An Evaluation of the Outcomes of Bariatric Surgery - a Cohort Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIHU Strasbourg

About this trial

A prospective bariatric database was carried out in the Department of Digestive and Endocrine Surgery at the University Hospital of Strasbourg, France, starting in January 1996. All potential candidates for obesity surgery were prospectively registered in the database. Patients were informed by the bariatric surgeon of the prospective database, and of the possibility of utilizing personal data for research purpose after anonymization.

A case-control study was performed, to compare the quality of life (QoL) of patients treated for internal hernia (IH group) with the QoL of patients with an uncomplicated course after Roux en Y gastric bypass (Uncomplicated RYGB group).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patient >18 years old

BMI > 35 kg/m²

Disqualifiers

Incapacity of giving an informed consent

Trial population

Patient \>18 years old BMI \>35 kg/m²

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Roux en Y gastric bypass

    Procedure/Surgery

    Laparoscopic RYGB is performed as following: a gastric pouch of approximately 30mL was obtained using successive firings of the Endo GIATM linear stapler, followed by the creation of an antecolic alimentary limb of 150cm and of a biliopancreatic limb of 75cm. A gastrojejunal anastomosis was fashioned with the PCEEA™ 28 circular stapler until 2012, and using the Endo GIA™ linear stapler afterwards. The mesenteric defect and Petersen's defect were closed using a non-absorbable running suture.

  • Sleeve gastrectomy

    Procedure/Surgery

    Laparoscopic SG is performed as following: after greater curvature mobilization, the gastric tube was calibrated over a 36F bougie and transection started approximately 5-6 cm from the pylorus toward the left diaphragmatic crus, using successive firings of 3.5- or 4.8-mm-high staples, depending on gastric thickness.

  • Gastric banding

    Procedure/Surgery

    Laparoscopic gastric banding is performed as following: a perigastric tunel is performed by blunt dissection and the banding is calibrated over the stomach.

  • Intragastric balloon

    Procedure/Surgery

    Flexible endoscopy is used to place intragastric balloon for a maximum interval of six months.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Excess weight loss

Time frame
1 - 3 - 5 - 10 - 15 and 30 years

Secondary outcomes

1

BMI

Time frame
1 - 3 - 5 - 10 - 15 and 30 years
2

Albumin

Albumin

Time frame
1 - 3 - 5 - 10 - 15 and 30 years
3

Pre-albumin

Pre-albumin

Time frame
1 - 3 - 5 - 10 - 15 and 30 years
4

Vitamin A

Vitamin A

Time frame
1 - 3 - 5 - 10 - 15 and 30 years

Other outcomes

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