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This study aims to evaluate post-operative pain in single-incision laparoscopic cholecystectomy (SILC) versus the conventional four port technique (LC). The investigators hypothesize that SILC is non-inferior in post-operative pain.
As above
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SILC | Experimental | Subjects in this arm were randomized to undergo single-incision laparoscopic cholecystectomy, through a transumbilical incision |
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| LC | Active Comparator | Subjects in this arm were randomized to undergo conventional 4-port laparoscopic cholecystectomy. Wound sites at umbilicus, right hypocondrium, epigastrium and right flank |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SILC | Procedure | Underwent single-incision laparoscopic cholecystectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative pain 4 hours | To evaluate post-operative pain in single-incision laparoscopic cholecystectomy vs the conventional 4 port technique. Measured at both umbilical and extra-umbilical sites, at rest and on movement. Visual analogue scale, from 1-10. | 4 hours post-operative |
| Post-operative pain 24 hours | To evaluate post-operative pain in single-incision laparoscopic cholecystectomy vs the conventional 4 port technique. Measured at both umbilical and extra-umbilical sites, at rest and on movement. Visual analogue scale, from 1-10. | 24 hours post-operative |
| Post-operative pain 14 days | To evaluate post-operative pain in single-incision laparoscopic cholecystectomy vs the conventional 4 port technique. Measured at both umbilical and extra-umbilical sites, at rest and on movement. Visual analogue scale, from 1-10. | 14 days post-operative |
| Post-operative pain 6 months | To evaluate post-operative pain in single-incision laparoscopic cholecystectomy vs the conventional 4 port technique. Measured at both umbilical and extra-umbilical sites, at rest and on movement. Visual analogue scale, from 1-10. | 6 months post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural complications | To evaluate complications between single-incision laparoscopic cholecystectomy vs the conventional four port technique. Conducted via telephone interview and review of hospital records in the intervening period | 6 months |
| Operative duration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Kin Yong Chang, FRCS | National University Hospital, Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University Hospital | Singapore | Singapore | 119074 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25446490 | Derived | Chang SK, Wang YL, Shen L, Iyer SG, Madhavan K. A randomized controlled trial comparing post-operative pain in single-incision laparoscopic cholecystectomy versus conventional laparoscopic cholecystectomy. World J Surg. 2015 Apr;39(4):897-904. doi: 10.1007/s00268-014-2903-6. |
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| LC | Procedure | Underwent conventional 4-port laparoscopic cholecystectomy |
|
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To evaluate operative duration between single-incision laparoscopic cholecystectomy vs the conventional four port technique |
| following skin closure |
| Subject satisfaction | To evaluate subject satisfaction between single-incision laparoscopic cholecystectomy vs the conventional four port technique. Measured on a Likert scale, from 1-5 (1 least satisfied, 5 most satisfied) | 14 days and 6 months |
| Return to function | To evaluate post-operative return to function following surgery, between single-incision laparoscopic cholecystectomy vs the conventional four port technique. Measured as days taken to independent toileting, and independently obtaining meals as a surrogate measure of function | 14 days |
| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| D042883 | Choledocholithiasis |
| D041761 | Cholecystolithiasis |
| D010195 | Pancreatitis |
| D002761 | Cholangitis |
| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D003137 | Common Bile Duct Diseases |
| D001649 | Bile Duct Diseases |
| D005705 | Gallbladder Diseases |
| D010182 | Pancreatic Diseases |
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