CholelithiasisNCT03768661
Incisional Hernia Rate After Single-incision Laparoscopic Cholecystectomy
An observational study of Cholelithiasis, run by Hospital Plató at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholelithiasis
- What is being tested?
- Single-incision Laparoscopic cholecystectomy and Laparoscopic Cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 185 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2009to 1 Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: - patients over 18 years with cholelithiasis and candidates for elective surgery (cholecystectomy)
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Incisional Hernia Rate After Single-Incision Laparoscopic Cholecystectomy (SILC) in Front of Standard Laparoscopy
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.
Read the 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.
- Conditions
- Cholelithiasis
- Being tested
- Single-incision Laparoscopic cholecystectomy, Laparoscopic Cholecystectomy
- Keywords
- cholecystectomy, laparoscopy, single-incision laparoscopic surgery, incisional hernia, trocar-site hernia
- Medical subject headings
- Cholelithiasis, Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-incision Laparoscopic cholecystectomyProcedure or surgery
laparoscopic cholecystectomy performed through a single device located at a unique umbilical incision
Laparoscopic CholecystectomyProcedure or surgery
laparoscopic cholecystectomy performed using three-trocars standard technique
| Study group | Role | What they receive |
|---|---|---|
| SILC Group | patients with symptomatic cholelithiasis submitted to a single-incision laparoscopic cholecystectomy Receives: Procedure: Single-incision Laparoscopic cholecystectomy | |
| Laparoscopy Group | patients with symptomatic cholelithiasis submitted to a standard three trocar laparoscopic cholecystectomy Receives: Procedure: Laparoscopic Cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
incisional hernia rate
Incisional Hernia by clinical examination or CT scan
Measured: 5 years
Secondary outcomes (5)
operating time of the procedure
Total duration of the surgical procedure (in minutes)
Measured: During the perioperative period
postoperative complications 1
biliary leak or bile duct injury
Measured: Rate of participants suffering from biliary complication assesed after 30 days of follow-up
postoperative complications 2
reoperations
Measured: Rate of participants who needed reoperation assesed after 30 days of follow-up
postoperative complications 3
surgical site occurrence
Measured: Rate of participants suffering from seroma and/or wound infection assesed after 30 days of follow-up
cosmetic satisfaction
patient's cosmetic evaluation
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start1 Jul 2009
- Primary completion30 Jun 2011
- Study completion1 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CholelithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Plató
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos Hoyuela, MD PhD, Principal investigator, Chief, Dept. of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03768661
- Sponsor's protocol ID
- SILS Chole Hernia
- Status last verified
- Apr 2020
- First submitted
- 3 Dec 2018
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20607556Evers 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.
PubMed 28039641Jorgensen 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.
PubMed 24536008Arezzo 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.
PubMed 27778171Hoyuela 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.
PubMed 31073959
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Incisional Hernia Rate After Single-Incision Laparoscopic Cholecystectomy (SILC) in Front of Standard Laparoscopy
- ClinicalTrials.gov ID
- NCT03768661
- Acronym / sponsor ID
- SILS Chole Hernia
- Conditions
- Cholelithiasis
- Keywords
- cholecystectomy, laparoscopy, single-incision laparoscopic surgery, incisional hernia, trocar-site hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Hospital PlatóUniversity, hospital or other
- Study start
- 1 Jul 2009 (actual)
- Primary completion
- 30 Jun 2011 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 7 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SILC Group | – | Procedure: Single-incision Laparoscopic cholecystectomypatients with symptomatic cholelithiasis submitted to a single-incision laparoscopic cholecystectomy |
| Laparoscopy Group | – | Procedure: Laparoscopic Cholecystectomypatients with symptomatic cholelithiasis submitted to a standard three trocar laparoscopic cholecystectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - patients over 18 years with cholelithiasis and candidates for elective surgery (cholecystectomy)
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (7 listed)
- acute cholecystitis
- associated common bile duct stones or pancreatitis
- emergency operation for complicated disease
- ASA 4 (American Society of Anesthesiologists)
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single-incision Laparoscopic cholecystectomylaparoscopic cholecystectomy performed through a single device located at a unique umbilical incision | Procedure or surgery | SILC Group |
| Laparoscopic Cholecystectomylaparoscopic cholecystectomy performed using three-trocars standard technique | Procedure or surgery | Laparoscopy Group |
Primary outcome
incisional hernia rate
Time frame: 5 years
Incisional Hernia by clinical examination or CT scan
5 secondary outcomes
operating time of the procedure
Time frame: During the perioperative period
postoperative complications 1
Time frame: Rate of participants suffering from biliary complication assesed after 30 days of follow-up
postoperative complications 2
Time frame: Rate of participants who needed reoperation assesed after 30 days of follow-up
postoperative complications 3
Time frame: Rate of participants suffering from seroma and/or wound infection assesed after 30 days of follow-up
cosmetic satisfaction
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Background: PubMed 20607556Antoniou 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.
- Background: PubMed 28039641Evers 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.
- Background: PubMed 24536008Jorgensen 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.
- Background: PubMed 27778171Arezzo 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.
- Derived from this study: PubMed 31073959Hoyuela 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.
- American Society of Anesthesiologists. ASA Physical Status Classification SystemLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Hoyuela, MD PhD principal investigator
Chief, Dept. of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholelithiasis, run by Hospital Plató at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incisional hernia rate (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03768661, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.