AdhesionsNCT00530322
Adhesion Formation Following Laparoscopic and Open Colorectal Surgery
An observational study of Adhesions, run by University of Surrey at 1 site in United Kingdom.
Trial summary
To ascertain whether there are fewer adhesions (internal scars) formed following laparoscopic (key-hole) surgery for colorectal diseases than traditional open surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adhesions
- What is being tested?
- Laparoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 46 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2006to Sep 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous elective colonic or rectal resection
- Having a further operative intervention at which time a laparoscopy can be performed
Who cannot join
- Children <18
- Further surgery not relating to the primary colorectal surgery
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Surrey County Hospital
Guildford, Surrey, GU2 4JX
About this study
To ascertain whether there are fewer adhesions (internal scars) formed following laparoscopic (key-hole) surgery for colorectal diseases than traditional open surgery.
- Conditions
- Adhesions
- Being tested
- Laparoscopy
- Keywords
- Adhesions, Laparoscopy, Colorectal surgery, Colorectal disease
- Medical subject headings
- Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaparoscopyProcedure or surgery
A "second-look" laparoscopy, in patients who require further surgery (for example a liver resection or closure of ileostomy).
| Study group | Role | What they receive |
|---|---|---|
| A | Patients who have had previous open colorectal surgery and are referred for a further operative procedure, at which time a "second-look" laparoscopy can be performed. Receives: Procedure: Laparoscopy | |
| B | Patients who have had a previous laparoscopic colorectal procedure and are having a "second-look" procedure Receives: Procedure: Laparoscopy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2007 (estimated)
- Study startJun 2006
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdhesionsStudies 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
- Defined population
- Time perspective
- Other
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Collaborators
- Ethicon Endo-Surgery
- Investigators
- Timothy A Rockall, FRCS, Study director, The Royal Surrey County Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00530322
- Sponsor's protocol ID
- 06/Q1909/68
- Status last verified
- Sep 2007
- First submitted
- 13 Sep 2007
- Last updated
- 17 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adhesion Formation Following Laparoscopic and Open Colorectal Surgery
- ClinicalTrials.gov ID
- NCT00530322
- Acronym / sponsor ID
- 06/Q1909/68
- Conditions
- Adhesions
- Keywords
- Adhesions, Laparoscopy, Colorectal surgery, Colorectal disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Collaborators
- Ethicon Endo-Surgery
- Study start
- Jun 2006
- Study completion
- Sep 2007 (actual)
- First posted
- 17 Sep 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.
To ascertain whether there are fewer adhesions (internal scars) formed following laparoscopic (key-hole) surgery for colorectal diseases than traditional open surgery.
Study design
- Observational model
- Defined population
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | Procedure: LaparoscopyPatients who have had previous open colorectal surgery and are referred for a further operative procedure, at which time a "second-look" laparoscopy can be performed. |
| B | – | Procedure: LaparoscopyPatients who have had a previous laparoscopic colorectal procedure and are having a "second-look" procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Previous elective colonic or rectal resection
- Having a further operative intervention at which time a laparoscopy can be performed
Key exclusion criteria (2 listed)
- Children <18
- Further surgery not relating to the primary colorectal surgery
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 |
|---|---|---|
| LaparoscopyA "second-look" laparoscopy, in patients who require further surgery (for example a liver resection or closure of ileostomy). | Procedure or surgery | A, B |
Primary outcome
Not reported in the source record.
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 17 Sep 2007.
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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.
Timothy A Rockall, FRCS study director
The Royal Surrey County Hospital
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 Adhesions, run by University of Surrey at 1 site in United Kingdom.
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 2 inclusion and 2 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 17 Sep 2007. 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 Kingdom. 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.
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 17 Sep 2007.