End to End AnastomosisNCT06546176
End to End Anastomosis With Omega Suture Versus End to Anterior Rectal Wall In Colorectal Anastomosis in Sigmoid and Upper Rectal Cancer
A study testing End to end with Omega suture and End to anterior rectal wall in people with End to End Anastomosis and Colorectal Anastomosis, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is to compare end to end anastomosis with omega suture versus end to anterior rectal wall in colorectal anastomosis as regard post operative anastomotic leakage, bowel function, operative time and intra operative blood loss. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End to End Anastomosis, Colorectal Anastomosis, End to Anterior Rectal Wall
- What is being tested?
- End to end with Omega suture and End to anterior rectal wall
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 1 Sep 2024
- 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 aged >18 years.
- Both sexes.
- Recto sigmoidal carcinoma.
- Upper rectal cancer.
Who cannot join
- Patients younger than 18 years
- Recurrent or non-resectable cancer
- Complicated cancer (e.g., obstructed or perforated)
- Previous left-sided colorectal surgery or anorectal surgeries
- Lower rectal cancer
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo
Asmaa F Hussein, Master, 00201009376712, asmaafathi@med.asu.edu.eg
Ahmed A Eldein, MD
About this study
Official title: Comparative Study Between End to End Anastomosis With Omega Suture Versus End to Anterior Rectal Wall In Colorectal Anastomosis in Sigmoid and Upper Rectal Cancer
The aim of this study is to compare end to end anastomosis with omega suture versus end to anterior rectal wall in colorectal anastomosis as regard post operative anastomotic leakage, bowel function, operative time and intra operative blood loss.
Read the detailed description
Colorectal cancer has been reported to be the 3rd most common and the second most deadly cancer world wide.
Anterior resection is the gold standard operation for both rectal and recto-sigmoid cancer with considering oncological safety maintenance to be the most important goal which can be achieved by keeping abundant resection margin and ensuring anastomotic safety, despite the technical difficulties of working in a narrow deep pelvis.
Understanding the characteristics of each anastomotic technique and establishing a stable anastomotic procedure both are pillars in anastomotic leakage prevention.
The intersection of the linear staple line and circular staple line in conventional anastomotic way is considered a risk factor for anastomotic leakage by creating stapled corners (called "dog-ears") which considered potentially ischemic and represent the area with high incidence of anastomotic leakage. Single stapled technique using ether end to end with omega suture or end to side stapled anastomosis allows avoidance of the formation of this intersection.
- Conditions
- End to End Anastomosis, Colorectal Anastomosis, End to Anterior Rectal Wall, Sigmoid Cancer, Upper Rectal Cancer
- Being tested
- End to end with Omega suture, End to anterior rectal wall
- Medical subject headings
- Sigmoid Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
End to end with Omega sutureOther
After the rectum was divided with a linear stapler, the circular stapler was placed allowing the anvil rod to penetrate the rectal stump near the linear stapler line. An omega suture including both ends of the linear stapler line was placed. The linear stapler line was approximated around the anvil rod of the circular stapler in an omega shape fashion as the omega suture was tied. This technique resulted in a complete resection of linear stapler line by the circular stapler.
End to anterior rectal wallOther
A burse string suture was applied over the anvil of the circular stapler at the transection point of the descending colon using prolene 2/0.
The circular stapler introduced though the anus and its rod directed toward the anterior rectal wall and colorectal anastomosis was performed.
| Study group | Role | What they receive |
|---|---|---|
| Group A(end to end with Omega suture) | Other | After the rectum was divided with a linear stapler, the circular stapler was placed allowing the anvil rod to penetrate the rectal stump near the linear stapler line. An omega suture including both ends of the linear stapler line was placed. The linear stapler line was approximated around the anvil rod of the circular stapler in an omega shape fashion as the omega suture was tied. This technique resulted in a complete resection of linear stapler line by the circular stapler. Receives: Other: End to end with Omega suture |
| Group B (end to anterior rectal wall) | Other | A burse string suture was applied over the anvil of the circular stapler at the transection point of the descending colon using prolene 2/0.
The circular stapler introduced though the anus and its rod directed toward the anterior rectal wall and colorectal anastomosis was performed. Receives: Other: End to anterior rectal wall |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomotic leakage
Anastomotic leakage will be measured for 5 days after surgery
Measured: 5 days after surgery
Secondary outcomes (4)
Operative time
Operative time will be measured from the start of surgery till the end of surgery.
