Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04279223
Other study ID # Konya TRH General Surgery
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
See also
  Status Clinical Trial Phase
Completed NCT00530998 - Minimally Invasive Surgery: Using Natural Orfices
Completed NCT00616616 - Single Incision Laparoscopy N/A
Recruiting NCT00416234 - Laparoendoscopic Rendez Vous Versus Standard Two Stage Approach for the Management of Cholelithiasis/Choledocholithiasis N/A
Recruiting NCT05975385 - Acupuncture for Prevention of Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy N/A
Recruiting NCT06038201 - Cholecystectomy vs EUS-guided GBD With Stone Removal N/A
Not yet recruiting NCT03981315 - Bile Composition in Healthy and Gallstones Patients
Completed NCT01824186 - Trial Comparing Pain in Single-incision Laparoscopic Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy N/A
Completed NCT00606762 - Comparison Between Low Pressure Versus High Pressure Laparoscopic Cholecystectomy N/A
Completed NCT00971750 - Laparoscopic Versus Transabdominal Ultrasound in Morbidly Obese Patients N/A
Terminated NCT01708109 - Optimal Handling of Common Bile Duct Calculus, a Prospective Study N/A
Completed NCT01881399 - Fluorescence Versus Intraoperative Cholangiography in the Visualization of Biliary Tree Anatomy N/A
Withdrawn NCT01146184 - Single Incision Laparoscopic Cholecystectomy Using a Flexible Endoscope and Ethicon Manually Articulating Devices (MAD) N/A
Terminated NCT00910325 - Natural Orifice Translumenal Endoscopic Surgery: Laparoscopic-Assisted Transvaginal Cholecystectomy Phase 1/Phase 2
Completed NCT04672902 - Treatment of Mirizzi Syndrome
Completed NCT03180229 - Granisetron Effect on Hemodynamic Changes in Laparoscopic Cholecystectomy Phase 4
Not yet recruiting NCT01339325 - Laparo-endoscopic Single Site (LESS) Cholecystectomy Versus Standard LAP-CHOLE Phase 4
Completed NCT02375529 - A Trial of Single Incision Versus Four Ports Laparoscopic Cholecystectomy N/A
Terminated NCT00486655 - NOTES-Assisted Laparoscopic Cholecystectomy Surgery N/A
Completed NCT00131131 - Epidemiology of Gallbladder Sludge and Stones in Pregnancy N/A
Terminated NCT00042549 - Lithotripsy for the Treatment of Gallstones Phase 4