Gastrointestinal NeoplasmsNCT04694521
Outcomes of Side-to-end Versus End-to-end Colorectal Anastomosis in Non-emergent Sigmoid and Rectal Cancers: Randomized Controlled Clinical Trial
A study testing openSide to end colorectal anastomosis . and open end end to end stapler anastomosis in people with Gastrointestinal Neoplasms, run by Zagazig University.
Trial summary
Introduction: Cancer rectum and sigmoid is increasing nowadays. Resection and anastomosis is done laparoscopic approach with various techniques of anastomosis. Aim of this study: to compare between open side to end colorectal anastomosis versus laparoscopic end to end colorectal anastomosis in Non-emergent colo… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Neoplasms
- What is being tested?
- openSide to end colorectal anastomosis . and open end end to end stapler anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Sep 2020
- 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
- 1. colo rectum adenocarcinoma proved by biopsy and histo-pathological examination.
- 2. Only resections performed with immediate anastomosis, not under cover of stoma.
- 3. Expected R0 resection. 4. patients >18 years ,both sex 6. No previous history of stool or flatus incontinence, and clinically normal function of anal sphincter.
Who cannot join
- Patients younger than 18 years , Pregnant female.
- Inability to understand the informed consent or refuse to participate or psychiatric patients.
- Patients with recurrent cancer, Irresectable tumour, widespread loco-regional, distant metastasis ,Combination operation and Complicated cancer e.g. obstructed or perforated.
- Cases covered by proximal stoma.
- Patients with lesion <3 cm from anal verge or cancer involving anal sphincter
- preoperative chemo radiotherapy
- Previous left sided colorectal surgery or anorectal surgeries.
- -
About this study
Introduction: Cancer rectum and sigmoid is increasing nowadays. Resection and anastomosis is done laparoscopic approach with various techniques of anastomosis.
Aim of this study: to compare between open side to end colorectal anastomosis versus laparoscopic end to end colorectal anastomosis in Non-emergent colo- rectal Cancers in adults as regard anastomotic leak, intestinal function and quality of life.
Patients and Methods: Randomized controlled trial was performed on patients with Non-emergent colo rectal cancers between September 2016 and September 2018.
Read the detailed description
ICancer rectum prevalence comes next to bronchogenic and prostatic malignant neoplasms in male, but it is the second cancer in female following cancer breast. [1] despite the fact that 1,000,000 patients notably every year and mortality by thousands, yet patients that live from this cancer is surging in the last years due to both sumptuous appliance of investigation and novel intervention techniques. Over two thirds of rectal cancer patients survived 5 years. [2].
Colorectal surgery principles target to merge the fulfillment of well-balanced free margin resection with bowel, urinary and potency activities. [3]. Laparoscopic rectal surgery for cancer had a famed corner in recent surgery that besieged open approach [4]. Rectal surgery has many troubles. The most troubled complication is anastomotic leakage. The prevalence of anastomotic leakage following rectal resection and anastomosis may wave to 15% of cases with high morbidity and mortality [5].The inauguration of the stapler in rectal surgery assisted the anastomosis to be in a homogeneous design, decrease strain on the suture, speedy surgery, no intra-abdominal contamination, no intrusion of anastomotic site perfusion and narrow the prevalence of anastomotic leakage. [6]. Resection of rectum is linked to low anterior resection syndrome (LARS) that usually affects quality of life [7].
- Aim of the work, gap statement and strength of the study: During rectal cancer surgery, no conclusive path of resection and anastomosis and usually followed by the surgeons according to their experience. In the current study, we have organized a randomized clinical trial to analyze the outcomes in two groups of patients with colo rectum cancers with two different laparoscopic approaches for resection and anastomosis. The primary aim was to correlate the prevalence of anastomotic leak after both interventions. The secondary aim was to appraise intestinal functional outcome and quality of life between both groups.
