Clinical trial NCT04694521: Outcomes of Side-to-end Versus End-to-end Colorectal Anastomosis in Non-emergent Sigmoid and Rectal Cancers: Randomized Controlled Clinical Trial
Official title: Outcomes of Side-to-end Versus End-to-end Colorectal Anastomosis in Non-emergent Sigmoid and Rectal Cancers: Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Neoplasms
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2021-01-05
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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- 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 \[7\].

2. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

1. Patients younger than 18 years , Pregnant female.
2. Inability to understand the informed consent or refuse to participate or psychiatric patients.
3. Patients with recurrent cancer, Irresectable tumour, widespread loco-regional, distant metastasis ,Combination operation and Complicated cancer e.g. obstructed or perforated.
4. Cases covered by proximal stoma.
5. Patients with lesion \<3 cm from anal verge or cancer involving anal sphincter
6. preoperative chemo radiotherapy
7. Previous left sided colorectal surgery or anorectal surgeries.

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Primary outcomes:
measure: : the incidence of the anastomotic leak during hospital admission and during 30 days postoperative.
timeFrame: 30 days
measure: intestinal function
timeFrame: 24 months after surgery.
Secondary outcomes:
measure: the overall postoperative morbidities
timeFrame: within 90 days
Other outcomes:
Locations:
Study officials:
References: