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Small Bowel GangreneNCT06759727

Outcomes of Different Surgical Procedures After High Level Resection for Patients With Small Intestinal Gangrene

An observational study of Small Bowel Gangrene and Mesenteric Artery Ischemia, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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Trial summary

In this cohort study, aim to evaluate and compare short-term postoperative outcomes of different surgical procedures for patients with intestinal gangrene who underwent high level small bowel resection (< 150 cm from DJ). Read more about this study

Who is it for?
Ages 18 years and older
How many people
40 participants
Where
No sites listed yet
Study dates
1 Jan 2025to 1 Oct 2026
How long will I take part?
3 Years
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: This study is a prospective non-randomized comparative study. Patients who will undergo high level small bowel resection for intestinal gangrene during the period from September 2024 to September 2026 are included.

Who may be able to join

  • 1) Distance of proximal resection margin less than 150 cm from DJ. 2) Mesenteric vascular ischemia. 3) Strangulating obstruction e.g. due to hernia, volvulus, band, etc.

Who cannot join

  • 1) Patients less than 18 years. 2) Patients with malignant disease. 3) Patients with almost all small bowel loops resected (< 60 cm remaining).

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

mohamed mohamed Abdelsayed, garduate contact

+201095421323

mo7amad.moha1001@gmail.com

About this study

In this cohort study, aim to evaluate and compare short-term postoperative outcomes of different surgical procedures for patients with intestinal gangrene who underwent high level small bowel resection (< 150 cm from DJ).

Read the detailed description

Patients with intestinal gangrene have a high mortality rate depending on etiology, degree, and length of an ischemic part, associated comorbidity, and time between the onset of symptoms and final diagnosis. This overall mortality ranges from 50 to 80%. When intestinal gangrene is evident or suspected, surgical laparotomy is mandatory, where the affected segment is resected, and the remaining part is either anastomosed or diverted on the anterior abdominal wall as stoma.

Small bowel anastomoses performed in the emergency settings have a high risk of anastomotic leakage. The leak rate in these settings may reach 35% . Intestinal gangrene is usually associated with peritonitis and sepsis. The performance of ostomy or intestinal anastomosis in cases of peritonitis or sepsis is a controversial theme. This controversy increases when proximal small bowel is involved .

Stomas avoid the risks of anastomotic leakage and re-operation and permit close examination of the bowel by inspection. However, creating stoma after proximal level of resection is associated with catastrophic sequels of high output fistula and short bowel syndrome. Hence, most of the time the risk of a high jejunal anastomosis dehiscence is preferred to the metabolic complications associated with ostomy .

A jejunostomy was defined as having less than 200 cm of proximal remaining small bowel. Since most nutrients are absorbed within the first 100-150 cm of the jejunum, the severity of short bowel syndrome and dependence on TPN is markedly increased if a jejunostomy is created at less than 150 cm from DJ . Distal refeeding of chyme "re-feeding enteroclysis", by reinfusing the chyme collected from the proximal stoma into the downstream small bowel through the distal stoma, was used by some surgeons to alleviate the complications of jejunostomy before re-establishment of digestive continuity . However, this procedure can be technically demanding. On the other hand, some authors prefer to use prophylactic tube enterostomy with primary anastomosis in cases of high risk of anastomotic leak .

The choice between these surgical technical varieties depends upon general health status of the patient, and local abdominal factors e.g. presence of peritoneal contamination, but mostly depends on surgeons' experience.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06759727
Study groupRoleWhat they receive
Group A: Primary anastomosis: using hand sewing techniqueNot described
Group B: Primary anastomosis with prophylactic tube enterostomy. Feeding jejunostomy may be insertedNot described
Group C: Jejunostomy: double barrel stoma.Not described
Group D: Jejunostomy: double barrel stoma with distal refeeding via the mucous fistula opening.Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. morality rate

    Measured: within 90 days of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2025
  2. Study start1 Jan 2025 (estimated)
  3. Primary completion1 Sep 2026 (estimated)
  4. Study completion1 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
40 participants (estimated)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06759727
Sponsor's protocol ID
small bowel gangrene surgery
Status last verified
Jan 2025
First submitted
29 Dec 2024
Last updated
7 Jan 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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