NCT04826055

Brief Summary

in all loop bypass bariatric procedure (mini gastric bypass \& single anastomosis sleeve jejunal bypass), biliary limb is fixed length. we do it as a percentage from total small intestine length rather than fixed length

Trial Health

87
On Track

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2022

Completed
Last Updated

May 10, 2022

Status Verified

May 1, 2022

Enrollment Period

1 year

First QC Date

March 29, 2021

Last Update Submit

May 7, 2022

Conditions

Keywords

biliary limb length in bypass bariatric surgery

Outcome Measures

Primary Outcomes (2)

  • effect on weight loss

    the effect on weight loss

    one year

  • effect on nutritional deficiency

    the effect on nutritional deficiency

    1 year

Secondary Outcomes (4)

  • operative time

    6 hours

  • effect on obesity comorbidities

    1 year

  • early complications

    30 days

  • late complications

    1 year

Study Arms (2)

loop bypass with fixed biliary limb length

ACTIVE COMPARATOR

in all loop bypass procedures we will don't count the total length of small intestine and make the biliary limb as a fixed from total small intestine length as mentioned in literature

Other: biliary limb as fixed length

loop bypass with a biliary limb is a percentage of the small intestine

EXPERIMENTAL

in all loop bypass procedures we count the total length of small intestine and make the biliary limb as a percentage from total small intestine length rather than fixed length

Other: biliary limb as a percentage from small intestine length

Interventions

n all loop bypass procedures we will don't count the total length of small intestine and make the biliary limb as a fixed from total small intestine length as mentioned in literature

loop bypass with fixed biliary limb length

in all loop bypass procedures we count the total length of small intestine and make the biliary limb as a percentage from total small intestine length rather than fixed length

loop bypass with a biliary limb is a percentage of the small intestine

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • obese patients with BMI more than 40 or more than 35 with comorbidity
  • patients fit for laparoscopic surgery
  • give approval to share in the study

You may not qualify if:

  • patients refused to share in the study
  • patients unfit for surgery
  • patients aged less than 18 and older than 50
  • patients with BMI less than 35
  • patient with previous upper abdominal surgery either for obesity or other diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine

Minya, 61511, Egypt

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor and consultant of general surgery

Study Record Dates

First Submitted

March 29, 2021

First Posted

April 1, 2021

Study Start

March 25, 2021

Primary Completion

March 25, 2022

Study Completion

March 25, 2022

Last Updated

May 10, 2022

Record last verified: 2022-05

Locations