Conventional Versus Individual Extralvator Abdominoperineal Excision for Advanced Lower Rectal Cancer

Study Overview
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Brief Summary
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An alternative treatment for low rectal cancer is the extralevator abdominoperineal excision (ELAPE) technique. We aim to compare the outcomes of patients undergoing conventional ELAPE versus Individual ELAPE.

Detailed Description
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We suppose that the ELAPE technique may be performed according to individual conditions. For the rectal tumors suitable for ELAPE, most of them were circular or nearly circular infiltrating tumors. Patients with these rectal tumors should receive full ELAPE resection. In those rectal tumors not involving the levator ani muscle, the dissection plane may continue close to the external anal sphincter and the levator ani muscle, leaving the ischioanal fat and the terminal branches of the pudendal nerve intact.If the tumor has only penetrated into 1 side of the levator ani muscle, the dissection might include the levator ani muscle and the fat of the ischioanal fossa on the side of the tumor to achieve a clear circumferential resection margin, whereas the ischioanal fat and levator ani muscle on the other side of the tumor may be left . This individual ELAPE may be as effective as conventional ELAPE while minimizing the operative trauma and the damage to the nerves of the genital organs.

Official Title
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Randomized Clinical Trial of Conventional Versus Individual Extralevator Abdominoperineal Excision for Locally Advanced Lower Rectal Cancer

Conditions
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Rectal Cancer

Intervention / Treatment
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* Procedure: conventional ELAPE
* Procedure: Individual ELAPE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Tumor within 5 cm of the anal verge or with a very narrow pelvis T3-T4 as determined by preoperative magnetic resonance imaging or endorectal ultrasonography examination or a low tumor is fixed or tethered at rectal examination Absence of distant metastases Absence of intestinal obstruction Exclusion Criteria: T1-T2 as determined by preoperative magnetic resonance imaging or endorectal ultrasonography examination With distant metastases With intestinal obstruction Pregnancy or lactation Allergic constitution to heterogeneous protein With operation contraindication

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individual ELAPE<br>Patients will receive Individual ELAPE technique | Procedure: Individual ELAPE<br>* device<br>|
| Experimental: Conventional ELAPE<br>Patients with advanced lower rectal cancer will receive conventional EALPE technique | Procedure: conventional ELAPE<br>* device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The perioperative morbidity | Sexual dysfunction,Urinary retention，Chronic perineal pain，Perineal wound infection，Urinary system infection，Pulmonary infection，Perineal seroma，Peristomal hernia，Abdominal wound infection，Perineal herniation | three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Three years survival postoperatively |  | three years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced Lower rectal cancer, Extralevator abdominoperineal excision, Circumferential resection margin, Morbidity, Survival