Clinical trial NCT04481659: Completely Abdominal Approach Laparoscopic Partial Intersphincteric Resection for Rectal Cancer
Official title: Completely Abdominal Approach Laparoscopic Partial Intersphincteric Resection for Rectal Cancer: A Non-randomized, Prospective, Single-center Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rectal Cancer
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
First posted: 2020-07-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The conventional intersphincteric resection (ISR) for low rectal cancer requires a combined abdominal and perineal approach, and followed with a handsewn coloanal anastomosis, which is time consuming and difficult to accomplish. A complete laparoscopic abdominal approach partial intersphincteric resection has been proved to be a safe and feasible alternative for low rectal cancer treatment, with the advantages of technical convenience and avoiding a permanent ostomy. But there are few reports concerning differences in clinical outcomes between patients with or without neoadjuvant chemoradiotherapy undergoing partial ISR surgery. Therefore, it is necessary to compare the functional outcomes (including anal and sexual function, and postoperative quality of life \[QOL\]) and oncologic outcomes of patients who underwent completely abdominal approach laparoscopic partial ISR surgery after neoadjuvant chemoradiotherapy, with those who received ISR surgery directly. Furthermore, the operation difficulty between the above two groups is also worthy of intensive study.

Detailed description: Patients with cT1 to cT2 low rectal cancer are directly operated through completely abdominal approach laparoscopic partial ISR surgery. Patients with cT3 low rectal cancer are firstly treated with standard neoadjuvant chemoradiotherapy until down staged to ycT1 to ycT2. The postoperatively functional outcomes and oncologic outcomes between the two groups are compared, including anal and sexual function, QOL and local recurrence rate. The operation difficulty between the above two groups is also investigated, including operation time, the intraoperative and postoperative complications, mesorectum integrity, time for mobilizing the intersphincteric plane, the intactness of the fascia of the levator ani muscle, pubis coccygeus, puborectalis, and external sphincter.

Eligibility criteria: Inclusion Criteria:

* Biopsy-proven moderate or well differentiated adenocarcinoma
* Rullier classification of low rectal cancer (types Ⅱ: juxta-anal tumor)
* Clinical staging: initially staged as T1 -2 or down staged to T1-2 after neoadjuvant chemoradiotherapy;

Exclusion Criteria:

* Without signing informed consent, poor compliance
* Unfit for laparoscopy
* Other serious diseases not suitable for participating in this clinical trial
* A degree of preoperative fecal incontinence
* After preoperative neoadjuvant chemoradiotherapy, the sphincter function, sexual function and others involved in this trail are seriously affected

Primary outcomes:
measure: The damage degree of anal function
timeFrame: 5 years
Secondary outcomes:
measure: Time for mobilizing the intersphincteric space
timeFrame: 5 years
measure: The intactness of levator anus muscle fascia
timeFrame: 5 years
measure: he quality of specimen pathology: total mesorectal excision (TME) quality, the involvement of distal margin and circumferential margin
timeFrame: 5 years
measure: Intraoperative and postoperative complications
timeFrame: 5 years
measure: Local recurrence
timeFrame: 5 years
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan Hospital, Wuhan University
state: Hubei
Study officials:
References: