DiverticulitisNCT00492193
Early Post-Op Recovery After Partial Large Bowel Resection
An observational study of Diverticulitis and Colon Polyps, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
The purpose of this trial is to gather information on the postoperative recovery time and hospital length of stay experienced by patients having laparoscopic surgeries. This trial will also collect data on daily surgical pain and pain medication and how it relates to recovery after surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diverticulitis, Colon Polyps, Colorectal Cancer
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to May 2008
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Colorectal Surgery clinic population
Who may be able to join
- be male or female at least 18 years of age
- be scheduled for laparoscopic (SL or HAL) partial large bowel resection with primary anastomosis.
- have an American Society of Anesthesiologists Physical Status Score of P1 to P3 (Appendix C.1 of the full protocol).
- are scheduled to receive postoperative pain management primarily with opioid analgesia via intravenous (IV) patient-controlled analgesia (PCA)
- are scheduled to have the NG tube removed on the morning of POD 1
- are able to read, write, and fully understand the language of the study diary
- be able to understand the study procedure, agrees to participate in the study program, and voluntarily provides informed consent.
Who cannot join
- be scheduled for a total colectomy, ileal pouch-anal anastomosis, colostomy, ileostomy, right HAL colectomy or have a history of total colectomy, gastric bypass, previous bowel resection or short bowel syndrome.
- has a complete bowel obstruction
- has taken therapeutic doses of opioids for 7 consecutive days immediately before surgery.
- has participated in a clinical trial with alvimopan or has taken alvimopan in the past 30 days.
- has a diagnosed history of alcoholism or drug addiction (eg, opioids or other drugs of abuse) within 1 year of the surgery date (Day 0).
- has a diagnosed history of constipation, pelvic floor disorder, or GI disorders known to affect bowel function (eg, chronic diarrhea)
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- has a history of laxative dependence or daily use (ie, hyperosmotics, mineral oil, saline, stimulants, bulking agents, suppositories, lubricants, enemas, or any other natural products that promote bowel motility or cleansing)
- has, as determined by the investigator or the sponsor's medical monitor, a history or clinical manifestations of significant renal, hepatic, cardiovascular, GI, metabolic disorders or mental conditions (e.g., depression, psychosis) that might confound the results of the study or pose additional risk to the subject.
- has participated in another investigational drug or medical device study within the last 30 days or will be enrolled in another investigational drug or medical device study or any study in which active patient participation is required outside normal hospital data collection during the course of this study.
- is unwilling or unable to complete the study diary.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals of Cleveland Case Medical Center
Cleveland, Ohio, 44106
About this study
Official title: A Prospective, Observational, Multi-center Study Assessing Early Post-Operative Recovery Following Laparoscopic Partial Large Bowel Resection
The purpose of this trial is to gather information on the postoperative recovery time and hospital length of stay experienced by patients having laparoscopic surgeries. This trial will also collect data on daily surgical pain and pain medication and how it relates to recovery after surgery. In addition, the investigators will collect data on the use of pain medication and laxatives in patients following laparoscopic large bowel resection.
Read the detailed description
Laparoscopic surgery was initially performed by surgeons in France in 1987 and was introduced in the United States in 1988. This minimally invasive procedure was performed for cholecystectomy, and is now the standard of care in the treatment of gallbladder disease. Recent advances in laparoscopic surgery and its success in cholecystectomy have permitted the procedure to be used for treating a variety of diseases and for diagnosing and staging.
Minimally invasive laparoscopic surgery has advantages over conventional open surgery, including smaller incisions, earlier gastrointestinal (GI) recovery, shorter hospital stays, less pain, and fewer complications. In recent years evidence is accumulating for some operations that laparoscopic procedures produce outcomes that are comparable to those produced by routine open surgery and may actually surpass others.
Whereas laparoscopic surgery has been successful and well accepted for various abdominal and pelvic surgeries, its use in the area of colorectal surgery has progressed at a slower rate. There are challenges impacting the wider use of laparoscopic bowel resection (LBR). These include the technical difficulty associated with the size of the colon, the need for complete immobilization of the bowel and the need for a watertight, non-leaking anastomosis. In addition, the equipment is expensive and surgeons require specialized training.
