Short Term Outcome Of Distal Mesogastric Fixation After Laparoscopic Sleeve Gastrectomy;
Condition: Bariatric Surgery Candidate
Study type: Interventional

Summary: 
      This study included patients who were admitted to investigator's center to do laparoscopic
      sleeve gastrectomy . Cases were collected in the period from December 2019 to December 2020.
      Sample size was 84 patients divided into 2 equal groups . Group 1: included 42 patients who
      were subjected to distal mesogastric fixation after laparoscopic sleeve gastrectomy. Group 2:
      included 42 patients who were subjected to laparoscopic sleeve gastrectomy alone without
      distal mesogastric fixation.
    

Detailed description: 
      Laparoscopic sleeve gastrectomy is one of weight loss operations and widely performed all
      over the world . although its widely performed ,it has serious complications like leakage and
      bleeding . The proposed etiology behind leakage after laparoscopic sleeve gastrectomy may be
      the axial rotation of the stomach owing to loss of abdominal ligament fixation along the
      greater curvature of the stomach . The mechanism of increased intra-gastric pressure due to
      axial gastric rotation may put a lot of stress on the staple lines with increased incidence
      of leakage. Other complications may occur such as vomiting, food intolerance or persistent
      reflux.

      Objectives:

      To assess the effect of distal mesogastric fixation after laparoscopic sleeve gastrectomy to
      minimize gastric axial rotation and subsequent leakage and other related complications.

      Patients and methods:

      investigators included all patients who were subjected to laparoscopic sleeve gastrectomy at
      investigators' center between December 2019 to December 2020. The study was approved by the
      research and Ethics committee of our university and performed in accordance with the code of
      ethics of the world medical association (Declaration of Helsinki) for studies involving
      humans. A written informed consent was obtained from all participants.

      Sample size The sample size was calculated using open Epi program using the following data ;
      confidence interval 95% , power of test 80% , the percent of patients without leak after LSG
      was 66.6% while after new technique expected to be 95% , odd ratio 9.5% and ratio between two
      group 1:1; so the calculated sample size was 72 patients , taking into consideration 20% drop
      outs so the final sample size will be 84 patients divided into 2 equal groups . Group 1:
      included 42 patients who were subjected to distal mesogastric fixation after laparoscopic
      sleeve gastrectomy. Group 2: included 42 patients who were subjected to laparoscopic sleeve
      gastrectomy alone without distal mesogastric fixation.

      Patients who had no contraindication for laparoscopic surgery (such as patients with no
      history of abdominal operations), good general condition with American society of
      anesthesiology (ASA) I & II, and patients with body mass index above 35 were included.
      investigators excluded patients who had bad general condition (ASA ≥3), patients with gastro
      esophageal reflux or hiatal hernia.

      Perioperative measures:

      In this prospective randomized control trials , all patients were subjected to the
      followings: patients were selected by randomization method , Full history taking , Complete
      physical examination , laboratory investigations ( complete blood picture , liver and kidney
      functions , coagulation profile ) , radiological investigations ( chest x- ray , CT with oral
      and I.V contrast ) & patients were subjected to upper GI endoscopy.

      Surgical techniques :

      investigators performed traditional laparoscopic sleeve gastrectomy then investigators fixed
      the greater omentum & mesocolon that were cut during gastrectomy to the remaining gstric
      pouch along the new greater curvature as high as possible along the stable line then we
      plicated the remaining staple line till angle of His. (the greater omentum & mesocolon not
      reach this part of staple line) , so the remaining gastric pouch remained tension free and
      was returned to original position and this may prevent the axial gastric rotation as in
      figures .

      Follow up after surgery and discharge from the hospital:

      investigators examined the patients clinically, made routine laboratory investigations , made
      follow up CT with oral and I.V contrast in first week after the operation if suspected
      leakage & patients were subjected to upper GI endoscopy in first week after the operation if
      suspected leakage. The patients were followed up for one week, two weeks and one month,
      6months post operatively.

      Statistical analysis:

      The collected data were analyzed by computer using Statistical Package of Social Services
      version 22 (SPSS), Data were represented in tables and graphs, Continuous Quantitative
      variables e.g. age were expressed as the mean ± SD & (range), and categorical qualitative
      variables were expressed as absolute frequencies (number) & relative frequencies
      (percentage).

      Suitable statistical tests of significance were used after checked for normality. Categorical
      data were cross tabulated and analyzed by the Chi-square test or Fisher's Exact Test;
      Continuous data were evaluated by student t- test. The results were considered statistically
      significant when the significant probability was less than 0.05 (P < 0.05). P-value < 0.001
      was considered highly statistically significant (HS), and P-value ≥ 0.05 was considered
      statistically insignificant (NS).
    

Intervention name(s): distal mesogastric fixation after sleeve gastrectomy
Intervention type(s): Procedure
Intervention description(s): Investigators performed traditional laparoscopic sleeve gastrectomy then we fixed the greater omentum & mesocolon that were cut during gastrectomy to the remaining gstric pouch along the new greater curvature as high as possible along the stable line then we plicated the remaining staple line till angle of His. (the greater omentum & mesocolon not reach this part of staple line) , so the remaining gastric pouch remained tension free and was returned to original position and this may prevent the axial gastric rotation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study included patients who were admitted to our center to do laparoscopic sleeve gastrectomy . Cases were collected in the period from December 2019 to December 2020. Sample size was 84 patients divided into 2 equal groups . Group 1: included 42 patients who were subjected to distal mesogastric fixation after laparoscopic sleeve gastrectomy. Group 2: included 42 patients who were subjected to laparoscopic sleeve gastrectomy alone without distal mesogastric fixation.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Laparoscopic Sleeve Gastrectomy