Incisional Hernia Rate After Single-incision Laparoscopic Cholecystectomy
Long-term Incisional Hernia Rate After Single-Incision Laparoscopic Cholecystectomy (SILC) in Front of Standard Laparoscopy
1 other identifier
observational
185
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2009
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedFirst Submitted
Initial submission to the registry
December 3, 2018
CompletedFirst Posted
Study publicly available on registry
December 7, 2018
CompletedApril 14, 2020
April 1, 2020
2 years
December 3, 2018
April 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
incisional hernia rate
Incisional Hernia by clinical examination or CT scan
5 years
Secondary Outcomes (5)
operating time of the procedure
During the perioperative period
postoperative complications 1
Rate of participants suffering from biliary complication assesed after 30 days of follow-up
postoperative complications 2
Rate of participants who needed reoperation assesed after 30 days of follow-up
postoperative complications 3
Rate of participants suffering from seroma and/or wound infection assesed after 30 days of follow-up
cosmetic satisfaction
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
Study Arms (2)
SILC Group
patients with symptomatic cholelithiasis submitted to a single-incision laparoscopic cholecystectomy
Laparoscopy Group
patients with symptomatic cholelithiasis submitted to a standard three trocar laparoscopic cholecystectomy
Interventions
laparoscopic cholecystectomy performed through a single device located at a unique umbilical incision
laparoscopic cholecystectomy performed using three-trocars standard technique
Eligibility Criteria
\- patients over 18 years with cholelithiasis and candidates for elective surgery (cholecystectomy)
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Platólead
Study Sites (1)
Hospital Plató
Barcelona, 08006, Spain
Related Publications (5)
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.
PMID: 20607556BACKGROUNDEvers 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.
PMID: 28039641BACKGROUNDJorgensen 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.
PMID: 24536008BACKGROUNDArezzo 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.
PMID: 27778171BACKGROUNDHoyuela 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.
PMID: 31073959DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carlos Hoyuela, MD PhD
Chief, Dept. of Surgery
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2018
First Posted
December 7, 2018
Study Start
July 1, 2009
Primary Completion
June 30, 2011
Study Completion
November 1, 2017
Last Updated
April 14, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share