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Completed

NCT Number: NCT02012023

Use of One Kind of Controllable Tube Ileostomy in the Low Rectal Cancer

Most surgeons suggest the use of fecal diverting to address the high morbidity and mortality associated with anastomotic leakage (AL) in patients with high risk factors on AL who are undergoing low anterior resections(LAR). This exploratory study was conducted to evaluate the efficacy and safety of one kind of controllable tube ileostomy(CTI), which was designed to protect rectal anastomosis in patients with high risk factors on AL. Results of SCCI were compared to those of the loop ileostomy (LI) method.

In fact when we told the patients about the tube ileustomy's effect and risk, almost all the almost all of my patients like to choose tube ileustomy(I have study this method for long time and have good expeience, and my patients either choose tube ileostomy directly or let me do the choice.) So I gave all the patients who meet the requirenments all tube ileustomy and have no control group.

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Key information

Conditions

Rectal Neoplasms Anastomotic Leak Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Low Anterior Resection Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rectal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Colorectal Surgery, First Affiliated Hospital, Zhejiang University

Hangzhou, Zhejiang, 310003, China

About this study

After low anterior resection(LAR), a double row of concentric purse-string sutures were placed in the ileum wall using 3-0 absorbable suture. The diameters of the purse-string rings were about 10 mm and 20 mm, respectively. The investigators then made a small incision within the inner purse-string and inserted the trachea cannula into the proximal end of the ileum. The inner purse-string suture then was tied, followed by the outer purse-string suture. The outer purse string should capsulate the inner purse string to prevent leakage. Normal saline was injected into the air bag until the ileum wall. The investigators will test the pressure of airbag, and control the pressure of airbag from 30-40cmHg. The investigators then pulled the cannula out through the abdominal wall. The incision site in the ileum was approximated to the inner abdominal wall and extraperitonized by fixing the mobilized ileum wall around the cannula to the inner abdominal wall. This was accomplished using 3-4 interrupted sutures.

In the CTI group, the tube will be removed after 3-4 weeks. If anastomotic leakage occurred, the investigators will test the airbag pressure and keep the pressure during 30-40cmHg. Because with time went on, the ileum will dilated , the airbag pressure will go down, then the feces may go through the airbag plane and flow into colon and the tube ileostomy will lose its defunctioning effect.When the investigators control the airbag pressure, we can control the defunctioning effect of tube stomy. So it is called controllable tube ileostomy. The investigators will keep the tube until the anastomotic leakage was cured.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Rectal Tumor After Low Anterior Resection the Anastomosis Located extraperitoneal
  • Patients Agreed to Undergo the tube ileostomy or loop ileostomy Procedure

Exclusion criteria

  • Bowel Preparation is not Satisfied Before Operation
  • Blood lose is more than 1500ml during operation
  • Critical incident during operation
  • The vagina or bladder is seriously damaged and the fix is not satisfied.

Treatment and study plan

Low anterior resection

Device

tube ileostomy

Device

loop ileostomy

Device

accept reversal operation

Device

remove the tube ileostomy

Device

Primary outcomes

  1. anastomotic leakage

    Time frame: about in 3 months after operaion

    Anastomotic leakage(AL) is the main complication after LAR.AL is defined as a defect of intestinal wall integrity at the colorectal or coloanal anastomotic site (including suture and staple lines of the neorectal reservoirs) leading to communication between intra- and extraluminal compartments.

  2. reoperation rate

    Time frame: about 3 months after operation

    When AL occurred, whether this patient need reoperation is determined by the clinical manifestation. Reoperation rate and mortality are two key index to evaluate the effect and safety of cannula ileostomy.

  3. mortality

    Time frame: about 3 months after operation

Secondary outcomes

  1. ileus rate

    Time frame: during the follow time(about 6 months after operaion)

    Another main operation complication was intestinal obstruction. Ileus conclude two types: temporally ileus and intractable ileus. Temporally ileus can be treated by conservative treatment and intractable ileus need reoperation.Ileus usually is caused by intestinal adhesion. But in CTI group, ileus maybe caused by the cannula obstruction.

  2. operation data

    Time frame: durting the operation time (about 1-5 h)

    including operation method, time, blood loss et al.

Other outcomes

  1. hospital stays

    Time frame: from admission time to discharge time(about 7-14days)

    In loop ileostomy group, hospital stays and costs include the readmission to close the stoma.

  2. hospital costs

    Time frame: from admission time to discharge time(about 7-14days)

    In loop ileostomy group, hospital stays and costs include the readmission to close the stoma.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Registry information

Official study title

Use of One Kind of Controllable Tube Ileostomy to Protect Anastomotic Leakage in the Low Rectal Cancer.

Acronym: CTI

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 16, 2013
Registry last updated
Aug 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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