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

Sponsor
Ethicon Endo-Surgery (Industry)
Overall Status
Completed
CT.gov ID
NCT00256984
Collaborator
(none)
75
7
32
10.7
0.3

Study Details

Study Description

Brief Summary

The primary purpose of this study is to determine how effective and how durable STARR (stapled transanal rectal resection) surgery is in relieving symptoms of intractable constipation associated with obstructive defecation syndrome (ODS).

Condition or Disease Intervention/Treatment Phase
  • Procedure: Stapled Transanal Resection (STARR) with Transtar (PROXIMATE®) 33 mm Circular Stapler
Phase 4

Detailed Description

Rectocele and rectal intussusception are frequent findings in women but are often asymptomatic apart from anatomical defects, which can be seen on vaginal examination. They can be associated, however, with refractory constipation that may be best described by the terms "Outlet Obstruction" or "Obstructive Defecation Syndrome (ODS)". ODS is characterized by a symptom complex, including the feeling of incomplete evacuation associated with the need to strain excessively and for external assistance (digital, mechanical or positional maneuvers, enemas or suppositories) to aid defecation. Abdominal or rectal pain is also a common complaint. Obstetric trauma is also recognized as a contributing factor. However, none of these symptoms/factors can be singled out to be pathognomonic for this problem. ODS has a prevalence of approximately 12% in the general population.

For individuals with ODS and related intussusception/rectocele, a variety of surgical techniques including abdominal, vaginal, transanal and perineal approaches have been devised. The impact of clinical studies to evaluate these techniques has been limited by variability of results and lack of comparators. Recently, a new surgical approach was developed by an Italian surgeon, A. Longo, and has been evaluated in several European centers. These early studies and observations indicate that this new procedure may in fact provide significantly better symptom resolution in ODS patients than other available treatments, and warrants further study. The procedure is referred to as "Stapled Transanal Rectal Resection (STARR)" and this study will assess its effectiveness in a United States population.

Study Design

Study Type:
Interventional
Actual Enrollment :
75 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multi-center Study to Assess the Outcomes of Stapled Trans-Anal Rectal Resection (STARR) in the Treatment of Obstructed Defecation Syndrome (ODS)
Actual Study Start Date :
Oct 1, 2005
Actual Primary Completion Date :
Mar 1, 2008
Actual Study Completion Date :
Jun 1, 2008

Outcome Measures

Primary Outcome Measures

  1. Percentage of Change (Reduction) in Total ODS Symptom Composite Score From Baseline to One Year Post Procedure [one year from Baseline]

    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.

Secondary Outcome Measures

  1. Percentage of Change in ODS Symptom Composite Score From Baseline at 1 Month Post Procedure [Baseline, 1 month post procedure]

    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.

  2. Maximum Change in Subject-reported Assessment of Symptom Severity and Frequency (PAC SYM). [Baseline, 6 months]

    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.

  3. Percentage of Change in ODS Symptom Composite Score From Baseline at 6 Months (0 is Worst Score, 24 is Best Score) [Baseline, 6 months post procedure]

    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.

  4. PAC QOL Patient Assessment of Constipation (Overall) [Baseline, 12 months]

    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

  5. SF-12 QOL Change From Baseline (Physical Component)at 12 Months [Baseline, 12 Months]

    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.

  6. SF-12 QOL Change (Mental Component) at 12 Months From Baseline [Baseline, 12 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 80 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Able to comprehend, understand, and speak the English language

  • Able to comprehend, follow, and sign an informed consent document (ICD)

  • Able to tolerate general or spinal anesthetic

  • Often experience excessive straining, sense of incomplete evacuation, and/or prolonged time for complete evacuation when attempting a bowel movement

  • Have experienced ODS symptoms for at least 12 months prior to enrollment

  • Have a minimum ODS score of 10

  • Have rectocele and/or rectal intussusception confirmed by defecography

  • Screened for colorectal neoplasia within 7 years of the screening visit (e.g., colonoscopy or barium enema)

  • Have an American Society of Anesthesiologists (ASA) score of no more than 3

  • Willing to comply with evaluation and management schedule through 5-year follow-up

Exclusion Criteria:
  • Fecal incontinence to solid stool

  • Full-thickness prolapse

  • Perineal infection

  • Recto-vaginal fistula

  • Enterocele (at rest)

  • Any complex pelvic floor prolapse requiring a combined surgical approach

  • Prior sigmoid or anterior resection or prior rectal anastomosis

  • Presence of foreign material adjacent to the rectum (e.g., vaginal mesh)

  • Grade IV hemorrhoids

  • Pregnancy

  • Chronic narcotic use

  • Evidence of colorectal neoplasia, carcinoma, or inflammatory bowel disease

  • Physical or psychological condition which would impair study participation

  • Unable or unwilling to attend follow-up visits and examinations

  • Surgical procedure required concurrently with STARR

  • Prior pelvic radiotherapy

  • Failure to identify any anatomical or physiological abnormality in the evaluation

  • Significant rectal fibrosis

  • Anal stenosis precluding insertion of the stapling device

  • Participation in any other investigational device or drug study 30 days prior to enrollment

  • Presence or history of hepatitis B, hepatitis C, and/or HIV positive test

Contacts and Locations

Locations

Site City State Country Postal Code
1 Colon and Rectal Clinic of Orlando Orlando Florida United States 32806
2 Lahey Clinic Burlington Massachusetts United States 01805
3 Colon & Rectal Surgery Associates Ltd. Minneapolis Minnesota United States 55454
4 University Hospitals of Cleveland Cleveland Ohio United States 44106
5 The Cleveland Clinic Foundation Cleveland Ohio United States 44195
6 Medical University of Ohio, Department of Surgery Toledo Ohio United States 43614
7 Portland Medical Center Portland Oregon United States 97205

