Incisional Hernia Rate After Single-incision Laparoscopic Cholecystectomy

Cholelithiasis Clinical Trial

Official title:

Long-term Incisional Hernia Rate After Single-Incision Laparoscopic Cholecystectomy (SILC) in Front of Standard Laparoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03768661
• Other study ID #: SILS Chole Hernia
• Status: Completed
• Start date: July 1, 2009
• Est. completion date: November 1, 2017

Study information

• Verified date: April 2020
• Source: Hospital Plató
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Single-incision laparoscopic cholecystectomy (SILC) requires a larger incision than standard laparoscopy, which may increase the incidence of incisional hernias.

This study evaluated SILC and standard multiport cholecystectomy with respect to perioperative outcomes, hospital stay, cosmetic results, and postoperative complications, including the 5-years incisional hernia rate.

Description:

A cohort study was performed for patients who underwent a laparoscopic cholecystectomy under an institutional review approved protocol. Between 2009 and 2011, 45 unselected patients underwent SILC performed by the same two surgeons.

The study inclusion criteria were the following: patients over 18 years with cholelithiasis, and candidates for elective surgery with no significant cardiopulmonary, hepatic or renal impairment (ASA score less than 4).

The exclusion criteria included the following: acute cholecystitis, associated CBD stones or pancreatitis, an emergency operation for complicated disease, mental illness, or patient refusal and/or absence of informed consent. All included patients signed a standard consent form after being informed about the characteristics of the SILC procedure.

The outcomes of these patients were compared with those of a control cohort series of 140 patients who underwent standard LC (with the same inclusion and exclusion criteria) during the same period.

The primary endpoint of the study was to determine the incisional hernia rate at the umbilical wound after 5 years of follow-up. Hernias were defined as evidence of a hernia at the clinical examination or those confirmed by ultrasound examination in case of clinical doubt.

The study secondary endpoints included the following: duration of surgery (from the start of the incision to skin closure), intraoperative and postoperative complications (30 days), hospital stay, and cosmetic satisfaction results (measured using a visual analogue scale score ranging from 0 to 10).

The following variables were also collected: age, gender, body mass index (BMI) and comorbidities. The anesthetic risk was measured according to the ASA classification system. Prolonged hospital stay (more than 24 h) and readmission (patients who returned for medical consultation before scheduled follow-up) were also recorded. All data were collected prospectively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: November 1, 2017
• Est. primary completion date: June 30, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients over 18 years with cholelithiasis and candidates for elective surgery (cholecystectomy)

• abscence of significant cardiopulmonary, hepatic or renal impairment (ASA score less than 4)

Exclusion Criteria:

• acute cholecystitis

• associated common bile duct stones or pancreatitis

• emergency operation for complicated disease

• ASA 4 (American Society of Anesthesiologists)

• pregnancy

• mental illness

• patient refusal and/or absence of informed consent

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstones
• Hernia
• Incisional Hernia
• Surgical Wound

Intervention

Procedure:
• Single-incision Laparoscopic cholecystectomy
laparoscopic cholecystectomy performed through a single device located at a unique umbilical incision
• Laparoscopic Cholecystectomy
laparoscopic cholecystectomy performed using three-trocars standard technique

Locations

Country	Name	City	State
Spain	Hospital Plató	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Plató

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Antoniou SA, Pointner R, Granderath FA. Single-incision laparoscopic cholecystectomy: a systematic review. Surg Endosc. 2011 Feb;25(2):367-77. doi: 10.1007/s00464-010-1217-5. Epub 2010 Jul 7. Review. — View Citation

Arezzo A, Passera R, Bullano A, Mintz Y, Kedar A, Boni L, Cassinotti E, Rosati R, Fumagalli Romario U, Sorrentino M, Brizzolari M, Di Lorenzo N, Gaspari AL, Andreone D, De Stefani E, Navarra G, Lazzara S, Degiuli M, Shishin K, Khatkov I, Kazakov I, Schrittwieser R, Carus T, Corradi A, Sitzman G, Lacy A, Uranues S, Szold A, Morino M. Multi-port versus single-port cholecystectomy: results of a multi-centre, randomised controlled trial (MUSIC trial). Surg Endosc. 2017 Jul;31(7):2872-2880. doi: 10.1007/s00464-016-5298-7. Epub 2016 Oct 24. — View Citation

Evers L, Bouvy N, Branje D, Peeters A. Single-incision laparoscopic cholecystectomy versus conventional four-port laparoscopic cholecystectomy: a systematic review and meta-analysis. Surg Endosc. 2017 Sep;31(9):3437-3448. doi: 10.1007/s00464-016-5381-0. Epub 2016 Dec 30. Review. — View Citation

Jørgensen LN, Rosenberg J, Al-Tayar H, Assaadzadeh S, Helgstrand F, Bisgaard T. Randomized clinical trial of single- versus multi-incision laparoscopic cholecystectomy. Br J Surg. 2014 Mar;101(4):347-55. doi: 10.1002/bjs.9393. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incisional hernia rate	Incisional Hernia by clinical examination or CT scan	5 years
Secondary	operating time of the procedure	Total duration of the surgical procedure (in minutes)	During the perioperative period
Secondary	postoperative complications 1	biliary leak or bile duct injury	Rate of participants suffering from biliary complication assesed after 30 days of follow-up
Secondary	postoperative complications 2	reoperations	Rate of participants who needed reoperation assesed after 30 days of follow-up
Secondary	postoperative complications 3	surgical site occurrence	Rate of participants suffering from seroma and/or wound infection assesed after 30 days of follow-up
Secondary	cosmetic satisfaction	patient's cosmetic evaluation	patient's own cosmetic evaluation using a visual analogue score ranging from 0 to 10 (0=worst to 10=best) after 30 days of follow-up

External Links

•   American Society of Anesthesiologists. ASA Physical Status Classification System
•   Centers for Disease Control and Prevention. National Healthcare Safety Network (NHSN) Procedure-Associated (PA) Module: Surgical Site Infection (SSI) Event
•   Sample size and power calculator (version 7.12). Institut Municipal d'Investigació Mèdica, Barcelona, Spain.