Clinical trial NCT03768661: Incisional Hernia Rate After Single-incision Laparoscopic Cholecystectomy
Official title: Long-term Incisional Hernia Rate After Single-Incision Laparoscopic Cholecystectomy (SILC) in Front of Standard Laparoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cholelithiasis
Keywords: cholecystectomy
laparoscopy
single-incision laparoscopic surgery
incisional hernia
trocar-site hernia
Lead sponsor: Hospital Plató
Sponsor class: OTHER
First posted: 2018-12-07
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - patients over 18 years with cholelithiasis and candidates for elective surgery (cholecystectomy)

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: incisional hernia rate
timeFrame: 5 years
Secondary outcomes:
measure: operating time of the procedure
timeFrame: During the perioperative period
measure: postoperative complications 1
timeFrame: Rate of participants suffering from biliary complication assesed after 30 days of follow-up
measure: postoperative complications 2
timeFrame: Rate of participants who needed reoperation assesed after 30 days of follow-up
measure: postoperative complications 3
timeFrame: Rate of participants suffering from seroma and/or wound infection assesed after 30 days of follow-up
measure: cosmetic satisfaction
timeFrame: 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
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Plató
Study officials:
affiliation: Chief, Dept. of Surgery
name: Carlos Hoyuela, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: Jorgensen 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.
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.
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.