Sponsors and Collaborators

  • Ethicon Endo-Surgery

Investigators

  • Study Director: Robin F Scamuffa, MS, Ethicon Endo-Surgery
  • Study Director: William Bernie, MD, Ethicon Endo-Surgery
  • Principal Investigator: Anthony J Senagore, MD, Medical University of Ohio
  • Principal Investigator: Anders F Mellgren, MD, PhD, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ethicon Endo-Surgery
ClinicalTrials.gov Identifier:
NCT00256984
Other Study ID Numbers:
  • CI-05-0004
First Posted:
Nov 22, 2005
Last Update Posted:
Jul 16, 2018
Last Verified:
Oct 1, 2017

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Stapled Trans-Anal Rectal Resection (STARR)
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

Baseline Characteristics

Arm/Group Title Stapled Trans-Anal Rectal Resection (STARR)
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 Participants 75
Age (years) [Median (Full Range) ]
Median (Full Range) [years]
48
Sex: Female, Male (Count of Participants)
Female
75
100%
Male
0
0%
ODS composite score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]
6.19
(3.13)
number of subjects in each age range having STARR procedure (participants) [Number]
<=29 years
4
5.3%
Between 30 and 39 years
9
12%
Between 40 and 49 years
26
34.7%
Between 50 and 59 years
18
24%
Between 60 and 69 years
11
14.7%
>=70 years
7
9.3%

Outcome Measures

1. Primary Outcome
Title Percentage of Change (Reduction) in Total ODS Symptom Composite Score From Baseline to One Year Post Procedure
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

Outcome Measure Data

Analysis Population Description
Per protocol
Arm/Group Title Stapled Trans-Anal Rectal Resection (STARR)
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
Measure Participants 59
Mean (Standard Deviation) [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
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Stapled Trans-Anal Rectal Resection (STARR)
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
Measure Participants 59
Mean (Standard Deviation) [percentage of change]
-50.7
(34.4)
3. Secondary Outcome
Title Maximum Change in Subject-reported Assessment of Symptom Severity and Frequency (PAC SYM).
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Stapled Trans-Anal Rectal Resection (STARR)
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
Measure Participants 59
Mean (Standard Deviation) [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)
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Stapled Trans-Anal Rectal Resection (STARR)
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
Measure Participants 59
Mean (Standard Deviation) [percentage of change]
-57.0
(34.4)
5. Secondary Outcome
Title PAC QOL Patient Assessment of Constipation (Overall)
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

Outcome Measure Data

Analysis Population Description
Sizing consistent with primary outcome; analysis was Intent-to-Treat
Arm/Group Title Stapled Trans-Anal Rectal Resection (STARR)
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
Measure Participants 59
Mean (Standard Deviation) [units on a scale]
0.95
(0.996)
6. Secondary Outcome
Title SF-12 QOL Change From Baseline (Physical Component)at 12 Months
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Stapled Trans-Anal Rectal Resection (STARR)
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
Measure Participants 59
Mean (Standard Deviation) [units on a scale]
6.32
(9.106)
7. Secondary Outcome
Title SF-12 QOL Change (Mental Component) at 12 Months From Baseline
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Stapled Trans-Anal Rectal Resection (STARR)
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
Measure Participants 59
Mean (Standard Deviation) [units on a scale]
4.83
(11.67)

Adverse Events

Time Frame 1 year
Adverse Event Reporting Description
Arm/Group Title Stapled Trans-Anal Rectal Resection (STARR)
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 (%) # Events
Total / (NaN)
Serious Adverse Events
Stapled Trans-Anal Rectal Resection (STARR)
Affected / at Risk (%) # Events
Total 14/75 (18.7%)
Gastrointestinal disorders
Intestinal hypomotility 1/75 (1.3%)
Rectal haemorrhage 1/75 (1.3%)
Rectal perforation 1/75 (1.3%)
Umbilical hernia 1/75 (1.3%)
Infections and infestations
Gastroenteritis 1/75 (1.3%)
Haematoma infection 1/75 (1.3%)
Injury, poisoning and procedural complications
Gastrointestinal injury 1/75 (1.3%)
Postprocedural haemorrhage 2/75 (2.7%)
Suture related complication 1/75 (1.3%)
Investigations
Blood count abnormal 1/75 (1.3%)
Metabolism and nutrition disorders
Diabetic ketoacidosis 1/75 (1.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer 1/75 (1.3%)
Renal and urinary disorders
Urinary retention 2/75 (2.7%)
Surgical and medical procedures
Colostomy 1/75 (1.3%)
Other (Not Including Serious) Adverse Events
Stapled Trans-Anal Rectal Resection (STARR)
Affected / at Risk (%) # Events
Total 33/75 (44%)
Nervous system disorders
Dizziness 6/75 (8%)
Psychiatric disorders
Insomnia 7/75 (9.3%)
Renal and urinary disorders
urinary retention 14/75 (18.7%)
Skin and subcutaneous tissue disorders
Pruritus 6/75 (8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Results Point of Contact

Name/Title Susan Knippenberg, Clinical Scientist
Organization Ethicon Endo-Surgery
Phone 513 337-3452
Email sknippen@its.jnj.com
Responsible Party:
Ethicon Endo-Surgery
ClinicalTrials.gov Identifier:
NCT00256984
Other Study ID Numbers:
  • CI-05-0004
First Posted:
Nov 22, 2005
Last Update Posted:
Jul 16, 2018
Last Verified:
Oct 1, 2017