NCT04534504

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 26, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 27, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

September 1, 2020

Status Verified

August 1, 2020

Enrollment Period

2 years

First QC Date

August 27, 2020

Last Update Submit

August 27, 2020

Conditions

Excessive Weight LossTotal Weight LossSleeve GastrectomyJejunojejunal BypassUncut

Keywords

sleeve gastrectomyJejunojejunal bypassWeight lossComplicationSG-uncut JJB

Outcome Measures

Primary Outcomes (2)

  • 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%.

    1 year postoperatively

  • total weight loss

    total weight loss compared with preoperative weight

    1 year postoperatively

Secondary Outcomes (3)

  • Complications

    30 days postoperatively

  • operating time

    during the operation

  • intraoperative blood loss

    during the operation

Study Arms (2)

SG-uncut JJB

EXPERIMENTAL

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

SG-JJB

ACTIVE COMPARATOR

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

SG-JJBPROCEDURE

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.

SG-JJBSG-uncut JJB

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • BMI ≥ 32.5 kg/m2 with or without T2DM;
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Chaoyang Hospital

Beijing, Beijing Municipality, 100020, China

RECRUITING

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Zhen Jun Wang

    Beijing Chao Yang Hospital

    STUDY CHAIR

Central Study Contacts

Jia Gang Han

CONTACT

86-10-85231604hanjiagang@ccmu.edu.cn

Zhi Wei Zhai

CONTACT

86-10-85231328913916215@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Beijing Chao Yang Hospital, Capital Medical University

Study Record Dates

First Submitted

August 27, 2020

First Posted

September 1, 2020

Study Start

August 26, 2020

Primary Completion

August 31, 2022

Study Completion

August 31, 2022

Last Updated

September 1, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)