Postoperative Pain Results According to Pressure to Form Pneumoperitoneum

Seoul St. Mary's Hospital

Status: Unknown

Conditions: Postoperative Pain; Cholecystitis

Treatments: Procedure: robotic single port cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04398810

Seoul-09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 estimated patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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108 participants in 2 patient groups

the low-pressure pneumoperitoneum during surgery

Experimental group

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.

Treatment:

Procedure: robotic single port cholecystectomy

the standard-pressure pneumoperitoneum during surgery

Experimental group

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.

Treatment:

Procedure: robotic single port cholecystectomy