Randomized Clinical Trial of Conventional Versus Individual Extralevator Abdominoperineal Excision for Locally Advanced Lower Rectal Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rectal Cancer
- Sponsor
- Beijing Chao Yang Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- The perioperative morbidity
- Last Updated
- 12 years ago
Overview
Brief Summary
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
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.
Investigators
Zhen Jun Wang
Professor
Beijing Chao Yang Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
The perioperative morbidity
Time Frame: three years
Sexual dysfunction,Urinary retention，Chronic perineal pain，Perineal wound infection，Urinary system infection，Pulmonary infection，Perineal seroma，Peristomal hernia，Abdominal wound infection，Perineal herniation
Secondary Outcomes
- Three years survival postoperatively(three years)