Comparison of Stapled and Hand-Sewn Sleeve Gastrectomy
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      Sleeve gastrectomy is a stapler dependent bariatric procedure. A hand-sewn sleeve gastrectomy
      can be necessary under certain circumstances. Here, the investigatorsaimed to compare the
      outcomes of hand-sewn and stapled sleeve gastrectomies for the first time.

      In the hand-sewn group, no staplers were used and after vertical resection of the stomach by
      energy devices, the remnant stomach was closed by two rows intracorporeal sutures. In the
      stapler group, sleeve gastrectomy was done in the usual way.
    

Detailed description: 
      Nowadays, morbid obesity is a major health problem that the investigatorsface in every age
      groups. In the treatment of morbid obesity, sleeve gastrectomy is applied more and more
      frequently. However, sleeve gastrectomy is a stapler dependent operation and sleeve
      gastrectomy without the use of staplers was very limited in the literature [1]. Hand-sewn
      sleeve gastrectomy can rarely be necessary in some special conditions such as technical
      defects of the staplers, patients allergies to titanium clips or sometimes when staplers were
      unusable [1]. As far as the investigatorsknow, there was no study that compare the results of
      stapled and hand-sewn sleeve gastrectomies so far. The purpose of this study was to compare
      the hand-sewn and stapled sleeve gastrectomies in a small case series.

      In June 2013, the investigatorslaunched a natural orifice surgery program including several
      procedures. In this context, the investigatorsplanned natural orifice (transoral) extraction
      of sleeve gastrectomy specimens. Patients who were eligible and agree with participation to
      the hand-sewn sleeve gastectomy combine with transoral specimen extraction study were
      accepted to two group. This study is conducted according to the STROCSS criteria. Total six
      morbidly obese patients (body mass index more than 40 kg/m2) who had undergone hand-sewn
      sleeve gastrectomy between the dates May-2014 and December 2014, were investigated
      retrospectively. In the same time period, seven another morbidly obese patients included in
      the control group were treated with stapled sleeve gastrectomies. Grouping was done by the
      acceptance of the patients. The hand-sewn sleeve gastrectomy group combined with natural
      orifice surgery. Patients who do not participate the hand-sewn group were treated by the
      stapled sleeve gastrectomy and the specimens were extracted through the trocar site. In both
      groups, patients' age, gender, height, weight, body mass index, comorbidity, and lifestyle
      properties were recorded. Intraoperative blood loss, operating time, length of hospital stay,
      postoperative complications, and the metabolic/bariatric results of the two groups in one and
      three years were evaluated. Statistical comparisons were performed with nonparametric
      statistical tests (Mann-Whitney U-test and Wilcoxon Signed Rank Test to analyze numerical
      data, and Fisher exact test to analyze cathegorical data). Numerical data expressed as median
      and range. P<0.05 was considered as significant.

      In the hand-sewn group, following pneumoperitoneum with a Veres needle, the first 5 mm trocar
      was entered 14 cm down and 4 cm left from the xyphoid process. Other two 5 mm trocars were
      applied to the left and right upper quadrant. Last two 5 mm trocars were placed just below
      the xyphoid process for automatic liver retractor and through the epigastrium as a working
      port. A 5 mm 300 optic camera was used and the intraabdominal pressure was set to 14 mmHg.
      Gastrocolic and gastrosplenic ligaments were divided by 5 mm Ligasure (Force Triad, Covidien,
      Boulder, CO, USA) starting from 4-6 cm to pylorus till the angle of His. The greater
      curvature was liberated up to the left crus of the diaphragm. The anterior and posterior wall
      of the stomach were transected with a 5 mm Ligasure device under the guidance of a 36 F
      bougie, starting 4-6 cm away from the pylorus and division of both gatric leaves headed
      vertically in the direction of angle of His. After completion of the gastric division, the
      resected specimen was removed through the mouth with the help of an intraoperative peroral
      endoscopy using an endoscopic snare. The remaining open anterior and posterior walls of the
      stomach was continiously sutured each other by 3/0 polypropylene sutures. The suture length
      was 20 cm.

      All the trocars were 5 mm in size in the hand-sewn group. The surgical technique of the
      stapled group has been defined in detail before (2). In short, vertical gastrectomy was
      applied with a 60 mm. lineer stapler (Endo GIATM Ultra, Covidien) under the guidance of 36 F
      bougie. These procedures were done through three 12 mm and two 5 mm trocars, that were placed
      to the same locations with the hand-sewn group. The specimen in the stapler group were
      extracted from the left upper quadrant trocar site. No supportive material or suture was use
      to the staple lines. Methylene blue test was done and a drain was place in all case.

      After 6-8 hours postoperatively, the patients were mobilized, thromboembolic stockings were
      kept for five days. A liquid diet was started on day one. Prophylaxis of deep vein thrombosis
      was continued for 15 days.
    

Intervention name(s): Hand-Sewn Sleeve Gastrectomy; Stapled Sleeve Gastrectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): After laparoscopic sleeve gastrectomy, gastrectomy site is hand-sewn with 3/0 polypropylene suture and the specimen is removed transorally.; Laparoscopic sleeve gastrectomy is performed via 60 mm linear stapler (Endo GIATM Ultra, Covidien) .
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Stapled Sleeve Gastrectomy Group and Hand-Sewn Sleeve Gastrectomy Group
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: morbid obesity; surgical stapling; suture techniques; natural orifice surgery; transoral; mini-laparoscopy