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NCT Number: NCT01269567

Drainage After Rectal Excision 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)

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU d'AMIENS, Amiens, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Rectal adenocarcinoma, histopathologically proved, with or without neoadjuvant treatment
  • 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.

Treatment and study plan

Laying and management of the drain (strictly randomized arm with drainage)

Procedure

At the end of intervention, the surgeon will position an aspiration drain in order to permit a postoperative pelvic drainage. The drain will be positioned forward sacrum, behind anastomosis. The drain will be leaved in place between 3 and 5 days. The criteria of drain ablation are the absence of haemorrhagic liquid and/or un daily debit < 100ml. Nursing care will be daily with change of bottle for collect pelvic serosity, accounting of quantity of collected liquid and realization of a dried bandage through contact with penetration of the drain.

No pelvic drainage

Procedure

no aspiration drain at the end of intervention

Primary outcomes

  1. Pelvic sepsis

    Time frame: within the first 30 days after surgery

    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.

Secondary outcomes

  1. Overall sepsis

    Time frame: up to 30 days after surgery

    Overall sepsis until 30 days (pelvic sepsis, wound abscess, urinary infection, pneumopathy, blood-poisoning)

  2. Peri-operative mortality

    Time frame: up to 30 days after surgery

    Peri-operative mortality (hospital mortality and/or until 30 days after surgery if the patient is already going out of hospital)

  3. Surgical morbidity according to Dindo classification

    Time frame: within the first 6 months after surgery

    Surgical morbidity according to Dindo classification

  4. Re-surgery during the hospitalization

    Time frame: during the hospitalization

  5. Rate of closure of stoma

    Time frame: within the first 6 months after surgery

    Rate of closure of stoma at 6 months

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: GRECCAR 5

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jan 4, 2011
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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