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Not yet recruiting NCT06759727

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

Observational Small Bowel Gangrene Mesenteric Artery Ischemia Strangulated Hernia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Small Bowel Gangrene, Mesenteric Artery Ischemia, Strangulated Hernia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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).

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.

Primary outcome measures

  • morality rate [Time frame: within 90 days of surgery]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06759727 · small bowel gangrene surgery

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