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

Cholelithiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04279223
• Other study ID #: Konya TRH General Surgery
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 15, 2020
• Est. completion date: September 15, 2023

Study information

• Verified date: August 2023
• Source: Konya Meram State Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 214
• Est. completion date: September 15, 2023
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Intervention

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

Locations

Country	Name	City	State
Turkey	Konya Training and Research Hospital	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Konya Meram State Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.