A Comparative Study to Evaluate Efficacy of Oversewing Versus Surgical Ligation Clips for Staple Line Reinforcement of the Gastric Pouch to Reduce Post Operative Bleeding in Laparoscopic One Anastomosis Gastric Bypass
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Cairo University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Incidence of Clinically Significant Postoperative Bleeding Within 30 Days
Study Overview
Brief Summary
- To test if there is a significant differences between Oversewing versus surgical ligation clips for staple line reinforcement of the gastric pouch regarding the reduction of post operative bleeding and the need for blood transfusions in laparoscopic one anastomosis gastric bypass.
- To assess whether oversewing or the use of surgical clips is more effective in reducing operative time and Cost analysis in (OAGB).
- To Provide evidence-based recommendations on staple line reinforcement techniques in OAGB, emphasizing patient safety and procedural efficiency
Detailed Description
Obesity is a disease related to reduced life expectancy, as well as increased morbidity and mortality. In recent years, bariatric surgery has become an increasingly widespread form of treatment for severe obesity and its associated diseases . The increased spread of bariatric surgery is associated with its long-term reliability and also its high cost-benefit ratio.
According to the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) registry (calendar years 2014-2018), there are three main surgical procedures in common use: sleeve gastrectomy (SG), Roux-en-Y gastric bypass (RYGB) and laparoscopic one anastomosis gastric bypass (OAGB) . OAGB, introduced by Rutledge in 1997 is a restrictive and malabsorptive bariatric surgical procedure and is the fourth most performed bariatric technique in Europe and in the Asia/Pacific area, with an increasing trend .
In the last 15 years, several authors have demonstrated the effectiveness of this surgical technique in terms of both weight loss and the resolution of comorbidities, especially type 2 diabetes mellitus (T2DM).
Despite the described advantages, LSG still conveys some risks. Early staple line complications, such as bleeding and leaks, may occur, and their incidence may vary from 1 to 6% . Such complications can be devastating and life-threatening. Besides, they entail additional healthcare-related costs. It has been proposed that staple line complications can be reduced by staple line reinforcement (SLR).
Staple line reinforcement (SLR) has been proposed to decrease the risk of these complications by several options: oversewing the staple line with a running absorbable suture, buttressing it with specific materials or roofing the staple line. Although it has been postulated that there are fewer complications, SLR remains controversial and its effectiveness is still unclear . Some surgeons still have concerns about SLR, either because of Uncertainty about its benefits and/or its financial costs. Moreover, it has been argued that oversewing itself could carry additional risks. The potential for leakage and bleeding could increase due to tearing at the suture penetration point, and the running suture may lead to sleeve stricture and tissue ischemia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •✔ Age ≥ 18years old
- •Sex: both sex
- •Fit for bariatric surgery
- •body mass index (BMI) of 40 kg/m 2 or higher or BMI between 35 and 40 kg/m2 with significant comorbidities, such as T2DM, hypertension, OSAS or significant osteo- articular alterations, not responsive to medical therapies
- •Patients should have tried and failed to lose weight using diet, exercise, and/or medication for at least 6 months
- •Patients or first guardians accept to participate in the current study
- •Patients or first guardians accept to provide informed written consent
Exclusion Criteria
- •Patients less than 18 years old
- •Patients or first guardians refused to participate in the current study
- •Patients or first guardians refused to provide informed written consent
- •All patients with bleeding disorders and patients needing re-exploration for bleeding other than staple line Pregnant or breastfeeding women
Arms & Interventions
Through-and-through sutures
through-and-through sutures with 3-0 absorbable monofilament sutures will be used .
Intervention: Oversewing (Procedure)
Titanium Ligation clips
Titanium Ligation clips will be used .
Intervention: Surgical Ligation Clips (Procedure)
Outcomes
Primary Outcomes
Incidence of Clinically Significant Postoperative Bleeding Within 30 Days
Time Frame: 30 days after laparoscopic one-anastomosis gastric bypass surgery
Proportion of participants experiencing clinically significant postoperative bleeding within 30 days of laparoscopic one-anastomosis gastric bypass. Clinically significant postoperative bleeding is defined as the occurrence of any of the following events within 30 days after surgery: 1. Re-operation for bleeding, 2. Endoscopic or radiologic intervention to control bleeding, 3. Transfusion of ≥ 1 unit of packed red blood cells for acute postoperative blood loss, or 4. Hemoglobin drop ≥ 2.0 g/dL from immediate postoperative baseline accompanied by hemodynamic instability (systolic blood pressure \< 90 mmHg or requiring vasopressor support). The analysis metric will be the number and percentage of participants (n, %) with at least one bleeding event in each treatment arm. Between-group comparison will use the risk difference with 95 % confidence interval (or the pre-specified statistical test per the statistical analysis plan).
Secondary Outcomes
- Operative Time(Intraoperative (recorded during procedure))
Investigators
Sameh Gamal Abd Elghany
General and Laparoscopic surgeon
Cairo University