Balloon Colonoscopy for Incomplete Colonoscopy

• Sponsor: Northwestern University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00935857
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 20
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

Patients with a prior incomplete colonoscopy will be enrolled in this study. Patients will be randomized to either an initial repeat attempt with a standard colonoscope or the single balloon enteroscope. If the procedures is unsuccessful, the patient can be crossed-over to the other group. The primary endpoint of the study is a complete colonoscopy.

Condition or Disease	Intervention/Treatment	Phase
Diverticulosis	Device: Single Balloon Colonoscopy; Device: Standard Colonoscopy	N/A

Detailed Description

Colonoscopy is a well-established practice utilized for the evaluation of lower gastrointestinal tract diseases including, mostly commonly, the screening for colorectal polyps and cancer. Despite improvements in endoscope technology, a significant minority of procedures (up to 10%) can not be safely completed due to a variety of patient factors and technical difficulties. These factors primarily include prior abdominal surgeries resulting in adhesions, severe diverticular disease, inadequate bowel cleansing, and patient discomfort.

Options for an incomplete colonoscopy include several endoscopic and non-endoscopic modalities. Non-endoscopic modalities include radiologic studies such as CT/MRI colonography as well as a retrograde barium study. Relative disadvantages of these modalities is the inability to remove colonic polyps, perform biopsies, and in the case of barium studies, a lower sensitivity for pathology. Alternative endoscopic modalities have been described that may assist in successfully completing colonoscopy Of these alternative methods, balloon-overtube assisted colonoscopy is the most promising, but this method has not been studied in a randomized, controlled fashion. In this study, we aim to compare balloon-overtube assisted colonoscopy versus standard colonoscopy for patients with prior incomplete colonoscopy.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Balloon Colonoscopy Versus Repeat Standard Colonoscopy for Prior Incomplete Colonoscopy: A Randomized Controlled Trial
• Study Start Date: Apr 1, 2009
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Balloon Colonoscopy Colonoscopy using the single balloon colonoscopy system (novel endoscope to facilitate difficult colonoscopy).	Device: Single Balloon Colonoscopy; Use of the single balloon enteroscopy system (enteroscope and balloon-overtube) to complete colonoscopy.
Active Comparator: Standard Colonoscopy Colonoscopy using a standard adult colonoscope	Device: Standard Colonoscopy; Use of the standard adult colonoscope to complete colonoscopy.

Outcome Measures

Primary Outcome Measures

1. Complete Colonoscopy to the Cecum [Day of Procedure]

   Number of patients with a complete colonoscopy to the cecum

Secondary Outcome Measures

1. Time (Minutes) to Cecum [Day of Procedure]

   Time, in minutes, until reaching cecum in each arm.

2. Procedural Complications [7 days post procedure]

   Number of patients with any procedural complications as assessed 7 days after procedure.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• prior colonoscopy that was incomplete within the previous 12 months or their two most recent colonoscopies (performed at any time interval) were incomplete

Exclusion Criteria:

• incomplete colonoscopy due only to poor bowel preparation or inadequate sedation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University Feinberg School of Medicine	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

• Principal Investigator: Rajesh N Keswani, MD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rajesh Keswani, Assistant Professor of Medicine, Northwestern University
• ClinicalTrials.gov Identifier: NCT00935857
• Other Study ID Numbers: STU00008540
• First Posted: Jul 9, 2009
• Last Update Posted: Sep 25, 2014
• Last Verified: Sep 1, 2014

• Keywords provided by Rajesh Keswani, Assistant Professor of Medicine, Northwestern University: Balloon Enteroscopy; Looping
• Additional relevant MeSH terms: Diverticulum; Diverticular Diseases

Study Results

Participant Flow

Recruitment Details	Subject recruitment completed.
Pre-assignment Detail	Early termination at 30 patients due to clinically significant differences at midpoint of study. Patients in the Standard Colonoscopy group could cross-over to the Balloon Colonoscopy group after 20 minutes of procedure time but they were not included in further analysis after cross-over.

Arm/Group Title	Balloon Colonoscopy	Standard Colonoscopy
Arm/Group Description	Colonoscopy using the single balloon enteroscope system.	Colonoscopy using a standard adult colonoscope
Period Title: Overall Study
STARTED	14	16
COMPLETED	14	16
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Balloon Colonoscopy	Standard Colonoscopy	Total
Arm/Group Description	Colonoscopy using the single balloon enteroscope system.	Colonoscopy using a standard adult colonoscope	Total of all reporting groups
Overall Participants	14	16	30
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	14 100%	16 100%	30 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.5 (12.5)	59.9 (10.0)	59.2 (11)
Sex: Female, Male (Count of Participants)
Female	10 71.4%	12 75%	22 73.3%
Male	4 28.6%	4 25%	8 26.7%
Region of Enrollment (participants) [Number]
United States	14 100%	16 100%	30 100%

Outcome Measures

1. Primary Outcome

Title	Complete Colonoscopy to the Cecum
Description	Number of patients with a complete colonoscopy to the cecum
Time Frame	Day of Procedure

Outcome Measure Data

Analysis Population Description

Per Protocol, Terminated at Interim Analysis

Arm/Group Title	Balloon Colonoscopy	Standard Colonoscopy
Arm/Group Description	Colonoscopy using the single balloon enteroscope system.	Colonoscopy using a standard adult colonoscope
Measure Participants	14	16
Number [patients]	13	8

2. Secondary Outcome

Title	Time (Minutes) to Cecum
Description	Time, in minutes, until reaching cecum in each arm.
Time Frame	Day of Procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Balloon Colonoscopy	Standard Colonoscopy
Arm/Group Description	Colonoscopy using the single balloon enteroscope system.	Colonoscopy using a standard adult colonoscope
Measure Participants	14	16
Mean (Standard Deviation) [minutes]	24 (15)	22 (18)

3. Secondary Outcome

Title	Procedural Complications
Description	Number of patients with any procedural complications as assessed 7 days after procedure.
Time Frame	7 days post procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Balloon Colonoscopy	Standard Colonoscopy
Arm/Group Description	Colonoscopy using the single balloon enteroscope system.	Colonoscopy using a standard adult colonoscope
Measure Participants	14	16
Number [participants]	0 0%	0 0%

Adverse Events

Time Frame	1 week after completion of endoscopy procedure.
Adverse Event Reporting Description	All subjects were called 1 week after completion of procedure to assess for adverse events.
Arm/Group Title	Standard Colonoscopy		Single Balloon Colonoscopy
Arm/Group Description	Patients who are randomized to received standard colonoscopy as initial treatment.		Patients who are randomized to received single balloon colonoscopy as initial treatment.
All Cause Mortality
	Standard Colonoscopy		Single Balloon Colonoscopy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Standard Colonoscopy		Single Balloon Colonoscopy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/14 (0%)
Other (Not Including Serious) Adverse Events
	Standard Colonoscopy		Single Balloon Colonoscopy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/14 (0%)

Limitations/Caveats

Early termination due to interim analysis showing statistical difference; single operator.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.