Идёт набор NCT07436013

Comparing Revisional Laparoscopic Roux-en-Y Gastric Bypass Versus Ringed Revisional Roux-en-Y Gastric Bypass After Laparoscopic Sleeve Gastrectomy

Без фазы С лечением Revisional Bariatric Surgery

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Standard revisional RYGB, Revisional Banded RYGB.
Кому может быть актуально: Состояния в реестре: Revisional Bariatric Surgery. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Египет
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Prospective Randomized Controlled Trial Comparing Revisional Laparoscopic Roux-en-Y Gastric Bypass Versus Ringed Revisional Roux-en-Y Gastric Bypass After Laparoscopic Sleeve Gastrectomy: 5-Year Outcomes on Weight Loss, BAROS Score, Quality of Life, and Food Tolerance

Обзор

Obesity remains a major global health challenge, with rising prevalence and significant metabolic, cardiovascular, and gastrointestinal comorbidities. Laparoscopic sleeve gastrectomy (LSG) has emerged as the most widely performed bariatric procedure due to its technical simplicity and satisfactory short- to mid-term results. However, a proportion of patients experience suboptimal weight loss, recurrent weight gain, or both. In this study, patients with recurrent weight gain of maximum weight loss or suboptimal weight loss or both following sleeve gastrectomy were included. Suboptimal weight loss is defined as total weight loss (TWL) of less than 20% of the preoperative weight and/or excess weight loss (EWL) of less than 50%, measured at least 12-18 months after the primary sleeve gastrectomy. Recurrent weight gain after sleeve gastrectomy is defined as an increase of ≥20% of the maximum weight loss (from nadir weight) or an increase in BMI of \>5, measured at least 24 months after the primary procedure.

Подробное описание

Roux-en-Y gastric bypass (RYGB) is considered the procedure of choice for revisional bariatric surgery following failed LSG, offering both restrictive and malabsorptive mechanisms and effectively controlling reflux symptoms. Despite its success, long-term weight regain may still occur due to gradual dilation of the gastric pouch or gastrojejunal anastomosis. To mitigate this, the incorporation of a fixed ring or silastic band around the gastric pouch-known as ringed RYGB (R-RYGB)-has been introduced to maintain restriction, prevent pouch enlargement, and enhance long-term weight maintenance.

While B-RYGB has shown promise in primary bariatric procedures, evidence in the revisional setting remains limited and inconclusive. Few studies have systematically compared standard revisional RYGB and ringed revisional RYGB following sleeve gastrectomy, particularly regarding long-term outcomes such as sustained weight loss, food tolerance, quality of life, and comprehensive composite outcomes like the Bariatric Analysis and Reporting Outcome System (BAROS) score.

This prospective randomized controlled trial aims to fill this gap by providing 5-year comparative data on revisional RYGB versus ringed revisional RYGB after sleeve gastrectomy, assessing not only the efficacy in maintaining weight loss but also the broader impact on patient well-being, food tolerance, and overall quality of life.

Вмешательства

Процедура Standard revisional RYGB
* Small gastric pouch (\~30 mL). * 100-150 cm alimentary limb, 50 cm biliopancreatic limb.
Процедура Revisional Banded RYGB
* Standard RYGB as above. * Placement of a silastic ring (5.5-7.0 cm circumference) around the gastric pouch, \~2 cm above the gastrojejunal anastomosis.

Первичные конечные точки

Percent EWL (excess weight loss) and percent TWL (Total weight loss) [Срок оценки: 1, 2, 3, 4, and 5 years postoperatively]

Вторичные конечные точки (12)

Comorbidity resolution [Срок оценки: 6 months, 1,2,3,4 and 5 years postoperatively]
Comorbidity resolution [Срок оценки: 6 months, 1,2,3,4 and 5 years postoperatively]
Comorbidity resolution [Срок оценки: 6 months, 1,2,3,4 and 5 years postoperatively]
Quality of Life (SF-36) [Срок оценки: 1, 2, 3, 4, and 5 years postoperatively]
Food tolerance (FTQ) [Срок оценки: 6 months, 3 and 5 years postoperatively.]
Comorbidity resolution [Срок оценки: 6 months, 1,2,3,4 and 5 years postoperatively]
Safety outcomes: Bleeding [Срок оценки: perioperative until 1 month postoperatively]
Safety outcomes: Anastomotic leak [Срок оценки: perioperative until 1 month postoperatively]
Safety outcomes: Infection [Срок оценки: perioperative until 1 month postoperatively]
Safety outcomes: DVT/PE [Срок оценки: perioperative until 1 month postoperatively]
Safety outcomes: Ring-related complications [Срок оценки: At 1, 3, 4, and 5 years, or earlier if symptomatic (dysphagia, vomiting, suspected stricture, ulcer, or band-related complication).]
Reoperation rates [Срок оценки: 1, 2, 3, 4, and 5 years postoperatively]

Критерии участия

Критерии включения

Adults aged 18-65 years.
Patients who experienced recurrent weight gain, suboptimal weight loss, or both within 12-24 months or more following sleeve gastrectomy.
Eligible and fit for bariatric surgery.
Willing to provide informed consent and adhere to follow-up.