Completely Abdominal Approach Laparoscopic Partial Intersphincteric Resection for Rectal Cancer

NCT04481659 | Unknown

• 1 other identifier: ZhongnanH1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Time for mobilizing the intersphincteric space

  5 years

• The intactness of levator anus muscle fascia

  5 years

• he quality of specimen pathology: total mesorectal excision (TME) quality, the involvement of distal margin and circumferential margin

  5 years

• Intraoperative and postoperative complications

  5 years

• Local recurrence

  5 years

Study Arms (2)

A group

EXPERIMENTAL

Patients who are initially staged as T1-2, according to MRI and intraluminal ultrasound, are assigned to the direct surgery group (determined by the multidisciplnary team \[MDT\] group)

Procedure: Lap partial ISR

B group

EXPERIMENTAL

Patients who are initially staged as T3M0, according to MRI and intraluminal ultrasound, should undertake preoperative chemoradiotherapy (determined by the MDT group). The operation was performed 8-12 weeks after the end of the chemoradiotherapy.

Combination Product: NCRT+Lap partial ISR

Interventions

Lap partial ISR PROCEDURE

A direct laparoscopic surgery with completely abdominal approach laparoscopic partial intersphincteric resection

A group

NCRT+Lap partial ISR COMBINATION_PRODUCT

Preoperative radiation and chemotherapy + laparoscopic completely abdominal approach laparoscopic partial intersphincteric resection

B group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhongnan Hospital: lead

Study Sites (1)

Zhongnan Hospital, Wuhan University

Wuhan, Hubei, 430071, China

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Qun Qian, M.D.

CONTACT

(+86)13517110773; wb002554@whu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2020
• First Posted: July 22, 2020
• Study Start: July 19, 2020
• Primary Completion: July 19, 2025
• Study Completion: July 19, 2025
• Last Updated: July 22, 2020

Record last verified: 2020-07

Locations

CN (1)