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Sleeve Gastrectomy With Reestablishment of the Acute Angle of His (SG-REACH) in Obese Patients (SG-REACH)

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ClinicalTrials.gov Identifier: NCT05452980
Recruitment Status : Recruiting
First Posted : July 12, 2022
Last Update Posted : July 12, 2022
Sponsor:
Information provided by (Responsible Party):
Zhen Jun Wang, Beijing Chao Yang Hospital

Tracking Information
First Submitted Date  ICMJE July 1, 2022
First Posted Date  ICMJE July 12, 2022
Last Update Posted Date July 12, 2022
Actual Study Start Date  ICMJE June 1, 2022
Estimated Primary Completion Date December 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2022)		 Rate of gastroesophageal reflux disease [ Time Frame: 1 year ]
The rate of gastroesophageal reflux disease following sleeve gastrectomy at 1 year
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2022)
  • Complications [ Time Frame: 30 days postoperatively] ]
    Complications within 30 days postoperatively
  • Operating time [ Time Frame: During the operation ]
    Time from opeing of the operation to the end of the operation
  • excessive weight loss [ Time Frame: 3 months, 6 months, 1 year, 3 years and 5 years postoperatively ]
    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 [ Time Frame: 3 months, 6 months, 1 year, 3 years and 5 years postoperatively ]
    total weight loss compared with preoperative weight
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sleeve Gastrectomy With Reestablishment of the Acute Angle of His (SG-REACH) in Obese Patients
Official Title  ICMJE Sleeve Gastrectomy With Reestablishment of the Acute Angle of His (SG-REACH) in Obese Patients, a Prospective Randomized Controlled Study
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%.

To preserve this natural barrier during SG, a careful dissection at the angle of His must be maintained in order to spare the sling fibers and avoid blunting the angle of His. During creation of the sleeve, the gastric sling fibers are frequently transected near the angle of His, particularly if the transection line is very close to this anatomic landmark. These sling fibers contribute significantly to the function of the LES.

The investigators suggest that after the finishing of SG, the anatomical structure of His horn was destroyed or partly destroyed, and the acute angle of His become obtuse angle. The investigators propose to perform a prospective randomized controlled study to reestablish the acute angle of His 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. Management of GERD consists primarily in the use of proton pump inhibitors and, in a subset of patients refractory to medical therapy, the use of some form of antireflux surgery. Goals for most antireflux procedures include restoration of a competent lower esophageal sphincter, transhiatal esophageal mobilization to establish 3 cm of intraabdominal esophagus, repair of concomitant hiatus hernia or crura separation, and performance of a partial or total fundoplication. Although the mechanism of action of the surgical fundoplication is multifactorial, one of the most important components is the reestablishment of the acute angle of His through the reconstruction and accentuation of the native musculomucosal, gastroesophageal flap valve.The anatomical mechanisms preventing GERD are the oblique sling fibers of the cardia, the phrenoesophageal ligament, the crura of the diaphragm, and the angle of His. The esophagus normally enters the stomach at an acute angle (the angle of His).

Several factors have been identified including the intrinsic lower oesophageal sphincter (LOS), extrinsic compression of the LOS by the pinchcock action of the crural diaphragm, the length of intra-abdominal oesophagus and the anatomical configuration of the gastric cardia, the angle of His. Emphasis has been placed on either LOS dysfunction, loss of support by the crural diaphragm because of hiatus hernia, or loss of the angle of His. Studies suggested that the angle of His is an important antireflux mechanism. The more acute this angle, the more the gastric fundus will be projected toward the esophagus as gastric distension occurs during a meal. And studies showed that the angle of His plays a role in reflux after distal gastrectomy and that the severity of reflux may be estimated by measuring this angle.

Laparoscopic sleeve gastrectomy (LSG) has become a popular technique and currently is the most frequently practiced surgical operation to treat obesity today. SM-BOSS and SLEEVEPASS studies proved that SG achieve similar weight loss and resolution of obesity-related comorbidities in comparison to those undergoing Roux-en-Y gastric bypass (RYGB). However, the prevalence of GERD following SG can be fairly high. Several studies have noted an incidence between 6% and 47%. This has prompted discussion among the surgical community with regard to the underlying pathomechanisms of GERD after SG and the postoperative management of reflux disease. So far, a number of new techniques have been reported to yield more encouraging results with regard to reflux symptoms after SG, but most evidence originates from retrospective studies with a small number of cases or is based on experts' opinions. The available data are limited, and very heterogeneous.

To preserve this natural barrier during SG, a careful dissection at the angle of His must be maintained in order to spare the sling fibers and avoid blunting the angle of His. During creation of the sleeve, the gastric sling fibers are frequently transected near the angle of His, particularly if the transection line is very close to this anatomic landmark. These sling fibers contribute significantly to the function of the LES.

The investigators suggest that after the finishing of SG, the anatomical structure of His horn was destroyed or partly destroyed, and the acute angle of His become obtuse angle. The investigators propose to perform a prospective randomized controlled study to reestablish the acute angle of His in obese patients followig sleeve gastrectomy to prevent GERD.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Gastroesophageal Reflux Disease
  • Excessive Weight Loss
  • Total Weight Loss
  • Sleeve Gastrectomy
  • Angle of His
Intervention  ICMJE
  • Procedure: reestablishment of the acute angle of His
    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 15 mm lateral to the esophagus is respected to reduce the risk of high leak.
    Other Name: sleeve gastrectomy
  • Procedure: sleeve gastrectomy
    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 15 mm lateral to the esophagus is respected to reduce the risk of high leak.
Study Arms  ICMJE
  • Active Comparator: sleeve gastrectomy
    For standard sleeve gastrectomy (SG), 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 15 mm lateral to the esophagus is respected to reduce the risk of high leak.
    Intervention: Procedure: sleeve gastrectomy
  • Experimental: SG with reestablishment of the acute angle of His
    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 15 mm lateral to the esophagus is respected to reduce the risk of high leak. Three stitches using nonabsorbable 2-0 Prolone were performed to reestablish the acute angle of His: anterior gastric fundus with esophagus, gastric fundus with left crural diaphragm, posterior gastric fundus with left crural diaphragm.
    Intervention: Procedure: reestablishment of the acute angle of His
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 6, 2022)		 66
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2025
Estimated Primary Completion Date December 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jia Gang Han +861085231604 hanjiagang@ccmu.edu.cn
Contact: Zhi Wei Zhai +861085231328 zhaizhiwei@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05452980
Other Study ID Numbers  ICMJE SG-REACH
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Zhen Jun Wang, Beijing Chao Yang Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Zhen Jun Wang
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Zhen Jun Wang Beijing Chao Yang Hospital
PRS Account Beijing Chao Yang Hospital
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP