Prospective Multicenter Randomized Controlled Trial On Two-Stage Turnbull-Cutait Coloanal Anastomosis For Rectal (TURNBULL-BCN)

Catalan Institute of Health

Status: Unknown

Conditions: Rectal Neoplasm

Treatments: Procedure: Two staged Turnbull-Cutait procedure; Procedure: Hand-sewn coloanal anastomosis; Procedure: Ultralow anterior rectal resection with total mesorectal excision

Study type: Interventional

Funder types: Other

Identifiers

NCT01766661

PR174/11 (Other Identifier)

TURNBULL-BCN-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 92 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 2 patient groups

Coloanal anastomosis with ileostomy

Active Comparator group

Description:

Hand-sewn coloanal anastomosis protected by a loop ileostomy

Treatment:

Procedure: Hand-sewn coloanal anastomosis

Procedure: Ultralow anterior rectal resection with total mesorectal excision

Two stage Turnbull-Cutait anastomosis

Experimental group

Description:

Two staged coloanal anastomosis without protective ileostomy (Turnbull-Cutait procedure).

Treatment:

Procedure: Ultralow anterior rectal resection with total mesorectal excision

Procedure: Two staged Turnbull-Cutait procedure