19 years of age.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tae ho Hong, MD. PhD
Phone
+82-10-5206-5266
Email
gshth@catholic.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Sung eun Park, MD
Phone
+82-10-5775-9351
Email
carin337@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Won jong Kim, MD
Organizational Affiliation
The Catholic University of Korea
Official's Role
Study Director
Facility Information:
Facility Name
Department of HBP Surgery, Seoul St. Mary's hospital
City
Seoul
State/Province
Seocho-gu, Banopo-dong
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taeho Hong, MD, PhD
Phone
+82-2-2258-6108
Email
gshth@catholic.ac.kr

12. IPD Sharing Statement

Plan to Share IPD
No

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Postoperative Pain Results According to Pressure to Form Pneumoperitoneum

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