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Study of Stapled Transanal Rectal Resection (STARR) Surgery in Refractory Constipation Associated With Obstructive Defecation Syndrome (ODS)

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ClinicalTrials.gov Identifier: NCT00256984
Recruitment Status : Completed
First Posted : November 22, 2005
Results First Posted : April 7, 2011
Last Update Posted : July 16, 2018
Sponsor:
Information provided by (Responsible Party):
Ethicon Endo-Surgery

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Obstructive Defecation Syndrome
Chronic Constipation
Rectocele
Intussusception
Intervention Procedure: Stapled Transanal Resection (STARR) with Transtar (PROXIMATE®) 33 mm Circular Stapler
Enrollment 75
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Stapled Trans-Anal Rectal Resection (STARR)
Hide Arm/Group Description STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
Period Title: Overall Study
Started 75
Completed 59
Not Completed 16
Arm/Group Title Stapled Trans-Anal Rectal Resection (STARR)
Hide Arm/Group Description STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
Overall Number of Baseline Participants 75
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Median (Full Range)
Unit of measure:  Years
Number Analyzed 75 participants
48
(23 to 80)
[1]
Measure Description: Median age at consent
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants
Female
75
 100.0%
Male
0
   0.0%
ODS composite score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 75 participants
6.19  (3.13)
[1]
Measure Description: Based upon Obstructed Defecation Syndrome (ODS) questionnaire. This questionnaire has eight questions, each dealing with frequency of a particular attribute associated with ODS (mechanical, difficulties to evacuate, digitation to evacuate, return to toilet to evacuate, feeling of incomplete evacuation, straining to evacuate, time needed to evacuate, and lifestyle alterations). Each is scored 0-3 (low to high on scale, no units. "0" is the lowest frequency of occurrence, "3" is the highest frequency of occurrence; the total of all attributes (0-24) is the final score.
number of subjects in each age range having STARR procedure  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 75 participants
<=29 years 4
Between 30 and 39 years 9
Between 40 and 49 years 26
Between 50 and 59 years 18
Between 60 and 69 years 11
>=70 years 7
1.Primary Outcome
Title Percentage of Change (Reduction) in Total ODS Symptom Composite Score From Baseline to One Year Post Procedure
Hide Description The primary endpoint used to assess effectiveness of STARR for treatment of ODS was the percentage of change in total ODS symptom composite score (0=worst, 24=best) 1 year after completion of the procedure.
Time Frame one year from Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol
Arm/Group Title Stapled Trans-Anal Rectal Resection (STARR)
Hide Arm/Group Description:
STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
Overall Number of Participants Analyzed 59
Mean (Standard Deviation)
Unit of Measure: percentage of change
60.8  (35.46)
2.Secondary Outcome
Title Percentage of Change in ODS Symptom Composite Score From Baseline at 1 Month Post Procedure
Hide Description Percentage of change in Obstructive Defecation Syndrome (ODS) symptom composite score from baseline at 1 month post procedure. This score is based on a series of questions designed to understand the extent ODS effects an individual's daily lifestyle (0 is worst score, 24 is best score). Sizing consistent with primary outcome; analysis was per-protocol.
Time Frame Baseline, 1 month post procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stapled Trans-Anal Rectal Resection (STARR)
Hide Arm/Group Description:
STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
Overall Number of Participants Analyzed 59
Mean (Standard Deviation)
Unit of Measure: percentage of change
-50.7  (34.4)
3.Secondary Outcome
Title Maximum Change in Subject-reported Assessment of Symptom Severity and Frequency (PAC SYM).
Hide Description Assessed as patient-reported assessment of symptom severity and frequency (PAC-SYM)associated with constipation. Patient response options are absent, mild, moderate, severe, and very severe.12 questions relate to severity, 8 questions relate to frequency of symptoms. The lower the score, the less severe the symptoms. Sizing consistent with primary outcome; analysis was per-protocol.
Time Frame Baseline, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stapled Trans-Anal Rectal Resection (STARR)
Hide Arm/Group Description:
STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
Overall Number of Participants Analyzed 59
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.43  (0.72)
4.Secondary Outcome
Title Percentage of Change in ODS Symptom Composite Score From Baseline at 6 Months (0 is Worst Score, 24 is Best Score)
Hide Description The primary endpoint used to assess effectiveness of STARR for treatment of ODS was the percentage of change in total ODS symptom composite score (0=worst, 24=best) 1 year after completion of the procedure.
Time Frame Baseline, 6 months post procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stapled Trans-Anal Rectal Resection (STARR)
Hide Arm/Group Description:
STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
Overall Number of Participants Analyzed 59
Mean (Standard Deviation)
Unit of Measure: percentage of change
-57.0  (34.4)
5.Secondary Outcome
Title PAC QOL Patient Assessment of Constipation (Overall)
Hide Description PAC-QOL is Patient Assessment of Constipation, Quality of Life. The instrument consists of 28 questions on a 0-4 scale. A lower score indicates better quality of life. The score is a number without units.Change from baseline in patient assessment of constipation in quality of life as measured by the PAC QOL instrument score. The questions are designed to measure the impact constipation has had on daily life during the week prior to the subject visit. Sizing was consistent with the primary outcome; analysis was per-protocol
Time Frame Baseline, 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Sizing consistent with primary outcome; analysis was Intent-to-Treat
Arm/Group Title Stapled Trans-Anal Rectal Resection (STARR)
Hide Arm/Group Description:
STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
Overall Number of Participants Analyzed 59
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.95  (0.996)
6.Secondary Outcome
Title SF-12 QOL Change From Baseline (Physical Component)at 12 Months
Hide Description The SF-12 is a validated 12 question quality-of-life questionnaire. The SF-12 extracts 12 items from the SF-36 questionnaire in two six-item subscales, PCS (physical functioning) and MCS (emotional functioning). The SF-12 scores can range from 10 (maximum impairment) to 70 (no impairment). For this study, the endpoint is the percentage of change from baseline over 12 months post procedure.
Time Frame Baseline, 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stapled Trans-Anal Rectal Resection (STARR)
Hide Arm/Group Description:
STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
Overall Number of Participants Analyzed 59
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.32  (9.106)
7.Secondary Outcome
Title SF-12 QOL Change (Mental Component) at 12 Months From Baseline
Hide Description SF 12 change from baseline, mental component. The SF-12 is a validated 12 question quality-of-life questionnaire. The SF-12 extracts 12 items from the SF-36 questionnaire in two six-item subscales, PCS (physical functioning) and MCS (emotional functioning). The SF-36 scores range from 0 (maximum impairment) to 100 (no impairment), the SF-12 scores range from 10 (maximum impairment) to 70 (no impairment). For this study, the endpoint is the percentage of change from baseline over 12 months post procedure.
Time Frame Baseline, 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stapled Trans-Anal Rectal Resection (STARR)
Hide Arm/Group Description:
STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
Overall Number of Participants Analyzed 59
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.83  (11.67)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Stapled Trans-Anal Rectal Resection (STARR)
Hide Arm/Group Description STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
All-Cause Mortality
Stapled Trans-Anal Rectal Resection (STARR)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Stapled Trans-Anal Rectal Resection (STARR)
Affected / at Risk (%)
Total   14/75 (18.67%) 
Gastrointestinal disorders   
Intestinal hypomotility  1/75 (1.33%) 
Rectal haemorrhage  1/75 (1.33%) 
Rectal perforation  1/75 (1.33%) 
Umbilical hernia  1/75 (1.33%) 
Infections and infestations   
Gastroenteritis  1/75 (1.33%) 
Haematoma infection  1/75 (1.33%) 
Injury, poisoning and procedural complications   
Gastrointestinal injury  1/75 (1.33%) 
Postprocedural haemorrhage  2/75 (2.67%) 
Suture related complication  1/75 (1.33%) 
Investigations   
Blood count abnormal  1/75 (1.33%) 
Metabolism and nutrition disorders   
Diabetic ketoacidosis  1/75 (1.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast cancer  1/75 (1.33%) 
Renal and urinary disorders   
Urinary retention  2/75 (2.67%) 
Surgical and medical procedures   
Colostomy  1/75 (1.33%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Stapled Trans-Anal Rectal Resection (STARR)
Affected / at Risk (%)
Total   33/75 (44.00%) 
Nervous system disorders   
Dizziness  6/75 (8.00%) 
Psychiatric disorders   
Insomnia  7/75 (9.33%) 
Renal and urinary disorders   
urinary retention  14/75 (18.67%) 
Skin and subcutaneous tissue disorders   
Pruritus  6/75 (8.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Susan Knippenberg, Clinical Scientist
Organization: Ethicon Endo-Surgery
Phone: 513 337-3452
EMail: sknippen@its.jnj.com
Publications:
Layout table for additonal information
Responsible Party: Ethicon Endo-Surgery
ClinicalTrials.gov Identifier: NCT00256984     History of Changes
Other Study ID Numbers: CI-05-0004
First Submitted: November 18, 2005
First Posted: November 22, 2005
Results First Submitted: October 27, 2009
Results First Posted: April 7, 2011
Last Update Posted: July 16, 2018