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| ID | Type | Description | Link |
|---|---|---|---|
| F-KY-0022-20220325-01 | Other Identifier | Yantai affiliated hospital of Binzhou Medical University |
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This observational study aims to compare two techniques for closing the common bile duct incision (choledochotomy) after laparoscopic common bile duct exploration (LCBDE) with T-tube drainage. Interrupted suturing is commonly used, but it can be time-consuming during laparoscopic surgery. A modified continuous suturing approach may improve efficiency while maintaining safety.
We will retrospectively review patients who underwent LCBDE with T-tube drainage at our institution. Patients will be grouped according to the choledochotomy closure technique used during routine clinical care (modified continuous suturing versus conventional interrupted closure). To reduce baseline differences between groups, propensity score matching based on preoperative and intraoperative characteristics will be applied.
The primary outcome is choledochotomy closure time. Secondary outcomes include total operative time and perioperative safety outcomes, such as bile leakage and other postoperative complications, as well as short-term postoperative recovery indicators. This study will provide comparative evidence on operative efficiency and safety of continuous versus interrupted choledochotomy closure in the setting of LCBDE with T-tube drainage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified Continuous Suturing |
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| Interrupted Suturing |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified continuous suture | Procedure | Modified continuous suture was performed using 4-0 knotless barbed polydioxanone sutures (Quill™, Surgical Specialties Corporation). A continuous full-thickness suture was placed from the distal (duodenal) end to the proximal (hepatic) end, with bites of approximately 2 mm and a stitch interval of 3-4 mm. After completion of the continuous closure, 1-2 reinforcing stitches were placed in the opposite direction (from proximal to distal), and the suture was secured by tying to the tail end of the initial stitch. |
| Measure | Description | Time Frame |
|---|---|---|
| Choledochotomy Closure Time | The time taken to complete choledochotomy closure, from the beginning of suturing to the completion of the final knot. This measure is recorded in minutes for each patient. | Closure time is measured intraoperatively during the procedure and recorded once closure is complete. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Operative Time | The total time from the initiation of the procedure to the completion of the surgery. This includes all steps of the surgery, from incision to closure. | The total operative time is measured during the procedure, from the first incision to the final closure. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative Blood Loss | The total estimated blood loss during the surgery, as measured by the surgeon and recorded at the end of the procedure. This is typically recorded in milliliters. | Blood loss is recorded intraoperatively at the end of the surgery, based on visual estimation and suction collection. |
Inclusion Criteria:
Exclusion Criteria:
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The study population consists of patients who underwent laparoscopic common bile duct exploration (LCBDE) with T-tube drainage at our institution between January 2020 and November 2024. Inclusion criteria include patients who had choledochotomy closure performed with either modified continuous suturing (MCS) or interrupted suturing (IS). Patients were retrospectively reviewed, and baseline characteristics such as age, gender, stone burden, and ASA classification were collected. Exclusion criteria include patients with incomplete data or those who underwent procedures other than LCBDE.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yantai affiliated hospital of Binzhou Medical University | Yantai | Shandong | 264100 | China |
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| ID | Term |
|---|---|
| D042882 | Gallstones |
| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D041761 | Cholecystolithiasis |
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| Interrupted suture | Procedure | Interrupted suture was performed using 4-0 antibacterial monofilament polydioxanone sutures (PDS™ Plus, Ethicon, LLC). Interrupted sutures were placed from the distal (duodenal) end to the proximal (hepatic) end, with bites of approximately 2 mm and a stitch interval of 3-4 mm; each stitch was tied separately. An additional 1-2 reinforcing stitches (transverse or figure-of-eight) were placed around the T-tube exit site to enhance apposition between the choledochotomy edge and the tube wall. |
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| D005705 |
| Gallbladder Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |