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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorKasr El Aini Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients with reversal gastric bypass to normal anatomy.

Patient with uncontrolled systemic disease.

Patients with active psychological disorders.

Patients with active substance abuse.

Trial design

Design model

Single group

Treatments tested in this trial

  • Stapled reversal of gastric bypass to sleeve gastrectomy utilising stapling technique.

    Procedure/Surgery

    This research entails a single-stage laparoscopic conversion of gastric bypass to sleeve gastrectomy. The procedure entails the closure of the gastrojejunostomy with an endo-stapler and the reconstruction of the stomach by resecting along the greater curvature to create a sleeve gastrectomy. An intraoperative leak test will be conducted using methylene blue. Patients are monitored postoperatively for at least 24 hours, with subsequent assessments of nutritional status, weight, gastroesophageal reflux disease (GERD) symptoms, and quality of life at 3 and 6 months.

Treatment groups

11 Participants
are divided into 1 treatment group
Group A: Candidates of several of bypass to sleeveExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Nutritional Status

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

Time frame
one year
2

Weight Regain

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

Time frame
one year

Secondary outcomes

1

Quality of Life

The Short Form 36 (SF-36) questionnaire will be used to assess quality of life and overall health status.

Time frame
one year
2

GERG symptoms

GERD symptoms will be assessed at three, six, and twelve months of follow-up. The GERD-Health Related Quality of Life (GERD-HRQL) Questionnaire will be used in this study.

Time frame
One year

Other outcomes

1

Possible Risks

1. Post operative pain. 2. Post operative nausea and vomiting. 3. Bleeding 4. Anastomotic leakage 5. Stricture

Time frame
One year

Sponsors and contacts

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