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Randomized Trial Comparing Drainage Versus no Drainage Following Rectal Excision With Low Anastomosis for Rectal Cancer

Phase 3
18 Years
Open (Enrolling)
Rectal Cancer Surgery, Randomized Clinical Trial, Multicenter Study, Pelvic Drainage

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Trial Information

Randomized Trial Comparing Drainage Versus no Drainage Following Rectal Excision With Low Anastomosis for Rectal Cancer

After rectal excision, the rate of anastomotic leak and abscess is higher than after colic
surgery. In order to limit and avoid the risk of pelvic sepsis after rectal excision, a
prophylactic pelvic drainage is usually used. If current data have confirmed the uselessness
of drainage in colic surgery, the question stay in abeyance in rectal surgery. This practice
had never been evaluated in patients with rectal excision and low anastomosis (patients with
a high risk of pelvic sepsis) The aim of the study is to assess the impact of pelvic
drainage vs. non pelvic drainage on risk of pelvic sepsis after rectal excision for cancer
with infraperitoneal anastomosis. The principal objective is to compare the rate of pelvic
sepsis until 30 days between the 2 groups of patients who had a rectal excision with and
without pelvic drainage. It is a randomized clinical trial of superiority, multicentric,
without blinding, in 2 parallel groups with ratio (1:1): distribution of the number of
patients in the groups.

Inclusion Criteria:

- Rectal adenocarcinoma, histopathologically proved, with or without neoadjuvant

- Stapler or manual infraperitoneal anastomosis

- With or without stoma

- With bowel preparation

- Open or laparoscopic approach

- Stage T1-T4 Nx Mx

- Age 18 years old or older

- Information of the patient and signature of informed consent

- Affiliation to a regime of social insurance

Exclusion Criteria:

- Colonic cancer (> 15 cm from anal verge)

- Abdominoperineal resection

- Associated resection (prostate, seminal bladder, vagina…)

- Simultaneous liver resection

- Total coloproctectomy

- Emergency

- Infected rectal tumour

- Pregnant women, suitable to be, or current suckling

- Persons deprived of freedom or under guardianship

- Persons under protection of justice

- Impossibility to accept the medical follow-up of the study for geographic , social or
psychic reasons.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Pelvic sepsis

Outcome Description:

Pelvic sepsis until 30 days after rectal excision is the primary end point. It is defined as the occurrence of an anastomotic leak revealed by peritonitis or discharge of gas, stools or pus, the vagina or the abdominal wound, and/or a pelvic abscess, between J0 and J30.

Outcome Time Frame:

within the first 30 days after surgery

Safety Issue:


Principal Investigator

Adélaïde Doussau, Dr

Investigator Role:

Study Chair

Investigator Affiliation:

University Hospital, Bordeaux


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

CHUBX 2010/24



Start Date:

January 2011

Completion Date:

December 2013

Related Keywords:

  • Rectal Cancer Surgery
  • Randomized Clinical Trial
  • Multicenter Study
  • Pelvic Drainage
  • RectalNeoplasms
  • Colorectal Neoplasms
  • Intestinal Neoplasms
  • Gastrointestinal Neoplasms
  • Digestive System Neoplasms
  • Neoplasms by Site
  • Digestive System Diseases
  • Gastrointestinal Diseases
  • Intestinal Diseases
  • Rectal Diseases
  • Rectal Neoplasms