NCT05208385

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2021

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 26, 2022

Completed
Last Updated

February 10, 2022

Status Verified

January 1, 2022

Enrollment Period

12 months

First QC Date

December 27, 2021

Last Update Submit

January 26, 2022

Conditions

Cholelithiasis (Without Cholecystitis)Pain, PostoperativeHernia Incisional

Keywords

laparoscopic cholecystectomypaintrocar site hernia

Outcome Measures

Primary Outcomes (1)

  • Trocar site hernia (TSH)

    trocar site hernia presence

    18 months

Secondary Outcomes (4)

  • Wound infection (WI)

    three weeks later

  • Hematoma (H)

    18 months (postoperative first day and three weeks later)

  • Length of hospital stay (LOH)

    18 months

  • Abdominal Pain

    Preoperative first day, postoperative first day

Study Arms (2)

Standard umbilical trocar incision closure (UC)

OTHER

standard umbilical trocar incision closure

Procedure: video-assisted umbilical closure

Video-assisted umbilical trocar incision closure (UCVA))

ACTIVE COMPARATOR

video-assisted umbilical trocar incision closure

Procedure: video-assisted umbilical closure

Interventions

video-assisted umbilical closurePROCEDURE

video-assisted umbilical closure

Also known as: standard umbilical fascial closure
Standard umbilical trocar incision closure (UC)Video-assisted umbilical trocar incision closure (UCVA))

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age above 18 years
  • symptomatic cholelithiasis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsun Education and Research Hospital

Samsun, 55060, Turkey (Türkiye)

Location

Related Publications (12)

  • 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.

    PMID: 25958296BACKGROUND

  • 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.

    PMID: 30846033BACKGROUND

  • 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.

    PMID: 32071382BACKGROUND

  • Bunting DM. Port-site hernia following laparoscopic cholecystectomy. JSLS. 2010 Oct-Dec;14(4):490-7. doi: 10.4293/108680810X12924466007728.

    PMID: 21605509BACKGROUND

  • 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.

    PMID: 22714582BACKGROUND

  • 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.

    PMID: 24112669BACKGROUND

  • 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.

    PMID: 30688041BACKGROUND

  • 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.

    PMID: 27536351BACKGROUND

  • 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.

    PMID: 26287316BACKGROUND

  • 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.

    PMID: 23925027BACKGROUND

  • 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.

    PMID: 19260458BACKGROUND

  • 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.

    PMID: 24680572BACKGROUND

MeSH Terms

Conditions

CholelithiasisPain, PostoperativeIncisional HerniaPain

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsHerniaPathological Conditions, Anatomical

Study Officials

  • Elif Colak

    Samsun Education and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 27, 2021

First Posted

January 26, 2022

Study Start

January 1, 2021

Primary Completion

December 24, 2021

Study Completion

December 27, 2021

Last Updated

February 10, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share

The datasets generated during the current study are available.

Shared Documents
STUDY PROTOCOL
Time Frame
January 2021
Access Criteria
The datasets generated during the current study are available.

Locations

TU(1)