Patients \& Methods:
3.1 Study design and study power: This is a prospective randomized controlled trial managed in the colorectal surgical units of our University Hospitals (solitary-center) between September 2016 to September 2018. A total of 74 patients diagnosed as colorectal cancer underwent openrectal cancer surgery. The patients were randomly labeled into two groups: Group (A): included 37 patients: open side to end colorectal anastomosis (SEA) and Group (B): included 37 patients: openend to end colorectal anastomosis (EEA). As percentage of leakage from previous paper [8] was 29% VS 5.4% so sample will be 37 in each group with power 80% and confidence level 95% would be suitable to reach statistical significance (p<0.05). It is a simple random sample with a balance. Patients were randomly allocated using a random sequence computer. Patients were randomly numbered in closed envelopes, which were opened just before accomplishing the anastomosis intraoperative. Patients were unaware to the any group until after the study. It is the role of registration office.
- Conditions
- Gastrointestinal Neoplasms
- Being tested
- openSide to end colorectal anastomosis ., open end end to end stapler anastomosis
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
openSide to end colorectal anastomosis .Procedure or surgery
open Side to end colorectal anastomosis
open end end to end stapler anastomosisProcedure or surgery
open end to end stapler anastomosis
| Study group | Role | What they receive |
|---|---|---|
| antegrade colorectal single stapler anastomosis | Experimental | open Side to end antegrade colorectal anastomosis colo rectal cancers. Receives: Procedure: openSide to end colorectal anastomosis . |
| open end to end colorectal stapler anastomosis | Experimental | open end to end colorectal single anastomosis in non-emergent colo rectal cancers. Receives: Procedure: open end end to end stapler anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
: the incidence of the anastomotic leak during hospital admission and during 30 days postoperative.
: the incidence of the anastomotic leak during hospital admission and during 30 days postoperative.
Measured: 30 days
intestinal function
intestinal function and LAR score
Measured: 24 months after surgery.
Secondary outcomes (1)
the overall postoperative morbidities
the overall postoperative morbidities by clavien-dindo classification
Measured: within 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study startSep 2016
- Primary completionSep 2018
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tamer Alsaied Alnaimy, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694521
- Sponsor's protocol ID
- zagazig university 2
- Status last verified
- Sep 2022
- First submitted
- 30 Dec 2020
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Side-to-end Versus End-to-end Colorectal Anastomosis in Non-emergent Sigmoid and Rectal Cancers: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04694521
- Acronym / sponsor ID
- zagazig university 2
- Conditions
- Gastrointestinal Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- Sep 2016 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 5 Jan 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.
Introduction: Cancer rectum and sigmoid is increasing nowadays. Resection and anastomosis is done laparoscopic approach with various techniques of anastomosis.
Aim of this study: to compare between open side to end colorectal anastomosis versus laparoscopic end to end colorectal anastomosis in Non-emergent colo- rectal Cancers in adults as regard anastomotic leak, intestinal function and quality of life.
Patients and Methods: Randomized controlled trial was performed on patients with Non-emergent colo rectal cancers between September 2016 and September 2018.
Detailed description
ICancer rectum prevalence comes next to bronchogenic and prostatic malignant neoplasms in male, but it is the second cancer in female following cancer breast. [1] despite the fact that 1,000,000 patients notably every year and mortality by thousands, yet patients that live from this cancer is surging in the last years due to both sumptuous appliance of investigation and novel intervention techniques. Over two thirds of rectal cancer patients survived 5 years. [2].
Colorectal surgery principles target to merge the fulfillment of well-balanced free margin resection with bowel, urinary and potency activities. [3]. Laparoscopic rectal surgery for cancer had a famed corner in recent surgery that besieged open approach [4]. Rectal surgery has many troubles. The most troubled complication is anastomotic leakage. The prevalence of anastomotic leakage following rectal resection and anastomosis may wave to 15% of cases with high morbidity and mortality [5].The inauguration of the stapler in rectal surgery assisted the anastomosis to be in a homogeneous design, decrease strain on the suture, speedy surgery, no intra-abdominal contamination, no intrusion of anastomotic site perfusion and narrow the prevalence of anastomotic leakage. [6]. Resection of rectum is linked to low anterior resection syndrome (LARS) that usually affects quality of life [7].
