Postoperative Pain Results According to Pressure to Form Pneumoperitoneum

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 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

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