Bariatric SurgeryTROCSLEEVENCT02973009
Impact of the Systematic Closure of the Epigastric Trocar on Postoperative Incisional Hernia After Sleeve Gastrectomy Rate of First Intention. Monocentric Study, Before / After Prospective.
An observational study of Bariatric Surgery, run by Centre Hospitalier Universitaire, Amiens.
Trial summary
The Sleeve Gastrectomy (SG) is a bariatric surgery procedure performed by laparoscopic booming in recent years. This is an effective intervention on weight loss over the long term with few early postoperative complications and low morbidity in the long term. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 16 May 2017to 16 May 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: major patients who underwent SG 1st intention by laparoscopy as part of the surgical management of obesity
Who may be able to join
- major patients (≥ 18 years) who underwent SG 1st intention by laparoscopy as part of the surgical management of obesity.
Who cannot join
- antecedent of previous gastric band.
- History of SG (repeat-SG).
- median laparotomy history or subcostal right.
- SG performed as an ambulatory surgery.
- Patients with early postoperative complications (≤ J90) specific to the SG (postoperative gastric fistula, postoperative bleeding, hematoma or postoperative intra-abdominal abscess)
About this study
The Sleeve Gastrectomy (SG) is a bariatric surgery procedure performed by laparoscopic booming in recent years.
This is an effective intervention on weight loss over the long term with few early postoperative complications and low morbidity in the long term.
Read more
Obesity is considered as a risk factor for hernia full after surgery by laparoscopy with a relative risk of 29% in connection with cholecystectomy.
Several series showed a rupture rate on trocar from 0 to 0.7%, but each time with a clinical evaluation.
Recently, it was shown eventrations rate between 26 and 38% under the Roux-en-Y gastric bypass with a rupture rate increased on epigastric trocar. The assessment in the context of this series was ultrasound.
Recent data suggest that the absence of closure of the epigastric trocar of 12mm through an SG of first intention was associated with a hernia rate of 17% with a scannographic evaluation.
Also, recently, Tabone suggests that the systematic closure of the epigastric trocar site would not be as effective as lateralize inserting the trocar from the white line of the abdomen. Change the positioning of this trocar induce an additional difficulty in handling instruments for the realization of the SG with an désaxassion instruments, a conflict between the instruments for the realization of the SG and the optical laparoscopy.
- Conditions
- Bariatric Surgery
- Keywords
- The Sleeve Gastrectomy (SG), bariatric surgery, laparoscopy, systematic closure of the epigastric
What is being measured
The primary outcome is the main question the study is designed to answer.
systematic closure of the epigastric trocar
Test the hypothesis that the systematic closure of the epigastric trocar 12 mm would reduce by three the number of rupture on epigastric trocar after SG first intent
Measured: 1 year
Secondary outcomes (5)
rate of incisional hernia.
Evaluate the rate of incisional hernia at 1 year after 1st SG intention.
Measured: 1 year
rate of rupture opposite
To evaluate the rate of rupture opposite the closure of the open laparoscopy incision closed using the conventional technique (Deguines JB, Qassemyar Q Dhahri A Brehant O, Fuks D Verhaeghe P Regimbeau JM. Technique of open laparoscopy .. for supramesocolic surgery in obese patients Surg Endosc 2010 Aug; 24 (8): 2053-5) from the rupture rate over the epigastric port with the use of WECK EFx ™ (Teleflex Medical SAS, F-31460 the Faget, France).
Measured: 1 year
Morbidity
Morbidity related to the closing act of the epigastric trocar (organ wound, local hematoma, surgical site infection).
Measured: 1 year
duration of the closure of the epigastric trocar.
Evaluation of the duration of the closure of the epigastric trocar.
Measured: during surgery
duration of the implementation of the device
Analysis of the evolution of the duration of the implementation of the device
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2016 (estimated)
- Study start16 May 2017
- Primary completion16 May 2017
- Study completion16 May 2017
Why it stopped: investigator choice
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Marc REGIMBEAU, PU-PH, Principal investigator, CHU amiens-Picardie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02973009
- Sponsor's protocol ID
- PI2016_843_0031
- Acronym
- TROCSLEEVE
- Status last verified
- Jun 2026
- First submitted
- 14 Nov 2016
- Last updated
- 16 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Systematic Closure of the Epigastric Trocar on Postoperative Incisional Hernia After Sleeve Gastrectomy Rate of First Intention. Monocentric Study, Before / After Prospective.
- ClinicalTrials.gov ID
- NCT02973009
- Acronym / sponsor ID
- TROCSLEEVE / PI2016_843_0031
- Conditions
- Bariatric Surgery
- Keywords
- The Sleeve Gastrectomy (SG), bariatric surgery, laparoscopy, systematic closure of the epigastric
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: investigator choice
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 16 May 2017 (actual)
- Primary completion
- 16 May 2017 (actual)
- Study completion
- 16 May 2017 (actual)
- First posted
- 25 Nov 2016 (estimated)
- 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.
The Sleeve Gastrectomy (SG) is a bariatric surgery procedure performed by laparoscopic booming in recent years.
This is an effective intervention on weight loss over the long term with few early postoperative complications and low morbidity in the long term.
Obesity is considered as a risk factor for hernia full after surgery by laparoscopy with a relative risk of 29% in connection with cholecystectomy.
Several series showed a rupture rate on trocar from 0 to 0.7%, but each time with a clinical evaluation.
Recently, it was shown eventrations rate between 26 and 38% under the Roux-en-Y gastric bypass with a rupture rate increased on epigastric trocar. The assessment in the context of this series was ultrasound.
Recent data suggest that the absence of closure of the epigastric trocar of 12mm through an SG of first intention was associated with a hernia rate of 17% with a scannographic evaluation.
Also, recently, Tabone suggests that the systematic closure of the epigastric trocar site would not be as effective as lateralize inserting the trocar from the white line of the abdomen. Change the positioning of this trocar induce an additional difficulty in handling instruments for the realization of the SG with an désaxassion instruments, a conflict between the instruments for the realization of the SG and the optical laparoscopy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- major patients who underwent SG 1st intention by laparoscopy as part of the surgical management of obesity
Key inclusion criteria (1 listed)
- major patients (≥ 18 years) who underwent SG 1st intention by laparoscopy as part of the surgical management of obesity.
Key exclusion criteria (5 listed)
- antecedent of previous gastric band.
- History of SG (repeat-SG).
- median laparotomy history or subcostal right.
- SG performed as an ambulatory surgery.
- Patients with early postoperative complications (≤ J90) specific to the SG (postoperative gastric fistula, postoperative bleeding, hematoma or postoperative intra-abdominal abscess)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
systematic closure of the epigastric trocar
Time frame: 1 year
Test the hypothesis that the systematic closure of the epigastric trocar 12 mm would reduce by three the number of rupture on epigastric trocar after SG first intent
5 secondary outcomes
rate of incisional hernia.
Time frame: 1 year
rate of rupture opposite
Time frame: 1 year
Morbidity
Time frame: 1 year
duration of the closure of the epigastric trocar.
Time frame: during surgery
duration of the implementation of the device
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
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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.
Jean-Marc REGIMBEAU, PU-PH principal investigator
CHU amiens-Picardie
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery, run by Centre Hospitalier Universitaire, Amiens.
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 1 inclusion and 5 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: withdrawn, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
systematic closure of the epigastric trocar (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jun 2026.