Completely Abdominal Approach Laparoscopic Partial Intersphincteric Resection for Rectal Cancer

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rectal Cancer
• Intervention / Treatment: Procedure: Lap partial ISR; Combination product: NCRT+Lap partial ISR

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qun Qian, M.D.; Phone Number: (+86)13517110773; Email: wb002554@whu.edu.cn

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430071
      • Zhongnan Hospital, Wuhan University
      • Contact: Qun Qian, M.D.; Phone Number: (+86)13517110773; Email: wb002554@whu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: A group; 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; A direct laparoscopic surgery with completely abdominal approach laparoscopic partial intersphincteric resection
EXPERIMENTAL: B group; 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; Preoperative radiation and chemotherapy + laparoscopic completely abdominal approach laparoscopic partial intersphincteric resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time for mobilizing the intersphincteric space	Time for mobilizing the intersphincteric space	5 years
The intactness of levator anus muscle fascia	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	The quality of specimen pathology: total mesorectal excision (TME) quality, the involvement of distal margin and circumferential margin	5 years
Intraoperative and postoperative complications	Intraoperative and postoperative complications	5 years
Local recurrence	Local recurrence	5 years

Collaborators and Investigators

• Sponsor: Zhongnan Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 19, 2020
• Primary Completion (ANTICIPATED): July 19, 2025
• Study Completion (ANTICIPATED): July 19, 2025

Study Registration Dates

• First Submitted: July 19, 2020
• First Submitted That Met QC Criteria: July 19, 2020
• First Posted (ACTUAL): July 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 19, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: ZhongnanH1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No