NCT00140868

CompletedPhase 3

Outcome of Palliative Management of Malignant Large Bowel Ob...

Memorial Sloan Kettering Cancer Center Source

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Other study identifiers

Sponsor study identifier

02-125

Study Type

interventional

Reported enrollment (type unavailable)

180

Locations

1 country

Sites

1

Timeline

Study Start

December 2002

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

October 2006

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 180 participants
Study completion date: October 2006
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
December 2002
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
August 30, 2005
Actual (reported)
First Posted
September 1, 2005
Actual (reported)
Study Completion
October 2006
Actual (reported)

Last Updated: December 10, 2007
Status Verified: December 2007
Last Update Submitted: December 6, 2007

Conditions

Large Bowel Obstruction

Keywords

Colonic Pseudo-ObstructionLarge bowel obstructionStentsLaparotomyPalliative SurgerySurgery, PalliativePalliative 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 stentsDevice

Minimally Invasive Surgical Bowel DiversionProcedure

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

Sponsors & Collaborators

Memorial Sloan Kettering Cancer Center
Otherlead

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

MeSH Terms

Conditions

Colonic Pseudo-Obstruction

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesIntestinal Pseudo-ObstructionIleusIntestinal 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 2002

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

October 2006

Actual (reported)

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

Contact the study team to confirm eligibility.

Last Updated

December 10, 2007

Record last verified: 2007-12

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00140868
Data provider: ClinicalTrials.gov
Source updated: 2007-12-10
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:35:34 UTC

Locations

US(1)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations