Small Bowel ObstructionPhase 2NCT02692638
Trial Comparing Early Laparoscopic Enterolysis Versus Nonoperative Management for High-grade SBO
A Phase 2 study testing Early laparoscopic enterolysis and nonoperative management in people with Small Bowel Obstruction, run by Yale University at 1 site in United States.
Trial summary
The goal is to assess the appropriateness of the standard practice of a trial of nonoperative management for high grade small bowel obstruction (currently up to 72 hours based on available literature). The investigator will offer early laparoscopic enterolysis (within 24 hours of admission) as the comparator group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Bowel Obstruction
- What is being tested?
- Early laparoscopic enterolysis and nonoperative management
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2016to 13 Oct 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CT A/P showing high grade obstruction (all patients will obtain a CT A/P as per Level 1 recommendations based on EAST practice guidelines) .
- High grade bowel obstruction is defined as:
- Transition point
- Distal small collapse with proximal dilatation
- Small bowel feces sign
- 50% difference in caliber change between proximal dilated bowel and distal decompressed bowel
- Intra-abdominal free fluid without clinical signs of ischemia
Who cannot join
- Hemodynamic instability (SBP<90)
- Peritonitis
- Enterocutaneous fistula
- Cirrhosis
- previous enterolysis (more than 1)
- Contraindication to laparoscopic surgery
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06510
About this study
Official title: Prospective, Randomized Trial Comparing Early Laparoscopic Enterolysis Versus a Time-limited Trial of Nonoperative Management for High-grade Small Bowel Obstruction
The goal is to assess the appropriateness of the standard practice of a trial of nonoperative management for high grade small bowel obstruction (currently up to 72 hours based on available literature). The investigator will offer early laparoscopic enterolysis (within 24 hours of admission) as the comparator group.
Read the detailed description
Small bowel obstruction is a common disorder without a clearly superior management strategy. There are an estimated 300,000 surgeries performed annually with a health care expenditure burden in excess of 2.8 billion dollars. The investigators propose a new management paradigm including early laparoscopic management.
Contemporary management of SBO includes a trial of nonoperative management (TNOM) reportedly with resolution in upwards of 70% of patients.
Although it is one of the most common diagnosis for surgical admissions, there are few prospective, clinical trials to address the question surgical timing. Additionally, there are no prospective, randomized trials comparing early laparoscopy versus TNOM for high grade SBO. The hypothesis is that early laparoscopic enterolysis will result in decreased overall complications, shorter length of stay, decreased health care cost, and lower conversion rate to open laparotomy.
- Conditions
- Small Bowel Obstruction
- Being tested
- Early laparoscopic enterolysis, nonoperative management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early laparoscopic enterolysisProcedure or surgery
The surgeon will make about 3-4 small incisions in the participant's abdomen. A port (nozzle) is inserted into one of the slits, and carbon dioxide gas inflates the abdomen. A laparoscope is inserted through another port. The laparoscope looks like a telescope with a light and camera on the end so the surgeon can see inside the abdomen. Surgical instruments are placed in the other small openings and used to cut the scar tissue in order to relieve the obstruction. After all this has been accomplished, the carbon dioxide is released out of the abdomen through the slits, and then these sites are closed with sutures or staples, or covered with glue-like bandage and steri-strips.
nonoperative managementProcedure or surgery
Sometimes a bowel obstruction can be treated by suctioning out the contents of the stomach, giving IV fluids, and not letting the patient eat for a few days.
| Study group | Role | What they receive |
|---|---|---|
| Early laparoscopic enterolysis | Experimental | Patient randomized to the early laparoscopy arm will undergo diagnostic laparoscopy within 24 hours of admission (depending on surgeon and operating room availability). Standard laparoscopy will be performed including supine positioning, sequential compression devices, and appropriate pre-incision antibiotics. Trocar placement will be at the surgeon's discretion and as appropriate for the patient's previous incisions. The necessity for conversion will be left to the discretion of the attending surgeon. Post operative management will conform to the standards of care. Nasogastric tubes will not be routinely placed. Receives: Procedure: Early laparoscopic enterolysis |
| trial of nonoperative management | Active comparator | Patients randomized to the trial of nonoperative management arm will undergo standard therapy including nil per os (NPO), nasogastric decompression only if actively vomiting, intravenous fluids while awaiting return of bowel function. Patients who do not achieve return of bowel function within 72 hours of admission will undergo attempted laparoscopic enterolysis with the understanding that conversion to open procedure may be necessary. Receives: Procedure: nonoperative management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of complications (per National Surgical Quality Improvement Project)
complications counted : Superficial surgical site infection (SSI), Deep SSI, Organ space SSI, Wound disruption, pneumonia, Pulmonary embolism, ventilator days, Acute Kidney Injury (AKI), Acute renal failure (ARF), Urinary Tract Infection (UTI), Stroke, Cardiac arrest, Myocardial Infarction (MI), Sepsis, Deep vein thrombosis (DVT)
Measured: 2 weeks
Secondary outcomes (5)
Average Length of stay
length, in days, of hospital stay, calculated by subtracting date of randomization from date of discharge
Measured: length of hospital stay, Time 0 is at randomization with expected length of stay less than 3 weeks.
