Clinical trial NCT06857097: Single Anastomosis Sleeve Jejunal Bypass Versus One Anastomosis Gastric Bypass in Management of Morbid Obese Patients: A Comparative Study
Official title: Single Anastomosis Sleeve Jejunal Bypass Versus One Anastomosis Gastric Bypass in Management of Morbid Obese Patients: A Comparative Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Single Anastomosis Sleeve Jejunal Bypass
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study was conducted aiming to assess the efficacy of SASJ bypass as a novel bariatric procedure in terms of operative time, weight loss, complications and effect on comorbidities compared to the outcomes of OAGB within two years after operation.

Detailed description: This study is going to be prospectively randomized. There will be one hundred people with morbid obesity undergoing bariatric surgery at the hospitals of Sohag University and Ainshams University. The investigator will select which individuals will have gastric bypass surgery after counseling patients about all bariatric procedures. The patients were randomly assigned to two equal groups (50 per group); the first patient was OAGB (group A), and the second was SASJ (group B). After the study has been approved by the ethics council of the Sohag University and Ain shams university, Faculty of Medicine, all patients must give written informed consent for participation.

the investigators included a total of 100 cases in this prospective randomized study, and they were divided into two equal groups; SASJ and OAGB groups. The two procedures were performed by the same surgical team adapting standardized techniques. Weight loss parameters were our primary objectives, while secondary outcomes included operative time ,post-operative complications, nutritional(macro and micro nutrients) status, improvement/resolution of comorbidities and quality of life.

Total number of 100 patients, aged between 16 and 60 years, with BMI \> 40 kg/m2, or BMI \> 35 kg/m2 with the presence of obesity related comorbidity (diabetes mellitus, hypertension, OSAS, osteoarthritis) were enrolled in this study.

An informed written consent was signed by all patients, after complete explanation of the idea of the study, along with the benefits and drawbacks of each procedure. Detailed history taking, physical examination, routine preoperative laboratory investigations and abdominal ultrasonography were performed for all cases.

The 100 cases were randomly allocated into two equal groups SASJ and OAGB groups. Randomization was done in the operating room . All cases were performed by laparoscopy under general anesthesia. The two procedures were performed by 5 ports, .

For the SASJ group , sleeve was created starting devascularization of greater gastric curve 6 cm proximal to pylorus. Devascularization was done via either a harmonic scalpel or a ligasure device. Dissection was continued proximally till reaching the left diaphragmatic crus. Afterwards that the stomach was resected along the greater curvature via an endostapler over a 36-Fr bougie. After creating the sleeve, two meters of the small bowel were counted starting from the ligament of Treitz, and an antecolic isoperistaltic gastrojejunostomy (4-cm wide) was created with the antrum via linear stapler, and the anterior wall defect was closed by sutures.

In the OAGB group .dissection started just distal to the crows' foot till reaching the lesser sac. A long narrow gastric pouch was created by the endostapler. After that, a longitudinal gastrojejunostomy (4-cm wide) was created at 200 cm distal to the Treitz ligament as the SASJ group.

For all procedures, intraoperative methylene blue test was done and an abdominal drain was inserted at the gastric staple line. After operation, all cases were transferred to the internal ward, and started oral intake 6 hours after surgery. Most cases were discharged on the 1st or 2nd post operative day after fully mobilized and appropriate oral intake. Patients were recommended to receive a liquid diet for the first week, followed by soft diet for the following three weeks. There after, a long-term solid diet (hypo-caloric, protein-enriched) was recommended. Daily oral supplements of multivitamins and weekly administration of the intramuscular vitamin B12 were commenced for all cases.

Regular follow up was scheduled for all cases for weekly in the first month then 3, 6 , 12 , 24 months after surgery. During these visits, patients were clinically and biochemically assessed. Any post-operative complications were noted and recorded. Weight changes were recorded as the percentage of excess weight loss (%EWL) and percentage of total weight loss (%TWL).

Our primary outcomes were the %EWL and %TWL, while secondary outcomes included post-operative complications, improvement/resolution of comorbidities.. Diabetes resolution was defined according to Buse et al. as the presence of normal glucose and Hba1c levels in the absence of antidiabetic medications \[23\], whereas resolution of OSAS was defined by STOPBANG questionnaire with score less than 2 after operation \[24\]. Hypertension improvement was defined as blood pressure \< 140/90 with reduction of medication dose and remission without its cessation \[25\]. De novo GERD was defined as the post-operative development of reflux symptoms in patients not suffering from it \[26\], and reflux was confirmed by endoscopy in these cases.

Eligibility criteria: Inclusion Criteria:

1. body mass index of over 35 plus the comorbidity presence.
2. body mass index of over 40 with/without comorbidity.
3. patients' willingness to participate in the study.
4. patients' cooperation in follow-up researches.
5. lacking any psychiatric disease.

Exclusion Criteria:

1. Patients negating to change their lifestyle.
2. drug abuse and/or addiction.
3. eating disorder background (e.g., bulimia nervosa).
4. Patients with contraindications to laparoscopic surgery and (or) unfit for surgery.
5. pregnant patients.
6. previous upper abdominal procedures,
7. reflux symptoms
8. major unstable psychiatric illness.

Primary outcomes:
measure: Weight loss parameters
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
affiliation: Sohag University
name: sohag university hospital
role: PRINCIPAL_INVESTIGATOR
References: