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

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.

Sex

All

Minimum age

18 Years

Maximum age

74 Years

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.

• DERIVEDBiondo S, Barrios O, Trenti L, Espin E, Bianco F, Falato A, De Franciscis S, Solis A, Kreisler E; TURNBULL-BCN Study Group. Long-Term Results of 2-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis for Low Rectal Cancer: A Randomized Clinical Trial. JAMA Surg. 2024 Sep 1;159(9):990-996. doi: 10.1001/jamasurg.2024.2262. PMID 38985480
• DERIVEDBiondo S, Trenti L, Espin E, Bianco F, Barrios O, Falato A, De Franciscis S, Solis A, Kreisler E; TURNBULL-BCN Study Group. Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis for Low Rectal Cancer: A Randomized Clinical Trial. JAMA Surg. 2020 Aug 1;155(8):e201625. doi: 10.1001/jamasurg.2020.1625. Epub 2020 Aug 19. PMID 32492131
• DERIVEDBiondo S, Trenti L, Galvez A, Espin-Basany E, Bianco F, Romano G, Kreisler E; Turnbull-BCN study group. Two-stage Turnbull-Cutait pull-through coloanal anastomosis versus coloanal anastomosis with protective loop ileostomy for low rectal cancer. Protocol for a randomized controlled trial (Turnbull-BCN). Int J Colorectal Dis. 2017 Sep;32(9):1357-1362. doi: 10.1007/s00384-017-2842-4. Epub 2017 Jun 30. PMID 28667499