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Background:
Single port access surgery is a rapidly progressing surgical approach which allows performance of standard laparoscopic surgery through a single transparietal port instead of multiple port accesses.
Objective:
Demonstrate the validity of Single port access (SPA) cholecystectomy compared to multiple ports laparoscopic cholecystectomy.
Hypothesis:
SPA cholecystectomy is associated with decreased parietal and body image trauma compare to multiple ports laparoscopic cholecystectomy. SPA cholecystectomy should be associated with better cosmetic results, may improve postoperative recovery due to lower parietal pain. SPA cholecystectomy may also be associated with decreased rate of parietal complications as lower numbers of transparietal port are placed.
Methods:
All patients offered cholecystectomy, either SPA or multiport cholecystectomy, included in the study will have recognized biliary pathology for which formal indication cholecystectomy are recognized internationally.
Surgical technique, either for SPA cholecystectomy or for multiple ports cholecystectomy, will be the same except, that one surgical technique is achieved through a single transparietal port and the other through multiple ports.
Randomization will be performed before surgeries after patients have given their informed consent to the study.
No specific test or cost will be necessitated by the study. Patients will be informed orally and will receive a short study summary, allowing them to give an informed consent.
Endpoints:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | SPA cholecystectomy |
|
| 2 | Other | laparoscopic cholecystectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPA cholecystectomy | Procedure | SPA cholecystectomy |
| |
| Laparoscopic cholecystectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Cosmesis, body image and quality of life scale | at 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative morbidity | at 30 days | |
| Post-operative pain | 10 days | |
| Operative time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pascal Bucher, MD | Contact | +41223723311 | 7958420 | pascal.bucher@hcuge.ch |
| Name | Affiliation | Role |
|---|---|---|
| Pascal Bucher, MD | University Hospital, Geneva | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Geneva | Recruiting | Geneva | Canton of Geneva | 1211 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19116734 | Background | Bucher P, Pugin F, Buchs N, Ostermann S, Charara F, Morel P. Single port access laparoscopic cholecystectomy (with video). World J Surg. 2009 May;33(5):1015-9. doi: 10.1007/s00268-008-9874-4. | |
| 21964736 | Derived | Bucher P, Pugin F, Buchs NC, Ostermann S, Morel P. Randomized clinical trial of laparoendoscopic single-site versus conventional laparoscopic cholecystectomy. Br J Surg. 2011 Dec;98(12):1695-702. doi: 10.1002/bjs.7689. Epub 2011 Sep 30. |
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| ID | Term |
|---|---|
| D002764 | Cholecystitis |
| ID | Term |
|---|---|
| D005705 | Gallbladder Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D017081 | Cholecystectomy, Laparoscopic |
| ID | Term |
|---|---|
| D002763 | Cholecystectomy |
| D001662 | Biliary Tract Surgical Procedures |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Procedure |
Laparoscopic cholecystectomy |
|
| day 1 |
| 21910897 | Derived | Steinemann DC, Raptis DA, Lurje G, Oberkofler CE, Wyss R, Zehnder A, Lesurtel M, Vonlanthen R, Clavien PA, Breitenstein S. Cosmesis and body image after single-port laparoscopic or conventional laparoscopic cholecystectomy: a multicenter double blinded randomised controlled trial (SPOCC-trial). BMC Surg. 2011 Sep 12;11:24. doi: 10.1186/1471-2482-11-24. |
| D010535 | Laparoscopy |
| D004724 | Endoscopy |
| D019060 | Minimally Invasive Surgical Procedures |