MedTrace Logo

Endoscopic Management Of Controlled Colo-cutaneous Fistula As A Complication of Acute Sigmoid Diverticulitis: A Randomized Controlled Trial

NCT05834985 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2023-04-28

No results posted yet for this study

Summary

Diverticular disease is a common condition in western countries with relatively uncommon complications\[1\]. Fistulae complicating diverticulitis are the result of a localized perforation into adjacent viscera, and occur in 4-23% of patients hospitalized for diverticular disease\[2\]. The types of fistulae include colovesical, colovaginal, colotubal, coloenteric, and colocutaneous fistulae\[3\]. Colocutaneous fistulae occur very rarely, accounting for 1-4% of the total number of fistulae complicating colonic diverticular disease\[4\]. Herein we describe a case of a fistula connecting the sigmoid colon with the left flank-lower lumbar area, due to diverticulitis of the sigmoid colon\[5\].

A new over-the-scope clip system, called OTSC (Ovesco Endoscopy, Tübingen, Germany), appeared on the market about 3 years ago\[6\]. The system consists of a nitinol clip loaded at the tip of the endoscope that can capture a large amount of tissue and compress the lesion until healed\[7\]. Results from animal models and initial clinical use support the efficacy of OTSC closure in the treatment of gastrointestinal bleeding; its role in the management of iatrogenic perforations in humans is less defined, and reports on its use in treating colorectal postsurgical leaks and fistulas are anecdotal \[8\]. Here we report on the use of OTSC in the endoscopic treatment of colo-cutaneous fistula as acomplication of acute diverticultis .

Conditions

  • Fistula; Sigmoid

Interventions

PROCEDURE

endoscopic management of fistula due to sigmoid diverticulitis by clip or endostitches

endoscopic management of fistula due to sigmoid diverticulitis by clip or endostitches

Sponsors & Collaborators

  • Zagazig University

    lead OTHER_GOV

Principal Investigators

  • Said Mohamed Negm, MD · ZAGAZIG UNIVERSITY HOSPITALS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2023-03-01
Completion
2023-04-01

Countries

  • Egypt

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05834985 on ClinicalTrials.gov