Benign Gallbladder Disease
Conditions
Interventions
Intraoperative ultrasound group:Intraoperative ultrasound scan of gallbladder wall, gallbladder triangle, and hepatoduodenal ligament
control group:Handle according to the conventional surgical procedure
Sponsors
Shanghai Tenth People's Hospital (the Tenth People's Hospital attached to Tongji University)
Eligibility
Sex/Gender
All
Age
16 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1.Diagnosis: Meets the diagnostic criteria for benign gallbladder diseases; 2.Informed consent: Sign the subject's informed consent form. According to the selection criteria for qualified subjects in the clinical trial protocol, subjects can only be included in this clinical trial if all four of the above criteria are "yes"; 3.Age: 16 to 90 years old; 4.General condition: severe complications such as heart, lung, liver, kidney, brain, etc., which can tolerate LC surgery; 5.Mental condition: Possess complete sociological functions and self-awareness, without severe mental illness, able to cooperate with diagnosis and treatment activities and research activities; No factors that may affect the normal conduct of the experiment, such as drug use, severe alcohol abuse, and drug abuse history; 6.Gallbladder and gallbladder wall condition: Mild thickening of the gallbladder wall (4-5mm) in patients with chronic cholecystitis; Patients with significant thickening of the gallbladder wall (>5mm) caused by acute/subacute inflammation/fibrosis waves; Benign nodules or thickened lesions that affect but do not penetrate the entire gallbladder wall; Atrophic gallbladder without considering cancer; Mirizzi syndrome. 7.Meets the conditions for laparoscopic intraoperative ultrasound examination: abdominal adhesions can be released, liver and hepatoduodenal ligaments can be exposed, without affecting laparoscopic ultrasound scanning; No history of liver surgery or liver resection, but it does not affect the ultrasound scan of gallbladder wall echoes during surgery.
Exclusion criteria
Exclusion criteria: 1. Informed consent: those who do not accept or sign the subject's informed consent form; 2. General condition: Patients with important organ or system complications who cannot tolerate general anesthesia or LC surgery; 3. Mental condition: severe and uncontrollable mental illness, inability to cooperate with diagnosis and treatment activities and research activities; Factors that affect the normal conduct of the experiment, such as drug use, severe alcohol abuse, and drug abuse history; 4. Gallbladder and gallbladder wall condition: Gallbladder cancer or highly suspected cancer, xanthogranulomatous cholecystitis; 5. Does not meet the conditions for laparoscopic intraoperative ultrasound examination: Due to abdominal adhesions, the gallbladder or duodenal ligament cannot be exposed, resulting in the inability to complete LC, or the inability to complete laparoscopic ultrasound scanning; Due to previous liver surgery, it is not possible to use intraoperative ultrasound to scan the echoes of the gallbladder wall.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Circumferential integrity rate of gallbladder (cystic duct) remnant.;Incidence rate of biliary injury;Injury rate of cystic artery/right hepatic artery;Rate of gallbladder rupture during dissection of the gallbladder bed;Liver and hepatic vein injury rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Operative time;Postoperative hospitalization duration;Fever after surgery;Abdominal drainage volume;The incidence of complications (including bleeding, biliary leakage, peritoneal infection, wound infection, etc.).;Total treatment cost; | — |
Countries
China
Contacts
Public ContactZhou Di
Shanghai Tenth People's Hospital (the Tenth People's Hospital attached to Tongji University)
Outcome results
None listed