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Video-assisted Umbilical Fascial Closure in Laparoscopic Cholecystectomy

Primary Purpose

Cholelithiasis (Without Cholecystitis), Pain, Postoperative, Hernia Incisional

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
video-assisted umbilical closure
Sponsored by
Samsun Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cholelithiasis (Without Cholecystitis) focused on measuring laparoscopic cholecystectomy, pain, trocar site hernia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age above 18 years
  • symptomatic cholelithiasis

Exclusion Criteria:

  • acute cholecystitis
  • age under 18 years
  • previous umbilical hernia repair
  • pre-existing umbilical hernia

Sites / Locations

  • Samsun Education and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Standard umbilical trocar incision closure (UC)

Video-assisted umbilical trocar incision closure (UCVA))

Arm Description

standard umbilical trocar incision closure

video-assisted umbilical trocar incision closure

Outcomes

Primary Outcome Measures

Trocar site hernia (TSH)
trocar site hernia presence

Secondary Outcome Measures

Wound infection (WI)
wound infection
Hematoma (H)
Hematoma
Length of hospital stay (LOH)
length of hospital stay (day)
Abdominal Pain
Abdominal pain assessment by visual analog scale (0 minimum-10 maximum values, higher scores mean worse outcome)

Full Information

First Posted
December 27, 2021
Last Updated
January 26, 2022
Sponsor
Samsun Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05208385
Brief Title
Video-assisted Umbilical Fascial Closure in Laparoscopic Cholecystectomy
Official Title
Effectiveness of the Video-assisted Umbilical Fascial Closure in Laparoscopic Cholecystectomy: Prospective Randomized Clinical Trial of 240 Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 24, 2021 (Actual)
Study Completion Date
December 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsun Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholelithiasis (Without Cholecystitis), Pain, Postoperative, Hernia Incisional
Keywords
laparoscopic cholecystectomy, pain, trocar site hernia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard umbilical trocar incision closure (UC)
Arm Type
Other
Arm Description
standard umbilical trocar incision closure
Arm Title
Video-assisted umbilical trocar incision closure (UCVA))
Arm Type
Active Comparator
Arm Description
video-assisted umbilical trocar incision closure
Intervention Type
Procedure
Intervention Name(s)
video-assisted umbilical closure
Other Intervention Name(s)
standard umbilical fascial closure
Intervention Description
video-assisted umbilical closure
Primary Outcome Measure Information:
Title
Trocar site hernia (TSH)
Description
trocar site hernia presence
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Wound infection (WI)
Description
wound infection
Time Frame
three weeks later
Title
Hematoma (H)
Description
Hematoma
Time Frame
18 months (postoperative first day and three weeks later)
Title
Length of hospital stay (LOH)
Description
length of hospital stay (day)
Time Frame
18 months
Title
Abdominal Pain
Description
Abdominal pain assessment by visual analog scale (0 minimum-10 maximum values, higher scores mean worse outcome)
Time Frame
Preoperative first day, postoperative first day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age above 18 years symptomatic cholelithiasis Exclusion Criteria: acute cholecystitis age under 18 years previous umbilical hernia repair pre-existing umbilical hernia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elif Colak
Organizational Affiliation
Samsun Education and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsun Education and Research Hospital
City
Samsun
ZIP/Postal Code
55060
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The datasets generated during the current study are available.
IPD Sharing Time Frame
January 2021
IPD Sharing Access Criteria
The datasets generated during the current study are available.
Citations:
PubMed Identifier
25958296
Citation
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. Erratum In: Int J Surg. 2015 Dec;24(Pt A):107.
Results Reference
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PubMed Identifier
30846033
Citation
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.
Results Reference
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PubMed Identifier
32071382
Citation
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.
Results Reference
background
PubMed Identifier
21605509
Citation
Bunting DM. Port-site hernia following laparoscopic cholecystectomy. JSLS. 2010 Oct-Dec;14(4):490-7. doi: 10.4293/108680810X12924466007728.
Results Reference
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PubMed Identifier
22714582
Citation
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.
Results Reference
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PubMed Identifier
24112669
Citation
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.
Results Reference
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PubMed Identifier
30688041
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
26287316
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
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Citation
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.
Results Reference
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Video-assisted Umbilical Fascial Closure in Laparoscopic Cholecystectomy

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