Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100020, China
NCT Number: NCT06732661
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.
This study is active but is not currently recruiting participants.
16 year–65 year
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, 100020, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 1 year
The rate of gastroesophageal reflux disease following sleeve gastrectomy at 1 year
Time frame: 30 days postoperatively
Complications within 30 days postoperatively
Time frame: During the operation
Time from opeing of the operation to the end of the operation
Time frame: 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%.
Time frame: 3 months, 6 months, 1 year postoperatively
total weight loss compared with preoperative weight
Beijing Chao Yang Hospital
Other
A Prospective Randomized Controlled Study on the Impact of Preserving the Pre-cardial Fat Pad During Sleeve Gastrectomy on Postoperative Gastroesophageal Reflux
Acronym: Pad and SG
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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