Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A prospective randomized study was performed including consecutive patients who underwent an elective laparoscopic cholecystectomy (LC) for symptomatic cholelithiasis during the 18 months period. This prospective randomized trial aims to compare two umbilical closure techniques for trocar site hernia (TSH) in laparoscopic cholecystectomy.
Laparoscopic cholecystectomy (LC) is currently the gold standard in the treatment for symptomatic cholelithiasis that offers a variety of advantages over conventional open surgery such as shorter recovery time, better cosmesis, less wound complication rates, and less pain (1,2). Despite these advantages, LC can result in unique complications. Among these complications, trocar site hernia (TSH) is one of the most important complications because laparoscopic cholecystectomy promises smaller abdominal incisions and better cosmetic outcomes. A second surgical intervention due to TSH may overshadow the gains of the previous laparoscopic surgery. In studies conducted to date, the rate of trocar hernia in laparoscopic cholecystectomy has been presented at very different rates. Many studies have shown that the most frequent site of TSH is the umbilical trocar site (3-6).
To avoid this important complication of laparoscopic cholecystectomy, many different techniques have been described to date for trocar port fascia repair (7-12). Most of these techniques require special devices. In addition, a few studies compare these techniques with standard fascial closure, which is mostly used by surgeons (11,12).
We hypothesized that the fascial closure of the umbilical trocar incision under the intra-abdominal vision with the laparoscopic camera could be reduced TSH. This prospective randomized controlled study aims to assess whether fascial closure of umbilical trocar site under direct laparoscopic vision in LC can reduce the incidence of TSH.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard umbilical trocar incision closure (UC) | Other | standard umbilical trocar incision closure |
|
| Video-assisted umbilical trocar incision closure (UCVA)) | Active Comparator | video-assisted umbilical trocar incision closure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| video-assisted umbilical closure | Procedure | video-assisted umbilical closure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Trocar site hernia (TSH) | trocar site hernia presence | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Wound infection (WI) | wound infection | three weeks later |
| Hematoma (H) | Hematoma | 18 months (postoperative first day and three weeks later) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Elif Colak | Samsun Education and Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsun Education and Research Hospital | Samsun | 55060 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25958296 | Background | Coccolini F, Catena F, Pisano M, Gheza F, Fagiuoli S, Di Saverio S, Leandro G, Montori G, Ceresoli M, Corbella D, Sartelli M, Sugrue M, Ansaloni L. Open versus laparoscopic cholecystectomy in acute cholecystitis. Systematic review and meta-analysis. Int J Surg. 2015 Jun;18:196-204. doi: 10.1016/j.ijsu.2015.04.083. Epub 2015 May 6. | |
| 30846033 |
Not provided
Not provided
The datasets generated during the current study are available.
January 2021
The datasets generated during the current study are available.
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 3, 2020 | Jan 12, 2022 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| D010149 | Pain, Postoperative |
| D000069290 | Incisional Hernia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Length of hospital stay (LOH) | length of hospital stay (day) | 18 months |
| Abdominal Pain | Abdominal pain assessment by visual analog scale (0 minimum-10 maximum values, higher scores mean worse outcome) | Preoperative first day, postoperative first day |
| Sanford DE. An Update on Technical Aspects of Cholecystectomy. Surg Clin North Am. 2019 Apr;99(2):245-258. doi: 10.1016/j.suc.2018.11.005. Epub 2019 Feb 10. |
| 32071382 | Background | Nofal MN, Yousef AJ, Hamdan FF, Oudat AH. Characteristics of Trocar Site Hernia after Laparoscopic Cholecystectomy. Sci Rep. 2020 Feb 18;10(1):2868. doi: 10.1038/s41598-020-59721-w. |
| 21605509 | Background | Bunting DM. Port-site hernia following laparoscopic cholecystectomy. JSLS. 2010 Oct-Dec;14(4):490-7. doi: 10.4293/108680810X12924466007728. |
| 22714582 | Background | Erdas E, Dazzi C, Secchi F, Aresu S, Pitzalis A, Barbarossa M, Garau A, Murgia A, Contu P, Licheri S, Pomata M, Farina G. Incidence and risk factors for trocar site hernia following laparoscopic cholecystectomy: a long-term follow-up study. Hernia. 2012 Aug;16(4):431-7. doi: 10.1007/s10029-012-0929-y. Epub 2012 Jun 20. |
| 24112669 | Background | Comajuncosas J, Hermoso J, Gris P, Jimeno J, Orbeal R, Vallverdu H, Lopez Negre JL, Urgelles J, Estalella L, Pares D. Risk factors for umbilical trocar site incisional hernia in laparoscopic cholecystectomy: a prospective 3-year follow-up study. Am J Surg. 2014 Jan;207(1):1-6. doi: 10.1016/j.amjsurg.2013.05.010. Epub 2013 Oct 7. |
| 30688041 | Background | Kawai H, Misawa T, Sasaya K, Aoyama Y. Dual-hemostat port closure technique with customized surgical suture after laparoscopic cholecystectomy: Single-center experience. Asian J Endosc Surg. 2020 Jan;13(1):83-88. doi: 10.1111/ases.12690. Epub 2019 Jan 27. |
| 27536351 | Background | Lasheen AE, Safwat K, Elsheweal A, Ibrahim A, Mahmoud R, Alkilany M, Ismaeil A. Effective, simple, easy procedure for laparoscopic port closure in difficult cases. Ann Med Surg (Lond). 2016 Jul 19;10:36-40. doi: 10.1016/j.amsu.2016.06.014. eCollection 2016 Sep. |
| 26287316 | Background | Rajendiran A, Maruthupandian D, Karunakaran K, Syed MN. Aneurysm Needle as an Effective Tool in Laparoscopic Port Closure. J Laparoendosc Adv Surg Tech A. 2015 Sep;25(9):744-6. doi: 10.1089/lap.2015.0249. Epub 2015 Aug 19. |
| 23925027 | Background | Lasheen A, Safwat K, Fiad A, Elmoregy A, Hamed AW. Port-site closure using a modified aptos needle. JSLS. 2013 Apr-Jun;17(2):312-5. doi: 10.4293/108680813X13693422522277. |
| 19260458 | Background | Calik A, Yucel Y, Topaloglu S, Hos G, Aktas A, Piskin B. Umbilical trocar site closure with Berci's needle after laparoscopic cholecystectomy. Hepatogastroenterology. 2008 Nov-Dec;55(88):1958-61. |
| 24680572 | Background | Armananzas L, Ruiz-Tovar J, Arroyo A, Garcia-Peche P, Armananzas E, Diez M, Galindo I, Calpena R. Prophylactic mesh vs suture in the closure of the umbilical trocar site after laparoscopic cholecystectomy in high-risk patients for incisional hernia. A randomized clinical trial. J Am Coll Surg. 2014 May;218(5):960-8. doi: 10.1016/j.jamcollsurg.2014.01.049. Epub 2014 Feb 18. |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |