跳至主要内容
临床试验/NCT06211699
NCT06211699已完成不适用

The Effect of Omentopexy and Clips on the Staple Line During Laparoscopic Sleeve Gastrectomy on Early Postoperative Outcomes: A Randomized Trial

Umraniye Education and Research Hospital2 个研究点 分布在 2 个国家目标入组 148 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
148
试验地点
2
主要终点
Postoperative Bleeding

研究概览

简要总结

In this prospective randomized study, patients were divided into two groups: clips group and omentopexy group. The groups were compared in terms of postoperative decrease in hemoglobin and hematocrit values, preoperative and peroperative blood pressure values, duration of surgery, number of patients requiring erythrocyte suspension (ES) transfusion, length of hospital stay, hospital readmissions in the first 30-days postoperatively and early postoperative complications.

详细描述

This prospective randomized controlled trial was conducted at the University of Health Science Umraniye Training and Research hospital between July 2023 and November 2023. The Patients who underwent LSG, were between the ages of 18 and 65, with a Body Mass Index (BMI) ≥ 40 or BMI ≥ 35 with at least one obesity-related comorbidity were included in the study. Patients who underwent other bariatric surgery procedures, had uncontrolled hypertension, and had preoperative history of gastroesophageal reflux disease (GERD) symptoms were excluded. Approval for the study was received from the ethics committee of tertiary health institution (21.06.2023/218494864). Before the surgery, each of the participants were received comprehensive information about the study, the techniques to be applied were explained, they would be randomly assigned in one of the two groups and the consent form obtained in this context.

Study Groups In the study, patients were divided into two groups: Patients who underwent consecutive clippping along the staple line of the remnant stomach during LSG (clips group) and patients who underwent continuous through-and-through omentopexy of the omentum to the remnant stomach staple line after resection during LSG (omentopexy group).

Data Collection Age, gender, comorbidities, smoking history, preoperative height-weight-BMI values, preoperative systolic blood pressure (SBP)-diastolic blood pressure (DBP) values, preoperative hemoglobin-hematocrit values, peroperative SBP-DBP-mean blood pressure (MBP), duration of surgery, postoperative 6th hour and time of discharge hemoglobin-hematocrit values, number of patients transfused erythrocyte suspension (ES) or requiring invasive intervention due to bleeding, length of hospital stay, hospital readmissions in the first postoperative month, and early postoperative complications were recorded. Duration of surgery was determined from the first skin incision to the last skin suture.

Preoperative, peroperative and Postoperative Evaluation Preoperative anesthesia, cardiology and pulmonology evaluations were performed for each patient. Hepatobiliary ultrasound and upper gastrointestinal endoscopy evaluation were performed. Each patient was administered low molecular weight heparin (enoxaparin 6000 units 1x1 subcutaneously) 12 hours before surgery and was taken to surgery with antiembolism stockings. Intermittant pneumatic compressor device was used perioperatively. Omentopexy was performed with 3-0 V-loc suture (26 mm, V-20 Tapper) and clippping was performed with endo clips II (10 mm, medium/large). Since ERAS protocol was applied in our clinic, no drain was placed in any patient.

At the 4th postoperative hour, all patients were mobilized, intensive respiratory exercise was performed and clear liquid food was started. Complete blood count and C-reactive protein (CRP) laboratory parameters were checked at postoperative 6th, 24th and 48th hour (discharge). Vital parameters were checked every 6 hours postoperatively. Patients who have an acute decrease in hemoglobin value together with a pulse rate of 100 or more per minute and systolic/diastolic blood pressure values below 90/60 mmHg were considered as bleeding and erythrocyte suspension was transfused. Early on the second postoperative day, the patient who could tolerate oral food and did not require additional intervention was discharged.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

The primary surgeon is naturally not blinded to the patient groups and the other surgeon who records and evaluates the data is blinded to the patient groups. The patient was blind to the intervention.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The Patients who underwent LSG
  • Between the ages of 18 and 65,
  • A Body Mass Index (BMI) ≥ 40 or BMI ≥ 35 with at least one obesity-related comorbidity

排除标准

  • Patients who underwent other bariatric surgery procedures,
  • Patients who declined to be participate
  • uncontrolled hypertension
  • preoperative history of gastroesophageal reflux disease (GERD) symptoms

结局指标

主要结局

Postoperative Bleeding

时间窗: up to 3 Months

The primary outcome of the study was to compare the two methods in terms of early postoperative bleeding. This comparison will be made with hemoglobin and hematocrit values measured at postoperative 6th hour, 24th hour and at discharge. The groups will be compared according to the decrease in hemoglobin and hematocrit values, whether ES displacement is required, and whether intervention is required.

次要结局

  • The duration of surgery (minutes)(Intraoperative)
  • Postoperative First Month Readmission(30-days postoperatively)

研究者

发起方
Umraniye Education and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Abdullah Sisik

Associate Prof., FEBS-MIS

Umraniye Education and Research Hospital

研究点 (2)

Loading locations...

相似试验