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.

Bariatric Surgery Clinical Trial

— TROCSLEEVE  

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02973009
• Other study ID #: PI2016_843_0031
• Status: Withdrawn
• Start date: May 16, 2017
• Est. completion date: May 16, 2017

Study information

• Verified date: July 2020
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 16, 2017
• Est. primary completion date: May 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• major patients (= 18 years) who underwent SG 1st intention by laparoscopy as part of the surgical management of obesity.

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Bariatric Surgery
• Incisional Hernia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year
Secondary	rate of incisional hernia.	Evaluate the rate of incisional hernia at 1 year after 1st SG intention.	1 year
Secondary	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).	1 year
Secondary	Morbidity	Morbidity related to the closing act of the epigastric trocar (organ wound, local hematoma, surgical site infection).	1 year
Secondary	duration of the closure of the epigastric trocar.	Evaluation of the duration of the closure of the epigastric trocar.	during surgery
Secondary	duration of the implementation of the device	Analysis of the evolution of the duration of the implementation of the device	1 year