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

Not Applicable

Active, not recruiting

• Conditions: Cholelithiasis
• Interventions: Procedure: Laparoscopic cholecystectomy

• Registration Number: NCT04279223
• Lead Sponsor: Konya Meram State Hospital

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.

Study Timeline

• Study First Submitted: 2020-02-18
• Study First Submitted QC: 2020-02-19
• Study First Posted: 2020-02-21
• Study Start: 2020-10-15
• Primary Completion: 2021-09-15
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-24
• Last Update Posted: 2023-08-25
• Study Completion: 2023-09-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 214

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5 mm trocar group	Laparoscopic cholecystectomy	A study with 107 patients was planned to compare the development of trocar site hernia.
10 mm trocar group	Laparoscopic cholecystectomy	A study with 107 patients was planned to compare the development of trocar site hernia.

Primary Outcome Measures

Name	Time	Method
Rate of people developing trocar site hernia	Three years has been designed from the completion of the operations.	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.

Trial Locations

Locations (1)

Konya Training and Research Hospital; 🇹🇷 Konya, Turkey