NCT06759727

Brief 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).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
5mo left

Started Jan 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Jan 2025Oct 2026

First Submitted

Initial submission to the registry

December 29, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 6, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

January 7, 2025

Status Verified

January 1, 2025

Enrollment Period

1.7 years

First QC Date

December 29, 2024

Last Update Submit

January 3, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • morality rate

    within 90 days of surgery

Study Arms (4)

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.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • \) 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

parts of small intestine

Central Study Contacts

mohamed mohamed Abdelsayed, garduate

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident

Study Record Dates

First Submitted

December 29, 2024

First Posted

January 6, 2025

Study Start

January 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

January 7, 2025

Record last verified: 2025-01