Postoperative Pain Results According to Pressure to Form Pneumoperitoneum

Not Applicable

• Conditions: Cholecystitis; Postoperative Pain
• Interventions: Procedure: robotic single port cholecystectomy

• Registration Number: NCT04398810
• Lead Sponsor: Seoul St. Mary's Hospital

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 Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-12
• Study First Submitted QC: 2020-05-18
• Last Update Submitted: 2020-05-18
• Study First Posted: 2020-05-21
• Last Update Posted: 2020-05-21
• Study Start: 2020-06-02
• Primary Completion: 2020-12-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 108

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the standard-pressure pneumoperitoneum during surgery	robotic single port cholecystectomy	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.
the low-pressure pneumoperitoneum during surgery	robotic single port cholecystectomy	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.

Primary Outcome Measures

Name	Time	Method
Visual Analogue Score(VAS)	24 hours after surgery	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

Name	Time	Method
postoperative complication	Participants will be followed for the duration of hospital stay, an expected average of 2 days	postoperative complication : bile leakage, atelectasis, pneumonia, wound infection, bleeding, etc..
hospital stay	Participants will be followed for the duration of hospital stay, an expected average of 2 days	hospital stay(days) : The duration between the operation day and the day of discharge
operation time	Participants will be followed for the duration of hospital stay, an expected average of 2 days	operation time(minutes)

Trial Locations

Locations (1)

Department of HBP Surgery, Seoul St. Mary's hospital; 🇰🇷 Seoul, Seocho-gu, Banopo-dong, Korea, Republic of