Clinical trial NCT04398810: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Cholecystitis
Postoperative Pain
Keywords: robot cholecystectomy
low-pressure pneumoperitoneum
postoperative pain
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2020-05-21
Enrollment: 108
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Visual Analogue Score(VAS)
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: postoperative complication
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 days
measure: hospital stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 days
measure: operation time
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of HBP Surgery, Seoul St. Mary's hospital
state: Seocho-gu, Banopo-dong
Study officials:
affiliation: The Catholic University of Korea
name: Won jong Kim, MD
role: STUDY_DIRECTOR
References: