Prospective Multicenter Randomized Controlled Trial On Two-Stage Turnbull-Cutait Coloanal Anastomosis For Rectal

Study Overview
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Brief Summary
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The aim of this study is to decrease the morbidity by 30% using the Turnbull-Cutait procedure in comparison to the standard surgery for low rectal cancer. The investigators compare quality of life, faecal incontinence and recurrence of neoplasm in patients who received standard colo-anal anastomosis with protective ileostomy or two-staged Turnbull-Cutait colo-anal anastomosis after Low Anterior Resection for rectal cancer.

Detailed Description
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Anastomotic leak represents the most frequent complication after rectal cancer surgery and a lateral covering ileostomy is usually performed to reduce its incidence. Other important consequences of rectal cancer surgery are alterations in bowel habits and function and a negative impact on quality of life. This prospective, randomized, multicenter and controlled trial compares post-operative complications, quality of life, faecal incontinence and recurrence rate in patients treated for low rectal cancer with colo-anal anastomosis protected by a lateral ileostomy or with a two-staged Turnbull-Cutait colo-anal anastomosis.

Official Title
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Prospective Multicenter Randomized Controlled Trial Comparing Postoperative Complications and Quality of Life in Low Rectal Cancer Surgery Between Coloanal Anastomosis and Lateral Ileostomy Versus Two-Stage Turnbull-Cutait Coloanal Anastomosis

Conditions
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Rectal Neoplasm

Intervention / Treatment
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* Procedure: Hand-sewn coloanal anastomosis
* Procedure: Two staged Turnbull-Cutait procedure
* Procedure: Ultralow anterior rectal resection with total mesorectal excision


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with adenocarcinoma of the lower-middle third of the rectum proctoscopy established by rigid proctoscopy, with histological confirmation and candidates of colo-anal anastomosis; Patients over 18 years and under 75 years, who can tolerate neoadjuvant and surgical treatment; Patients who undergo an ultra-low anterior rectal resection with total mesorectal excision and nerve and sphincter-sparing with curative intention Any extension of the primary tumor (T 1-2-3-4) according to the TNM classification; Patients with or without lymph node metastasis (N - / +) and with or without resectable distant metastases; Patients clinically without fecal incontinence prior to the current illness and with a Wexner incontinence Score less than or equal to 5; Patients ASA I, II or III and adequate hematological, renal and hepatic function; Patients who signed informed consent. Exclusion Criteria: Altered cognitive state(eg mental retardation or dementia) that prevents collaboration in the study or patients who can neither read nor write Fecal incontinence (Wexner equal to or greater than 6); Previous surgery or proctological, colonic and anorectal functional disease Diagnosis of synchronous colorectal or any other active neoplasm; Patients ASA IV, V; Pregnancy and lactation; Rejection of the patient to sign the consent form.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Coloanal anastomosis with ileostomy<br>Hand-sewn coloanal anastomosis protected by a loop ileostomy | Procedure: Hand-sewn coloanal anastomosis<br>* After low anterior rectal resection due to low rectal neoplasm patients undergo intestinal reconstructions as hand-sewn coloanal anastomosis with protective loop ileostomy.<br>Procedure: Ultralow anterior rectal resection with total mesorectal excision<br>* Standard ultralow anterior rectal resection with total mesorectal excision<br>|
| Experimental: Two stage Turnbull-Cutait anastomosis<br>Two staged coloanal anastomosis without protective ileostomy (Turnbull-Cutait procedure). | Procedure: Two staged Turnbull-Cutait procedure<br>* After low anterior rectal resection due to low rectal neoplasm patients undergo intestinal reconstructions as two staged Turnbull-Cutait procedure anastomosis without protective ileostomy.<br>Procedure: Ultralow anterior rectal resection with total mesorectal excision<br>* Standard ultralow anterior rectal resection with total mesorectal excision<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-operative morbidity |  | within the first 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | by COREFO questionnaire. | 3 years | 
| Fecal incontinence | by Wexner Incontinence Score | 3 years | 
| local and/or distant recurrence of neoplasm |  | 3 years |