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

Konya Meram State Hospital

Status: Active, not recruiting

Conditions: Cholelithiasis

Treatments: Procedure: Laparoscopic cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04279223

Konya TRH General Surgery

Details and patient eligibility

About

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.

Full 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.

Enrollment: 214 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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214 participants in 2 patient groups

5 mm trocar group

Active Comparator group

Description:

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

Treatment:

Procedure: Laparoscopic cholecystectomy

10 mm trocar group

Sham Comparator group

Description:

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

Treatment:

Procedure: Laparoscopic cholecystectomy