Laparoscopic ColectomyNCT04972994
Laparoscopic Colectomies In Management of Colonic Cancers
A study testing laparoscopic intracorporeal versus extracorporeal anastomosis for right and left hemicolectomies in people with Laparoscopic Colectomy and Cancer Colon, run by Sohag University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the Surgical outcomes after laparoscopic intracorporeal versus extracorporeal anastomosis for right and left hemicolectomies in management of colonic cancers . Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Laparoscopic Colectomy, Cancer Colon, Intracorporeal Anastomosis
- What is being tested?
- laparoscopic intracorporeal versus extracorporeal anastomosis for right and left hemicolectomies
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 1 Dec 2022
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients had to present histologically confirmed cancer( right and left) colon.
- All grades of cancer will be included.
- Cancer at cecum ,appendix, ascending colon, hepatic flexure or at splenic flexure , descending colon and sigmoid colon.
Who cannot join
- Locally advanced disease with invasion of adjacent important organs.
- Acute bowel obstruction or perforation from cancer.
- Pregnant ladies.
- Rectal cancer and transverse colon cancer.
Trial locations and contacts
1 site in 1 country.
Abdullah AA Abdullah, M.B.B.Ch,M.Sc contact
Omar AS AlTabary, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
Omar AS Al tabary, professor
Abd El-Aal AS Mahran, Assistant professor
About this study
Official title: Surgical Outcomes After Laparoscopic Intracorporeal Versus Extracorporeal Anastomosis for Right and Left Hemicolectomies In Management of Colonic Cancers
The aim of this study is to compare the Surgical outcomes after laparoscopic intracorporeal versus extracorporeal anastomosis for right and left hemicolectomies in management of colonic cancers .
Read the detailed description
This is clinical trial ,Interventional quasi experiment study to evaluate the surgical outcomes between intracorporeal versus extracorporeal anastomosis in laparoscopic right and left hemicolectomies including post operative pain, hospital stay, leakage from anastomosis, early recurrence, hernias patient satisfaction operative time and more surgical outcomes.
In Egyptian hospitals. Source of data the investigators follow up and medical reports and more . surgical procedures This trial including two groups of patients with right and left cancer colon undergoing Laparoscopic colectomy. First group (A) will be operated as intracorporeal anastomosis while the second group (B) will be operated as extracorporeal anastomosis.
Sample size more than 50 person Statistical analysis plan Statistical Package for the Social Sciences (SPSS) program
- Being tested
- laparoscopic intracorporeal versus extracorporeal anastomosis for right and left hemicolectomies
- Keywords
- laparoscopic, intracorporeal, extracorporeal, anastomosis, hemicolectomies, , colonic cance
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic intracorporeal versus extracorporeal anastomosis for right and left hemicolectomiesProcedure or surgery
laparoscopic intracorporeal versus extracorporeal anastomosis for right and left hemicolectomies in management of colonic cancers
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic intracorporeal anastomosis for right and left hemicolectomies | Active comparator | Surgical outcomes after laparoscopic intracorporeal versus for right and left hemicolectomies in management of colonic cancers Receives: Procedure: laparoscopic intracorporeal versus extracorporeal anastomosis for right and left hemicolectomies |
| laparoscopic extracorporeal anastomosis for right and left hemicolectomies | Active comparator | Surgical outcomes after laparoscopic extracorporeal anastomosis for right and left hemicolectomies in management of colonic cancers Receives: Procedure: laparoscopic intracorporeal versus extracorporeal anastomosis for right and left hemicolectomies |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative time of surgery
intraoperative time of surgery by minutes
Measured: intraoperative time of surgery
post operative hospital stay
post operative hospital stay by days
Measured: up to 1 year
Post operative leakage
Post operative leakage of anastomosis by follow up ultrasound, Abdominal Xray erect \& wound infection
Measured: 1 year
early recurrence of the cancer
early recurrence of the cancer by CT scan
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start1 Jun 2021
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic ColectomyStudies of the same condition, open and under way.
