Splenic Flexure MobilizationNCT03001375
Laparoscopic Splenic Flexure Mobilization
A study testing Laparoscopic high anterior resection splenic flexure mobilization and Laparoscopic high anterior resection without splenic flexure mobilization in people with Splenic Flexure Mobilization, run by Ain Shams University.
Trial summary
This retrospective cohort study conducted on 140 patients who underwent laparoscopic anterior resection for upper rectal cancer in the period from May 2011 to November 2015, comparison will be done on splenic flexure mobilization excluding . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Splenic Flexure Mobilization
- What is being tested?
- Laparoscopic high anterior resection splenic flexure mobilization and Laparoscopic high anterior resection without splenic flexure mobilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Dec 2016
- Phase
- Interventional
- 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
- Patients with upper rectal tumors.
Who cannot join
- Low and mid rectal cancer
- Splenic flexure tumors, descending colon cancer,
- patients with associated lesions in the right or transverse colon
- Emergency cases.
About this study
Official title: Is it Necessary to do Splenic Flexure Mobilization in Laparoscopic Resection of Upper Rectal Tumors?
This retrospective cohort study conducted on 140 patients who underwent laparoscopic anterior resection for upper rectal cancer in the period from May 2011 to November 2015, comparison will be done on splenic flexure mobilization excluding .
Read the detailed description
Presently, it is acknowledged that laparoscopic colectomy for left sided colorectal cancer is the most common surgery operated in laparoscopic colorectal surgeries, However the most debatable question in such type of operations that is it mandatory to do splenic flexure mobilization or not? In the literatures colorectal surgeons divided into 2 teams, those with splenic flexure mobilization in laparoscopic left colorectal resection to have tension free, well vascularized anastomosis On the other hand those against splenic flexure mobilization reported that omitting this step does not significantly affect the leakage rate, morbidity or the oncological outcomes In this study, we evaluate the necessity of splenic flexure mobilization in laparoscopic anterior resection for upper rectal tumors and its impact on the operative time, total morbidity, leakage rate, oncological safety and continence level
- Conditions
- Splenic Flexure Mobilization
- Being tested
- Laparoscopic high anterior resection splenic flexure mobilization, Laparoscopic high anterior resection without splenic flexure mobilization
- Keywords
- Laparoscopic colectomy., Splenic flexure mobilization., Anastomotic leakage.
- Medical subject headings
- Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic high anterior resection splenic flexure mobilizationProcedure or surgery
Laparoscopic high anterior resection without splenic flexure mobilizationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Mobilization group | Active comparator | Laparoscopic splenic flexure mobilization will be done. Receives: Procedure: Laparoscopic high anterior resection splenic flexure mobilization |
| Non mobilization group | Active comparator | No mobilization of splenic flexure. Receives: Procedure: Laparoscopic high anterior resection without splenic flexure mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of leakage rate in laparoscopic anterior resection with splenic flexure mobilization versus non mobilization of splenic flexure
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 posted23 Dec 2016 (estimated)
- Study startMay 2011
- Primary completionNov 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Splenic Flexure MobilizationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasser Mohamed Abdel-samii, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03001375
- Sponsor's protocol ID
- 6379
- Status last verified
- Dec 2016
- First submitted
- 9 Dec 2016
- Last updated
- 23 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is it Necessary to do Splenic Flexure Mobilization in Laparoscopic Resection of Upper Rectal Tumors?
- ClinicalTrials.gov ID
- NCT03001375
- Acronym / sponsor ID
- 6379
- Conditions
- Splenic Flexure Mobilization
- Keywords
- Laparoscopic colectomy., Splenic flexure mobilization., Anastomotic leakage.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 23 Dec 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.
This retrospective cohort study conducted on 140 patients who underwent laparoscopic anterior resection for upper rectal cancer in the period from May 2011 to November 2015, comparison will be done on splenic flexure mobilization excluding .
Detailed description
Presently, it is acknowledged that laparoscopic colectomy for left sided colorectal cancer is the most common surgery operated in laparoscopic colorectal surgeries, However the most debatable question in such type of operations that is it mandatory to do splenic flexure mobilization or not? In the literatures colorectal surgeons divided into 2 teams, those with splenic flexure mobilization in laparoscopic left colorectal resection to have tension free, well vascularized anastomosis On the other hand those against splenic flexure mobilization reported that omitting this step does not significantly affect the leakage rate, morbidity or the oncological outcomes In this study, we evaluate the necessity of splenic flexure mobilization in laparoscopic anterior resection for upper rectal tumors and its impact on the operative time, total morbidity, leakage rate, oncological safety and continence level
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobilization group | Active comparator | Procedure: Laparoscopic high anterior resection splenic flexure mobilizationLaparoscopic splenic flexure mobilization will be done. |
| Non mobilization group | Active comparator | Procedure: Laparoscopic high anterior resection without splenic flexure mobilizationNo mobilization of splenic flexure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with upper rectal tumors.
Key exclusion criteria (4 listed)
- Low and mid rectal cancer
- Splenic flexure tumors, descending colon cancer,
- patients with associated lesions in the right or transverse colon
- Emergency cases.
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 |
|---|---|---|
| Laparoscopic high anterior resection splenic flexure mobilization | Procedure or surgery | Mobilization group |
| Laparoscopic high anterior resection without splenic flexure mobilization | Procedure or surgery | Non mobilization group |
Primary outcome
the incidence of leakage rate in laparoscopic anterior resection with splenic flexure mobilization versus non mobilization of splenic flexure
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 23 Dec 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Splenic Flexure Mobilization
Not yet recruiting
Inferior Mesenteric Artery First Combined With Complete Medial Approach for Laparoscopic Splenic Flexure Mobilization in Left Sided Colorectal Cancer
Laparoscopic Splenic Flexure Mobilization
Enrolling by invitationObservational study
Surgical Outcomes in Splenic Flexure Cancers: A Multicenter Comparison of Segmental vs. Extended Hemicolectomy (SPARROW Study)
Colon Cancer, Splenic Flexure Mobilization
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic high anterior resection splenic flexure mobilization and Laparoscopic high anterior resection without splenic flexure mobilization in people with Splenic Flexure Mobilization, run by Ain Shams University.
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 1 inclusion and 4 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 23 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
the incidence of leakage rate in laparoscopic anterior resection with splenic flexure mobilization versus non mobilization of splenic flexure (time frame: One year). 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 23 Dec 2016.