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 statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCairo University

About this trial

1. 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. 2. To assess whether oversewing or the use of surgical clips is more effective in reducing operative time and Cost analysis in (OAGB). 3. To Provide evidence-based recommendations on staple line reinforcement techniques in OAGB, emphasizing patient safety and procedural efficiency

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

✔ 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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Oversewing

    Procedure/Surgery

    Through-and-through sutures with 3-0 absorbable monofilament sutures will be placed over the staple line to reinforce it in laparoscopic one anastomosis gastric bypass surgery.

  • Surgical Ligation Clips

    Procedure/Surgery

    Titanium Ligation clips will be used to secure hemostasis and reinforce staple line by approximating tissue edges in laparoscopic one anastomosis gastric bypass surgery.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Through-and-through suturesExperimental treatment 1 intervention
Group B: Titanium Ligation clipsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Clinically Significant Postoperative Bleeding Within 30 Days

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).

Time frame
30 days after laparoscopic one-anastomosis gastric bypass surgery

Secondary outcomes

1

Operative Time

Duration of surgery measured in minutes from skin incision to skin closure. Analysis metric: mean (SD) operative time per group; compared using pre-specified statistical tests.

Time frame
Intraoperative (recorded during procedure)

Other outcomes

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