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

F

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)

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

Trial contacts and locations

0

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Central trial contact

Guo-xian Guan, MD,PhD

Data sourced from clinicaltrials.gov

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