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Conventional Versus Individual Extralvator Abdominoperineal Excision for Advanced Lower Rectal Cancer

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02036112
Acronym
ELAPE
Enrollment
60
Registered
2014-01-14
Start date
2013-08-31
Completion date
2016-08-31
Last updated
2014-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Keywords

Advanced Lower rectal cancer, Extralevator abdominoperineal excision, Circumferential resection margin, Morbidity, Survival

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.

Interventions

PROCEDUREconventional ELAPE

device

PROCEDUREIndividual ELAPE

device

Sponsors

Beijing Chao Yang Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The perioperative morbiditythree yearsSexual dysfunction,Urinary retention,Chronic perineal pain,Perineal wound infection,Urinary system infection,Pulmonary infection,Perineal seroma,Peristomal hernia,Abdominal wound infection,Perineal herniation

Secondary

MeasureTime frame
Three years survival postoperativelythree years

Other

MeasureTime frame
Three years local recurrence postoperativelythree years

Countries

China

Contacts

Primary ContactJiagang Han, Professor
hjg211@163.com8613522867841

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026