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Not yet recruitingNCT06759727Updated Jan 7, 2025

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

An observational study in Small Bowel Gangrene, Mesenteric Artery Ischemia and Strangulated Hernia, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-07.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Small Bowel Gangrene
  • Mesenteric Artery Ischemia
  • Strangulated Hernia

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

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.

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

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).
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Target follow-up
3 Years
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • Group A: Primary anastomosis: using hand sewing technique
  • Group B: Primary anastomosis with prophylactic tube enterostomy. Feeding jejunostomy may be inserted
  • Group C: Jejunostomy: double barrel stoma.
  • Group D: Jejunostomy: double barrel stoma with distal refeeding via the mucous fistula opening.
05

What researchers measure

Primary outcomes

  1. morality rate

    Time frame: within 90 days of surgery

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT06759727
Lead sponsor
Assiut University
Responsible party
Mohamed Mohamed Shendy Abdelsayed (resident, Assiut University) — Principal investigator
First posted
Jan 6, 2025
Start date
Jan 1, 2025 (estimated)
Primary completion
Sep 1, 2026 (estimated)
Completion
Oct 1, 2026 (estimated)
Last update
Jan 7, 2025

Study contacts

mohamed mohamed Abdelsayed, garduate
Contact
mo7amad.moha1001@gmail.com
+201095421323

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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