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Trial Title:
End to End Versus Side to End Anastomosis After Anterior Resection of Cancer Rectum
NCT ID:
NCT06311279
Condition:
Rectum Cancer
Conditions: Official terms:
Rectal Neoplasms
Conditions: Keywords:
cancer rectum
Anastomosis
End to end
side to end
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Single Group Assignment
Intervention model description:
Comparison between end to end and side to end anastomosis after anterior resection of
cancer rectum and compare the outcomes of both surgical techniques. The main outcomes
were bowel functional outcomes and QoL. Bowel functional outcomes mainly included three
indexes: stool frequency, urgency, incomplete defecation, and incontinence. The secondary
outcomes were surgical outcomes including operative time, postoperative hospital stay,
postoperative complications, reoperation, and mortality
Primary purpose:
Treatment
Masking:
Double (Participant, Outcomes Assessor)
Masking description:
randomized comparative clinical trial
Intervention:
Intervention type:
Procedure
Intervention name:
Anterior resection of Rectal cancer
Description:
Anterior resection of cancer rectum and type of anastomosis (End to end or side to end)
Arm group label:
Group A
Arm group label:
Group B
Summary:
Comparison between end to end and side to end anastomosis after anterior resection of
cancer rectum and compare the outcomes of both surgical techniques. The main outcomes
were bowel functional outcomes and QoL. Bowel functional outcomes mainly included three
indexes: stool frequency, urgency, incomplete defecation, and incontinence. The secondary
outcomes were surgical outcomes including operative time, postoperative hospital stay,
postoperative complications, reoperation, and mortality.
Detailed description:
During the past two decades, remarkable progress has been made in the treatment of rectal
cancer. The main goal of rectal surgery for malignancy is oncologic radicality in an
effort to achieve the preservation of sphincters and sexual-urinary function.The
introduction of circular stapling devices is largely responsible for their increasing
popularity and utilization. Sphincter-saving procedures associated to partial or total
mesorectal excision (TME) for the treatment of mid and distal rectal cancer have become
increasingly prevalent as their safety and efficacy have been proved. Total mesorectal
excision (TME) is the best available treatment for rectal cancer. With the advancement of
surgical techniques, the majority of patients with mid and upper rectal cancer can
undergo a sphincter-saving TME procedure. After TME, the most widely used reconstructive
technique is straight coloanal anastomosis. With the advancement of surgical technique,
the local recurrence rate after rectal cancer surgery has been decreased from 25-50% to
3-8%. Naturally, it is time to focus on how to improve bowel functional outcomes and
quality of life (QoL) for rectal cancer patients. However, because the sigmoid colon is
usually excised during surgery which decreases the storage volume of stool, there is a
common problem seriously influencing the life quality of patients, including increased
tool frequency, urgency and incontinence, which is termed as anterior resection syndrome
(ARS). About 19-56% of patients would suffer from ARS. Thus, the demand for a technique
with better functional outcomes made surgeons modify the straight anastomotic technique.
Thus, another modified anastomotic technique, side-to-end anastomosis, which has been
used since 1966, has gained attention. Side-to-end anastomosis usually needs a 3-5
cm-long colonic segment. Multiple studies on the literature have shown that compared with
straight anastomosis, side-to-end anastomosis has advantages in bowel functional and
operative outcomes.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 18 years of age to 80 years.
- Laparoscopic or open anterior resection of cancer rectum.
Exclusion Criteria:
- synchronous colorectal carcinoma
- emergency surgery
- history of colon or rectal segmental resections
- fixed rectal carcinoma who received preoperative radiotherapy
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sohag university
Address:
City:
Sohag
Zip:
82511
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Nabil A Al-Ameer, MD
Phone:
1118416290
Email:
Nabil.abdelnaser@med.sohag.edu.eg
Contact backup:
Last name:
Ahmed G Hassanein, MD
Phone:
1552538300
Phone ext:
0020
Email:
ethics@med.sohag.edu.eg
Start date:
March 5, 2024
Completion date:
March 20, 2025
Lead sponsor:
Agency:
Sohag University
Agency class:
Other
Source:
Sohag University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06311279