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临床试验/NCT07038148
NCT07038148招募中不适用

Exploring the Efficacy of Single-stage Stapled Conversion of Gastric Bypass to Sleeve Gastrectomy, More Leak?

Kasr El Aini Hospital1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2025年1月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
11
试验地点
1
主要终点
Nutritional Status

研究概览

简要总结

Laparoscopic gastric bypass - including both Roux-en-Y gastric bypass (RYGB) and one anastomosis gastric bypass (OAGB) - is one of the most frequently performed procedures. However, as the number of gastric bypass surgeries increases, complications are being reported more often. While most post-bypass complications can be managed non-surgically, a small number of persistent cases may require a reversal to normal anatomy or conversion to another procedure.

Many patients who experience severe complications from gastric bypass are reluctant to undergo a reversal to normal anatomy due to fears of regaining weight. As a result, converting to another type of surgery becomes a more logical alternative.

Complications requiring conversion are numerous and negatively affect the quality of life, such as retrograde intussusception, weight regain, intractable dumping syndrome, and nutritional deficiencies. The high cost of obligatory postoperative vitamins is a potential cause of conversion especially in low-income countries.

The conversion procedure is technically demanding and has a relatively higher rate of postoperative complications, making it less commonly performed. Additionally, limited data is available regarding the procedure and its long-term outcomes, making it an unexplored sea of hope for people who wish to manage intractable complications of gastric bypass and maintain weight loss.

详细描述

Objectives: To study efficacy, safety, and patient outcomes following laparoscopic gastric bypass conversion to sleeve gastrectomy.

Study population & Sample size :

Adult patients undergoing single-stage laparoscopic stapled conversion of gastric bypass to sleeve gastrectomy in Kasr Alainy Sample size: 11 patients Study Design: This is a prospective single-arm clinical trial.

Methods: Patients who will attend our bariatric outpatient clinic will be enlisted according to inclusion criteria. A detailed history of anthropometric measures, chronic diseases, and previous surgeries will be recorded. After patient education, preoperative routine labs and imaging will be performed.

A preoperative 3D gastric volumetry CT scan will be performed to all patients included in this study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age between 18-70
  • •Adult patients undergoing single-stage laparoscopic stapled conversion of gastric bypass to sleeve gastrectomy.
  • •Patients accept to sign an informed consent and will commit to follow-up.

排除标准

  • •Patients with reversal gastric bypass to normal anatomy.
  • •Patient with uncontrolled systemic disease.
  • •Patients with active psychological disorders.
  • •Patients with active substance abuse.
  • •Patients with intra-operative technical difficulties hindering the conversion of gastric bypass to sleeve gastrectomy.
  • •Patients refusing to sign an informed consent.

研究组 & 干预措施

Candidates of several of bypass to sleeve

Experimental

This interventional study with a single arm assesses the effectiveness and safety of converting gastric bypass to sleeve gastrectomy using a laparoscopic stapling technique in adults who have complications from earlier gastric bypass procedures. The approach entails closing the prior gastrojejunostomy and performing a sleeve gastrectomy with a stapling method. The outcomes measured will include enhancements in nutritional status, weight regain, quality of life, and symptoms of GERD over a follow-up period of 6 months.

干预措施: Stapled reversal of gastric bypass to sleeve gastrectomy utilising stapling technique. (Procedure)

结局指标

主要结局

Nutritional Status

时间窗: one year

nutritional status of patient will be assessed by general examination, assessment of lower limb edema, serum albumin and hemoglobin

Weight Regain

时间窗: one year

The initial weight at the time of the procedure will be measured in kg, and at follow-up, it will be reassessed at three, six, and twelve months. Weight assessment will be part of the BMI assessment in kg/m2

次要结局

  • Quality of Life(one year)
  • GERG symptoms(One year)

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Abdelsalam M

Associate Professor of General and Laparoscopic Surgery

Kasr El Aini Hospital

研究点 (1)

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