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A study that included patients of any gender between 15 and 70 years, with the diagnosis of choledocholithiasis who required a cholecystectomy with an exploration of bile ducts. Conventional cholecystectomy was performed and a T-tube was inserted in the common bile duct (CBD) to measure the intraluminal pressure immediately after the procedure, and weekly thereafter, with a 6-week follow-up. A control T-tube radiological study was performed at six weeks to exclude residual stones.
A clinical, controlled, prospective, longitudinal, descriptive, observational and double-blinded study was designed. Patients of any gender between 15 and 70 years, with a diagnosis of choledocholithiasis, and who required a cholecystectomy with an exploration of bile ducts were included. Conventional cholecystectomy was performed and perioperative T-tube CBD pressure was registered immediately after the procedure, and weekly thereafter, with a 6-week follow-up.
Control T-tube cholangiogram was performed at six weeks to exclude residual stones. Data was analyzed with T-test for parametric values.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Choledocholithiasis | Experimental | Patients were managed by elective open cholecystectomy and operative exploration of the common bile duct. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecystectomy and common bile duct exploration | Procedure | During elective open cholecystectomy, a basal commcn dile duct (CBD) manometry was obtained immediately after cholecystectomy, with a 10 Fr. silicone T tube introduced into the cystic duct and connected to a glass manometer. |
| Measure | Description | Time Frame |
|---|---|---|
| Basal common bile duct (CBD) pressure | Basal CBD manometry was obtained immediately after cholecystectomy | Intraoperative |
| First week control common bile duct pressure | CBD manometry was obtained one week after cholecystectomy | First week |
| Second week control common bile duct pressure | CBD manometry was obtained two weeks after cholecystectomy | Second week |
| Third week control common bile duct pressure | CBD manometry was obtained three weeks after cholecystectomy | Third week |
| Fourth week control common bile duct pressure | CBD manometry was obtained four weeks after cholecystectomy | Fourth week |
| Fifth week control common bile duct pressure | CBD manometry was obtained five weeks after cholecystectomy | Fifth week |
| Sixth week control common bile duct pressure | CBD manometry was obtained six weeks after cholecystectomy | Sixth week |
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Inclusion Criteria: Choledocholithiasis -
Exclusion Criteria: To not complete the follow-up period
-
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| Name | Affiliation | Role |
|---|---|---|
| David Saldaña-Cortés, MD | General Surgery Service | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8462367 | Background | Mendez-Sanchez N, Jessurun J, Ponciano-Rodriguez G, Alonso-de-Ruiz P, Uribe M, Hernandez-Avila M. Prevalence of gallstone disease in Mexico. A necropsy study. Dig Dis Sci. 1993 Apr;38(4):680-3. doi: 10.1007/BF01316800. | |
| Background | González-Pérez LG, ZaldÃvar-RamÃrez FR, Tapia-Contla BR, DÃaz-Contreras-Piedras CM, Arellano-López PR, Hurtado-López LM. Factores de riesgo de la coledocolitiasis asintomática; experiencia en el Hospital General de México. Cir Gen. 2018;40(3):164-168. | ||
| 3369934 |
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All individual participant data (IPD) that underlie results in a publication
When summary data are published
All information should be requested from the corresponding author.
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| ID | Term |
|---|---|
| D042883 | Choledocholithiasis |
| ID | Term |
|---|---|
| D003137 | Common Bile Duct Diseases |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D002763 | Cholecystectomy |
| ID | Term |
|---|---|
| D001662 | Biliary Tract Surgical Procedures |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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|
| Background |
| Csendes A, Sepulveda A, Burdiles P, Braghetto I, Bastias J, Schutte H, Diaz JC, Yarmuch J, Maluenda F. Common bile duct pressure in patients with common bile duct stones with or without acute suppurative cholangitis. Arch Surg. 1988 Jun;123(6):697-9. doi: 10.1001/archsurg.1988.01400300039005. |
| 24141714 | Background | World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available. |
| 499707 | Background | Csendes A, Kruse A, Funch-Jensen P, Oster MJ, Ornsholt J, Amdrup E. Pressure measurements in the biliary and pancreatic duct systems in controls and in patients with gallstones, previous cholecystectomy, or common bile duct stones. Gastroenterology. 1979 Dec;77(6):1203-10. No abstract available. |
| 26615165 | Result | Copelan A, Kapoor BS. Choledocholithiasis: Diagnosis and Management. Tech Vasc Interv Radiol. 2015 Dec;18(4):244-55. doi: 10.1053/j.tvir.2015.07.008. Epub 2015 Jul 15. |
| D002769 | Cholelithiasis |