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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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].

  1. 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.

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 groups in NCT04694521
Study groupRoleWhat they receive
antegrade colorectal single stapler anastomosisExperimentalopen Side to end antegrade colorectal anastomosis colo rectal cancers.
Receives: Procedure: openSide to end colorectal anastomosis .
open end to end colorectal stapler anastomosisExperimentalopen 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.

  1. : 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

  2. intestinal function

    intestinal function and LAR score

    Measured: 24 months after surgery.

Secondary outcomes (1)
  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.

  1. First posted5 Jan 2021
  2. Study startSep 2016
  3. Primary completionSep 2018
  4. Study completionSep 2020

Resources

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)
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

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.

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