Internal Hernias After Gastric Bypass Can be Prevented Safely With Primary Closure of All Mesenteric Defects With Clips

NCT ID: NCT01595230

Last Updated: 2020-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

405 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2023-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine whether closure of all mesenteric defects with clips at the time of Gastric bypass, can avoid the complication of late bowel obstruction- internal hernias

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Internal Hernias

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Inertervention group_Clips to avoid internal herniation

LRYGB with closure of the defects with simple hernia stapler clips. Aim of this study is to evaluate the benefits and disadvantages of closing the mesenteric defects during gastric bypass in order to avoid internal herniation.

Group Type EXPERIMENTAL

Closing the mesenteric defects with clips during opration

Intervention Type PROCEDURE

The laparoscopic Roux-en-Y gastric bypass surgery will be performed as usual. The patient will receive the closing of the mesenteric defects (the Petersen´s space and the entero-enterostomy site).The closing will happen at the end of the operation, using clips (herniestapler).

Control group

conventional LRYGB without closure of the mesenteric defects

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Closing the mesenteric defects with clips during opration

The laparoscopic Roux-en-Y gastric bypass surgery will be performed as usual. The patient will receive the closing of the mesenteric defects (the Petersen´s space and the entero-enterostomy site).The closing will happen at the end of the operation, using clips (herniestapler).

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Clips, Herniestapler, Internal hernia, Gastric bypass

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All patients who meet the requirements for a Gastric Bypass at Køge Hospital.

* Patients who converted to open surgeon
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Region Zealand

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sara Kristensen

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sara Kristensen, Doctor

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery, Bariatric Clinic, Koge Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Surgery;Bariatric Clinic, Køge Hospital

Køge, Sealand, Denmark

Site Status

Bariatric clinic, Department of Surgery, Køge hospital

Køge, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

References

Explore related publications, articles, or registry entries linked to this study.

Kristensen SD, Gormsen J, Naver L, Helgstrand F, Floyd AK. Randomized clinical trial on closure versus non-closure of mesenteric defects during laparoscopic gastric bypass surgery. Br J Surg. 2021 Mar 12;108(2):145-151. doi: 10.1093/bjs/znaa055.

Reference Type DERIVED
PMID: 33711136 (View on PubMed)

Kristensen SD, Naver L, Jess P, Floyd AK. Effect of closure of the mesenteric defect during laparoscopic gastric bypass and prevention of internal hernia. Dan Med J. 2014 Jun;61(6):A4854.

Reference Type DERIVED
PMID: 24947625 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SJ-284

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.