Conversion to SADI-S, RYGB or OAGB After Failed Sleeve

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorGeneral Committee of Teaching Hospitals and Institutes, Egypt

About this trial

Assess what revisional surgery is superior and provides the best weight loss after primary LSG. What is the occurrence of complications and the nutritional laboratory status? And if the resolution and /or improvement of associated medical problems after the weight loss will occur.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Undergone primary laparoscopic sleeve gastrectomy in the past

Weight regain

defined as any increase in weight above the nadir as reported by the patient

BMI at the time of revisional surgery was around 45 kg/m2

Disqualifiers

Didn't follow preoperative consultation

Cannot give of sign informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • revision surgery

    Procedure/Surgery

    revision procedure after failed sleeve gastrectomy

Treatment groups

234 Participants
are divided into 3 treatment groups
Group A: RYGB procedure arm 1Active comparator 1 intervention
Group B: OAGB procedure arm 2Active comparator 1 intervention
Group C: SADI-S procedure arm 3Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

The number of participants who will have early complications related to surgery

the incidence of re-operation, bleeding or leakages

Time frame
6 weeks
2

The percentage Excess body weight loss (%EWL)

the amount of weight loss after revision surgery

Time frame
3,6,12,24 months
3

somscore of food tolerance

validated food tolerance questions: Food tolerance (FT) was evaluated using a one-page questionnaire divided into 4 sections, 3 of which were used to calculate the score: overall patient satisfaction with eating (score: 1-5); tolerability to certain food types (score: 0-16); and frequency of vomiting/regurgitation (score: 0-6), with a total score between 1 and 27; higher scores indicate better food tolerance

Time frame
2,6 weeks and 3,6,12,24 months

Secondary outcomes

1

Nutritional levels of albuminemia

the albuminemia level will be tested after surgery (g/dl)

Time frame
3,6,12,24 months
2

Nutritional levels of proteinemia

the proteinemia level will be tested after surgery (mg/dl)

Time frame
3,6,12,24 months
3

Nutritional levels of anemia

the anemia level will be tested after surgery (Mcl)

Time frame
3,6,12,24 months
4

Nutritional levels of calcemic

the calcemic level will be tested after surgery (mg/dl)

Time frame
3,6,12,24 months

Other outcomes

1

The number of participants who will have late complications related to surgery

the incidence of re-operations or complications will be collected

Time frame
60 months
2

The number of participants whereby revision surgery necessary after the RCT

the incidence of re-operations or other procedure will be collected

Time frame
60 months
3

The percentage Excess body weight loss (%EWL)

the amount of weight loss after revision surgery

Time frame
60 months
4

Incidence of Reflux

GERD classification

Time frame
60 months

Sponsors and contacts

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