Excessive Weight Loss, Gastroesophageal Reflux Disease, Pre-cardial Fat Pad, Sleeve Gastrectomy, Total Weight Loss
Conditions
Keywords
sleeve gastrectomy, pre-cardial fat pad, Gastroesophageal Reflux Disease, Weight Loss
Brief summary
Gastroesophageal reflux disease (GERD) is one of the most common chronic conditions that can affect one's quality of life. Laparoscopic sleeve gastrectomy (LSG) has become a popular technique and currently is the most frequently practiced surgical operation to treat obesity today. However, the prevalence of GERD following SG can be fairly high. Several studies have noted an incidence between 6% and 47%. The angle of His is important for the maintenance of esophageal anti-reflux ability, and prevent GERD. Most SG operating consensus recommends surgeons should stay at least 1 cm away from the angle of His. However, on consensus was reached about the pre-cardial fat pad should be routinely dissected or not to avoid leaving behind a large fundus consensus. The investigators propose to perform a prospective randomized controlled study to dissect the pre-cardial fat pad or not in obese patients followig sleeve gastrectomy to prevent GERD.
Detailed description
Gastroesophageal reflux disease (GERD) is one of the most common chronic conditions that can affect one's quality of life. Laparoscopic sleeve gastrectomy (LSG) has become a popular technique and currently is the most frequently practiced surgical operation to treat obesity today. However, the prevalence of GERD following SG can be fairly high. Several studies have noted an incidence between 6% and 47%. The angle of His is important for the maintenance of esophageal anti-reflux ability, and prevent GERD. Most SG operating consensus recommends surgeons should stay at least 1 cm away from the angle of His. However, on consensus was reached about the pre-cardial fat pad should be routinely dissected or not to avoid leaving behind a large fundus consensus. The dissection of pre-cardial fat pad is helpful to fully expose the gastric fundus, to accurately judge the distance between the incision line and the esophagus, and to help the suture embedding of the incision line. However, the disadvantages might increase the rate of GERD. While retaining the pre-cardial fat pad may contribute to the reduction of GERD rate. However, it might not be conducive to the judgment of cutting distance to the esophagus and the procedure of suture embedding. Futhermore, there may be gastric fundus residue during SG. The investigators propose to perform a prospective randomized controlled study to dissect the pre-cardial fat pad or not in obese patients followig sleeve gastrectomy to prevent GERD.
Interventions
PROCEDUREPreserve pre-cardial fat pad
For this group, a sleeve was fashioned starting 4 cm proximal to the pylorus using serial applications of an 60 stapler over a 36Fr oro-gastric bougie. A security distance of 10 mm lateral to the esophagus is respected without dissection of pre-cardial fat pad.
PROCEDUREDissect pre-cardial fat pad
For this group, a sleeve was fashioned starting 4 cm proximal to the pylorus using serial applications of an 60 stapler over a 36Fr oro-gastric bougie. Dissect the pre-cardial fat pad, and a security distance of 10 mm lateral to the esophagus is respected.
Sponsors
Beijing Chao Yang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* BMI ≥ 32.5 kg/m2 with or without T2DM; * 27.5 kg/ m2 \< BMI \< 32.5 kg/m2 with T2DM but failed conservative treatment and combined with at least two metabolic diseases or comorbidities; * Duration of T2DM ≤15 years with fasting Cpeptide ≥ 50% of normal lower limit * Waist circumference: male ≥ 90 cm, female ≥ 85 cm * Age within 16\ 65 years old
Exclusion criteria
* GERD preoperatively * Hiatus hernia approved by gastroscopy preoperatively * Pregnancy; * A history of mental illness and neurological disease; * The patient refuses surgery; * Combined with pituitary tumor; * Long-term use of antidepressant drugs; * Long-term use of immunosuppressants; * Situations in which the investigator or other examiner considers from the enrolled study that there are good reasons for nonconformity: if there are potential inconsistencies with the clinical protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of gastroesophageal reflux disease | 1 year | The rate of gastroesophageal reflux disease following sleeve gastrectomy at 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications | 30 days postoperatively | Complications within 30 days postoperatively |
| Operating time | During the operation | Time from opeing of the operation to the end of the operation |
| excessive weight loss | 3 months, 6 months, 1 year postoperativel | Percentage of excess weight loss (EWL) at any time postoperative was calculated as the amount of weight loss divided by the amount of excess weight times 100%. |
| total weight loss | 3 months, 6 months, 1 year postoperatively | total weight loss compared with preoperative weight |
Countries
China
Outcome results
None listed