- Aim of the work, gap statement and strength of the study: During rectal cancer surgery, no conclusive path of resection and anastomosis and usually followed by the surgeons according to their experience. In the current study, we have organized a randomized clinical trial to analyze the outcomes in two groups of patients with colo rectum cancers with two different laparoscopic approaches for resection and anastomosis. The primary aim was to correlate the prevalence of anastomotic leak after both interventions. The secondary aim was to appraise intestinal functional outcome and quality of life between both groups.
Patients \& Methods:
3.1 Study design and study power: This is a prospective randomized controlled trial managed in the colorectal surgical units of our University Hospitals (solitary-center) between September 2016 to September 2018. A total of 74 patients diagnosed as colorectal cancer underwent openrectal cancer surgery. The patients were randomly labeled into two groups: Group (A): included 37 patients: open side to end colorectal anastomosis (SEA) and Group (B): included 37 patients: openend to end colorectal anastomosis (EEA). As percentage of leakage from previous paper [8] was 29% VS 5.4% so sample will be 37 in each group with power 80% and confidence level 95% would be suitable to reach statistical significance (p<0.05). It is a simple random sample with a balance. Patients were randomly allocated using a random sequence computer. Patients were randomly numbered in closed envelopes, which were opened just before accomplishing the anastomosis intraoperative. Patients were unaware to the any group until after the study. It is the role of registration office.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| antegrade colorectal single stapler anastomosis | Experimental | Procedure: openSide to end colorectal anastomosis .open Side to end antegrade colorectal anastomosis colo rectal cancers. |
| open end to end colorectal stapler anastomosis | Experimental | Procedure: open end end to end stapler anastomosisopen end to end colorectal single anastomosis in non-emergent colo rectal cancers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. colo rectum adenocarcinoma proved by biopsy and histo-pathological examination.
- 2. Only resections performed with immediate anastomosis, not under cover of stoma.
- 3. Expected R0 resection. 4. patients >18 years ,both sex 6. No previous history of stool or flatus incontinence, and clinically normal function of anal sphincter.
Key exclusion criteria (8 listed)
- Patients younger than 18 years , Pregnant female.
- Inability to understand the informed consent or refuse to participate or psychiatric patients.
- Patients with recurrent cancer, Irresectable tumour, widespread loco-regional, distant metastasis ,Combination operation and Complicated cancer e.g. obstructed or perforated.
- Cases covered by proximal stoma.
- Patients with lesion <3 cm from anal verge or cancer involving anal sphincter
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 |
|---|---|---|
| openSide to end colorectal anastomosis .open Side to end colorectal anastomosis | Procedure or surgery | antegrade colorectal single stapler anastomosis |
| open end end to end stapler anastomosisopen end to end stapler anastomosis | Procedure or surgery | open end to end colorectal stapler anastomosis |
Primary outcome
: the incidence of the anastomotic leak during hospital admission and during 30 days postoperative.
Time frame: 30 days
: the incidence of the anastomotic leak during hospital admission and during 30 days postoperative.
intestinal function
Time frame: 24 months after surgery.
intestinal function and LAR score
1 secondary outcome
the overall postoperative morbidities
Time frame: within 90 days
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 7 Sep 2022.
- Individual participant dataSharing planned: No
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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.
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 openSide to end colorectal anastomosis . and open end end to end stapler anastomosis in people with Gastrointestinal Neoplasms, run by Zagazig 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 3 inclusion and 8 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 7 Sep 2022. 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 the anastomotic leak during hospital admission and during 30 days postoperative. (time frame: 30 days). The study lists 2 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 7 Sep 2022.