A Phase 4 interventional study of Stapled Transanal Resection (STARR) with Transtar (PROXIMATE®) 33 mm Circular Stapler in Obstructive Defecation Syndrome, Chronic Constipation and Rectocele, sponsored by Ethicon Endo-Surgery. Completed at 7 sites in United States. Open to female participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-07-16.
Sponsored by Ethicon Endo-Surgery (part of Johnson & Johnson) · Phase 4, Interventional, and Treatment
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).
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.
50 studies on the registry are indexed under Rectocele; 9 are open to participants now.
This study's enrollment of 75 is above the median of 62 across 37 interventional studies indexed under Rectocele.
Browse Rectocele studies →Ethicon Endo-Surgery is the lead sponsor of 47 studies on the registry; 1 is open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 7 (100%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Percentage of Change (Reduction) in Total ODS Symptom Composite Score From Baseline to One Year 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.
Time frame: one year from Baseline
Percentage of Change in ODS Symptom Composite Score From Baseline at 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.
Time frame: Baseline, 1 month post procedure
Maximum Change in Subject-reported Assessment of Symptom Severity and Frequency (PAC SYM).
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
Percentage of Change in ODS Symptom Composite Score From Baseline at 6 Months (0 is Worst Score, 24 is Best Score)
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
PAC QOL Patient Assessment of Constipation (Overall)
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
SF-12 QOL Change From Baseline (Physical Component)at 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.
Time frame: Baseline, 12 Months
SF-12 QOL Change (Mental Component) at 12 Months From Baseline
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
| Milestone | Stapled Trans-Anal Rectal Resection (STARR) |
|---|---|
| Started | 75 |
| Completed | 59 |
| Not completed | 16 |
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.
| percentage of change | Stapled Trans-Anal Rectal Resection (STARR) |
|---|---|
| Percentage of Change (Reduction) in Total ODS Symptom Composite Score From Baseline to One Year Post Procedure | 60.8 ± 35.46 |
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.
| percentage of change | Stapled Trans-Anal Rectal Resection (STARR) |
|---|---|
| Percentage of Change in ODS Symptom Composite Score From Baseline at 1 Month Post Procedure | -50.7 ± 34.4 |
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.
| units on a scale | Stapled Trans-Anal Rectal Resection (STARR) |
|---|---|
| Maximum Change in Subject-reported Assessment of Symptom Severity and Frequency (PAC SYM). | 1.43 ± 0.72 |
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.
| percentage of change | Stapled Trans-Anal Rectal Resection (STARR) |
|---|---|
| Percentage of Change in ODS Symptom Composite Score From Baseline at 6 Months (0 is Worst Score, 24 is Best Score) | -57.0 ± 34.4 |
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
| units on a scale | Stapled Trans-Anal Rectal Resection (STARR) |
|---|---|
| PAC QOL Patient Assessment of Constipation (Overall) | 0.95 ± 0.996 |
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.
| units on a scale | Stapled Trans-Anal Rectal Resection (STARR) |
|---|---|
| SF-12 QOL Change From Baseline (Physical Component)at 12 Months | 6.32 ± 9.106 |
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.
| units on a scale | Stapled Trans-Anal Rectal Resection (STARR) |
|---|---|
| SF-12 QOL Change (Mental Component) at 12 Months From Baseline | 4.83 ± 11.67 |
Collected over 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Stapled Trans-Anal Rectal Resection (STARR) | — | 14/75 (18.7%) | 33/75 (44%) |
| Event | Stapled Trans-Anal Rectal Resection (STARR) |
|---|---|
| Postprocedural haemorrhageInjury, poisoning and procedural complications | 2/75 |
| Urinary retentionRenal and urinary disorders | 2/75 |
| Blood count abnormalInvestigations | 1/75 |
| Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/75 |
| ColostomySurgical and medical procedures | 1/75 |
| Diabetic ketoacidosisMetabolism and nutrition disorders | 1/75 |
| GastroenteritisInfections and infestations | 1/75 |
| Gastrointestinal injuryInjury, poisoning and procedural complications | 1/75 |
| Haematoma infectionInfections and infestations | 1/75 |
| Intestinal hypomotilityGastrointestinal disorders | 1/75 |
| Event | Stapled Trans-Anal Rectal Resection (STARR) |
|---|---|
| urinary retentionRenal and urinary disorders | 14/75 |
| InsomniaPsychiatric disorders | 7/75 |
| DizzinessNervous system disorders | 6/75 |
| PruritusSkin and subcutaneous tissue disorders | 6/75 |
| Age, Continuous(years) | Stapled Trans-Anal Rectal Resection (STARR) |
|---|---|
| Median | 48 (23 to 80) |
| Sex: Female, Male(Participants) | Stapled Trans-Anal Rectal Resection (STARR) |
|---|---|
| Female | 75 |
| Male | 0 |
| ODS composite score(units on a scale) | Stapled Trans-Anal Rectal Resection (STARR) |
|---|---|
| Mean | 6.19 ± 3.13 |
| number of subjects in each age range having STARR procedure(participants) | Stapled Trans-Anal Rectal Resection (STARR) |
|---|---|
| <=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 |
Ran from Oct 2005 to primary completion in Mar 2008, 29 months.
Results were first posted in Apr 2011, 3 years 1 month after primary completion.
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