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Cholelithiasis (Without Cholecystitis)NCT05208385

Video-assisted Umbilical Fascial Closure in Laparoscopic Cholecystectomy

A study testing video-assisted umbilical closure in people with Cholelithiasis (Without Cholecystitis) and Pain, Postoperative, run by Samsun Education and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
video-assisted umbilical closure
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2021to 27 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • age above 18 years
  • symptomatic cholelithiasis

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Samsun Education and Research Hospital

    Samsun, 55060

Other trials in Turkey (Türkiye)

About this study

Official title: Effectiveness of the Video-assisted Umbilical Fascial Closure in Laparoscopic Cholecystectomy: Prospective Randomized Clinical Trial of 240 Patients

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.

Read the 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.

Being tested
video-assisted umbilical closure
Keywords
laparoscopic cholecystectomy, pain, trocar site hernia
Medical subject headings
Cholelithiasis, Pain, Postoperative, Incisional Hernia, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • video-assisted umbilical closureProcedure or surgery

    Also called standard umbilical fascial closure

    video-assisted umbilical closure

Study groups in NCT05208385
Study groupRoleWhat they receive
Standard umbilical trocar incision closure (UC)Otherstandard umbilical trocar incision closure
Receives: Procedure: video-assisted umbilical closure
Video-assisted umbilical trocar incision closure (UCVA))Active comparatorvideo-assisted umbilical trocar incision closure
Receives: Procedure: video-assisted umbilical closure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Trocar site hernia (TSH)

    trocar site hernia presence

    Measured: 18 months

Secondary outcomes (4)

  1. Wound infection (WI)

    wound infection

    Measured: three weeks later

  2. Hematoma (H)

    Hematoma

    Measured: 18 months (postoperative first day and three weeks later)

  3. Length of hospital stay (LOH)

    length of hospital stay (day)

    Measured: 18 months

  4. Abdominal Pain

    Abdominal pain assessment by visual analog scale (0 minimum-10 maximum values, higher scores mean worse outcome)

    Measured: Preoperative first day, postoperative first day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2022
  2. Study start1 Jan 2021
  3. Primary completion24 Dec 2021
  4. Study completion27 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05208385
Sponsor's protocol ID
KAEK2020/3 /1
Status last verified
Jan 2022
First submitted
27 Dec 2021
Last updated
10 Feb 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The datasets generated during the current study are available.

Publications

  • 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.

    PubMed 25958296

  • 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.

    PubMed 30846033

  • 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.

    PubMed 32071382

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

    PubMed 21605509

  • 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.

    PubMed 22714582

  • 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.

    PubMed 24112669

  • 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.

    PubMed 30688041

  • 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.

    PubMed 27536351

  • 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.

    PubMed 26287316

  • 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.

    PubMed 23925027

  • 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.

    PubMed 19260458

  • 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.

    PubMed 24680572

Questions about this trial

What is this clinical trial studying?

A study testing video-assisted umbilical closure in people with Cholelithiasis (Without Cholecystitis) and Pain, Postoperative, run by Samsun Education and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Trocar site hernia (TSH) (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05208385, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2022.

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