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Diverting Loop Ileostomy: With or Without Rod

2014-08-27 03:20:01 | BioPortfolio

Summary

Diverting ileostomies are created to protect a rectal anastomosis or in situations with a risk of intestinal perforation. Currently, the application of a rod to hinder slippage of the loop is an established technique to perform a diverting loop ileostomy. However, various "rod-less" techniques have been described and are performed with similar success. The aim of this study is to determine, whether a modification (without rod) of the current standard method of protective loop ileostomy formation (with rod) could improve ileostomy specific morbidity. Secondary endpoints include stoma care, determinants of quality of life and stoma function.

Description

Background

For rectal anastomoses within 6 cm of the anal verge, leakage rates are up to 15%. Here liberal use of protective stomas is widely accepted. Fecal diversion by loop ostomy may also be performed after extended adhesiolysis with serosal lesions and risk of intestinal perforation, in patients with obstructing rectal tumours requiring neoadjuvant radio-chemotherapy or in patients with complex anorectal injuries or fistulas. Generally, diverting loop ileostomies are secured at skin level by means of a supporting device in order to prevent retraction of the loop ileostomy into the abdomen. Nevertheless, due to the supporting rod, difficulties may occur in applying a stoma bag correctly and leakage of feces onto the skin may occur even with correct eversion of the afferent limb. Despite easier application of stoma bags and therefore reduced risk of skin irritation, none of these alternative techniques are established. In various non-randomized studies rodless loop ileostomies were described with an overall morbidity between 3 and 39%. However definition of morbidity varies significantly in these studies and randomised controlled trials are missing so far.

Objective

The aim of this study is to determine, whether a modification (without rod) of the current standard method of protective loop ileostomy formation (with rod) could improve ileostomy specific morbidity. Secondary endpoints include stoma care, determinants of quality of life and stoma function.

Methods

The study is designed as multi-institutional, randomized controlled, two-armed study. Patients scheduled for a protective loop ileostomy and meeting the eligibility criteria will be randomized to creation of a loop ileostomy with or without sustaining rod.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Ileostomy

Intervention

Diverting loop ileostomy with rod, diverting loop ileostomy without rod

Location

Bern University Hospital, Dep. of Visceral and Transplant Surgery
Bern
Switzerland
3010

Status

Recruiting

Source

University Hospital Inselspital, Berne

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:20:01-0400

Clinical Trials [315 Associated Clinical Trials listed on BioPortfolio]

Pilot Study Evaluating the Efficacy of AlloMEM After Loop Ileostomy

The objective of this study is to investigate whether the use of Human Peritoneal Membrane (HPM) in a temporary loop ileostomy is beneficial to patients. Benefit will be defined, for purp...

Does Bowel Stimulation Before Loop Ileostomy Closure Reduce Postoperative Ileus?

Postoperative ileus is the most commonly observed morbidity following ileostomy closure. Studies have previously demonstrated that the defunctionalized bowel of a loop ileostomy undergoes ...

Trial to Reduce Wound Infection With Contralateral Drainage in Loop Ileostomy Closure

1. Introduction: The most common complication of loop ileostomies closure for rectal cancer patients undergoing a low anterior rectum resection, is the superficial surgical site...

Early Temporary Stoma Closure After Proctectomy

We conducted a prospective randomized study to evaluate the results of early closure of temporary loop ileostomy at eight days in comparison with late closure at two months, after elective...

Evaluation of the Safety and Effectiveness of Sepraspray™ in Reducing Post-surgical Adhesions

This study will examine the safety and efficacy of Sepraspray in the following model of abdominal surgery: total proctocolectomy and pelvic pouch with diverting ileostomy via laparotomy to...

PubMed Articles [982 Associated PubMed Articles listed on BioPortfolio]

Study Protocol Evaluating the Use of Bowel Stimulation Before Loop Ileostomy Closure to Reduce Postoperative Ileus: A Multicenter Randomized Controlled Trial.

Postoperative ileus is the most commonly observed morbidity following ileostomy closure. Studies have demonstrated that the defunctionalized bowel of a loop ileostomy undergoes a series of functional ...

Risk factors for complications after diverting ileostomy closure in patients who have undergone rectal cancer surgery.

To clarify the risk factors for complications after diverting ileostomy closure in patients who have undergone rectal cancer surgery.

Clinical Value of Contrast Enema Prior to Ileostomy Closure.

Purpose To determine the value of routine contrast enema of loop ileostomy before elective ileostomy closure regarding the influence on the clinical decision-making. Materials and Methods Retrospe...

Loop Ileostomy Closure as an Overnight Procedure: Institutional Comparison With the National Surgical Quality Improvement Project Data Set.

Enhanced recovery pathways have decreased length of stay after colorectal surgery. Loop ileostomy closure remains a challenge, because patients experience high readmission rates, and validation of enh...

Loop Ileostomy Vs. Total Colectomy As Surgical Treatment For Clostridium Difficile Associated Disease: An Eastern Association for the Surgery of Trauma Multicenter Trial.

The mortality of patients with Clostridum Dificile Associated Disease (CDAD) requiring surgery continues to be very high. Loop ileostomy (LI) was introduced as an alternative procedure to total colect...

Medical and Biotech [MESH] Definitions

Surgical creation of an external opening into the ILEUM for fecal diversion or drainage. This replacement for the RECTUM is usually created in patients with severe INFLAMMATORY BOWEL DISEASES. Loop (continent) or tube (incontinent) procedures are most often employed.

A subfamily of ligand-gated ion channel receptors that share a characteristic loop which is formed by a disulfide bond between two CYSTEINE residues. These receptors typically contain five subunits with the cysteine-loop occurring near an N-terminal extracellular domain.

CIRCULAR DNA that is interlaced together as links in a chain. It is used as an assay for the activity of DNA TOPOISOMERASES. Catenated DNA is attached loop to loop in contrast to CONCATENATED DNA which is attached end to end.

Na-K-Cl transporter in the ASCENDING LIMB OF LOOP OF HENLE. It mediates active reabsorption of sodium chloride and is inhibited by LOOP DIURETICS such as FUROSEMIDE; and BUMETANIDE. Mutations in the gene encoding SLC12A1 are associated with a BARTTER SYNDROME.

Head to tail array of covalently joined DNA sequences generated by concatenation. Concatenated DNA is attached end to end in contrast to CATENATED DNA which is attached loop to loop.

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