Laparoscopic Anterior Resection With or Without "Dog Ear" Double-stapled Anastomosis for Rectal Cancer

Fujian Medical University

Status and phase: Unknown; Phase 3

Conditions: Laparoscopy; Rectal Carcinoma; Anastomotic Leak

Treatments: Procedure: with "Dog Ear" group; Procedure: without "Dog Ear" group

Study type: Interventional

Funder types: Other

Identifiers

NCT02770911

FJMU-20160424

Details and patient eligibility

About

The study evaluates the feasibility and advantage of modified laparoscopic double-staple anastomosis technique which to eliminate the 'dog ears' in laparoscopic rectal anterior resection.

Full description

Laparoscopic surgeons commonly make rectal transection intracorporeally by laparoscopic linear stapler during rectal anterior resection and perform an end-to-end anastomosis by circular stapler. But the so-called 'dog ears', two stapled corners of the rectal stump after laparoscopic linear transection of rectum, are very common. The lateral intersections of double-stapled anastomoses are structural weak spot area, and they are considered to be the potential ischemic areas leading to anastomosis leakage and the possible sites occurring local recurrence. Previous study reported a modified technique for rectal reconstruction during open surgery, and they could use circular stapler to eliminate the staple line on the rectal stump and cut off the 'dog ears'. But because of the narrow pelvic cavity, it is very difficult to perform this technique in laparoscopic rectal surgery and there is no related report on laparoscopic application. In this study, we evaluates the feasibility and advantage of modified laparoscopic double-staple anastomosis technique, to eliminate the "dog ears" in laparoscopic rectal anterior resection by laparoscopic suturing on the staple line.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Eligibility rule of enrollment
• Rectal adenocarcinoma above the peritoneal reflection
• at least 18 years old & at most 80 years old
• Clinically diagnosed cT1-T4aN0-2 disease
• no contraindication to laparoscopic surgery
• without other malignancies in medical history

Exclusion criteria

• concurrent or previous diagnosis of invasive cancer within 5 years
• locally advanced cancers requiring en bloc multivisceral resection
• intestinal obstruction
• intestinal perforation
• American Society of Anesthesiologists(ASA) class 4 or 5
• pregnant or breast-feeding women
• history of mental disorder
• participation in another rectal cancer clinical trial relating to surgical technique

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

without "Dog Ear" group

Experimental group

Description:

Before anastomosis, the surgeon made a laparoscopic suturing on the two dog ears by using 3-0 monofilament sutures, and pull two dogears of staple line around the trocar by a tied suture through two dog ears. By this way, the staple line was kept within the circular knife when the circular stapler was closed. Then a true end-to-end anastomosis was performed after stapler firing.

Treatment:

Procedure: without "Dog Ear" group

with "Dog Ear" group

Active Comparator group

Description:

traditional double-stapled anastomosis was used for laparoscopic anterior resection

Treatment:

Procedure: with "Dog Ear" group