Comparison Between Sleeve Gastrectomy and Loop Bipartition (Short-term Outcomes)
Condition: Loop Bipartition
Study type: Interventional

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:

             1. Positioning:

                It should be ensured that the operating table has the capacity to support the
                weight of the patient. The patient may be positioned supine or in French position
                with legs apart. The feet are secured to the foot board so that reverse
                trendelenburg position is possible. The arms should be well padded to prevent
                neurological injury should the arms be stretched out and secured to an arm board.
                Once the patient is strapped down, the table should be tilted to extremes to ensure
                that the patient is well secured and would not slip off the table.

             2. Decompression of the stomach:

                This can be achieved by insertion of orogastric tube, a hollow calibration tube by
                gastroscopy. The operators insert disposable 38 french calibration tube after
                positioning the patient and prior to draping. In doing so, surgeons are able to
                empty the gastric contents prior to surgery and during surgery, to maneuver the
                calibration tube to size the sleeve.

             3. Port placement:

                5 ports are typically inserted for LSG in our patients. A 10-12 optical trocar is
                inserted 20 cm below the left costal margin along the mid-clavicular line to gain
                access to the abdominal cavity. Other techniques like the use of Veress needle and
                open Hasson technique may be used. A 5mm epigastric port is inserted for
                introduction of a liver retractor. For patients where the distance between the
                xyphoid and umbilicus is up to 35cm we insert an infra-umbilical 15mm port as the
                working port for the surgeon. If the distance is more or the patient has central
                obesity this port is changed to a 10-12mm port that is placed approximately 20cm
                from xyphoid to the left of the mid line. Two 5mm ports are inserted in the left
                and right hypochondrial regions of the patient for assistant and surgeon.

             4. Measurement of the Antral pouch:

                Once pneumoperitoneum is established, a diagnostic laparoscopy is performed and
                hepatic steatosis assessed. The greater gastrocolic omentum is divided 5 cm from
                the pylorus with the aid of an energy device. There is consensus among bariatric
                surgeons that the antral pouch should be measured 2-6cm from the pylorus along
                greater curve as risk benefit ratio is best within these limits. However, some
                surgeons also believe that cutting too close to pylorus increases risk of leak and
                most would prefer to stay 4-6cm away.

             5. Devascularization:

                In the lateral technique, the devascularization process 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. The left crus muscle is
                then routinely dissected and hiatus explored by some for a hernia, while others may
                differ. Surgeons selectively explore the hiatus of the symptomatic and
                endoscopically proven hiatus hernia as all our patients are evaluated for symptoms
                of reflux by questionnaire pre-operative and also have a gastroscopy performed. In
                patients with hiatus hernia, the hernia should be reduced and the defect repaired.

                In the medial approach, once the lesser sac is entered the process of stapling
                starts and devascularization is done only upon completion of sleeve.

             6. Gastric tube calibration:

                The 38 French Bougie inserted preoperatively is then advanced into the stomach
                along the lesser curve. This serves as the border of transection with the linear
                staple with the remnant lesser curve forming the neo- gastric pouch. One of the
                controversies lies in the optimal size of bougie to be used to size the sleeve.

             7. Creating the gastric tube:

                Linear transaction of the stomach can be performed using 3.5mm, 3.8 mm or 4.1 mm
                staples height depending on the thickness of the stomach wall. Any serosal tears
                during stapling or excessive unexpected bleeding should be carefully evaluated as
                it may be signaling a poorly stapled area.

                The use of staple-line reinforcement either through suturing or buttressing with
                biological or synthetic material is a hotly debated topic.

             8. Closure:

                The specimen is then delivered via the umbilical port. The staple line is then
                checked for any leaks; we do not routinely oversew the staple line. The 15mm port
                site is then closed with absorbable suture and the overlying skin stitched with a
                monofilament absorbable suture after local anesthesia is administered.

        -  SECONDLY,Combined sleeve gastrectomy and loop bipartition technique:

      Sleeve gastrectomy is performed first, then a loop gastro-ileostomy 250-300 cm from the
      ileocecal valve or 200-250 cm from duodeno-jejunal junction was created at the dependent part
      of the antrum with 2 layers of handsewn suture 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 gastroileostomy. The staple
      line and anastomosis was tested with methylene blue test at the end of the procedure.

      Post-operative evaluation:

      The patients will be followed up for a period for one year using the the same parameters as
      preoperative and the outcomes of each procedure will be collected and compared with each
      other ;

        1. Regular follow up of weight and estimation of Excess Weight Loss (EWL).

        2. Regular follow up of blood pressure.

        3. Regular follow up of blood glucose and HbA1c.

        4. Follow up investigations as serum electrolytes , iron studies and lipid profile.

        5. Regular hospital follow up and strict adherence to nutritional supplementation and
           dietary instructions.

        6. Follow up of outcomes for a period of one year; including effect on weight loss, and the
           resulting complications of each procedure.
    

Intervention name(s): loop bipartition
Intervention type(s): Procedure
Intervention description(s): A loop gastro-ileostomy 250-300 cm from the ileocecal valve or 200-250 cm from duodeno-jejunal junction was created at the dependent part of the antrum with 2 layers of handsewn suture 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 gastroileostomy.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomized into two groups according to the surgical procedure performed as follows:
Group A: Patients undergoing sleeve gastrectomy.
Group B: Patients undergoing combined sleeve gastrectomy with loop bipartition.
Masking: None (Open Label)
Primary purpose: Treatment