openSide to end colorectal anastomosis .
Procedureopen Side to end colorectal anastomosis
NCT Number: NCT04694521
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
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].
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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open Side to end colorectal anastomosis
open end to end stapler anastomosis
Time frame: 30 days
: the incidence of the anastomotic leak during hospital admission and during 30 days postoperative.
Time frame: 24 months after surgery.
intestinal function and LAR score
Time frame: within 90 days
the overall postoperative morbidities by clavien-dindo classification
Zagazig University
Other Gov
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