Completely Abdominal Approach Laparoscopic Partial Intersphincteric Resection for Rectal Cancer

Rectal Cancer Clinical Trial

Official title:

Completely Abdominal Approach Laparoscopic Partial Intersphincteric Resection for Rectal Cancer: A Non-randomized, Prospective, Single-center Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04481659
• Other study ID #: ZhongnanH1
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 19, 2020
• Est. completion date: July 19, 2025

Study information

• Verified date: July 2020
• Source: Zhongnan Hospital
• Contact: Qun Qian, M.D.
• Phone: (+86)13517110773
• Email: wb002554[@]whu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 19, 2025
• Est. primary completion date: July 19, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Biopsy-proven moderate or well differentiated adenocarcinoma

• Rullier classification of low rectal cancer (types ?: 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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• Lap partial ISR
A direct laparoscopic surgery with completely abdominal approach laparoscopic partial intersphincteric resection

Combination Product:
• NCRT+Lap partial ISR
Preoperative radiation and chemotherapy + laparoscopic completely abdominal approach laparoscopic partial intersphincteric resection

Locations

Country	Name	City	State
China	Zhongnan Hospital, Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Zhongnan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The damage degree of anal function	The value of this index in group A was defined as the preoperative anal function score minus the postoperative anal score. The value of this index in group B was defined as the anal function score which the patients have completed the standard neoadjuvant therapy minus the postoperative anal function score.	5 years
Secondary	Time for mobilizing the intersphincteric space	Time for mobilizing the intersphincteric space	5 years
Secondary	The intactness of levator anus muscle fascia	The intactness of levator anus muscle fascia	5 years
Secondary	he quality of specimen pathology: total mesorectal excision (TME) quality, the involvement of distal margin and circumferential margin	The quality of specimen pathology: total mesorectal excision (TME) quality, the involvement of distal margin and circumferential margin	5 years
Secondary	Intraoperative and postoperative complications	Intraoperative and postoperative complications	5 years
Secondary	Local recurrence	Local recurrence	5 years