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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2022-02-28

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.

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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.

Conditions

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Rectal Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Coloanal anastomosis with ileostomy

Hand-sewn coloanal anastomosis protected by a loop ileostomy

Group Type ACTIVE_COMPARATOR

Hand-sewn coloanal anastomosis

Intervention Type PROCEDURE

After low anterior rectal resection due to low rectal neoplasm patients undergo intestinal reconstructions as hand-sewn coloanal anastomosis with protective loop ileostomy.

Ultralow anterior rectal resection with total mesorectal excision

Intervention Type PROCEDURE

Standard ultralow anterior rectal resection with total mesorectal excision

Two stage Turnbull-Cutait anastomosis

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

Group Type EXPERIMENTAL

Two staged Turnbull-Cutait procedure

Intervention Type PROCEDURE

After low anterior rectal resection due to low rectal neoplasm patients undergo intestinal reconstructions as two staged Turnbull-Cutait procedure anastomosis without protective ileostomy.

Ultralow anterior rectal resection with total mesorectal excision

Intervention Type PROCEDURE

Standard ultralow anterior rectal resection with total mesorectal excision

Interventions

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Hand-sewn coloanal anastomosis

After low anterior rectal resection due to low rectal neoplasm patients undergo intestinal reconstructions as hand-sewn coloanal anastomosis with protective loop ileostomy.

Intervention Type PROCEDURE

Two staged Turnbull-Cutait procedure

After low anterior rectal resection due to low rectal neoplasm patients undergo intestinal reconstructions as two staged Turnbull-Cutait procedure anastomosis without protective ileostomy.

Intervention Type PROCEDURE

Ultralow anterior rectal resection with total mesorectal excision

Standard ultralow anterior rectal resection with total mesorectal excision

Intervention Type PROCEDURE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No