Results from studies in colon cancer now indicate that LBR reduces perioperative morbidity, and decreases hospital stay with comparable cancer-related survival as compared to open colectomy. The use of LBR in short-term outcomes is increasing because clinical trial data have demonstrated superiority of LBR, particularly in short-term outcomes over conventional open surgery.
Gastrointestinal recovery and related patient outcomes during the early postoperative period following open segmental colon resection have been extensively evaluated in previous randomized, controlled, multicenter trials. Current data in laparoscopic colectomy have been collected from retrospective, single center clinical trials which lacked standardized definitions and endpoints. Therefore, this prospective, multicenter study in LBR is being undertaken to determine how this surgical technique impacts GI recovery and related outcomes relative to the open laparotomy.
The primary objective of this study is to assess the clinical course of gastrointestinal (GI) recovery and hospital length of stay in subjects undergoing laparoscopic partial large bowel resection. The secondary objective is to assess the immediate post discharge clinical course of subjects undergoing laparoscopic bowel resection with respect to opioid-induced GI effects, daily surgical pain, opioid consumption and laxative use.
- Conditions
- Diverticulitis, Colon Polyps, Colorectal Cancer
- Keywords
- Hand assist laparoscopic partial large bowel resection, Laparoscopic partial large bowel resection
- Medical subject headings
- Diverticulitis, Colonic Polyps, Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to upper and lower GI recovery and post-operative hospital length of stay.
The primary outcome or end points were time to upper and lower GI recovery (GI-2: tolerance of solid food and bowel movement) and post-operative hospital length of stay.
Measured: One year
Secondary outcomes (1)
Postoperative ileus related mobidity.
The secondary outcome or endpoints are postoperative ileus(POI) related morbidity (postoperative nasogastric tub insertion or investigator-assisted POI resulting in prolonged hospital stay or readmission), conversion rate, and protocol-defined prolonged POI (GI-2>5 postoperative days.)
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiverticulitisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Responsible party
- Principal investigator, Conor Delaney, MD, PhD, University Hospitals Cleveland Medical Center
- Investigators
- Conor P. Delaney, MD, PhD, Principal investigator, University Hospitals of Cleveland/ Institute for Surgical Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00492193
- Sponsor's protocol ID
- 01-07-14
- Other IDs
- 14CL401
- Status last verified
- Aug 2008
- First submitted
- 25 Jun 2007
- Last updated
- 15 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Delaney CP, Marcello PW, Sonoda T, Wise P, Bauer J, Techner L. Gastrointestinal recovery after laparoscopic colectomy: results of a prospective, observational, multicenter study. Surg Endosc. 2010 Mar;24(3):653-61. doi: 10.1007/s00464-009-0652-7. Epub 2009 Aug 18.
PubMed 19688390
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational, Multi-center Study Assessing Early Post-Operative Recovery Following Laparoscopic Partial Large Bowel Resection
- ClinicalTrials.gov ID
- NCT00492193
- Acronym / sponsor ID
- 01-07-14
- Conditions
- Diverticulitis, Colon Polyps, Colorectal Cancer
- Keywords
- Hand assist laparoscopic partial large bowel resection, Laparoscopic partial large bowel resection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Study start
- Jun 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 27 Jun 2007 (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 purpose of this trial is to gather information on the postoperative recovery time and hospital length of stay experienced by patients having laparoscopic surgeries. This trial will also collect data on daily surgical pain and pain medication and how it relates to recovery after surgery. In addition, the investigators will collect data on the use of pain medication and laxatives in patients following laparoscopic large bowel resection.
Detailed description
Laparoscopic surgery was initially performed by surgeons in France in 1987 and was introduced in the United States in 1988. This minimally invasive procedure was performed for cholecystectomy, and is now the standard of care in the treatment of gallbladder disease. Recent advances in laparoscopic surgery and its success in cholecystectomy have permitted the procedure to be used for treating a variety of diseases and for diagnosing and staging.
