Early Ileostomy Closure for Cancer of Rectum

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Jewish General Hospital, Montreal, Canada
Cancer of Rectum+2 More
Early Ileostomy Closure - Procedure
Eligibility
18+
Female
Eligible conditions
Select

Study Summary

This study is evaluating whether early closure of a stoma is safe and feasible in rectal cancer patients undergoing restorative proctectomy.

See full description

Eligible Conditions

  • Cancer of Rectum
  • Rectal Carcinoma
  • Stoma Ileostomy

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Early Ileostomy Closure will improve 8 secondary outcomes in patients with Cancer of Rectum. Measurement will happen over the course of Starting from restorative proctectomy post-operative day 1 through the course of the study (1 year follow-up).

Day 30
Post-operative recovery
2-, 6-, 9-, and 12-months post-diverting loop ileostomy closure
Bowel function
2-, 6-, and 9-months post-restorative proctectomy
Complications
Baseline (day of patient recruitment), 2-, 6-, 9-, and 12-months post-restorative proctectomy
EORTC QLQ-C30 score
EORTC QLQ-CR29 score
Calculated at 6- and 12-months post restorative proctectomy
Cost of patient care (in dollars)
Monitored for from date of ileostomy closure to day of discharge from hospital
Occurrence of post-operative ileus following ileostomy reversal
Year 1
Time to chemotherapy (weeks)

Trial Safety

Trial Design

2 Treatment Groups

Traditional closure (control)
1 of 2
Early Ileostomy Closure
1 of 2
Active Control
Experimental Treatment

This trial requires 118 total participants across 2 different treatment groups

This trial involves 2 different treatments. Early Ileostomy Closure is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Early Ileostomy Closure
Procedure
Following a negative leak test (CT scan with rectally-administered water-soluble contrast on post-operative day 7, 8 or 9), patients will undergo standardized reversal of their diverting loop ileostomy (stapled side-side functional end-to end anastomosis, purse-string closure of the ileostomy wound, and no use of epidural analgesia) between post-operative days 10-14.
Traditional closure (control)Following a negative leak test (CT scan with rectally-administered water-soluble contrast on post-operative day 7, 8 or 9), patients will undergo a standardized reversal of their diverting loop ileostomy. The latter will be performed with a stapled side-side functional end-to end anastomosis, purse-string closure of the ileostomy wound, and no use of epidural analgesia and will be performed no earlier than 12 weeks following their index surgery.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2-, 6-, 9-, and 12-months post-diverting loop ileostomy closure
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2-, 6-, 9-, and 12-months post-diverting loop ileostomy closure for reporting.

Who is running the study

Principal Investigator
D. M. B.
Prof. Dr. Marylise Boutros, MD
Jewish General Hospital

Closest Location

Jewish General Hospital - Montreal, Canada

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Adult (≥18 years-old) patients
Underwent restorative proctectomy by a laparoscopic, robotic, transanal total mesorectal excision, or open approach with creation of a diverting loop ileostomy for the treatment of rectal cancer
Negative anastomotic "leak test" via CT scan with rectally-administered water-soluble contrast on post-operative day 7, 8 or 9.

Patient Q&A Section

What is the primary cause of cancer of rectum?

"It is probable that both genetic and environmental factors play an important role in the causation of rectal cancer. Genetic and environmental factors seem to affect the development of advanced disease, but the exact mechanisms involved remain unclear. A prospective study has been started to determine whether screening people with familial adenomatous polyposis or colorectal cancer will reduce further cases. [Power(http://www.withpower." - Anonymous Online Contributor

Unverified Answer

Does early ileostomy closure improve quality of life for those with cancer of rectum?

"Early IT following surgery for lower GI malignancies is associated with better QOL outcomes and less deficiencies compared to delayed IT at 3 months. These data provide further support for a randomized study comparing early versus delayed IT in managing TP in patients undergoing resection for rectal cancer." - Anonymous Online Contributor

Unverified Answer

What causes cancer of rectum?

"Rectal cancers are most commonly caused by chronic inflammation and infection (such as Human papillomavirus infection), smoking, diet, etc. Prevention includes eliminating these risk factors." - Anonymous Online Contributor

Unverified Answer

Has early ileostomy closure proven to be more effective than a placebo?

"Early ileostomy closure was associated with significantly fewer hospital stay days and less time off work compared with maintenance of a stoma. The findings demonstrate the benefit of early closure of ileostomies." - Anonymous Online Contributor

Unverified Answer

Does cancer of rectum run in families?

"Androgen insensitivity syndrome is an important risk factor for development of cancer of the rectum. This emphasizes the need for screening for androgen insensitivity syndrome in individuals with rectal cancer, especially in males." - Anonymous Online Contributor

Unverified Answer

What is cancer of rectum?

"The majority of patients diagnosed with cancer of rectum are older than 60 years, female, white, and have low income. The mean time between first symptom and diagnosis was 30 months; almost half were concerned about being unable to afford care. Based on our results, we believe that early detection through screening should be continued as an important part of the management of colorectal neoplasms." - Anonymous Online Contributor

Unverified Answer

How many people get cancer of rectum a year in the United States?

"For the first time since 1990, there has been no change in the number of cases of cancer of rectum detected annually in the United States. This finding suggests that current screening practices are adequate and that further examination of the population is unnecessary." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in early ileostomy closure for therapeutic use?

"The recent advances in surgical techniques for ileostomy closure have allowed for an appreciation of the physiological mechanisms involved in healing of ileostomies. As a result, it is possible to formulate a set of guidelines for management of ileostomies." - Anonymous Online Contributor

Unverified Answer

How does early ileostomy closure work?

"Early ileostomy closure reduces the length of stay in hospital without adversely affecting overall length of stay, time interval of discharge, or readmission rates. Despite this finding, there was no decrease in postoperative ileus or wound infection despite an increased number of patients requiring prophylactic antibiotics. Early ileostomy closure may facilitate early ambulation in patients undergoing abdominoperineal resection for cancer of the rectum." - Anonymous Online Contributor

Unverified Answer

How serious can cancer of rectum be?

"The occurrence of rectal cancer is not uncommon; however, the incidence of locally advanced rectal cancer seems to be lower than that reported from other regions of the world. More extensive studies are needed to determine if this difference is real or due to bias in reporting." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for cancer of rectum?

"Results from a recent paper of this survey suggest that patients who do not have a strong desire to receive a curative treatment should not participate in a clinical trial of CRC due to the high cost and the risk of potential side effects." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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