A Comparative Study Between Sleeve Gastrectomy and Combined Sleeve Gastrectomy With Loop Bipartition (Short-term Outcomes).
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Assiut University
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Comparison between sleeve gastrectomy and combined sleeve gastrectomy with loop bipartition (short-term outcomes).
Study Overview
Brief Summary
Aim of the study is To compare short-term outcomes of sleeve gastrectomy operation with those of combined sleeve gastrectomy and loop bipartition procedure.
Detailed Description
Bariatric surgery has been shown to be the most effective and durable treatment for morbid obesity. Surgery results in significant weight loss and helps prevent, improve or resolve more than 40 obesity-related diseases or conditions including type 2 diabetes, heart disease, obstructive sleep apnea and certain cancers.
Surgery results in greater improvement in weight loss outcomes and obesity-related co-morbidities when compared with non-surgical interventions, regardless of the type of surgical procedure used. The most impressive change in bariatric procedure is the advent of laparoscopic sleeve gastrectomy (LSG). Since 2014, LSG has become the leading bariatric procedure in the USA.
Sleeve gastrectomy with loop bipartition ( SG+LB) was derived from the combined concepts of sleeve gastrectomy with transit bipartition (SG+TB), single anastomosis duodenal-ileostomy (SADI), mini-gastric bypass (MGB) and duodenal-jejunal bypass (DJB) with less nutritional and surgical complications.
Transit bipartition with sleeve gastrectomy (TB-SG) has been getting increased acceptance due to the advantage of preservation of the normal physiology and anatomy of duodenum. In iloe-duodenal sleeve bypass ,patients have a bypassed duodenum which is important in eliminating the foregut's negative incretin effects on insulin; however, this prevents any biliary access, if required later. TB-SG overcomes this problem by preserving the normal duodenal access, which makes the procedure more physiologic and easier to perform. With time, the gastroileal anastomosis has a tendency to enlarge resulting in "functional bypass" of duodenum, enhancing the anti-diabetic effect of the procedure.
- FIRSTLY,Sleeve gastrectomy technique:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients whose body mass index (BMI) exceeds
- •Patients with BMIs between 35 and 40 with high-risk co-morbid conditions or lifestyle-limiting obesity-induced physical conditions.
- •Age between 18 and 60 years old.
- •Both sexes.
Exclusion Criteria
- •Patients younger than 18 and older than 60 years old.
- •Obesity due to medical diseases as hypothyroidism, cushing's , ......etc.
- •Surgically-unfit patients as those with contraindications to general anesthesia or uncorrectable coagulopathy.
- •Patients with limited life expectancy due to irreversible cardiopulmonary or other end-organ failure or metastatic or in-operable malignancy.
- •Patients who are pregnant or who expect to be pregnant within 12 months.
Arms & Interventions
sleeve gastrectomy
The greater omentum is divided 5 cm from the pylorus with an energy device. The antral pouch is measured 2-6cm from the pylorus along greater curve as risk benefit ratio is best within these limits.
Devascularization is continued up the greater curve of the stomach to the short gastric vessels with the help of the assistant who maintains traction and exposure during this process. Eventually, one reaches the left crus which is an important landmark of dissection. We selectively explore the hiatus of the symptomatic and endoscopically proven hiatus hernia , and the hernia should be reduced and repaired.
Intervention: loop bipartition (Procedure)
sleeve gastrectomy with loop bipartition
Sleeve gastrectomy is performed first, then a loop gastro-ileostomy 200-250 cm from doudeno-jejunal junction was created at the dependent part of the antrum with 2 layers of with stapler but without division of the 1st part of duodenum. The resultant stomach tube has two outlets, one to the first part of duodenum through the pylorus and one to the terminal ileum through the gastro-ileostomy. The staple line and anastomosis was tested with methylene blue. A drain is inserted.
Intervention: loop bipartition (Procedure)
Outcomes
Primary Outcomes
Comparison between sleeve gastrectomy and combined sleeve gastrectomy with loop bipartition (short-term outcomes).
Time Frame: one year
Analysis of the effects of both stand-alone sleeve gastrectomy procedure and combined sleeve gastrectomy with loop bipartition on weight loss and obesity-related hypertension and diabetes mellitus, and also the complications associated with each procedure .
Secondary Outcomes
No secondary outcomes reported
Investigators
Ahmed Abdou Gad Youssef
doctor
Assiut University