NCT04279223

Brief Summary

10 mm telescope is generally used in laparoscopic cholecystectomy surgery. The use of a 10 mm telescope, although rare, causes the development of a trocar site hernia. İnvestigators thought that the incidence of trocar site hernia would decrease by using a 5 mm trocar, and investigators planned a study.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
214

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 18, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 21, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

October 15, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

August 25, 2023

Status Verified

August 1, 2023

Enrollment Period

11 months

First QC Date

February 18, 2020

Last Update Submit

August 24, 2023

Conditions

Cholelithiasis

Outcome Measures

Primary Outcomes (1)

  • Rate of people developing trocar site hernia

    Patients in both groups will undergo a physical examination every six months postoperatively. Those with suspected clinical hernia will be evaluated by ultrasonography. Whether the Trokar site hernia has developed will be recorded in the study registration forms. At the end of the third year, the controls will be completed, and the study will be terminated.

    Three years has been designed from the completion of the operations.

Study Arms (2)

5 mm trocar group

ACTIVE COMPARATOR

A study with 107 patients was planned to compare the development of trocar site hernia.

Procedure: Laparoscopic cholecystectomy

10 mm trocar group

SHAM COMPARATOR

A study with 107 patients was planned to compare the development of trocar site hernia.

Procedure: Laparoscopic cholecystectomy

Interventions

Laparoscopic cholecystectomyPROCEDURE

Comparative study to investigate the effect of small-scale trocar use on the development of trocar site hernia in laparoscopic cholecystectomy

10 mm trocar group5 mm trocar group

Eligibility Criteria

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

You may qualify if:

  • Patients with symptomatic gallstones above 18 years of age

You may not qualify if:

  • Those with a history of abdominal surgery,
  • Open cholecystectomy,
  • Patients who develop cholecystectomy complications,
  • Those with decompensated systemic disease,
  • Patients who do not want to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya Training and Research Hospital

Konya, 42090, Turkey (Türkiye)

Location

Related Publications (3)

  • Chatzimavroudis G, Papaziogas B, Galanis I, Koutelidakis I, Atmatzidis S, Evangelatos P, Voloudakis N, Ananiadis A, Doundis A, Christoforidis E. Trocar site hernia following laparoscopic cholecystectomy: a 10-year single center experience. Hernia. 2017 Dec;21(6):925-932. doi: 10.1007/s10029-017-1699-3. Epub 2017 Oct 25.

    PMID: 29071498BACKGROUND

  • Casaccia M, Papadia FS, Palombo D, Di Domenico S, Sormani MP, Batistotti P, Mascherini M, De Cian F. Single-Port Versus Conventional Laparoscopic Cholecystectomy: Better Cosmesis at the Price of an Increased Incisional Hernia Rate? J Laparoendosc Adv Surg Tech A. 2019 Sep;29(9):1163-1167. doi: 10.1089/lap.2019.0374. Epub 2019 Jul 2.

    PMID: 31264921BACKGROUND

  • Hoyuela C, Juvany M, Guillaumes S, Ardid J, Trias M, Bachero I, Martrat A. Long-term incisional hernia rate after single-incision laparoscopic cholecystectomy is significantly higher than that after standard three-port laparoscopy: a cohort study. Hernia. 2019 Dec;23(6):1205-1213. doi: 10.1007/s10029-019-01969-x. Epub 2019 May 9.

    PMID: 31073959BACKGROUND

MeSH Terms

Conditions

Cholelithiasis

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

CholecystectomyBiliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeLaparoscopyEndoscopyMinimally Invasive Surgical Procedures

Study Officials

  • alpaslan şahin, md

    general surgeon

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, General Surgeon

Study Record Dates

First Submitted

February 18, 2020

First Posted

February 21, 2020

Study Start

October 15, 2020

Primary Completion

September 15, 2021

Study Completion

September 15, 2023

Last Updated

August 25, 2023

Record last verified: 2023-08

Locations

TU(1)