Trial of colonic stenting for large bowel obstructio

Phase 1

• Conditions: Colorectal cancers; Large bowel obstructions; Cancer - Bowel - Back passage (rectum) or large bowel (colon)

• Registration Number: ACTRN12606000199516
• Lead Sponsor: Dr Christopher Young

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-05-26
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

All adult patients who present with malignant large bowel obstruction proven radiologically & deemed non-curable by surgical interention.

Exclusion Criteria

If a patient is unfit for surgical iintervention (ASA grade iv & v), require urgent laparotomy due to perferation or ischaemia of the bowel, have evidence of synchronous & seperate sites of the small & large bowel, or are cognitively impaired or otherwise unable to give informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare quality of life between surgical intervention and colonic stent insertion in the first 12 months following the procedure.[Daily until discharge from hospital, then at 1, 2, and 4 weeks and 3, 6 and 12 months]

Secondary Outcome Measures

Name	Time	Method
1. Permanent stoma rate[Immediately postoperative];2. length of procedure[Immediately postoperatively];3. length of intensive care[Postoperatively until discharge form intensive care];4. length of hospital stay[Admission to discharge];5. complication rate[Admission to discharge];6. 30 day mortality rate[Admission to 30 days post procedure];7. cost utility[Admission to discharge]