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Loop Ileostomy Closure:Stapled or Hand-sewn Anastomoses? Suture or Mesh Closure of the Stoma Site?

ConditionRectal Neoplasm
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorKarolinska University Hospital

About this trial

There are severel problems associated with the closing of a temporary loop-ileostomy after surgery for rectal cancer. The purpose of this study is to answer two questions:

1. The choice of anastomotic method - does it influence the postoperative course? 2. The use of a prophylactic mesh when closing the stoma site - will there be less hernias?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

loop ileostomy after rectal cancer surgery

loop ileostomy closure is permitted and possible according to clinical practice

Disqualifiers

patient unable to understand written or oral information

Trial design

Design model

Factorial

Treatments tested in this trial

  • Stapled or Hand-sewn anastomosis

    Procedure/Surgery

    Randomization between stapled or hand-sewn anastomosis

  • Mesh or suture stoma site closure

    Procedure/Surgery

    Randomization between suture or Mesh closure of the stoma site

Treatment groups

400 Participants
are divided into 4 treatment groups
Group A: Stapled anastomosisExperimental treatment 1 intervention
Group B: Hand-sewn anastomosisActive comparator 1 intervention
Group C: Abdominal wall mesh closureExperimental treatment 1 intervention
Group D: Abdominal wall suture closureActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with postoperative bowel obstruction

Postoperative bowel obstruction within 30 Days, detected clinically or by the use of x-ray

Time frame
30 days
2

Number of participants with postoperative stoma site hernia

Herni postoperatively on the site of previous stoma detected within 2 years

Time frame
2 year

Secondary outcomes

1

Number of participants with postoperative complications

Time frame
30 days
2

Postoperative Hospital stay

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Karolinska University Hospital

Lead sponsor

Source ClinicalTrials.gov
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