N/A
Completed N=198
Effects of Drainage in Laparoscopic Cholecystectomy
cholecystitis · Empyema of Gallbladder · Abscess of Gallbladder
Source: ClinicalTrials.gov NCT02027402 ↗
Enrolled (actual)
198
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcomePrimary: Complication — 7; 7 participants
Summary
During laparoscopic surgery for an acutely inflamed gallbladder, most surgeons routinely insert a drain. However, no consensus has been reached regarding the need for drainage in these cases, and the use of a drain remains controversial. This study is coordinated to find out the surgical outcomes and perioperative morbidity according to the insertion of drain after laparoscopic cholecystectomy. Investigators expect that the routine use of a drain after laparoscopic cholecystectomy for an acutely inflamed gallbladder will have no effects on the postoperative morbidity.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complication |
7; 7 | — |
| SECONDARY Operative Time |
47.8; 43.1 | — |
| SECONDARY Postoperative Hospital Stay |
2.5; 2.3 | — |
| SECONDARY Postoperative Pain Score |
5.0; 5.2; 3.9; 3.3; 2.1; 1.5 | — |
Eligibility Criteria
Inclusion Criteria
- acutely inflamed gallbladder
Exclusion Criteria
- chronic cholecystitis
- gallbladder polyp or gallbladder cancer
- the patient who underwent reduced port surgery
- the patient who underwent common bile duct exploration during the operation
- the patient who underwent concurrent operation
- the patient who had past history of upper abdominal surgery
- the patient who had a immunodeficiency state
- the case which had a suspicion of delayed bile leakage
- the case which had a incomplete cystic duct ligation
- the patient who underwent open conversion surgery during the operation
- the patient who had a high risk of bleeding
Data sourced from ClinicalTrials.gov (NCT02027402). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.