Optimum-pressure for Reducing Postoperative Shoulder-tip Pain in Laparoscopic Cholecystectomy
1 other identifier
interventional
84
1 country
1
Brief Summary
Laparoscopic cholecystectomy (LC) is the standard treatment of gallbladder disease. LC is the common procedure for general surgeons. Although LC is a safe procedure with very low mortality (\<1%), it has some associated major morbidity. Bile duct injury is the most serious complication of LC. However, there are some postoperative morbidity including shoulder-tip pain. The incidence of shoulder-tip pain is about 15-45%, which might be influencing the patient outcome including length of hospital stay. From the previous studies, one of the important factor associated with this condition is pneumoperitoneum pressure. Thus, the suggestion of the intra-abdominal pressure should be low pressure as about 8 mmHg. However, the optimum pressure for the low-pressure during laparoscopic cholecystectomy is controversial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 23, 2019
CompletedStudy Start
First participant enrolled
December 25, 2019
CompletedFirst Posted
Study publicly available on registry
December 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedFebruary 25, 2021
February 1, 2021
2 years
December 23, 2019
February 23, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Shoulder tip pain
The shoulder tip pain was assessed by the investigator during postoperative period unfil 48 hours. The measurement of the outcome, the investigator would ask the participant by the clinical record form and questionnair. The answer of the questionnaire is presence or absence of the shoulder pain or pain around the shoulder and scapular region.
48 hours
Secondary Outcomes (2)
Change of intra-abdominal pressure
Immediately after surgery
Difficulty of the operation
Immediately after surgery
Study Arms (2)
Control group
NO INTERVENTION8 mmHg pressure group
Study group
EXPERIMENTAL10 mmHg group
Interventions
Limited intraabdominal pressure during laparoscopic cholecystectomy between 8 and 10 mmHg.
Eligibility Criteria
You may qualify if:
- Age \> 15 years
- Elective procedure of laparoscopic cholecystectomy
- Sign to Inform consent
You may not qualify if:
- Emergency surgery
- Concomitant other procedure performed
- Deny to participant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Bangkok, 10400, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Narongsak Rungsakulkij, M.D.
Ramathibodi Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
December 23, 2019
First Posted
December 30, 2019
Study Start
December 25, 2019
Primary Completion
December 31, 2021
Study Completion
June 30, 2022
Last Updated
February 25, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share