Average cost in dollars
average cost of care of patients per arm for length of hospital stay
Measured: length of hospital stay, Time 0 is at randomization with expected length of stay less than 3 weeks.
number of subjects with hospital readmission
Measured: within 2 weeks of discharge
number of subjects with unplanned return to operating room
Measured: within two weeks of discharge
number of subjects with 30 day mortality
Measured: 30 days post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study start2 Feb 2016
- Primary completion13 Oct 2016
- Study completion13 Oct 2016
Why it stopped: Low enrollment; PI left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Bowel ObstructionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin Pei, MD, Principal investigator, Yale UniversityKimberly Davis, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692638
- Sponsor's protocol ID
- 1512016944
- Status last verified
- Feb 2020
- First submitted
- 15 Feb 2016
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Trial Comparing Early Laparoscopic Enterolysis Versus a Time-limited Trial of Nonoperative Management for High-grade Small Bowel Obstruction
- ClinicalTrials.gov ID
- NCT02692638
- Acronym / sponsor ID
- 1512016944
- Conditions
- Small Bowel Obstruction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment; PI left institution
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 2 Feb 2016 (actual)
- Primary completion
- 13 Oct 2016 (actual)
- Study completion
- 13 Oct 2016 (actual)
- First posted
- 26 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal is to assess the appropriateness of the standard practice of a trial of nonoperative management for high grade small bowel obstruction (currently up to 72 hours based on available literature). The investigator will offer early laparoscopic enterolysis (within 24 hours of admission) as the comparator group.
Detailed description
Small bowel obstruction is a common disorder without a clearly superior management strategy. There are an estimated 300,000 surgeries performed annually with a health care expenditure burden in excess of 2.8 billion dollars. The investigators propose a new management paradigm including early laparoscopic management.
Contemporary management of SBO includes a trial of nonoperative management (TNOM) reportedly with resolution in upwards of 70% of patients.
Although it is one of the most common diagnosis for surgical admissions, there are few prospective, clinical trials to address the question surgical timing. Additionally, there are no prospective, randomized trials comparing early laparoscopy versus TNOM for high grade SBO. The hypothesis is that early laparoscopic enterolysis will result in decreased overall complications, shorter length of stay, decreased health care cost, and lower conversion rate to open laparotomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early laparoscopic enterolysis | Experimental | Procedure: Early laparoscopic enterolysisPatient randomized to the early laparoscopy arm will undergo diagnostic laparoscopy within 24 hours of admission (depending on surgeon and operating room availability). Standard laparoscopy will be performed including supine positioning, sequential compression devices, and appropriate pre-incision antibiotics. Trocar placement will be at the surgeon's discretion and as appropriate for the patient's previous incisions. The necessity for conversion will be left to the discretion of the attending surgeon. Post operative management will conform to the standards of care. Nasogastric tubes will not be routinely placed. |
| trial of nonoperative management | Active comparator | Procedure: nonoperative managementPatients randomized to the trial of nonoperative management arm will undergo standard therapy including nil per os (NPO), nasogastric decompression only if actively vomiting, intravenous fluids while awaiting return of bowel function. Patients who do not achieve return of bowel function within 72 hours of admission will undergo attempted laparoscopic enterolysis with the understanding that conversion to open procedure may be necessary. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- CT A/P showing high grade obstruction (all patients will obtain a CT A/P as per Level 1 recommendations based on EAST practice guidelines) .
- High grade bowel obstruction is defined as:
Key exclusion criteria (7 listed)
- Hemodynamic instability (SBP<90)
- Peritonitis
- Enterocutaneous fistula
- Cirrhosis
- previous enterolysis (more than 1)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early laparoscopic enterolysisThe surgeon will make about 3-4 small incisions in the participant's abdomen. A port (nozzle) is inserted into one of the slits, and carbon dioxide gas inflates the abdomen. A laparoscope is inserted through another port. The laparoscope looks like a telescope with a light and camera on the end so the surgeon can see inside the abdomen. Surgical instruments are placed in the other small openings and used to cut the scar tissue in order to relieve the obstruction. After all this has been accomplished, the carbon dioxide is released out of the abdomen through the slits, and then these sites are closed with sutures or staples, or covered with glue-like bandage and steri-strips. | Procedure or surgery | Early laparoscopic enterolysis |
| nonoperative managementSometimes a bowel obstruction can be treated by suctioning out the contents of the stomach, giving IV fluids, and not letting the patient eat for a few days. | Procedure or surgery | trial of nonoperative management |
Primary outcome
Number of complications (per National Surgical Quality Improvement Project)
Time frame: 2 weeks
complications counted : Superficial surgical site infection (SSI), Deep SSI, Organ space SSI, Wound disruption, pneumonia, Pulmonary embolism, ventilator days, Acute Kidney Injury (AKI), Acute renal failure (ARF), Urinary Tract Infection (UTI), Stroke, Cardiac arrest, Myocardial Infarction (MI), Sepsis, Deep vein thrombosis (DVT)
5 secondary outcomes
Average Length of stay
Time frame: length of hospital stay, Time 0 is at randomization with expected length of stay less than 3 weeks.
Average cost in dollars
Time frame: length of hospital stay, Time 0 is at randomization with expected length of stay less than 3 weeks.
number of subjects with hospital readmission
Time frame: within 2 weeks of discharge
number of subjects with unplanned return to operating room
Time frame: within two weeks of discharge
number of subjects with 30 day mortality
Time frame: 30 days post operation
Results and safety
The study was stopped early (reason given: Low enrollment; PI left institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Pei, MD principal investigator
Yale University
Kimberly Davis, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Early laparoscopic enterolysis and nonoperative management in people with Small Bowel Obstruction, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low enrollment; PI left institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of complications (per National Surgical Quality Improvement Project) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2020.