Measured: Until the procedure is completed
Hospital stay
Hospital stay will be assessed from admission till discharge from hospital
Measured: 28 days postoperative
Time of bowel function
Time of bowel function will be assessed
Measured: 7 days postoperative
Wound complications
Wound complications will be recorded as bleeding and infection.
Measured: 7 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Sep 2023
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End to End AnastomosisStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa fathi, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546176
- Sponsor's protocol ID
- 13/8/2023
- Status last verified
- Aug 2024
- First submitted
- 4 Aug 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between End to End Anastomosis With Omega Suture Versus End to Anterior Rectal Wall In Colorectal Anastomosis in Sigmoid and Upper Rectal Cancer
- ClinicalTrials.gov ID
- NCT06546176
- Acronym / sponsor ID
- 13/8/2023
- Conditions
- End to End Anastomosis, Colorectal Anastomosis, End to Anterior Rectal Wall, Sigmoid Cancer, Upper Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 9 Aug 2024 (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 end to end anastomosis with omega suture versus end to anterior rectal wall in colorectal anastomosis as regard post operative anastomotic leakage, bowel function, operative time and intra operative blood loss.
Detailed description
Colorectal cancer has been reported to be the 3rd most common and the second most deadly cancer world wide.
Anterior resection is the gold standard operation for both rectal and recto-sigmoid cancer with considering oncological safety maintenance to be the most important goal which can be achieved by keeping abundant resection margin and ensuring anastomotic safety, despite the technical difficulties of working in a narrow deep pelvis.
Understanding the characteristics of each anastomotic technique and establishing a stable anastomotic procedure both are pillars in anastomotic leakage prevention.
The intersection of the linear staple line and circular staple line in conventional anastomotic way is considered a risk factor for anastomotic leakage by creating stapled corners (called "dog-ears") which considered potentially ischemic and represent the area with high incidence of anastomotic leakage. Single stapled technique using ether end to end with omega suture or end to side stapled anastomosis allows avoidance of the formation of this intersection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A(end to end with Omega suture) | Other | Other: End to end with Omega sutureAfter the rectum was divided with a linear stapler, the circular stapler was placed allowing the anvil rod to penetrate the rectal stump near the linear stapler line. An omega suture including both ends of the linear stapler line was placed. The linear stapler line was approximated around the anvil rod of the circular stapler in an omega shape fashion as the omega suture was tied. This technique resulted in a complete resection of linear stapler line by the circular stapler. |
| Group B (end to anterior rectal wall) | Other | Other: End to anterior rectal wallA burse string suture was applied over the anvil of the circular stapler at the transection point of the descending colon using prolene 2/0. The circular stapler introduced though the anus and its rod directed toward the anterior rectal wall and colorectal anastomosis was performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged >18 years.
- Both sexes.
- Recto sigmoidal carcinoma.
- Upper rectal cancer.
Key exclusion criteria (5 listed)
- Patients younger than 18 years
- Recurrent or non-resectable cancer
- Complicated cancer (e.g., obstructed or perforated)
- Previous left-sided colorectal surgery or anorectal surgeries
- Lower rectal 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 |
|---|---|---|
| End to end with Omega sutureAfter the rectum was divided with a linear stapler, the circular stapler was placed allowing the anvil rod to penetrate the rectal stump near the linear stapler line. An omega suture including both ends of the linear stapler line was placed. The linear stapler line was approximated around the anvil rod of the circular stapler in an omega shape fashion as the omega suture was tied. This technique resulted in a complete resection of linear stapler line by the circular stapler. | Other | Group A(end to end with Omega suture) |
| End to anterior rectal wallA burse string suture was applied over the anvil of the circular stapler at the transection point of the descending colon using prolene 2/0. The circular stapler introduced though the anus and its rod directed toward the anterior rectal wall and colorectal anastomosis was performed. | Other | Group B (end to anterior rectal wall) |
Primary outcome
Anastomotic leakage
Time frame: 5 days after surgery
Anastomotic leakage will be measured for 5 days after surgery
4 secondary outcomes
Operative time
Time frame: Until the procedure is completed
Hospital stay
Time frame: 28 days postoperative
Time of bowel function
Time frame: 7 days postoperative
Wound complications
Time frame: 7 days postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing End to end with Omega suture and End to anterior rectal wall in people with End to End Anastomosis and Colorectal Anastomosis, run by Ain Shams 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 4 inclusion and 5 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 9 Aug 2024. 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 Asmaa F Hussein, Master (00201009376712, asmaafathi@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastomotic leakage (time frame: 5 days after surgery). 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 9 Aug 2024.