- More trials run by Sohag 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- right and left hemicolectomies in colonic cancers
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdullah Atyah Ali, Sohag University
- Investigators
- Omar AS Al tabary, Professor, Study director, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972994
- Sponsor's protocol ID
- Soh-Med206018
- Status last verified
- Jul 2021
- First submitted
- 6 Jul 2021
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Outcomes After Laparoscopic Intracorporeal Versus Extracorporeal Anastomosis for Right and Left Hemicolectomies In Management of Colonic Cancers
- ClinicalTrials.gov ID
- NCT04972994
- Acronym / sponsor ID
- Soh-Med206018
- Keywords
- laparoscopic, intracorporeal, extracorporeal, anastomosis, hemicolectomies, , colonic cance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 22 Jul 2021 (actual)
- 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 aim of this study is to compare the Surgical outcomes after laparoscopic intracorporeal versus extracorporeal anastomosis for right and left hemicolectomies in management of colonic cancers .
Detailed description
This is clinical trial ,Interventional quasi experiment study to evaluate the surgical outcomes between intracorporeal versus extracorporeal anastomosis in laparoscopic right and left hemicolectomies including post operative pain, hospital stay, leakage from anastomosis, early recurrence, hernias patient satisfaction operative time and more surgical outcomes.
In Egyptian hospitals. Source of data the investigators follow up and medical reports and more . surgical procedures This trial including two groups of patients with right and left cancer colon undergoing Laparoscopic colectomy. First group (A) will be operated as intracorporeal anastomosis while the second group (B) will be operated as extracorporeal anastomosis.
Sample size more than 50 person Statistical analysis plan Statistical Package for the Social Sciences (SPSS) program
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- right and left hemicolectomies in colonic cancers
| Arm | Type | Receives |
|---|---|---|
| laparoscopic intracorporeal anastomosis for right and left hemicolectomies | Active comparator | Procedure: laparoscopic intracorporeal versus extracorporeal anastomosis for right and left hemicolectomiesSurgical outcomes after laparoscopic intracorporeal versus for right and left hemicolectomies in management of colonic cancers |
| laparoscopic extracorporeal anastomosis for right and left hemicolectomies | Active comparator | Procedure: laparoscopic intracorporeal versus extracorporeal anastomosis for right and left hemicolectomiesSurgical outcomes after laparoscopic extracorporeal anastomosis for right and left hemicolectomies in management of colonic cancers |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients had to present histologically confirmed cancer( right and left) colon.
- All grades of cancer will be included.
- Cancer at cecum ,appendix, ascending colon, hepatic flexure or at splenic flexure , descending colon and sigmoid colon.
Key exclusion criteria (4 listed)
- Locally advanced disease with invasion of adjacent important organs.
- Acute bowel obstruction or perforation from cancer.
- Pregnant ladies.
- Rectal cancer and transverse colon cancer.
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 intracorporeal versus extracorporeal anastomosis for right and left hemicolectomieslaparoscopic intracorporeal versus extracorporeal anastomosis for right and left hemicolectomies in management of colonic cancers | Procedure or surgery | laparoscopic extracorporeal anastomosis for right and left hemicolectomies, laparoscopic intracorporeal anastomosis for right and left hemicolectomies |
Primary outcome
intraoperative time of surgery
Time frame: intraoperative time of surgery
intraoperative time of surgery by minutes
post operative hospital stay
Time frame: up to 1 year
post operative hospital stay by days
Post operative leakage
Time frame: 1 year
Post operative leakage of anastomosis by follow up ultrasound, Abdominal Xray erect \& wound infection
early recurrence of the cancer
Time frame: 6 months after surgery
early recurrence of the cancer by CT scan
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
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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.
Abdullah AA Abdullah, M.B.B.Ch,M.Sc contact
Omar AS AlTabary, professor contact
Omar AS Al tabary, Professor study director
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic intracorporeal versus extracorporeal anastomosis for right and left hemicolectomies in people with Laparoscopic Colectomy and Cancer Colon, run by Sohag University at 1 site in Egypt.
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 3 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: status not confirmed, as of the sponsor's last update on 22 Jul 2021. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdullah AA Abdullah, M.B.B.Ch,M.Sc (01060105272 ext. 0114386363, abdallah.attia@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraoperative time of surgery (time frame: intraoperative time of surgery). The study lists 4 primary outcomes in all. 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 22 Jul 2021.