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Status unknownNCT04534504Updated Sep 1, 2020

Sleeve Gastrectomy With Uncut Jejunal Bypass (SG-uncut JJB) Verus Sleeve Gastrectomy in Obese Patients

An interventional study of SG-JJB in Excessive Weight Loss, Total Weight Loss and Sleeve Gastrectomy, sponsored by Zhen Jun Wang. Status unknown at 1 site in China. Open to participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-09-01.

Sponsored by Zhen Jun Wang · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
16 Years to 65 Years
Sex
All
01

Study summary

Among various bariatric procedures, sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) are the most frequently performed procedures worldwide. Though SG provides similar weight loss effect to RYGB in short-term follow-up, its long-term and very long-term weight loss effect was reported to be inferior to RYGB. Weight regain after SG remains the major concern after 2-year follow-up due to gradual loss of appetite suppression and lack of malabsorption function. SG plus procedures have been developed to strengthen the effect of SG on diabetes control. It has been reported that SG plus jejunojejunal bypass (SG - JJB) offered better weight loss than SG and similar weight loss to RYGB. The present study aims to evaluate the efficacy and safety of sleeve gastrectomy plus uncut jejunojejunal bypass (SG - uncut JJB).

Read the detailed description

Among various bariatric procedures, sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) are the most frequently performed procedures worldwide. Though SG provides similar weight loss effect to RYGB in short-term follow-up, its long-term and very long-term weight loss effect was reported to be inferior to RYGB. Weight regain after SG remains the major concern after 2-year follow-up due to gradual loss of appetite suppression and lack of malabsorption function. SG plus procedures have been developed to strengthen the effect of SG on diabetes control. It has been reported that SG plus jejunojejunal bypass (SG - JJB) offered better weight loss than SG and similar weight loss to RYGB. The present study aims to evaluate the efficacy and safety of sleeve gastrectomy plus uncut jejunojejunal bypass (SG - uncut JJB).

For SG-JJB procedure, after SG was finished, the jejunum was transected 20-cm distal to Treiz ligament. After that, another 200-cm jejunum was measured and side-to-side jejunojejunal anastomosis was made. The anastomotic and mesenteric defects were closed by hand suture.

For SG-uncut JJB procedure, the jejunum was not transected, only 200-cm jejunum 20-cm distal to Treiz ligament was measured and side-to-side jejunojejunal anastomosis was made. And the jejunum 3-5cm distal to the anastomosis was ligated with 10# suture.

02

Conditions studied

  • Excessive Weight Loss
  • Total Weight Loss
  • Sleeve Gastrectomy
  • Jejunojejunal Bypass
  • Uncut

Keywords

  • sleeve gastrectomy
  • Jejunojejunal bypass
  • Weight loss
  • Complication
  • SG-uncut JJB
03

In context

Body Weight

1,223 studies on the registry are indexed under Body Weight; 131 are open to participants now.

This study's planned enrollment of 60 is close to the median of 64 across 947 interventional studies indexed under Body Weight.

Browse Body Weight studies →

Lead sponsor

Zhen Jun Wang is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • BMI ≥ 32.5 kg/m2 with or without T2DM;
  • 27.5 kg/ m2 \< BMI \< 32.5 kg/m2 with T2DM but failed conservative treatment and combined with at least two metabolic diseases or comorbidities;
  • Duration of T2DM ≤15 years with fasting Cpeptide ≥ 50% of normal lower limit
  • Waist circumference: male ≥ 90 cm, female ≥ 85 cm
  • Age within 16\~65 years old

Exclusion criteria

Exclusion Criteria:

  • Pregnancy;
  • A history of mental illness and neurological disease;
  • The patient refuses surgery;
  • Combined with pituitary tumor;
  • Long-term use of antidepressant drugs;
  • Long-term use of immunosuppressants;
  • Situations in which the investigator or other examiner considers from the enrolled study that there are good reasons for nonconformity: if there are potential inconsistencies with the clinical protocol
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    SG-uncut JJB

    For SG-uncut JJB procedure, the jejunum was not transected, only 200-cm jejunum 20-cm distal to Treiz ligament was measured and side-to-side jejunojejunal anastomosis was made. And the jejunum 3-5cm distal to the anastomosis was ligated with 10# suture.

    Procedure: SG-JJB

  • Active comparator
    SG-JJB

    For SG-JJB procedure, after SG was finished, the jejunum was transected 20-cm distal to Treiz ligament. After that, another 200-cm jejunum was measured and side-to-side jejunojejunal anastomosis was made. The anastomotic and mesenteric defects were closed by hand suture.

    Procedure: SG-JJB

Interventions

  • ProcedureSG-JJB

    Base on SG-JJB procedure, the jejunum was not transected, only 200-cm jejunum 20-cm distal to Treiz ligament was measured and side-to-side jejunojejunal anastomosis was made. And the jejunum 3-5cm distal to the anastomosis was ligated with 10# suture.

06

What researchers measure

Primary outcomes

  1. excessive weight loss

    Percentage of excess weight loss (EWL) at any time postoperative was calculated as the amount of weight loss divided by the amount of excess weight times 100%.

    Time frame: 1 year postoperatively

  2. total weight loss

    total weight loss compared with preoperative weight

    Time frame: 1 year postoperatively

Secondary outcomes

  1. Complications

    Complications within 30 days postoperatively

    Time frame: 30 days postoperatively

  2. operating time

    time from opeing of the operation to the end of the operation

    Time frame: during the operation

  3. intraoperative blood loss

    blood loss during the operation

    Time frame: during the operation

07

Study locations

1 of 1 sites recruiting
  • Beijing Chaoyang Hospital
    Beijing, Beijing 100020, China
    • Jiagang Han, Professor · Contact · hjg211@163.com · 8613522867841
    • Jiagang Han, Professor · Principal investigator
    • Zhenjun Wang, professor · Principal investigator
    • Guanghui WEI, Professor · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04534504
Lead sponsor
Zhen Jun Wang
Responsible party
Zhen Jun Wang (Beijing Chao Yang Hospital, Capital Medical University, Beijing Chao Yang Hospital) — Sponsor-investigator
First posted
Sep 1, 2020
Start date
Aug 26, 2020
Primary completion
Aug 31, 2022 (estimated)
Completion
Aug 31, 2022 (estimated)
Last update
Sep 1, 2020

Study contacts

Jia Gang Han
Contact
hanjiagang@ccmu.edu.cn
86-10-85231604
Zhi Wei Zhai
Contact
913916215@qq.com
86-10-85231328
Zhen Jun Wang
study chair · Beijing Chao Yang Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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