Minimally invasive laparoscopic surgery has advantages over conventional open surgery, including smaller incisions, earlier gastrointestinal (GI) recovery, shorter hospital stays, less pain, and fewer complications. In recent years evidence is accumulating for some operations that laparoscopic procedures produce outcomes that are comparable to those produced by routine open surgery and may actually surpass others.
Whereas laparoscopic surgery has been successful and well accepted for various abdominal and pelvic surgeries, its use in the area of colorectal surgery has progressed at a slower rate. There are challenges impacting the wider use of laparoscopic bowel resection (LBR). These include the technical difficulty associated with the size of the colon, the need for complete immobilization of the bowel and the need for a watertight, non-leaking anastomosis. In addition, the equipment is expensive and surgeons require specialized training.
Results from studies in colon cancer now indicate that LBR reduces perioperative morbidity, and decreases hospital stay with comparable cancer-related survival as compared to open colectomy. The use of LBR in short-term outcomes is increasing because clinical trial data have demonstrated superiority of LBR, particularly in short-term outcomes over conventional open surgery.
Gastrointestinal recovery and related patient outcomes during the early postoperative period following open segmental colon resection have been extensively evaluated in previous randomized, controlled, multicenter trials. Current data in laparoscopic colectomy have been collected from retrospective, single center clinical trials which lacked standardized definitions and endpoints. Therefore, this prospective, multicenter study in LBR is being undertaken to determine how this surgical technique impacts GI recovery and related outcomes relative to the open laparotomy.
The primary objective of this study is to assess the clinical course of gastrointestinal (GI) recovery and hospital length of stay in subjects undergoing laparoscopic partial large bowel resection. The secondary objective is to assess the immediate post discharge clinical course of subjects undergoing laparoscopic bowel resection with respect to opioid-induced GI effects, daily surgical pain, opioid consumption and laxative use.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Colorectal Surgery clinic population
Key inclusion criteria (7 listed)
- be male or female at least 18 years of age
- be scheduled for laparoscopic (SL or HAL) partial large bowel resection with primary anastomosis.
- have an American Society of Anesthesiologists Physical Status Score of P1 to P3 (Appendix C.1 of the full protocol).
- are scheduled to receive postoperative pain management primarily with opioid analgesia via intravenous (IV) patient-controlled analgesia (PCA)
- are scheduled to have the NG tube removed on the morning of POD 1
Key exclusion criteria (10 listed)
- be scheduled for a total colectomy, ileal pouch-anal anastomosis, colostomy, ileostomy, right HAL colectomy or have a history of total colectomy, gastric bypass, previous bowel resection or short bowel syndrome.
- has a complete bowel obstruction
- has taken therapeutic doses of opioids for 7 consecutive days immediately before surgery.
- has participated in a clinical trial with alvimopan or has taken alvimopan in the past 30 days.
- has a diagnosed history of alcoholism or drug addiction (eg, opioids or other drugs of abuse) within 1 year of the surgery date (Day 0).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to upper and lower GI recovery and post-operative hospital length of stay.
Time frame: One year
The primary outcome or end points were time to upper and lower GI recovery (GI-2: tolerance of solid food and bowel movement) and post-operative hospital length of stay.
1 secondary outcome
Postoperative ileus related mobidity.
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2014.
- Results publication: PubMed 19688390Delaney CP, Marcello PW, Sonoda T, Wise P, Bauer J, Techner L. Gastrointestinal recovery after laparoscopic colectomy: results of a prospective, observational, multicenter study. Surg Endosc. 2010 Mar;24(3):653-61. doi: 10.1007/s00464-009-0652-7. Epub 2009 Aug 18.
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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.
Conor P. Delaney, MD, PhD principal investigator
University Hospitals of Cleveland/ Institute for Surgical Innovation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diverticulitis and Colon Polyps, run by University Hospitals Cleveland Medical Center 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 10 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: finished, as of the sponsor's last update on 15 Dec 2014. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to upper and lower GI recovery and post-operative hospital length of stay. (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00492193, which also lists 1 linked publication.
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 15 Dec 2014.