Outcome of Palliative Management of Malignant Large Bowel Obstruction w/Colorectal Stents or Surgery

NCT00140868 | Completed Phase 3

• 1 other identifier: 02-125
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess quality of life and bowel symptoms after treatment.The main objective is to compare the effect on quality of life of minimally invasive bowel surgery and endoscopic stent placement in the treatment of malignant large bowel obstruction.

Conditions

Large Bowel Obstruction

Keywords

Colonic Pseudo-Obstruction; Large bowel obstruction; Stents; Laparotomy; Palliative Surgery; Surgery, Palliative; Palliative Therapy

Outcome Measures

Primary Outcomes (1)

• Primary objective: compare the effect on quality of life of minimally invasive surgical bowel diversion and endoscopic stent placement in the treatment of malignant large bowel obstruction.

Secondary Outcomes (1)

• Secondary objectives:the symptom response and complication rate of treatment of malignant large bowel obstruction with endoscopic stent placement or minimally invasive surgical bowel diversion

Interventions

Luminal stents DEVICE

Minimally Invasive Surgical Bowel Diversion PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• men and women over 18 years of age
• presentation of large bowel obstruction based on clinical symptoms AND an imaging study.
• clinical symptoms: one of : progressive constipation, multiple small liquid bowel movements daily, abdominal distention, abdominal pain or nausea and vomiting.
• imaging study: one of: CT scan, barium or gastrograffin enema, flexible sigmoidoscopy or colonoscopy, showing any degree of colonic narrowing by tumor.
• large bowel obstruction due to stage IV colorectal cancer unresectable for cure OR unresectable local-regional colorectal cancer OR unresectable extra-colonic cancer (such as gastric, ovarian, prostate, pancreatic cancers).
• ability to give informed consent, indicating the investigational nature of this study in keeping with the policies of Memorial Sloan-Kettering Cancer Center.

You may not qualify if:

• presence of acute bowel perforation
• presence of a second synchronous large or small bowel obstruction site
• contra-indication to stent placement:
• obstruction greater than 12 cm in length (ie precluding treatment with one stent)
• obstruction located within 2 cm of dentate line
• contra-indication to laparoscopy:
• presence of MI, unstable angina, or CVA in the previous four weeks
• tense ascites
• uncorrectable coagulopathy
• prior abdominal surgery with known prohibitive adhesions
• prior PALLIATIVE treatment of malignant large bowel obstruction with surgery or stent
• inability to speak or read English, or other impairment which causes an inability to complete the quality of life questionnaires
• unable or unwilling to give informed consent

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Colonic Pseudo-Obstruction

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Pseudo-Obstruction; Ileus; Intestinal Obstruction

Study Officials

• Hans Gerdes, M.D.

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 30, 2005
• First Posted: September 1, 2005
• Study Start: December 1, 2002
• Study Completion: October 1, 2006
• Last Updated: December 10, 2007

Record last verified: 2007-12

Locations

US (1)