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Does Using a 5 mm Telescope in Laparoscopic Cholecystectomy Reduce the Incidence of Trocar Site Hernia?

Primary Purpose

Cholelithiasis

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Laparoscopic cholecystectomy
Sponsored by
Konya Meram State Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cholelithiasis

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with symptomatic gallstones above 18 years of age

Exclusion Criteria:

  • 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

Sites / Locations

  • Konya Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

5 mm trocar group

10 mm trocar group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 18, 2020
Last Updated
August 24, 2023
Sponsor
Konya Meram State Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04279223
Brief Title
Does Using a 5 mm Telescope in Laparoscopic Cholecystectomy Reduce the Incidence of Trocar Site Hernia?
Official Title
Does Using a 5 mm Telescope in Laparoscopic Cholecystectomy Reduce the Incidence of Trocar Site Hernia? Multicentric Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
September 15, 2021 (Actual)
Study Completion Date
September 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konya Meram State Hospital

4. Oversight

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

5. Study Description

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.
Detailed Description
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. Investigators thought that the incidence of trocar site hernia would decrease by using a 5 mm trocar, and investigators planned a study. Elective laparoscopic with a diagnosis of symptomatic cholelithiasis Patients hospitalized in Mogadishu-Somalia Recep Tayyip Erdoğan Training and Research Hospital and Konya Training and Research Hospital General Surgery clinic for cholecystectomy operation will be included in the study and randomized into two groups. In the first group, a 10 mm telescope will be used, and in the second group, a 5 mm telescope will be used. Patients will be followed up for a total of 3 years in 6-month periods for the development of trocar site hernia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholelithiasis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
214 (Actual)

8. Arms, Groups, and Interventions

Arm Title
5 mm trocar group
Arm Type
Active Comparator
Arm Description
A study with 107 patients was planned to compare the development of trocar site hernia.
Arm Title
10 mm trocar group
Arm Type
Sham Comparator
Arm Description
A study with 107 patients was planned to compare the development of trocar site hernia.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic cholecystectomy
Intervention Description
Comparative study to investigate the effect of small-scale trocar use on the development of trocar site hernia in laparoscopic cholecystectomy
Primary Outcome Measure Information:
Title
Rate of people developing trocar site hernia
Description
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.
Time Frame
Three years has been designed from the completion of the operations.

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: Patients with symptomatic gallstones above 18 years of age Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
alpaslan şahin, md
Organizational Affiliation
general surgeon
Official's Role
Study Director
Facility Information:
Facility Name
Konya Training and Research Hospital
City
Konya
ZIP/Postal Code
42090
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29071498
Citation
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.
Results Reference
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PubMed Identifier
31264921
Citation
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.
Results Reference
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PubMed Identifier
31073959
Citation
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.
Results Reference
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Does Using a 5 mm Telescope in Laparoscopic Cholecystectomy Reduce the Incidence of Trocar Site Hernia?

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