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Status unknownNCT01595230Updated Apr 1, 2020

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

An interventional study of Closing the mesenteric defects with clips during opration in Internal Hernias, sponsored by Region Zealand. Status unknown at 2 sites in Denmark. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-04-01.

Sponsored by Region Zealand · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
405
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Internal Hernias

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Keywords

  • Internal Hernias
  • Clips
  • Gastric Bypass
  • Avoid
03

In context

Internal Hernia

8 studies on the registry are indexed under Internal Hernia; 3 are open to participants now.

Browse Internal Hernia studies →

Lead sponsor

Region Zealand is the lead sponsor of 12 studies on the registry; 4 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients who do not meet the inclusion criteria
  • Patients who converted to open surgeon
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
405 participants (actual)

Study arms

  • Experimental
    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.

    Procedure: Closing the mesenteric defects with clips during opration

  • No intervention
    Control group

    conventional LRYGB without closure of the mesenteric defects

Interventions

  • ProcedureClosing 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).

    Also known as: Clips, Herniestapler, Internal hernia, Gastric bypass

06

What researchers measure

Primary outcomes

  1. To avoid the risk of Internal Hernias in patient with a Gastric bypass

    Time frame: 5 year

Secondary outcomes

  1. Postoperative pain score (VAS)

    Time frame: 5 years

  2. Operative time consumption, the amount of clips, trocar and sutures used

    Time frame: 3 years

Other outcomes

  1. 30 days complication

    30 days complications: * Anastomotic leak * Bleeding (Hb) * Blood transfusions (MAF) * Ileus due to kinking, blowout of the bypassed stomach * Intraperitoneal abscesses.

    Time frame: 3 years

07

Study locations

2 sites
  • Department of Surgery;Bariatric Clinic, Køge Hospital
    Køge, Sealand 4600, Denmark
  • Bariatric clinic, Department of Surgery, Køge hospital
    Køge, 4600, Denmark
08

References and documents

Publications

  • 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. PubMed 33711136 ↗
  • 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. PubMed 24947625 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 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
NCT01595230
Lead sponsor
Region Zealand
Responsible party
Sara Kristensen (Doctor, Region Zealand) — Principal investigator
First posted
May 10, 2012
Start date
May 2012
Primary completion
Jan 2023 (estimated)
Completion
Jan 2023 (estimated)
Last update
Apr 1, 2020

Study contacts

Sara Kristensen, Doctor
principal investigator · Department of Surgery, Bariatric Clinic, Koge Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

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